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october 2011 Volume 7, Number 10 www.drugdiscoverynews.com Global News 6 Instruments & Informatics 14 what’s inside Diagnostics19 PTH at picograms Thermo Fisher Scientific acquires Intrinsic Bioprobes to enhance workflow for biomarker research and diagnostics 28 research & development 33 Contract Research Services 39 finance.........................................................3 Markets........................................................4 Editorial/commentary..............................12 products & services................................44 facts & figures..........................................46 Taking aim at Alzheimer’s Evotec, Roche to partner on development of Alzheimer’s treatment By Kelsey Kaustinen By Lloyd Dunlap Dr. James Ladine, global director of R&D with Thermo Fisher’s lab consumables division, says there are two trends in biomarker assays for PTH—greater complexity and lower abundance. In terms of complexity, he cites PSA as an example of a “traditional marker” that is being seen as more complex than previously thought. and software creates a complete, integrated workflow for the quantitative detection of protein pth continued on page 30 HAMBURG, Germany—After tackling cancer and central nervous system diseases, longtime drug discovery partners Roche and Evotec AG are setting their sights on Alzheimer’s disease (AD). The two companies signed an exclusive worldwide agreement in early September to develop and commercialize Evotec’s MAO-B inhibitor for patients suffering from AD. “We are delighted to have Roche as our strategic partner to fight Alzheimer’s disease,” Dr. Werner Lanthaler, CEO of Evotec, said in a press release. “Their outstanding commitment to pharmaceutical innovation makes Roche the ideal partner to fight one of the biggest healthcare problems of our time.” Per the agreement, Evotec will receive an upfront payment from Roche of $10 million, and could receive devel- Digging in the dirt Researchers at the universities of Nottingham and Maastricht make headway in the use of the bacteria strain Clostridia as a way to safely and effectively deliver drugs to tumor sites dirt continued on page 38 opment and commercial milestone payments of up to $820 million as a result of the deal, in addition to tiered double-digit royalties on sales. Roche will begin studies in 2012 to demonstrate proof-of-concept, and will also ad continued on page 10 PerkinElmer acquires Caliper Life Sciences for approximately $600 million, with eye toward expansion into preclinical work and companion Dx By Amy Swinderman NOTTINGHAM, U.K.—Scientists at the U.K.’s University of Nottingham and the Netherlands’ University of Maastricht are digging deep in the fight against cancer—and they aren’t afraid to get their hands dirty. Building on decades of research into the drug delivery potential of a harmless soildwelling bacteria, the scientists recently presented evidence showing how this strain can specifically target cancerous tumors, and ultimately, be used as a vehicle to deliver drugs in frontline cancer therapy. In their recently signed Alzheimer’s disease research deal, Roche will be responsible for running and monitoring all clinical trials, and Evotec will handle clinical development. Looking beyond imaging and detection By Jeffrey Bouley WALTHAM, Mass.—PerkinElmer Inc. has its Nigel Minton, a professor of Applied Molecular Microbiology in the faculty of Medicine and Health Sciences at the University of Nottingham, and his colleagues are preparing to test in clinical trials a soil-dwelling bacteria that can specifically target cancerous tumors. According to these researchers, because the bacteria, Clostridia, cannot grow in the presence of oxygen, it may be used as a vehicle to deliver drugs to tumors without exposing healthy, oxygenated tissue to toxicity. sights set on strengthening its market position for molecular imaging and detection for human and environmental health, but is also seeking to expand into the preclinical realm, companion diagnostics and other “compelling customer solutions in a broad range of high-growth end markets.” To those ends, the company announced in caliper continued on page 16 show preview ROCHESTER, N.Y.—Thermo Fisher Scientific Inc. has enhanced its workflow for biomarker research and diagnostics by acquiring Intrinsic Bioprobes Inc. (IBI), a manuf acturer of immunoenrichment, sample-preparation tools used in quantitative mass spectrometry. Adding IBI’s consumable sample-preparation technologies to Thermo Fisher’s automated sample processing and quantitative mass spectrometry instruments Omics & Systems Biology Products like PerkinElmer’s Operetta high-content imaging system may soon be joined by Caliper’s technologies to potentially usher in a suite of tools that create the in vitro to in vivo human “bridge” for personalized medicine. The big brains Society for Neuroscience brings a wide range of perspectives to the nation’s capital with Neuroscience 2011 See page 24 FINaNCe For more information, visit www.DrugDiscoveryNews.com octobeR 2011 • Drug Discovery News 3 Series D financing round nets $13.1 million for Metabolon RESEARCH TRIANGLE PARK, N.C.— Diagnostics and services company Metabolon Inc. recently announced the closing of a Series D round of financing, one that netted the company $13.1 million. Several of the company’s existing investors took part in the financing round, including Sevin Rosen Funds, Syngenta Ventures, Fletcher Spaght, Fulcrum Financial Partners, Harris & Harris Group and Aurora Funds. Keating Capital Inc. joined the fi nancing round as a new investor. “We’re very impressed with Metabolon’s disruptive technology and commercial success. Its diagnostic portfolio is targeting disease areas where there is a significant unmet clinical need and we’re excited to become a part of the team,” Timothy J. Keating, CEO of Keating Capital, said in a press release. The company specializes in making pre-IPO investments in highgrowth companies committed to and capable of going public. According to John Ryals, presi- oncocyte secures $10 million for oncology programs ALAMEDA, Calif.—OncoCyte Corp., a majority-owned subsidiary of BioTime Inc., recently received a new round of equity financing consisting of $4 million in cash ($3 million from an outside investor and $1 million from BioTime) and $6 million of BioTime common shares. The financing will help to fund the expansion of OncoCyte’s development of novel proprietary cancer diagnostics and therapeutics. OncoCyte’s focus is the development of novel products for cancer diagnosis and treatment based on embryonic stem cell-derived technology, and through the use of its proprietary algorithms, the company has discovered and filed patent applications on more than 100 novel cancerassociated genes. “Our research has demonstrated that many of the same genes associated with the normal growth of embryonic stem cells are abnormally reactivated by cancer cells,” Dr. Joseph Wagner, CEO of OncoCyte, said in a press release. “Using this logic, we have developed a discovery platform that has already identified numerous, previously unknown cancerassociated genes. We intend to use this platform to develop novel cancer diagnostic products that will address large, unmet needs in the field of cancer detection and treatment. The near-term revenue opportunity of this product line is also a perfect complement to our ongoing stem cell-derived therapeutic development efforts.” ddn dent and CEO of Metabolon, the proceeds of the financing round “will support further growth in our Metabolytics division and ongoing development of our oncology diagnostics product portfolio.” “We are pleased by the participation of current investors in the Series D round, and are delighted to have esteemed new investor Keating Capital among our backers,” said Ryals. Among Metabolon’s offerings are its global biochemical profiling services (Metabolytics) for researchers specializing in drug safety and toxicology, bioprocess optimization and consumer products, among other areas. That technology has been utilized to identify biochemical biomarkers with development potential in a variety of clinical diagnostics, and the markers are being applied to the development of pro- prietary diagnostic tools, with prostate cancer and insulin resistance being the primary focus points. Metabolon’s oncology diagnostics product portfolio consists of nine metabolic diagnostics tests for prostate cancer, kidney cancer, bladder cancer and nephrotoxicity (damage to the kidneys) of chemotherapy drugs. On its website, the company notes that its tests “are designed to provide information that will change clinical practice by allowing physicians to choose the best course of therapy for each patient. In some cases, unnecessary surgical procedures, expensive imaging tests, and drug treatments can be avoided. Developing tests based on the unique metabolic physiology of individual patients and their tumors to guide therapy truly advances the frontiers of personalized medicine.” ddn CDAS In-Cell Kinase Service Platform Caliper Discovery Alliances & Services offers fully integrated preclinical contract research services. CDAS In-Cell KinaseScreen Assay Platform is a breakthrough service product that enables scientists to study effects of drugs on kinases of interest in a more physiological predictive cellular context. In-Cell KinaseScreen has the unique ability to differentiate Kinase Activation from Kinase Activity. This allows you to study the actual kinase effects on its direct and specific target protein. CDAS In-Cell Kinase Platform: • • • • Direct Assessment of Drug Effect Screening and Selectivity Assays Pathway Indentification and Analysis Complement to Conventional Drug Safety Data • • • • Highly Specific Multiplexable Customizable Accurate, Reliable, Reproducible Don’t Miss Our In-Cell Kinase Assay Webinar October 26, 2011 at 11 AM EST Register today at www.CaliperLS.com/CDAS or contact us directly Call Caliper Discovery Alliances & Services Today! www.CaliperLS.com/CDAS 410.712.4410 or send an e-mail to [email protected] to discuss your specific research and development needs. markets 4 Drug Discovery News • October 2011 For more information, visit www.DrugDiscoveryNews.com Pharmaceutical and biotech market indices A ccording to venture capital firm Burrill & Co., IPO activity for the month of August saw a couple U.S. companies having to seek funding outside of the United States. Renewable chemicals company EcoSynthetix went public Aug. 4, completing a $101.6 million offering on the Toronto Stock Exchange. Similarly, GI Dynamics, a medical device company that commercializes non-surgical treatments for diabetes and obesity, completed an $85 million offering on the Australian Securities Exchange on Aug. 30. Burrill & Co.’s report notes that collectively, the 13 U.S. life sciences IPOs closed in 2011 on U.S. markets had moved into negative territory by the end of the month, down an average 7.4 percent from their IPO price, a disappointing comparison to the 17.2 percent gain they realized by the end of July. The August group fell 18.9 percent, consisting of three advancers and 10 decliners. Amex Pharmaceutical Index 302.88 307.85 307.01 305.54 299.73 318.66 1195.6 1001 909.86 1025.2 1159 1065 1071.9 937.21 977.74 1058 1165 325.53 306.68 306.14 1375 1406 1386 1136 1140 1400 1385 1266 1265 1200 1229 1000 800 600 400 200 0 Source: Burrill & Co. 1043.5 300 1353 1097 350 331 1600 1510 1404 Burrill Select 335.18 317.16 Burrill Mid-Cap Biotech and Small-Cap Biotech 1056.7 1070.1 1090.7 1085 1082 1231 1159 1149 1179 1079 1126 1200 1000 250 800 200 600 150 400 100 50 200 0 0 Source: Yahoo Finance Source: Burrill & Co. Industry limps through August due to market instability By Burrill & Co. SAN FRANCISCO—According to venture capi- tal firm Burrill & Co., the volatility of the market in August caught up with several companies trying to go public this year, with almost $1.3 billion in capitalization being demolished as unstable trading activity took its toll. In fact, life sciences companies were hit harder than the broader market, IPOs in general and biotech stocks as a whole, according to the company’s latest report. While life sciences IPOs outperformed broader market indices by the end of July, they are significantly underperforming the Burrill Biotech Select Index, the Dow Jones Industrial Average, the Nasdaq Composite Index and the AMEX Biotech Index. “Investors took flight from risk in the recent market turmoil and that does not bode well for life sciences companies hoping to complete public offerings,” says G. Steven Burrill, CEO of Burrill & Co. “If the volatile market activity that characterized August persists, it could cause private life sciences companies to turn away from the IPO market and seek financing elsewhere.” There were some bright points in August, however, with personalized medicine breathing some life into the sector as Roche secured U.S. Food and Drug Administration (FDA) approval for its melanoma drug Zelboraf and Pfizer securing approval for its non-small cell lung cancer drug Xalkori. Both drugs received approval to be used in conjunction with companion diagnostics. Seattle Genetics also gained FDA approval, with the agency giving the go-ahead on Adcetris, which combines an antibody with a toxic chemotherapeutic payload. “There has been criticism of late about the slow progress in realizing the promise of personalized medicine,” says Burrill. “The recent activity, though, points to the very real changes that are underway to incorporate genomic medicine into standard practice of healthcare today.” P u b l i c Q2 sees revenue drop 1 percent for Pfizer NEW YORK—Pfizer posted a Q2 profit of $2.6 billion, up 5 percent from the same quarter last year. Overall revenue for the quarter was $17 billion, which matched analyst expectations while representing a 1 percent decrease from the same quarter in 2010. Revenue fell by $1.5 billion due to patent expirations, and by $158 million due to healthcare reform in the United States. Sales of biopharmaceuticals fell 3 percent for the quarter, dropping to $14.6 billion, with quarterly sales of Lipitor falling 8 percent to $2.6 billion as it lost patent exclusivity in both Canada and Spain last year. Effexor also faced generic competition, with sales dropping a hefty 89 percent. Analysts expect Lipitor sales to decrease by half in 2012 once generic competition reaches the United States this November. Overall sales for the quarter dropped 9 percent to $6.7 billion, though international revenues increased 5 percent to $10.3 billion. Pfizer reaffirmed its previous full-year guid- ues across the board could spur an increase in M&A activity, according to Burrill. “Big Pharma’s problems have not gone away. The need to find new sources of revenue to replace income from sales of drugs going off patent continues to fuel deal-making,” says Burrill. “With values depressed, acquirers will likely find more bargains today when they go shopping. We could see a pick-up in activity between now and year-end.” ddn The instability of the market, spurred by continuing concern over the U.S. debt ceiling debate and ongoing economic turmoil in Europe, limited capital market activity for life sciences companies, with only immunotherapeutics company Agenus completing a followon offering of only $7 million. On the whole, nearly six decliners were seen for each advancer for stocks trading over $1 in the life sciences sector in August. The depressed val- C o m pa n ance of earnings per share in the range of $2.16 to $2.26 per share. Accelrys posts revenue of $36.7 million for Q2 SAN DIEGO—Accelrys Inc. ended its second quar- ter June 30, posting non-GAAP revenue for the quarter of $36.7 million, up 86 percent from $19.8 million in the same quarter last year. NonGAAP revenue for the six months ended June 30 was $76.2 million, an 88 percent increase from last year’s revenue of $40.5 million. For the quarter, non-GAAP free cash flow was $6.9 million, up significantly from the $1.2 million posted for the same quarter in 2010. GAAP net loss was $4.5 million or $0.08 per diluted share for the second quarter, compared to a GAAP net loss of $1.6 million or $0.06 per diluted share for the same quarter in 2010. GAAP results for the quarter were affected by the business combination accounting associated with the Symyx Technologies, Inc. merger completed last July and the acquisition of y N e w s Contur Industry Holding AB and Contur Software AB this May, as well as other nonrecurring acquisition-related and restructuring costs. Ranbaxy sees 25 percent drop in profits HARYANA, India— Ranbaxy, which is majority owned by Daiichi Sankyo, reported a 25 percent drop in profits for the second quarter, with profits down to $53.7 million. Despite the decline, the company still managed to beat analyst expectations of a forecasted profit of $43.6 million. Sales for the quarter were $460.5 million, representing a 1.8 percent drop from the same quarter in 2010. Sales in Europe rose 15 percent to $80.5 million. Within the company’s domestic market, revenue increased to $107 million, up 11 percent from the same quarter last year. Revenue for the company reached $93.9 million in the United States, though growth was affected by Ranbaxy’s loss of market exclusivity on its generic version of Eisai’s Aricept, which was launched in 2010. FL_SureSelect_DDN:Layout 1 8/8/11 11:40 AM Page 1 Timely Service Quality Results Unmatched Expertise Bringing High Performance to Target Capture Fully automated Agilent SureSelect* target capture services for next generation sequencing Beckman Coulter Genomics has developed a fully automated target capture pipeline using the research-proven Agilent SureSelect system. • Process hundreds to thousands of samples • LIMS sample tracking • Enhanced sample to sample reproducibility • Flexible multiplexing options By utilizing Beckman Coulter’s innovative SPRIworks Fragment Library System and the Biomek laboratory automation platform, the conventional manual tasks associated with target capture have been eliminated. To learn more about automated target capture please visit www.beckmangenomics.com * All trademarks are property of their respective owners. Beckman Coulter, the stylized logo, Biomek and SPRIworks are registered trademarks of Beckman Coulter, Inc. Sequencing Gene Expression Genotyping Biologics Testing 6 Drug Discovery News • October 2011 b r i e f s Aurobindo and DIOD establish Russian joint venture An affinity for Graffinity ANDHRA PRADESH, India—OJSC DIOD and Aurobindo Pharma Ltd., through their respective investment holding subsidiaries, have established a Russian joint venture on a parity basis. The joint venture, Aurospharma Co., will manufacture and sell pharmaceuticals in the markets of Russia, Belarus and Kazakhstan, and will construct a state-of-the-art plant to manufacture non-penicillin and non-cephalosporin prescription generics as well as other over-thecounter drugs in Russia. Penicillins, cephalosporins and other Aurobindo therapy products will be sourced to sell in the same markets. The plant will be constructed in the Podolsk District, in the Moscow region, and is expected to be completed and reach its rated capacity near the end of 2013. Eisai and SFJ Pharma partner on Phase III studies TOKYO— Eisai Co. recently announced the establishment of a partnership with Pleasanton, Calif.-based SFJ Pharmaceuticals, a private biotechnology firm that focuses on unique development business models for pursuing regulatory approval for drugs in the Japanese market. Under the agreement, the two companies will conduct Phase III studies of Eisai’s thyroid cancer drug E7080, lenvatinib. The compound is a multi-kinase inhibitor that is under development as a molecular-targeted agent for several types of cancer, including thyroid, melanoma, glioma and endometrial cancer. The agreement is intended to accelerate late-stage development of Eisai’s pipeline and take advantage of external resources. SFJ will fund the study and will receive milestone payments from Eisai if E7080 gains regulatory approval, while Eisai will retain commercial rights to the drug. Pall Centre of Excellence debuts in Singapore PORT WASHINGTON, N.Y.—Pall Corp. recently announced the inauguration of its Pall Life Sciences Centre of Excellence in Singapore, located in Gemini Science Park II. As the latest addition to Pall’s global customer support network, it provides advanced process demonstration, validation support and training capabilities for the company’s growing base of life sciences customers in the region. The facility has 430 square meters and hosts a range of life sciences equipment and solutions, including single-use systems, Stax systems, tangential flow filtration, depth filter systems, process monitoring, chromatography systems and sterile filters, among others. Eric Garnier, president of Pall Asia, noted that “the Singapore Life Sciences Centre of Excellence consolidates training and technical services, making it unparalleled as a resource for biotechnology companies seeking solutions for their process challenges.” For more information, visit www.DrugDiscoveryNews.com NovAliX and Galapagos collaborate in osteoarthritis discovery research program By Kimberley Sirk NovAliX’s Graffinity fragment-based screening technology is suited for soluble proteins and has been successful with kinases, proteases, proteinprotein interactions and most recently with intrinsically disordered proteins that are challenging to screen with other methods. NovAliX will use Graffinity to discover specific smallmolecule lead candidates for a novel, validated osteoarthritis target chosen by Galapagos. STRASBOURG, France—NovAliX announced at the end of August it has entered into drug discovery collaboration in the field of osteoarthritis with Galapagos NV. Under the terms of the agreement, NovAliX will be responsible for the discovery of specific small-molecule lead candidates for a novel, validated osteoarthritis target chosen by its new partner. NovAliX will receive technology access fees, research funding and is eligible to receive success-based milestones from Galapagos. The partners are eyeing the European market (primarily France and Germany), but also seek to grow in Japan and the United States. NovAliX will identify hits using its Graffinity fragment-based screening technology that combines chemical microarrays with a proprietary SPR imaging method for the detection of compound-protein interactions. It will then further work toward the lead can- didate stage by applying its medicinal chemistry and structural biology expertise. The name “Graffinity” comes with some history. Graffinity was originally a company formed in 1998 funded by U.S. and European partners to pioneer the chemogenomics space combining SPR and microarrays. Built from scratch, it took a few years to bring the technology to the appropriate level. Over time, the original company took on other partners and changed its focus, but in 2005, Graffinity was re-established as a separate legal entity. The new Graffinity was then on the road to market its unique screening capability with good success, as it has since inked deals with giants in the biopharma space such as Genentech, Amgen, Rigel, Pfizer, Elan and Boehringer-Ingelheim. Company officials say the Graffinity platform is suited for soluble proteins and has been successful with kinases, proteases, protein-protein interactions and most recently with intrinsically disordered proteins (IDPs) that are challenging to graffinity continued on page 8 U.K. union has great chemistry Lilliputian meets Brobdingnagian Cresset, Redx Pharma to collaborate on drug discovery for a wide range of therapeutic areas By Kelsey Kaustinen Astellas Pharma signs a license agreement with Evec for a fully human antibody WELWYN GARDEN CITY, U.K.— By Lloyd Dunlap Drug development company Redx Pharma and Cresset, which develops software for calculating and comparing the molecular field characteristics of chemical compounds, recently announced the signing of a drug discovery collaboration. Through the agreement, Redx Pharma gains access to Cresset’s publicly available and proprietary computational chemistry technologies, which will be utilized within the company’s portfolio of drug discovery programs. Cresset will also provide consulting services in terms of candidate selection across a range of therapeutic areas and targets. SAPPORO, Japan—Evec Inc. and redx continued on page 11 Dr. Robert Scoffin, CEO of Cresset, notes that the company “has developed an extensive range of consulting services around the critical areas of library design, compound design, virtual screening and lead optimization.” Astellas Pharma Inc. have entered into a license agreement for one of Evec’s fully human antibodies against infectious diseases. Based on the agreement, Astellas has worldwide exclusive development, manufacturing and commercialization rights for the program. In return, Evec expects to receive an upfront payment of approximately $7.86 million upon signing the license agreement and milestone payments, depending on development and sales phases from Astellas, totaling up to $17 million. Astellas will also pay additional royalties associated with potential sales. The development stage of the program is preclinical. A 13-employee laboratory launched in 2003, Evec developed its own technology for producing fully human antibodies in order to circumvent U.S. and European patents, which the company claims are too expensive to license. The company says it now has a dozen patents granted or pending. The company founder and chairman, Dr. Kenza Takada, notes that “human blood teems with highly active antibodies which can never be induced by the mouse immunizing method. Evec has the unique technique to develop antibodies from human blood lymphocytes by using EpsteinBarr (EB) virus that induces B-lymphocytes to proliferate. evec continued on page 9 hyperblu_DDN:_d 7/25/11 8:56 AM Page 1 Selective picking with HyPerBlu HyPerBlu The right choice for correctly identifying the best drug candidates Introducing Lumigen HyPerBlu – a sensitive substrate for the direct chemiluminescent detection of hydrogen peroxide in the blue spectrum. HyPerBlu is a ready-to-use, one component formulation that provides outstanding stability and robustness, compared to others requiring manual mixing of four components and the need to be used within one day. With HyPerBlu, you can trust the data and be confident that you’ve picked the best choice for your high throughput screening needs. Go to LUMIGEN.com/HyPerBlu to see the light! Lumigen, the stylized logo and HyPerBlu are registered trademarks of Lumigen, Inc. Beckman Coulter is a registered trademark of Beckman Coulter, Inc. © 2011 Beckman Coulter, Inc. global news 8 Drug Discovery News • October 2011 For more information, visit www.DrugDiscoveryNews.com Small but mighty Ascenta Therapeutics licenses experimental small-molecule cancer drug candidate to Debiopharm Debiopharm says it should be possible to combine Debio 1143 with other pro-apoptotic agents, which could potentially bring huge benefits to patients by enhancing the efficiency of their treatment. By David Hutton LAUSANNE, Switzerland—Debiopharm and cancer drug firm Ascenta Therapeutics have reached an exclusive license agreement for the development and commercialization of Ascenta’s Phase I stage candidate AT-406. AT-406 is an orally available small molecule that is designed to neutralize major inhibitors of apoptosis. AT-406 was discovered in the laboratory of Dr. Shaomeng Wang at the University of Michigan. Clinical trials with AT-101 are ongoing in the United States and Europe. Phase I and Phase II trials evaluating AT-101 as single-agent therapy have already demonstrated cytoreductive activity in several cancers, including chronic lymphocytic leukemia, non-Hodgkin lymphoma and prostate cancer. Phase II trials evaluating AT-101 in combination with chemotherapy and/or radiotherapy have also been carried out in a number of cancers including hormone-refractory prostate cancer, non-small cell lung cancer, B-cell malignancies, small cell lung cancer, glioma and esophageal cancer. Debiopharm will designate the molecule Debio 1143. The molecule is designed to block the activity of a number of IAPs including XIAP, c-IAP1, c-IAP2 and ML-IAP. Dr. Rolland-Yves Mauvernay, president and founder of Debiopharm, says it should be possible to combine Debio 1143 with other proapoptotic agents, which could potentially bring huge benefits to patients by enhancing the efficiency of the treatment. Evasion of apoptosis is a hallmark of cancer, enabling cancer cells to live indefinitely and grow uncontrollably. Most current cancer therapies, including chemotherapeutic agents, radiation and immunotherapy, work by inducing apoptosis. However, because of molecular alterations in the apoptotic pathways, many cancer cells are resistant or develop resistance to these agents. A promising new direction for drug development involves targeting apoptotic pathways directly to induce cell death and/or restore sensitivity to other treatments. According to Maurice Wagner, director of corporate affairs and communications for Debiopharm Group, the timeline to develop the small-molecule IAP inhibitor may be hard to gauge at this stage, as Phase I clinical trials have yet to be completed. INTRODUCING “In any event, we will proceed as quickly as we can, whilst observing all safety standards,” he says. “As is our business model, we will not commercialize the drug ourselves, but license it out in due time to a company that can sell and market it internationally. The out-licensing partner will be selected at a later stage.” Looking forward, Wagner says as the company proceeds with development, it will set objectives to reach. “We will in particular design carefully clinical studies in cancers with high medical needs,” he explains. “Our success will depend upon whether we can reach our objectives. In the short term, successes might be related to preclinical synergistic activity of Debio 1143 and other anti-cancer agents, and most importantly, obtaining encouraging clinical data from the ongoing Phase I study. The long-term success will depend upon our findsmall continued on page 9 Your gateway to the latest oncology news, trends and resources ■ ■ ■ ■ ■ Visit: www.ddncancer.com Top cancer-related news and opinion stories Archive of all of ddn’s cancer-related news stories Interviews with key oncology leaders Links to various companies, research centers and organizations involved in the field of oncology and much more! graffinity continued from page 6 screen with other methods. “We look forward to utilizing NovAliX’s capabilities in biophysics and lead-generation methodologies for this novel target-based drug discovery program,” said Dr. Graham Dixon, senior vice president for drug discovery at Galapagos, in a prepared statement. NovAliX officials say the two companies have enjoyed a “longstanding relationship.” In part, this relationship is described as including a fee paid to Galapagos for service-based chemistry and medchem support. As for Galapagos, it will provide two things to the collaboration: an expertise in drug development, and a strong expertise in the osteoarthritis field. The company has a history in a cascade of other mergers and spin-offs that has led it to its strong current position in its field. NovAliX officials point to Galapagos’ key areas of expertise and multiple pharmaceutical alliances in the joint and bone diseases field as attractive attributes. For its part, Galapagos was described as enticed by NovAliX’s technology toolbox and trusted medchem expertise, which is revered because of past results. Stephan Jenn, president of NovAliX, says this “drug discovery collaboration with a leading European biotech confirms the quality of our technologies and science, and underlines the value of our platform as an important tool to deliver valuable lead candidates.” In key ways, the two companies differ. NovAliX is private, rather discreet and still small, yet it strives to build a company that provides external research capabilities with strong technology. The company calls its most attractive trait “integrated drug discovery,” but notes it goes beyond basic pharma because of biophysics capabilities that appeal to other industry sectors. NovAliX provides enabling chemistry and biophysical technologies to support the pharmaceutical industry’s outsourcing needs from discovery to manufacturing. With proprietary SPR technology, X-ray protein crystallography, supramolecular mass spectrometry and chemistry, NovAliX offers comprehensive integrated services for small-molecule drug discovery. With advanced NMR technologies, NovAliX also provides fine characterization of biologics, thorough analysis of APIs and polymorphism studies to support pharmaceutical development and manufacturing teams. Galapagos, in contrast, is a big, public pharmaceutical company. One NovAliX official calls Galapagos, in his words, “gold diggers,” while NovAliX “sells sieves and shovels.” The two companies’ goals are aligned as they don’t compete with each other, but their combination of capabilities complement each other. Galapagos specializes in the discovery and development of small-molecule and antibody therapies, and it is progressing one of the largest pipelines in biotech, with six programs in development and more than 50 discovery programs. ddn EDITCONNECT: E101105 global news For more information, visit www.DrugDiscoveryNews.com eVec continued from page 6 I am confident that our technique will replace the currently major one to develop antibodies using mouse, and will be the standard method of antibody development.” Most of the antibody medicines currently available are of chimeric or humanized antibody, which is a modification of mouse antibody with replacement of the mouse element. Recently, however, Evec notes that fully human antibodies containing no mouse elements are coming to the fore. Evec has devised a technique to develop fully human antibodies from B-lymphocytes, cells responsible f or antibody p roduction in humans. Evec points out on its website that humans are exposed to various antigens, from infections, for example. On each exposure, antibodyproducing lymphocytes are activated, which then remain as memory B-lymphocytes. “Our peripheral B-lymphocyte population can be considered as a library of memory B-lymphocytes expressing antibodies,” Takada says. His technique uses the EB virus to induce proliferation of B-lymphocytes and promote antibody production. In in-vitro experiments, EB virus-infected lymphocytes stably proliferate over six months, while non-infected lymphocytes die within a week or so, according to Evec. “We develop antibodies by using the EB virus activity to proliferate B lymphocytes. B-lymphocytes are separated from 10∼20 ml blood, and infected with EB virus. From the proliferated B-lymphocytes, cell clones producing the antibody of interest are separated. The clone separation is carried out by a combination of the clone culture method SMaLL continued from page 8 ing a good combination in the clinics, such as a combination that will prove therapeutically superior to the standard of care.” According to Wagner, the company has worked with Ascenta in the past few years, but this is the first time that the two companies have entered into a partnership with each other. Wagner says there were two factors that led Debiopharm to target Ascenta as a collaborator for this effort: “We saw the expertise of Ascenta in the field of apoptosis, and the quality of the relationship that we could establish with the Ascenta team,” he says. Mel Sorensen, president and CEO of Ascenta, says Debiopharm proved to be an attractive collaborator because of its commitment to and expertise in the development of medicines to help cancer patients. ddn eDitcOnnect: e101106 (repeating dilution culture) and the sorting method (selectively separating the antibody of interest with the use of FACS). After the separation, the antibody gene is cloned and transfected into CHO cells for antibody production. Namely, the EB virus is used merely as a means to isolate antibody genes from blood lymphocytes. There is no risk for contamination of the antibody with EB virus,” Takada states. The highest binding activity of the antibodies developed by mouse immunization is around 10-9M, and OctOber 2011 • Drug Discovery News “evec has the unique technique to develop antibodies from human blood lymphocytes by using epstein-barr virus that induces b-lymphocytes to proliferate. i am confident that our technique will replace the currently major one to develop antibodies using mouse, and will be the standard method of antibody development.” dr. Kenza takada, founder and chairman of evec those of the antibody medicines already in the market are much the same, says Takada. In contrast, the binding activity of Evec’s antibodies developed from blood B-lymphocytes is 10-11M, 100 times higher than that of mouse antibody, he asserts. Based in Tokyo, Astellas hopes to strengthen its pipeline in infectious diseases therapies through its collaboration with Evec. It is currently Japan’s second largest pharmaceutical company and ranks within the top 20 in the global market. Astellas Pharma U.S. Inc., the company’s U.S. affiliate, reported North American sales of $1.9 billion in 2009. The company employs 1,900 and is headquartered in Deerfield, Ill. ddn eDitcOnnect: e101107 E L E C T R O P H O R E S I S A N D B L O T T I N G // T R A N S - B LOT T U R B O Efficient protein transfers in 3 minutes. That’s transferapidly. From your trusted leader in western blotting, Bio-Rad’s new Trans-Blot® Turbo™ transfer system sets a new standard in protein transfer that is easier, more efficient, and faster than ever before. ■■ ■■ ■■ ■■ 9 Turbo Transfers — Fast, efficient, and reproducible protein transfers in as little as 3 minutes Superior Transfer Efficiency — Higher sensitivity and better transfer efficiency than other blotting techniques High Throughput — Up to 4 mini or 2 midi gels simultaneously A. Trans-Blot Turbo system 10 ng 5 ng 2.5 ng 1.25 ng B. Tank blotting 10 ng 5 ng 2.5 ng 1.25 ng System Flexibility — Can also accommodate both traditional semi-dry as well as rapid transfers To learn more, call your Bio-Rad sales representative. Sign up to learn about special offers at www.bio-rad.com/ad/turboblot. Research. Together. C. Semi-dry blotting Superior transfer efficiency. Serial dilutions of transferrin were separated on a Criterion™ TGX™ 4–20% gel and transferred using four different techniques. A, Trans-Blot Turbo system (25 V for 7 min); B, tank blotting (100 V for 30 min); C, semi-dry blotting (25 V for 30 min); D, iBlot system (P3 for 7 min). iBlot is a registered trademark of Invitrogen Corporation. To find your local sales office, visit www.bio-rad.com/contact/ In the U.S., call toll free at 1-800-4BIORAD (1-800-424-6723) D. iBlot system Visit us at www.bio-rad.com global news 10 Drug Discovery News • October 2011 Valeant ups ante in bid to nab Afexa MISSISSAUGA, Ontario—Mere hours after Paladin Labs Inc. confirmed Sept. 26 that it is increasing its offer to acquire Afexa Life Sciences Inc. to 81 cents per share, Valeant Pharmaceuticals International Inc. said it will increase its own bid to 85 cents per share from its previous offer of 71 cents per share made in August—for a total value of about $78 million. Valeant is in a bidding war with Montreal-based Paladin Labs, which launched a hostile takeover bid for Afexa in August. “We have decided to offer a premium to Paladin Labs’ most recent proposal as we are able to attribute more value than Paladin to the Afexa business given both our larger scale and resources in Canada, coupled with our extensive international consumer footprint,” said J. Michael Pearson, chairman and CEO of Valeant, in announcing the offer increase. “While we normally don’t participate in an auction process, given that our existing offer has the full support of the board and management of Afexa, we felt it was appropriate to continue to respond quickly to Paladin’s hostile overtures.” The brass ring that both Valeant and Paladin are after is over-the-counter flu remedy Cold-FX, sales for which Valeant plans to boost by marketing it in the United States and globally—particularly in Australia, Latin America and Central Europe—if it successfully acquires Edmonton-based Afexa. ddn For more information, visit www.DrugDiscoveryNews.com ad continued from page 1 assume responsibility for clinical development, manufacturing and commercialization activities. According to Lanthaler, Roche will be responsible for running and monitoring all clinical trials, and Evotec will “fully hand over the clinical development package.” “Roche is committed to bringing innovative treatments to patients suffering from devastating neurodegenerative diseases, and is developing a number of approaches to tackle Alzheimer’s,” Jean-Jacques Garaud, head of Roche Pharma Research & Early Development, said in a press release. “The addition of EVT-302 to our CNS pipeline complements other approaches we are investigating including tau- and amyloid-targeted therapies.” Evotec’s EVT-302 compound is a novel, potent inhibitor of monoamine oxidase type B (MAO-B), an enzyme known to break down dopamine in the brain and contribute to the production of free radicals. Free radicals can cause oxidative stress, which may contribute to pathogenesis of AD, as seen in the upregulation of MAO-B expression in the brains of AD patients. The use of a selective MAO-B inhibitor is targeted for the treatment of AD symptoms and can potentially slow the progression of the disease. According to the World Health Organization, AD currently affects approximately 35 million people worldwide. The disease is the most common form of dementia, in which protein plaques begin to manifest in the brain, eventually leading to the death of brain cells. Though specific genes contribute to or predispose someone to Alzheimer’s disease, no one factor has been identified as its cause. However, patients suffering from Parkinson’s disease also display dopamine shortages, which sheds some light on just how much of an impact a lack of dopamine can have on the brain. Dopamine is a neurotransmitter, and has several important Dr. Werner Lanthaler, CEO of Evotec, explains that the MAO-B inhibitor his company and Roche are developing is a stand-alone intervention that slows down the progression of AD significantly. “On a broader scale, one could see also potential combinations, where the addition of EVT-302 could complement other approaches such as tau- and/or amyloid-targeted therapies,” he adds. roles in the brain, including punishment and rewards, sleep, memory, learning and movement. Given the results of Phase I studies, which showed EVT-302 to be well tolerated and highly selective for MAO-B, Lanthaler is optimistic regarding the therapeutic potential of EVT-302. “In the best case, this is a stand-alone intervention that slows down the progression of AD significantly,” says Lanthaler. “On a broader scale, one could see also potential combinations, where the addition of EVT-302 could complement other approaches such as tau- and/or amyloid-targeted therapies.” As for whether this has the potential to become a standard early treatment measure to slow or halt the progression of Alzheimer’s, Lanthaler notes that there is “a very good rationale and already clinical data,” adding that the partners will wait to see what the final trials reveal. ddn EDITCONNECT: E101101 Evotec reports 34 percent revenue and earnings growth HAMBURG, Germany—Evotec AG recently reported a strong operational performance for the first half of 2011. Total group revenues increased by 34 percent to $45.7 million, including $5.3 million from the acquisitions of DeveloGen, Kinaxo and Compound Focus in the first half of the year. Meanwhile, R&D expenses increased by $2.3 million, mainly from the inclusion of DeveloGen and Kinaxo R&D expenses and the strategic build-up of Evotec’s beta cell franchise, CureBeta. Liquidity, including cash, cash equivalents, investments and long-term financial assets, remained strong at $73.3 million. Based on these results, Evotec raised its revenue guidance for the current fiscal year. Total group revenues are now expected to grow by approximately 30 percent, leading to revenues of $95.7 million to $98.5 million. Evotec said potential milestone achievements in the second half of the year are expected to further enhance the company’s operating financial performance, giving it a strong basis for increased operating profitability over 2010. ddn More Info @ adv-connect.com global news For more information, visit www.DrugDiscoveryNews.com redx continued from page 6 Financial terms of the agreement were not disclosed. “Cresset has developed an extensive range of consulting services around the critical areas of library design, compound design, virtual screening and lead optimization,” Dr. Robert Scoffin, CEO of Cresset, said in a press release. “In this case, we will initially be focusing our skills on helping Redx with their lead candidate selection process, whilst the collaboration also gives Redx the ability to access our expertise, in a very flexible manner, across the full range of computational drug discovery services.” According to Scoffin, Redx Pharma will be responsible for “setting overall project direction, selection of targets, synthesis of analogues and testing of molecules,” while Cresset will be responsible for evaluating the candidate molecules and determining the “most appropriate molecules to be synthesized.” This is the first time the two companies have worked together, Scoffin notes, though Cresset ran a short pilot project for Redx Pharma at the end of last year, which led to “a larger engagement in designing and evaluating candidate molecules for their various discovery projects.” “Redx has a very interesting business model and a refreshing approach to building value through a mixture of innovation and re-use of existing knowledge,” says Scoffin. “Their desire to create an efficient and mostly virtual discovery organization, featuring best-ofbreed companies in chemistry, biology and computational drug design, matched very well with our continued growth as a leading provider of outsourced drug design solutions and services.” Redx Pharma’s programs utilize several of Cresset’s chemistry tools, such as FieldTemplater to provide binding hypotheses and FieldAlign to predict likely biological similarity for sets of molecules in different lead series. The company’s Switch platform, as explained on the company’s website, “modifies existing drugs, enabling faster candidate selection and development towards clinical trials for improved, nextgeneration therapies.” Redx Pharma’s pipeline focuses on the development of new compounds in four main areas, including cardiovascular, influenza, antibiotics and neuropathic pain. “Cresset is a valuable partner in our drug discovery programs,” Dr. Neil Murray, CEO of Redx Pharma, said in a press release. “Their deep knowledge of computational chemistry and its application to drug discovery is enabling us to progress multiple projects across a wide range of target classes very quickly and cost effectively.” Cresset’s Field technology evaluates the activities and properties of October 2011 • Drug Discovery News 11 molecules based on their surface properties, rather than 2D structure similarity. The technology works to provide “views of the way in which ligands interact with proteins, to interrelate compounds from different chemical series that act at the same protein site, to find novel chemical series through virtual screening and to decode Structure Activity Relationships by comparing molecules as proteins ‘see’ them,” according to the company’s website. Scoffin says using Cresset’s technology in collaboration with Redx Pharma is a combination that will benefit both companies. “We hope to develop novel drug candidates across a very broad range of therapeutic targets which can then be put through the development process in the most appropriate manner for each target,” says Scoffin. “Cresset gain excellent knowledge and experience of a wide range of targets and molecule classes, which feeds back into the further development of our scientific and technological platforms.” ddn “In this case, we will initially be focusing our skills on helping Redx with their lead candidate selection process, whilst the collaboration also gives Redx the ability to access our expertise, in a very flexible manner, across the full range of computational drug discovery services.” Dr. Robert Scoffin, CEO of Cresset EDITCONNECT: E101108 TUNEivity [too-ni´-vı̆-teˉ] Adjective: Versatile in both flexible wavelength tuning and rapid read speeds while also achieving the highest sensitivity The breakthrough optical technology inside TUNE combines wavelength selection with up to 10x greater sensitivity than monochromator-based systems. The SpectraMax® Paradigm® system with TUNE lets you screen faster with on-the-fly detection, get increased Z-factors, and preserve valuable fluorophore. Find your TUNEivity at www.paradigm-TUNE.com/HTS/ Scan the QR code with your smartphone to TUNE in to Paradigm’s applications www.paradigm-TUNE.com/HTS/ www.moleculardevices.com For Research Use Only. Not for use in diagnostic procedures. © 2011 Molecular Devices, LLC. All Right Reserved. Molecular Devices, the Molecular Device logo, and all other trademarks are the property of Molecular Devices, LLC. 12 Drug Discovery News • October 2011 editorial For more information, visit www.DrugDiscoveryNews.com Announcing the ddn Cancer Research Portal: Your gateway to the latest oncology news, trends and resources I By Amy Swinderman n a May 2009 editorial in this publication, fresh off the American Association for Cancer Research’s 100th Annual Meeting in Denver, I shared with our readers that I had never personally known anyone who suffered from or died of cancer—despite the sobering statistics put forth by the American Cancer Society that nearly 1.5 million new cancer cases were diagnosed and more than a half million people died of cancer in the United States alone the year prior. In late 2011, this isn’t the case for me anymore. Startlingly, a little more than two years later, I now need two hands to count how many friends and colleagues have been impacted by some form of this disease … and I am quickly running out of fingers. For some of these friends and colleagues, the battle was waged uphill. For others, a cancer diagnosis was but a mild hiccup in their lives, and they quickly moved on from treatment to emerge healthier and more proactive about maintaining their health. At the same time, in the course of reviewing the past year and planning for 2012, the journalists of ddn recently took a look at how much of our news coverage involves oncology, and we were stunned to learn that in the last two years, our cancer-related news stories have doubled. Amy Swinderman, Today, cancer research ddn Chief Editor dominates nearly every section of our newspaper and other news vehicles. From diagnostics to R&D and everything in between, cancer is clearly a hot topic. That’s why we decided to launch our latest news division, the ddn Cancer Research Portal, your gateway to the latest oncology news, trends and resources. Here, on this special website, you will have immediate access to all of our cancerrelated coverage, as well as featured news and spotlights on some of the industry’s oncology leaders and links to various companies, research centers and organizations dedicated to treating— or even curing—cancer. It’s our hope that this news portal will serve as a bridge between you and the growing cancer community. In the months to come, we will be announcing special coverage that will shine a light on the various players in oncology research—from bench to bedside. Much like the I received emails exhorting me to “stop complaining and propose something.” I agree that we’re exhausted from defining the problem and it’s time to define solutions. With the election coming up in 2012, let’s go! I am disappointed in both Republicans and Democrats, often for the same reason. In an election cycle, they are like Michigan and Ohio State fans arguing before a big game. Once on the field, they play by the same rules and the proposals made beforehand quickly fade away. Candidates don’t change Washington; Washington changes them. After the inauguration, it’s quickly back to business as usual. This really matters today because time is short. My party is the Pragmatic People’s Party (PPP). Our slogan is “What works—no magic!” We have a few central fiscal themes. First, the federal government is the people, not something separate from the people. We need it for very few purposes, including shared defense, shared infrastructure (physical, electrical, environmental), international relations and regulating commerce (patents, safety). The federal government should stay far away from limiting social choices, beyond allowing those choices to be made. Second, it makes perfect sense to support these common interests with user fees and income, sales/excise and property taxes. Third, our party, unique among the others, insists that taxes should rarely, if ever, be a means to influence human behavior. Fourth, we, the PPP, also accept the principle that if you are more fortunate, you should contribute more to the common good in linear proportion to your success, not more and surely not less. Fortune consists of various combinations of luck and effort. Neither should be considered unfair. Fairness is a concept for meteorologists and elementary school students. Adults know life is unfair, and we get over it. Our platform specifically rejects the idea that taxes should appear to accelerate with success and then be countered with incentives and then countered again (alternative minimum tax) when those special incentives are perceived by some to be used too Peter T. Kissinger, much. Huh? This is a CEO, Prosolia riddle wrapped in a mystery inside an enigma. Speaking of Churchill, we agree “that for a nation to try to tax itself into prosperity is like a man standing in a bucket and trying to lift himself up by the handle.” It’s time to trim the rose bushes at the Internal Revenue Service. Its complexities are a large drain on our productivity as a nation. Some calculate that it costs 30 percent of tax revenues collected to both calculate what is due and then scheme to find ways to avoid it. That’s more than $400 billion annually, a great potential source for United Way, your local symphony or even my life science startup. Fifth, our party opposes corporate income tax and the corporate component of social welfare taxes. These indirect tax channels from individuals (employees, shareholders, customers) provide opportunity for political and business shenanigans that are not transparent. Following this tenet, life science companies will not be arguing for R&D tax credits. Depreciation rates need not be different for taxes versus book accounting. There will be no credit unions. There will be no income tax preferences for drilling for oil or building a plant in a special real estate zone. Real estate and property tax abatement are development tools that would remain for local government. No company will be motivated to hide cash overseas for tax reasons. All organizations should be profitable Publisher Bruce Poorman Associate Publisher Laurence Doyle Editorial Amy Swinderman, Chief Editor [email protected] Jeffrey Bouley, Managing Editor [email protected] Kelsey Kaustinen, Associate Editor [email protected] Contributing Editors Lloyd Dunlap, David Hutton, Lori Lesko, Kimberley Sirk Advertising Northeast ever-changing news, we expect the ddn Cancer Research Portal to exist as a living, breathing entity that alters in reaction to the most up-todate announcements and trends. Whether you are a cancer researcher, a student pursuing the oncology field, a company engaged in the search for anti-cancer compounds, a member of government or just an interested party, we hope you enjoy this new resource, which you can access by visiting www.ddncancer.com. Thanks for reading. ddn Taxes, innovation and life science jobs By Peter T. Kissinger n response to several recent columns, I www.drugdiscoverynews.com including churches, museums, universities, families and governments. To be nonprofit is a curse to be overcome, not a badge to be proudly worn. Sixth, revenue would come to the federal government primarily from the income tax directly on individuals with few—if any—deductions. There also would be user fees for parks, highways, airways, patents, FDA and the like. Charities would be supported from the heart. To collect adequate revenue without deductions, the rates will be modest for all. Seventh, Sarbanes-Oxley (SOX, or the Full Employment Act for Attorneys and Accountants of 2002) should be reversed (NOSOX, or the Unemployment Act for Attorneys and Accountants of 2012). We must slow down responding to the question, “Why didn’t the government do something about that?” We ARE the government. A few of us will behave very badly no matter what. We have long proven that rules to prevent the malfeasance of a few often do great damage to the majority and little to those selfaggrandizing slimes who are a side effect of sexual conjugation. The Enron and Tyco boards screwed up. Now the rest of us pay. Shutting down the IPO route to investment liquidity was equivalent to taking milk from babies and venture capital from startups. Eighth, as we have proven time and again, reducing capital gains tax rates increases capital gains tax revenues. Life science investing is a long-term activity that must be driven by hope for more than just change, but for gold. Should we tax those gains at all? I’m thinking perhaps not. Whatever gains there are will be put to work and thereby soon enough provide tax revenue from sales taxes, property taxes and income taxes. Growth catalyzes tax revenue. Rates can do the opposite. A lot of cash is frozen today by an uncertain upside and repeated short term plans that purtaxes continued on page 13 Sarah Paxton 49 Meadowbrook Road North Chatham, MA 02650 508.348.1130 Tel 508.348.1131 Fax [email protected] Midwest/MidAtlantic Steven Loerch/Jeffrey Dembski 95 Revere Drive, Suite H Northbrook, IL 60062 847.498.4520 Tel 847.498.5911 Fax [email protected] [email protected] Northwest/Southwest Kayte Miller 8667 Pendleton Drive Granite Bay, CA 95746 510.759.7529 Tel [email protected] Germany, Switzerland, Austria & Benelux Krampitz Verlagsvertretung Im Schlenk 34, 47055 Duisburg, Germany +49 203 4568 266 Tel +49 203 4568 538 Fax [email protected] United Kingdom, Scandinavia, France, Italy, Spain, Greece Stephanie Painter Painter-Lowe Communications [email protected] www.painter-lowe.com +44 1634 829386 Tel +44 1634 281504 Fax Marketing Laurence Doyle 610.619.3568 Tel 610.450.4906 fax [email protected] Production John O’Brien [email protected] 207.865.9908 Tel Operations Margaret Gorsline, Manager [email protected] 440.331.6600 Tel 440.331.7563 Fax Reprints Chris West [email protected] Reader Services ICN, Inc. 2900 New Rodgers Road, Bristol, PA 19007 215.785.5196 Tel 19035 Old Detroit Road #203 Rocky River, OH 44116 440.331.6600 Tel 440.331.7563 Fax President Bruce Poorman Executive Vice President Laurence Doyle Bio-Ohio Membership Application to Mail at Periodicals Postage Rates is at Cleveland, OH 44101-9603 For more information, visit www.DrugDiscoveryNews.com editorial October 2011 • Drug Discovery News 13 Multi-parameter optimization: The delicate balancing act of drug discovery A By Matthew Segall, Optibrium Ltd. safe and efficacious drug has percent, it is common for computational models in drug discovery to have uncertainties of an order of magnitude, and even experimental measurements may have uncertainties of a factor of two or more. Therefore, when selecting and designing compounds, it is important to consider the confidence with which we can choose between compounds in order to avoid missed opportunities. A number of MPO methods are being applied in drug discovery. Here, we will briefly discuss some key, illustrative examples. a balance of many properties. Potency against the therapeutic target is essential, and appropriate physicochemical and absorption, distribution, metabolism and elimination (ADME) properties are also required in order to achieve suitable in-vivo disposition. Furthermore, selectivity against off targets and an absence of non-specific and idiosyncratic toxicities are necessary to achieve acceptable side effect and safety profiles. Unfortunately, these requirements are often conflicting, with improve- Rules-of-Thumb ments in one property leading to detrimental The most famous example of a rule-of-thumb changes in another. is Lipinski’s Rule of Five (RoF), which relates The challenge of successfully achieving this the molecular weight, lipophilicity and hydrodelicate balancing act is illustrated by a his- gen bonding characteristics of a compound to torical view of pharmaceutical R&D, a picture its likelihood of achieving good oral absorpdominated by increasing costs and low suc- tion. The RoF has since been joined in the cess rates. The causes of the medicinal chemists’ armory high attrition rates for cliniby many other rules-of-thumb cal candidates have changed that relate the biological propover the years. In particular, erties, development potential the previously high failure or safety of compounds to rate due to poor pharmacosimple characteristics, includkinetics (PK) has been ing polar surface area, flexibilreduced, while the failures ity, number of sp3 carbons and du e t o t ox i c it y h ave number of aromatic rings. increased. The reduction in The enormous popularity PK f ailures has been of rules-of-thumb derives achieved through the introfrom the ease with which they duction of early in-vitro may be applied and interpretscreens to filter out comed. They provide clear guidepounds with potential lines that help chemists to ADME issues, and similar Matthew Segall, Optibrium focus on factors that will efforts are underway to increase the potential to idendevelop early tests for toxicities. However, the tify high-quality compounds while optimizing overall success rate has not improved, and the potency and eliminate chemistries with a low hidden cost of missed opportunities due to chance of success early in the process. good compounds incorrectly eliminated is Rules-of-thumb have been derived from also likely to be high. This suggests that an extensive statistical analysis of historical data alternative approach is required, taking a and most relate to a specific objective. Thereholistic approach to designing compounds fore, it is important to apply them in an approwith a good balance of properties as early as priate context; for example, the RoF was develpossible in the process. oped as a guide to improving the chance of This realization has led to a recent surge in achieving oral absorption, but it is frequently interest in methods for simultaneously opti- applied as a definition of “drug-likeness,” mizing multiple factors, described as multi- despite the fact that the requirements for a parameter optimization (MPO). Many MPO compound intended for other routes of adminmethods have been developed in fields such istration such as intravenous or inhalation are as engineering, economics and quality control quite different, potentially leading to inapprothat may be readily adapted to the drug dis- priate decisions. covery environment, and in the context of It is also important not to be too rigid when drug discovery, a good MPO method needs to applying rules-of-thumb, particularly when satisfy the following requirements: options are limited. The correlations between ■■ Interpretability: The output must provide these simple characteristics and the biological intuitive guidance on the impact of individual properties of a compound are not strong. Is properties on the quality of a compound and there a significant difference in the chance of oral absorption for a compound with a molechow it could be improved. ■■ Flexibility: There is no “one-size-fits-all” ular weight of 501 Da versus one with 499 Da? definition of a perfect drug. A project team should be able to define the profile of proper- Filtering ties they require, depending on the therapeu- Probably the most common approach used in tic and commercial objectives of the project, an attempt to identify compounds with an historical data and experience. appropriate property profile is to filter out ■■ Weighting: Not all properties are equally those compounds that fail to meet each criteimportant. Compromise is usually neces- rion in turn, with the hope that one or more sary, and it should be possible for a project “ideal” compounds will emerge at the end, team to define the acceptable trade-offs by having satisfied all of the criteria. Early in a project, the criteria corresponding to one of weighting individual property criteria. ■■ Uncertainty: Unlike engineering discithe rules-of-thumb may be applied as filters, plines, where it is often possible to simulate the but predicted and experimentally measured properties of a design within a fraction of a properties are often compared against a target product profile in this way. The apparent simplicity of a filtering approach hides a number of dangers. Achieving a balance of properties often requires compromise, as the requirements often conflict and it is very common for no compounds to emerge from the sequence of filters. Hard cut-offs introduce artificially harsh distinctions between options, and this is exacerbated by the effect of the uncertainty in the underlying data; combining multiple uncertain filters accumulates error and dramatically increases the chance of incorrectly discarding a good compound. As a simple illustration, if we apply 10 filters that are each 90 percent accurate in passing/failing a compound, the probability of an ideal compound emerging, even if it was present in the set being filtered, is only 35 percent; we are more likely to throw away an ideal compound than accept it. Desirability An alternative approach that avoids hard cutoffs and allows acceptable trade-offs to be defined is provided by “desirability functions.” A desirability function maps a property value onto a scale between zero and one that represents the desirability of a compound with that property value; an ideal value will achieve a desirability score of one, while a completely unacceptable value will receive a desirability score of zero. Desirability functions give excellent flexibility, as a desirability function can take any shape. For example, a slope indicating increasing desirability as the property value approaches the ideal range or even non-linear relationships, such as a sigmoid or bell curve. The desirability scores of individual properties can then be easily combined into a “desirability index” to reflect the overall quality of a compound by adding them together or taking the average or geometric mean. Furthermore, the results may also be easily interpreted, as the impact of each individual property to the overall desirability index can be calculated to guide strategies to improve the overall quality. A group at Pfizer described an application of desirability functions to prioritize compounds with a greater chance of success against a central nervous system (CNS) target. Its “CNS MPO” approach employs six calculated physicochemical parameters to calculate a desirability index in the range 0 to 6. They found that 74 percent of a set of marketed drugs for CNS targets achieved a CNS MPO index of about 4, compared with only 60 percent of the Pfizer candidates, a statistically significant difference. They also found that high CNS MPO index correlated with positive outcomes for several key invitro ADME and toxicity endpoints including permeability, metabolic stability, active transport by P-glycoprotein, cytotoxicity and hERG inhibition. Considering uncertainty The probabilistic scoring method builds on the flexibility and interpretability of desirability functions by explicitly taking into account the uncertainty in the underlying data. Thus, not only is a score calculated for each compound, representing the likelihood of achieving the required profile of properties, but an uncertainty in each overall score is also estimated. This provides much more information, as it becomes possible to see when the data allows compounds to be confidently distinguished or, alternatively, when higher resolution data or another criterion is necessary to make a clear choice. The objectivity this introduces allows projects to focus their efforts on chemistries with the highest chance of success while not missing potential opportunities. Conclusion Dealing with complex, multi-parameter data with high uncertainty is an enormous challenge. The temptation is to focus on a single property, often targeting potency, in the hope that issues that arise can be dealt with later in the process. This is a risky strategy, as once locked into a tight chemical series, it becomes difficult to break out if other necessary properties are not achievable. This leads to long optimization cycles and late-stage failures, increasing the time and cost of drug discovery and reducing productivity. It is much better to consider the overall balance of properties as early as possible in the process to focus on chemistries with the best chance of quick progress and downstream success. ddn Dr. Matthew Segall is director and CEO of Optibrium Ltd. Segall has a M.Sc. degree in computation from the University of Oxford and a Ph.D. in theoretical physics from the University of Cambridge. As associate director at Camitro, ArQule Inc. and then Inpharmatica, he led a team developing predictive ADME models and state-of-the-art intuitive decision-support and visualization tools for drug discovery. In January 2006, he became responsible for management of Inpharmatica’s ADME business, including experimental ADME services and the StarDrop software platform. Following acquisition of Inpharmatica, Segall became senior director, where he was responsible for BioFocus DPI’s ADMET division. In 2009, he led a management buyout of the StarDrop business to found Optibrium. taxes continued from page 12 port to create jobs, but simply move money from one private economy job to another or to the public sector. Capital senses irrational behavior and hides. Consider the tax on medical device revenues proposed to begin in 2013. How does this make healthcare more affordable any more than raising the price of milk makes milk more affordable? How does reducing social security taxes for a brief time encourage long-term hiring and solve the economic problems of entitlements? Prune the IRS rose bushes now. We can lower tax rates, simplify the process, improve transparency and raise government revenues while freeing capital to get back to work. That’s where jobs will come from. We in life sciences neither need nor deserve any special help. Freedom now! We’ll get it done the day we see a future of opportunity, not the threat of taking it away. Paying taxes is the result of success. I’d love to pay more to do my share. ddn Peter T. Kissinger is professor of chemistry at Purdue University, chairman emeritus of BASi and a director of Chembio Diagnostics, Phlebotics and Prosolia. 14 Drug Discovery News • October 2011 b r i e f s PCR services are basis of new Exiqon, AROS agreement WOBURN, Mass.—Exiqon AS and AROS Applied Biotechnology AS recently signed a Center of Excellence agreement by which AROS will gain the ability to provide real-time PCR services based on Exiqon’s miRCURY LNA Universal RT microRNA PCR product line. The agreement leverages Exiqon’s and AROS’ positions as leaders in the supply of high-value gene expression analysis products and total genomic solutions services, respectively. Additionally, LNA-based microRNA profiling has significant potential as a non-invasive method of discovering new biomarkers, since including LNA in the PCR primers adds a sensitivity that makes it possible to profile non-invasive samples, such as serum or plasma, with a very low quantity of RNA. Brian Sorensen, CEO of AROS, said the company is “convinced that Exiqon’s miRCURY LNA Universal RT microRNA PCR product line is a strong addition to our offering.” Promega, Puracyp merge cell lines, assay systems MADISON, Wis.—Puracyp Inc. and Promega Corp. recently came together to provide allinclusive kits for the assessment of nuclear receptor activation, P450 metabolism and cellular toxicity during the development process. The kits boast components that are designed and tested to work together in comprehensive user protocols. Puracyp brings to the table its proprietary nuclear receptor expressing cell lines, while Promega brings its assay and detection technologies for bioluminescent reporters, cell viability and P450-Glo substrate-based metabolism assays. In addition, the two companies have also launched a product line made up of DPX2 cells (human PXR), rPXR cells (rodent PXR), MkB3 cells (monkey PXR) and 1A2-DRE cells (human AhR). The cell-based assay systems are compatible to multiplexing in which activation, metabolism and toxicity can be assessed in one well of a 96- or 384-well plate. TEMIS, Alfresco launch content management integration LONDON—TEMIS and Alfresco have recently announced an integration that will enable the deployment of Luxid, TEMIS’ flagship content enrichment platform, to Alfresco’s open-source content management solutions. Luxid is a content enrichment solution that extracts important information from documents automatically, and when combined with Alfresco Enterprise, it can access documents to generate metadata and complete the embedded Apache Tika metadata and extraction with semantic analysis. The extracted semantic metadata can then be utilized through Alfresco Enterprise to strengthen search facets, identify related content, link to enterprise knowledge bases, feed business intelligence dashboards or trigger business workflows. For more information, visit www.DrugDiscoveryNews.com Going with the flow EMD Millipore acquires cell-imaging instrument maker Amnis By David Hutton SEATTLE—In an effort to strengthen its bioscience business, EMD Millipore, the life science division of Merck KGaA of Germany, has acquired Amnis Corp., a cell-imaging instrumentation maker based here. Financial terms of the deal have not been released. The transaction is subject to regulatory approvals and closing is expected to take place in the fourth quarter. According to Steffen Grimminger, director of Communication Strategy & Governance for EMD Millipore, the acquisition will help EMD Millipore to execute upon its strategy to build a powerful systems biology platform. “Currently, there are no solutions available that enable customers to directly link the outputs of flow and image analysis,” he says. “Specifically, confirming flow data with image analysis, linking multi-parameter flow data with protein localization via imaging and con- Amnis is EMD Millipore’s second acquisition this year. The company, which spun out of the University of Washington in 1998, makes an imaging device that provides detailed images of large numbers of cells, potentially enabling researchers to detect trace amounts of cancer in a blood sample, or determine whether a drug will hit a particular protein target. necting cell characteristics such as morphology to protein expression. All of these are significant unmet needs that we have validated through extensive market analysis and voice of customer through our rigorous strategic planning process.” Jonathan DiVincenzo, head of the Bioscience business unit within EMD Millipore, says the acquisition of Amnis significantly contributes to the company’s strategy to be a leader in cellular analysis and systems biology. “Amnis’ technology will put EMD Millipore at the forefront of cell analysis by providing us access to breakthrough, combined imaging flow cytometry, addressing several unmet needs in the field of cell analysis and systems biology,” he says. “Today, there are no comparable alternatives that enable our customers to combine flow cytometry and image analysis in one integrated solution. With this acquisition, EMD Millipore becomes the only provider of this technology.” This is the second acquisition for EMD Millipore this year. In March, Merck acquired the microbiology business of Biotest AG of Germany and added it to the operations of EMD Millipore, to boost its business in hygiene monitoring and ready-to-use media products for contamination detection. Grimminger says both EMD Millipore and its parent company Merck KGaA have a longterm view when considering acquisitions. “It is kind of hard to measure success when flow continued on page 15 Broadway On a kidney quest boogie-woogie NuGEN will partner with Advanced Liquid Logic to co-develop Mondrian-like microfluidic sample preparation automation By Lloyd Dunlap SAN CARLOS, Calif.—NuGEN Technologies Inc., which focuses on the development of sample preparation solutions for next-generation sequencing (NGS) and genomic profiling applications, and Advanced Liquid Logic (ALL), a pioneer in digital microfluidics technology, have inked an exclusive co-development and supply agreement under which ALL will Artist Piet Mondrian painted traditional provide instrumentation, software subjects in an increasingly abstract and digital microfluidic cartridge style. In his Broadway Boogie Woogie, technology to NuGEN for Mondrian depicts the restless motion of New York City. commercialization. As part of the co-development process, NuGEN will focus on reagent and sample preparation, and ALL will provide its expertise in digital microfluidic design and programming. NuGEN will be the exclusive provider of both the instrument and reagent technology commercially to the life-science research market. “I became aware of Advanced Liquid Logic as I was searching for a mondrian continued on page 18 Critical Path Institute’s collaboration with Pharsight explores new model in battle against kidney disease By David Hutton ST. LOUIS—The Critical Path Institute’s PKD Consortium has entered a collaboration with the scientists at software and consulting firm Pharsight to develop quantitative models of kidney disease. This work is the latest step in the Critical Path Institute (C-Path) PKD Consortium’s quest to advance CDISC research data standards and an imaging biomarker for autosomal dominant polycystic kidney disease (ADPKD), which affects one in 500 Americans and more than 12 million people worldwide. The consortium is led by C-Path and funded through a grant from the PKD Foundation and philanthropic donations. Additionally, a representative from the U.S. Food and Drug Administration (FDA) serves as an active advisor to the consortium. The consortium also includes four leading academic medical centers: Tufts University, the University of Colorado Denver, Emory University and the Mayo Clinic. The primary goals of the PKD Consortium are to develop CDISC research data standards for PKD and to use clinical data from PKD patients collected over many years through patient registries and clinical trials to support the FDA’s qualification of an imaging biomarker, total kidney volume (TKV), as an endpoint in drug development trials. Financial terms and other details of the deal are confidential and have not been released. According to Lisa Romero, kidney continued on page 16 DDN 1-2 Pg Ad VERTICAL_DDN 1-2 Pg Ad VERTICAL 8/30/11 2:36 PM Page 1 Instruments & informatics Sweet deal for Agilent in Asia Agilent Technologies and Chungnam National University team up to push glycomics research forward By Jeffrey Bouley SANTA CLARA, Calif.—Marking the first part- tion and funding situation.” “We are excited about this collaboration with one of the world’s leading universities on glycan research,” said Rod Minett, general manager, Agilent Life Sciences Group, South Asia Pacific and Korea, in the news release about the deal. “The knowledge gleaned from the collaboration will not only contribute toward the improvement of the biosimilars industry nership of its kind for Agilent Technologies Inc. in Asia, the company has come together with Chungnam National University (CNU) in Daejeon, Korea, to announce an agreement for developing new applications, methods, technologies and software tools in the field of g l yc o m i c s , o r t h e study of complex sugars. The university’s primary goal in this effort is to identify and develop biomarkers for diseases such as cancer, thereby leading to develop- Present at the signing of the memorandum of understanding between Agilent Technologies and Chungnam National University were, from left to right: Dr. ment of therapeutic Rudolf Grimm, director of science and technology for Agilent’s Life Science antibody products. Group; Park Si-Young, country manager for the Life Science Group in Korea; Prof. “This collaboration Kwang Hwa Chung, dean of faculty of analytical science and technology at the is a perfect fit to Agi- university; and Prof. An Hyun Joo, head of the new Asia Glycomics Education lent as key focus areas Center and a member of the analytical science and technology faculty at the in life science are the university’s Graduate School of Analytical Science and Technology. academic market as well as the biotech/phar- in Korea, but also help scientists discover ma industry,” Dr. Rudolf Grimm, director of new cures and develop new drugs and vacscience and technology for Agilent’s Life Sci- cines to treat and prevent diseases.” The research will be jointly led by Prof. ence Group, tells ddn in describing how the deal fits into his company’s strategic goals Hyun Joo An, a professor of analytical sciand the university’s. “CNU’s benefit is in the ence and technology at Chungnam National first bigger university-industry relationship, University’s Graduate School of Analytical which will increase the university’s reputaasia continued on page 17 flow continued from page 14 a technology that was created by a company of 40 people gets integrated into an organization with 40,000 employees,” he says. “Having said that, it will be truly rewarding for EMD Millipore to be the only provider of the flow and image analysis technology going forward.” Amnis has had an interesting path to date. The company spun out of the University of Washington in 1998. It makes an imaging device that provides detailed images of large numbers of cells, potentially enabling researchers to detect trace amounts of cancer in a blood sample, or determine whether a drug will hit a particular protein target. The company’s customers include academic researchers and big drugmakers. According to David Basiji, CEO of Amnis, the main reason behind his company’s decision to sell was to accelerate the growth of its technology. “We’re comfortably profitable, and our business has grown at an 80 percent compounded annual rate since 2005,” he says, “but with the addition of the lower price/ higher volume FlowSight product, plus three clinical applications in development, we now have far more to do than we can fund organically.” Amnis generated sales of $14 million in 2010. Basiji also points out that Amnis’ technology is highly complementary to EMD Millipore’s existing flow cytometry-related products and capabilities, both from an instr umentation and application perspective. “It’s too early to talk about specific strategic moves, but I think we have all the ingredients in place to become a major player in all aspects of cellular analysis and systems biology,” he says. “This will help us to drive the penetration of Amnis’ technology, not only with our combined customer base, but also in adjacent fields and markets of cell analysis where we see a huge potential. We expect Millipore will both accelerate our existing projects as well as allow us to broaden into areas we’ve wanted to go, but haven’t been able to pursue due to resource constraints.” Amnis, which currently has 40 employees, will remain in Seattle with its existing staff and management, according to Basiji. ddn EDITCONNECT: E101109 NDRI recovers human tissue for your research Photo: Digital rendition of a triple-labeled section of human retina, courtesy of Lauren C. Liets, Ph.D., University of California, Davis, CA Human tissue is the pathway to drug discovery Every human tissue is available through NDRI’s national system. You are a phone call away from immediate service from a reliable, national source of human biomaterials for your research studies. Specialized protocol development ensures that the tissues are procured in the manner that best meets your needs. Visit w w w.NDRIresource.org to learn more. NDRI, is nationally renowned as the National Human Tissue Center serving scientists for the past 30 years. Call NDRI for customized service 800-222-NDRI (6374) donate discover cure 16 Drug Discovery News • October 2011 caliper continued from page 1 September the signing of a definitive agreement to acquire Hopkinton, Mass.-based Caliper Life Sciences Inc. “It was featured in our strategic plans back at the end of 2008 or beginning of 2009 that we had identified preclinical work as a natural stepping stone from cellular imaging,” Alan Fletcher, vice president of strategic marketing for the Bio-discovery unit of PerkinElmer, tells ddn. “If you think about our capabilities in detection as well, we have a natural progression to proceed into clinically relevant data for trials. We’ve been looking at areas like toxicology and animal imaging, which are high-growth areas in our view.” Under the terms of the agreement, PerkinElmer will buy Caliper for $10.50 per share, or a total of about $600 million in cash. The deal is expected to close in the fourth quarter of 2011, and Kevin Hrusovsky, Caliper’s CEO, plans to join PerkinElmer’s senior leadership team following the close of the transaction. Robert F. Friel, chairman and CEO of PerkinElmer, said in the news release about the deal that the combined R&D expertise and intellectual property of the companies will accelerate their ability to bring new innovations to market, adding, “The acquisition of Caliper Life Sciences brings innovative molecular imaging and detection technologies to our portfolio, complement- Instruments & informatics world-leading microfluidics platform for genomics and proteomics applications, for improved detection and screening through low sample use and efficiency; and high-value sample preparation technologies for key scientific workflow areas such as next-generation DNA sequencing. In addition, PerkinElmer foresees more comprehensive solutions and services for identification of therapeutic response, biotherapeutics development and biologics QA/QC; platform technology additions that will drive expansion into attractive areas such as detection for environmental contaminants and food pathogens; and broadened services capabilities that will leverage multi-vendor asset management, custom research and profiling for contaminants and adverse effects. Fletcher believes the cultural fit between the two companies is good, saying that change in the Bio-discovery unit and health sciences in general at PerkinElmer for the past few years has been strongly driven by a commitment to innovation. “If you look at Caliper, Kevin himself stands up as an extremely motivational individual, and the culture he has encouraged overlaps significantly with our own Bio-discovery business with the potential for spreading out to other divisions of PerkinElmer,” Fletcher adds. “Throughout the past eight years, Caliper has assembled an unparalleled suite of disruptive technologies to revolutionize medicine. We are excited about the merger with PerkinElmer as it Cellular imaging is one of PerkinElmer’s strengths, but the company’s leaders want to expand on that to enter the preclinical realm, companion diagnostics and other “compelling customer solutions in a broad range of highgrowth end markets.” ing our world-leading offerings in life science, diagnostics, environmental and food markets.” Reportedly, the combined technology platforms will expand PerkinElmer’s portfolio of solutions and services for global customers, including: broader offerings for molecular, cellular, animal and tissue imaging to enable translational medicine research; the addition of a enables us to rapidly ramp the adoption of these technologies and accelerate our expansion into molecular diagnostics and environmental health markets—areas where PerkinElmer has established and growing market positions,” Hrusovsky says. “We are confident that this merger maximizes value for Caliper’s key stakeholders while strengthening the company’s posi- For more information, visit www.DrugDiscoveryNews.com kidney continued from page 14 Combining the R&D power and the intellectual property of PerkinElmer with Caliper’s will accelerate their ability to bring new innovations to market, says Robert F. Friel, chairman and CEO of PerkinElmer. tion as a leading provider of enabling technologies for personalized medicine.” He adds that PerkinElmer and Caliper’s technologies are “a great fit” and the resulting combined portfolio promises to be the “premier suite of tools that create the in vitro to in vivo to human ‘bridge’ for personalized medicine.” Hrusovsky predicts synergistic opportunities in several key technology areas, including small-molecule discovery, biotherapeutics and vaccines, biomarker discovery and companion diagnostics, next-generation sequencing and regenerative medicine. This deal follows the acquisition of several other companies by PerkinElmer earlier in the year, but it has a much different character. For one thing, the Caliper acquisition is the largest of the lot, but also the previous acquisitions— Geospiza, CambridgeSoft and ArtusLabs— focused on expansion of PerkinElmer’s bioinformatics capabilities. Still, while this acquisition may seem to be of a different character, Fletcher emphasizes that the informatics focus earlier in the year and the Caliper acquisition now stand to provide “significant overlap” and strengthen the overall offerings by bringing together such things as DNA and RNA sample preparation, bioinformatics, toxicology CRO services, imaging and more, “complementing not only Bio-discovery, but also the broader PerkinElmer portfolio.” Fletcher also notes that PerkinElmer has been looking to expand in Asia and sees that region and other emerging markets as attractive places to market Caliper’s products. The total purchase price represents a premium of 42 percent for Caliper Life Sciences shareholders, relative to the closing price of $7.39 on Sept. 7, which was the last trading day prior to the announcement of the acquisition plans. The acquisition has received the unanimous support of the boards of directors of both companies, and the transaction is expected to be dilutive to PerkinElmer’s 2012 GAAP earnings per share by approximately 5 cents and accretive to PerkinElmer’s 2012 First Call consensus adjusted earnings per share by approximately 8 cents. The transaction is subject to customary closing conditions, including approval of Caliper Life Sciences stockholders, and the expiration or termination of the waiting period under the HartScott-Rodino Antitrust Improvements Act. ddn EDITCONNECT: E101102 Caliper Life Sciences and Yale Center for Genome Analysis automate next-gen sequencing workflows HOPKINTON, Mass.— Caliper Life Sciences Inc. last month announced a collaboration with the Center for Genome Analysis at Yale University to implement automated protocols for exome capture and library preparation workflows. Yale has purchased Caliper’s Sciclone NGS Workstation and Lab- Chip GXI to improve key bottlenecks in the Illumina HiSeq2000 NGS sample preparation process, said Dr. Shrikant Mane, director of the Yale Center for Genome Analysis, in a statement. “We chose these systems because of their flexibility, which will enable us to automate protocols for the Pacific Biosciences sequencing workflow in the future, and because of the hands-on support Caliper provides in customizing their systems to automate the numerous sequencing workflows utilized at our center,” Mane said. Caliper is working to enhance its NGS sample preparation suite to accelerate sample preparation for each of its sequencing instrumenta- tion and reagent platforms, added Kevin Hrusovsky, the company’s president and CEO. “Our team is committed to providing the highest level of support and resources to enable leading NGS institutions to conduct fundamental research that will enable the delivery of medicine in a more personalized manner,” he added. ddn communications and strategic outreach manager for Critical Path Institute, the company “works with many collaborators on its various consortia/ projects and is looking forward to a productive new partnership between its PKD Consortium and Pharsight.” “The PKD Consortium is very pleased about this significant partnership to create and study quantitative models of disease progression in patients with autosomal dominant polycystic kidney disease,” she says, noting how much need there is for a biomarker that will assess disease progression “Traditional endpoints of renal function only show changes very late in the course of the disease, making it difficult to assess the effectiveness of new medications. There is critical need for a biomarker that will assess disease progression at an earlier stage when patients may be more likely to respond to new therapies.” Dr. Eslie Dennis, executive director of the PKD Consortium at C-Path earlier and make it easier to give patients the right kind of therapy at the right time. The timeline to develop a quantitative disease progression model, Romero notes, depends on C-Path’s plans and the plans of collaborators and pharmaceutical companies. She adds that the model provides an incentive for industry to develop a treatment for this disease since there is an approval path. “A qualified measure will encourage drug development organizations to test potential new disease-modifying treatments for ADPKD,” she adds. Dr. Eslie Dennis, executive director of the PKD Consortium at C-Path, says the project l eve r age s t h e p owe r o f collaboration. “Traditional endpoints of renal function only show changes very late in the course of the disease, making it difficult to assess the effectiveness of new medications,” Dennis says. “There is critical need for a biomarker that will assess disease progression at an earlier stage when patients may be more likely to respond to new therapies.” ddn EDITCONNECT: E101111 For more information, visit www.DrugDiscoveryNews.com asia continued from page 15 A lab at Chungnam National University, outfitted with Agilent instruments as part of the collaborative work between the university and the company. drugs and biosimilar drugs as well as glycan biomarkers. Since Korea is investing heavily into academic research on one hand as well as into the biosimilar industry—but so far lacked local expertise in glycan research/analysis—our partnership will strongly benefit the entire community.” “There has been an increased interest in the area of glycomics research in Korea,” said An in the official statement about the collaboration. “I am very pleased that Chungnam National University and Agilent have chosen to combine their cutting-edge technology and knowledge in Korea to further research in this very exciting field.” “Chungnam National University, with our motto, ‘Creativity, development and service to the community,’ has been offering the best possible environment for excellence in research and education for over 50 years,” added Prof. Kwang Hwa Chung, dean of Chungnam National University. “We are proud to announce this collaboration with Agilent that will see our university using the latest analytical and scientific technologies for research in glycomics.” Under the agreement, GRAST will also develop glycomics training courses for Agilent’s customers and employees to help further the advancement in the field, while Agilent Life Sciences will use GRAST October 2011 • Drug Discovery News 17 “The knowledge gleaned from the collaboration will not only contribute toward the improvement of the biosimilars industry in Korea, but also help scientists discover new cures and develop new drugs and vaccines to treat and prevent diseases.” Rod Minett, general manager, Agilent Life Sciences Group as its strategic glycomics reference site in Korea and Southeast Asia. A collaboration with “a worldclass analytical scientist like Prof. An” is a critical step in efforts to push innovation in the field of gly- comics, Grimm says, adding that “such partnerships will ensure that Agilent remains a leading provider of knowledge and analytical solutions to further research.” The partnership will also ben- efit from familiarity, as Grimm and An are previously acquainted. Grimm explains that he has known An for more than seven years from her former postdoctoral time at Prof. Carlito Lebrilla’s lab at the University of CaliforniaDavis, which was the site of another strategic glycomics collaboration with Agilent. “When she became a professor at Chungnam National University in March 2011, we started to talk about continuing our collaborative work in the form of a glycomics network between Agilent, UC Davis and Chungnam National University,” Grimm says. “We have published jointly several papers in the past several years.” ddn EDITCONNECT: E101112 Synergy™2 Alpha Science and Technology (GRAST) and head of the new Asia Glycomics Education Center, and by Grimm, whose duties also include serving as Agilent’s manager of collaborations in the Asia Pacific region. Grimm was appointed as an adjunct professor by the university for his work in the glycomics field. Both researchers will define and conduct joint research projects to develop new applications, methods or analytical tools for glycan analysis. As Grimm tells ddn, “Agilent will provide cutting-edge technologies to An, and she will use those technologies to develop novel analytical methods to analyze glycoprotein Instruments & informatics Reader technology with an alternate perspective: Same results, less cost. BioTek’s Synergy™2 Alpha Microplate Reader is the proven alternative to other expensive microplate readers at a significantly lower price. Synergy 2 Alpha is pre-configured with the right filters, mirrors, software and modules to read all Alpha assays right out of the box. Even better, Synergy 2 Alpha is easily upgradable to a full multi-mode Synergy. For more information visit www.biotek.com/synergy2alpha AlphaLISA® AlphaScreen® SureFire® Detection Limit <100 amol of biotinylated-LCK-P peptide, 25 µL/well in 384-well plate On par with more expensive laser-based systems! China • France • Germany • India • Singapore • Switzerland • United Kingdom • United States AlphaScreen, AlphaLisa and SureFire are registered trademarks of PerkinElmer, Inc. 18 Drug Discovery News • October 2011 Instruments & informatics For more information, visit www.DrugDiscoveryNews.com Aridhia, Glencoe create analysis products mondrian continued from page 14 GLASGOW, Scotland—Aridhia Informatics Ltd., a multidisciplinary health informatics company, recently partnered with Glencoe Software to create products to aid the development of personalized therapies and deliver improved patient outcomes. The partnership brings together Aridhia’s capabilities in accessing, storing and analyzing healthcare information with Glencoe’s exper- tise in managing, sharing and publishing large scientific datasets generated in laboratories around the world. Anticipating an increased focus on stratified medicine in coming years, the two companies will work together to create products for the international healthcare, life and biomedical science markets using real-world clinical, genetic and research information. As part of the agreement, Aridhia will make a major investment in Seattle-based Glencoe to further accelerate its already rapid growth in these areas. “Dundee is a great place for life sciences companies such as Aridhia and Glencoe to do business,” said Prof. Peter Downes, principal of the university, in a statement. “Their collaboration here will create jobs and further strengthen our innovation economy. It is good news for Dundee and good news for Scotland.” Aridhia Informatics is a joint venture between the University of Dundee, NHS Tayside and Sumerian IT Analytics. Aridhia provides a combination of clinical expertise, academic excellence and high-performance computing experience to generate real-time information services that improve the safety, quality and efficiency of healthcare. ddn way to provide affordable automation of sample preparation to the market,” says NuGen CEO Elizabeth Hutt. “This is a natural extension of our commitment to develop technologies that solve bottlenecks in sample processing, streamline workflows and expand access to precious clinical specimens. There is a strong synergy between the two companies, as both have unique offerings that change the way scientists think about their research.” NuGEN will market the system under the brand name Mondrian SP, she notes, because NuGEN’s brand identity evokes a Mondrian look and feel. “We recognized that there was a strong similarity between the cartridge design and Piet Mondrian’s Broadway Boogie Woogie—where art meets science—the perfect description of an innovative and elegant design,” Hutt adds. ALL’s technology enables direct electrical manipulation of submicroliter droplets without requiring pumps, valves or channels. The instrument itself is small, very reliable, easy to maintain and lowcost, as it has virtually no moving parts, Hutt notes. Single instruments accommodate lower throughput requirements effectively, while multiple units reportedly can be used in tandem with HTP robotics to further streamline larger workflow processes. The collaboration will focus initially on NGS library preparation protocols for Illumina sequencing platforms. The first protocols are currently being developed in partnership with the Broad Institute. NuGEN is also collaborating with the Broad Institute and Advanced Liquid Logic on method development on the digital microfluidic cartridge. A broad menu of protocols will be developed for applications that will be compatible with all major NGS platforms and also for other genomic analysis techniques, including microarrays and qPCR. Future development plans from NuGEN include Ovation RNA-Seq and Encore Amplification Free NGS Library Systems, with availability expected by year’s end. “We think NuGEN has demonstrated unique capabilities in enabling researchers to work with very small amounts of starting materials,” says Hutt. “The need for these cost-effective tools and efficient workflows in sub-microliter volumes transcends laboratories of all sizes.” “Increasing interest in employing NGS technology has created a need for sample preparation automation that is cost-effective to acquire and operate,” adds Richard West, president and CEO of ALL. “We expect the Mondrian SP to gain broad adoption in the research laboratory environment.” ddn EDITCONNECT: E101110 For more information, visit www.DrugDiscoveryNews.com b r i e f s 3M, Lumora ink joint developing and licensing agreement LONDON—Lumora Ltd., headquartered in Ely, Cambridgeshire, and St. Paul, Minn.-based 3M have announced the recent signing of a joint development and licensing agreement. The conclusion of this agreement will allow 3M, a research and development leader specializing in the manufacture of products for several markets, to develop and sell nucleic acid test kits that utilize Lumora’s Bioluminescent Assay in Real-Time (BART) technology. Lumora focuses on the development of robust, affordable, easyto-use molecular diagnostics systems based on BART, a novel reporter system designed for use in conjunction with isothermal nucleic acid amplification technologies, primarily as a molecular diagnostic tool. No financial details for the agreement were disclosed. October 2011 • Drug Discovery News 19 Billion-dollar boost GE’s health business unit earmarks $1 billion for cancer diagnostics and molecular imaging By Amy Swinderman CHALFONT ST. GILES, U.K.—As the medical community continues to struggle to tackle the complexity of cancer, GE Healthcare, the health business division of General Electric Co., is rising to the challenge with a $1 billion boost to its R&D budget over the next five years to expand its cancer diagnostic and molecular imaging capa- Much of GE Healthcare’s $1 billion R&D investment will focus on the identification of new cancer biomarkers, says Dr. Nigel Darby, vice president of biotechnologies and chief technology officer at GE Healthcare Life Sciences. bilities, as well as technologies for the manufacture of biopharmaceuticals and for cancer research. The investment is congruent with GE Healthcare’s “Healthymagination challenge,” an open call to action for oncology researchers NIH to establish brain injury database Market report forecasts growth for molecular imaging market LONDON—According to market research firm Companies and Markets, the molecular imaging market is expected to reach more than $6 billion by 2015. Despite its growth being slowed by the recession, the molecular imaging market is only in its early stages and has much potential for growth, with key applications most likely to be found in neurological diseases such as Alzheimer’s, oncology, cardiovascular disease and drug development, according to the firm. Its report, “Molecular Imaging: A Market Coming of Age,” also highlights consolidation as an expected trend for the market, with the landscape changing from its current fragmented, highly populated state to trend toward an increase in licensing and M&A deals as companies strive for dominance in the market. In addition, Brazil, China and India are identified as three countries driving molecular imaging demand in emerging economies. ge continued on page 23 Colorectal cancer compatriots WASHINGTON. D.C.—In partnership with the U.S. Department of Defense, the National Institutes of Health (NIH) is creating the Federal Interagency Traumatic Brain Injury Research (FITBIR) database, a central database on traumatic brain injuries. The database will be funded $10 million over four years and is intended to accelerate research on brain injury treatments and diagnosis, serve as a repository for data, link to existing databases and allow cross-study results comparison. The FITBIR database will, through collecting uniform data such as brain-imaging scans and neurological test results, allow for enhanced diagnostic criteria, clearer understanding of the effects of physical characteristics on injury and recovery, comparison of treatment efficacy and improved guidelines for patient care. and healthcare innovators seeking ideas to accelerate innovation in breast cancer. Through the challenge, GE and its venture partners will award up to $100 million to fund breakthrough ideas that advance early detection, more accurate diagnoses and targeted treatment of breast cancer. According to the company’s announcement, made Sept. 15, the investment crosses all lines of GE Healthcare’s global businesses. Dr. Nigel Darby, vice president of biotechnologies and chief technology officer at GE Healthcare Life Sciences, tells ddn, “We’ve not broken down the investment commitment by project; however, technologies for cancer research and the discovery and manufacture of the new cancer therapies are a key part of this initiative.” Arizona State and China’s Sun Yat-sen University to develop early diagnostics against colorectal cancer By Lloyd Dunlap with Eli Lilly & Co. and Pfizer Inc., both with a focus on companion diagnostics for cancer treatments. Financial details were not disclosed for either agreement. Lilly and QIAGEN will work together on the development, manufacturing and commercialization of a molecular companion diagnostic for Lilly’s proprietary compound, called a JAK2 inhibitor. It targets the Janus TEMPE, Ariz.—Arizona State University (ASU) and China’s Sun Yat-sen University (SYSU) have formalized a research collaboration aimed at developing early and predictive diagnostics to improve patient outcomes for colorectal cancer (CRC). ASU’s Nobel Laureate, Dr. Leland Hartwell, chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Dr. Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou, Guangdong, China. According to Hartwell, “Recent advances in molecular technologies promise great improvements in medical care through prevention and early detection of disease. Developing these advances to the stage where they are useful in the clinic requires a systematic, dedicated and long-term collaboration between the most advanced clinical research sites and state-of-the-art technology centers. We are optimistic that this collaboration will help advance the quality of colorectal cancer care worldwide.” The Center for Sustainable Health (CSH) is a multimilliondollar, ASU-led partnership within the Biodesign Institute with a mission of improving healthcare and reducing costs through advances in diagnostics. The Sixth Affiliated Hospital (500 beds, soon to expand to 1,000 beds) is one of eight affiliated hospitals at SYSU that have a total of 7,500 beds. SYSU is named after Dr. Sun Yat-sen, founder of both the university and the Republic of China. He is said to be the only figure that is revered among people on both sides of the Taiwan qiagen continued on page 21 colorectal continued on page 23 Members of QIAGEN’s manufacturing team put together the company’s diagnostic kits in clean room conditions. The company recently established partnerships with Pfizer and Lilly for the development of companion diagnostics. Queue up with QIAGEN QIAGEN announces companion Dx partnerships with Pfizer, Lilly By Kelsey Kaustinen GERMANTOWN, Md.— QIAGEN recently announced a pair of collaborations, revealing that it has entered into separate partnerships diagnostics 20 Drug Discovery News • OctOber 2011 For more information, visit www.DrugDiscoveryNews.com TOGETHER AGAIN AGAINST PROSTATE CANCER Genomatix and uniformed service university build on previous work to seek prognostic genetic markers through next-gen sequencing by JeFFrey bOuley MUNICH, Germany—Genomatix Soft- ware recently entered into a Cooperative Research and Development Agreement (CRADA) with the Uniformed Service University of the Health Sciences (USU) and the Henry M. Jackson Foundation for the Advancement of Military Medicine to undertake a joint research effort that will seek to differentiate prostate cancer patients with favorable versus poor prognosis at the time of diagnosis and primary treatment using definitive genetic markers discovered through the use of next-generation sequencing (NGS) technology. As the parties in the CRADA note, the majority of prostate cancer cases in those people screened via prostate-specific antigen tests fall into a “gray zone” of prostate cancer in which outcomes are extremely difficult to predict at the time of diagnosis. The collaboration will combine the translational research resources of the USU’s Center for Prostrate Disease Research (CPDR) with Genomatix’s data analysis expertise in, as Genomatix founder Dr. Thomas Werner puts it, “teasing out novel androgen receptor binding sites in the genome and analyzing prostate cancer metastasis using prostate cancer model systems and clinical specimens.” Werner maintains that Genomatix is one of the world’s leading suppliers of technologies to analyze and interpret genomic data and notes that “as well as laying the groundwork for microarray experiments and NGS data analyses, our hardware and software solutions help answer the typical questions posed by systems biology.” All of this fuels the company’s stated approach to research, which is to combine multiple lines of evidence to perform an integrated meta-analysis. This isn’t the first time Genomatix and USU’s CPDR have worked together. In fact, their substantive work goes back to the early 2000s, having conducted research leading to two key publications: “Androgen receptor binding sites identified by a GREF_GATA model” in 2005 in the Journal of Molecular Biology and “Transcriptome analyses of benign and malignant prostate epithelial cells in formalin-fixed paraffinembedded whole-mounted radical prostatectomy specimens” in 2007 in the journal Prostate Cancer and Prostatic Diseases. “This CRADA is a natural extension of accomplishments we have already achieved together,” Werner says. “Next-generation sequencing Glucose (2DG) Uptake Assay KIT ive! act io Rad Non photometric detection (420nm) advanced recycling enzymatic amplification picomole sensitivity 96 well, add only, robot compatible protocol usa.com smobio www.co 1 760.43 .4600 driving force behind daily work at Genomatix. It’s the engine that propels fundamental advances in biology and medicine. Our knowhow helps keep this motor running and—wherever we can— make it even more powerful than it is today.” Work such as this is expected to help advance Genomatix’s goal to and functional context. In their 2007 article, they noted that formalin-fixed paraffinembedded (FFPE) prostate specimens are rich sources of molecular pathological information, but noted that FFPE-based microarray analysis of tissue samples may be hampered by the degradation and chemical alteration of RNA mole- “next-generation sequencing opens a new dimension in biomarker research and will allow a finer grained, unbiased look at some of the genomic mechanisms behind prostate disease, thus providing the opportunity for the discovery of new prognostic biomarkers, some of which also may be targets for therapeutic intervention and treatment monitoring.” DR. THOMAS WERNER, fOuNDER Of GENOMATIx Dr. Shiv Srivastava, the CPDR’s co-director and scientific director, as well as a professor of surgery at USU, agrees that USU and Genomatix work well together, noting, “our work to date with Genomatix has been very productive. People from both our organizations have already established quality working relationships. Leveraging this and moving forward together into a technology as groundbreaking as next-generation sequencing holds great promise for significant progress in prostate disease research.” As Genomatix notes on its website with regard to its scientific publications, “Research has always been and always will be the find more meaningful answers to biology’s fundamental questions by focusing on gene regulation and gene expression, and the work of the CRADA fits in with the company’s stated vision of being built of the three pillars of better diagnoses, better prognoses, better therapies, with an eye toward helping to usher in an era of personalized medicine. In their 2005 article, Genomatix and the CPDR found that a complex model combing the glucocorticoid responsive element matrix family (GREF) and GATA transcription factor binding sites could be more predictive than GATA alone by recognizing transcription factor binding sites in their proper biological cules due to the preservation procedure. To get around this problem, they used probe analyses of Affymetrix oligonucleotide arrays at individual probe level to compensate for the potential loss of gene identifications associated with compromised mRNA quality in FFPE preparations and used laser capture microdissection of prostate tumor and benign epithelial cells. They concluded it was quite possible that a combination of laser capture dissection with computational enhancement of microarray data might be useful for the assessment of gene expression changes in FFPE prostate cancer specimens. ddn editcOnnect: e101116 Genomatix launches secure cloud-like model for nextgen sequencing data analysis I for insulin responsive cells and tissue [email protected] opens a new dimension in biomarker research and will allow a finer grained, unbiased look at some of the genomic mechanisms behind prostate disease, thus providing the opportunity for the discovery of new prognostic biomarkers, some of which also may be targets for therapeutic intervention and treatment monitoring.” bilities, complementing our turn-key in-house N OTHER NEXT-GENERATION sequencing (NGS) news at Genomatix Software, the platforms, the Genomatix Mining Station and the company announced in mid-March the Genomatix Genome Analyzer,” said Genomatix launch of a new service, mygenomatix, CEO Dr. Martin Seifert at the time. “We have been said to “incorporate all the power of its in-house platform and combine it with the affordability of cloud computing and the security of an in-house solution.” Genomatix says the service will return analyzed data back in a matter of one to two weeks and grant users access to the full Genomatix software DR. MARTIN SEIfERT, GENOMATIx CEO and background data content as part of the service. For ease of use, the service uses exploring a cloud-like model for quite some time, graphical user interface and standard operating and our service model addresses the issue of secuprocedures and workflows, and access to software rity by getting the data to our computers via a and data content is possible via any standard hard disk shipment program. With mygenomatix, anyone doing NGS data analysis now has access Internet browser. “We want to provide an easy entry to our excel- to an easy entry path to our technology and lent NGS data analysis and interpretation capa- databases.” ddn “we want to provide an easy entry to our excellent NGS data analysis and interpretation capabilities.” diagnostics For more information, visit www.DrugDiscoveryNews.com QIAGEN coNtINuED From PAGE 19 kinase 2 (JAK2) gene, which plays a role in myeloproliferative neoplasms, an assortment of blood cancers that lead to abnormal growth of blood cells. Per the terms of the agreement, QIAGEN will develop a companion diagnostic test that will provide quantitative and qualitative results for the JAK2 V617F mutation to aid in the identification of patients who are more likely to respond to Lilly’s JAK2 inhibitor. “The collaboration with Lilly is a strong testament to QIAGEN’s capabilities in companion diagnostics, biomarkers and personalized healthcare,” Dr. Stephen Little, vice president of personalized healthcare at QIAGEN, said in a press release. “We look forward to developing the potential for this innovative diagnostic-therapeutic combi- opment of a KRAS companion diagnostic to be used in conjunction with dacomitinib. The partnership includes clinical trials and submissions for a Premarket Approval application in the United States and the CE mark in Europe, in addition to applicable regulatory approvals in other regions. “We are pleased to collaborate with Pfizer seeking to advance personalized healthcare with a new potential tool in the fight against non-small cell lung cancer, a major killer around the world,” said Little in a press release. “This partnership unites QIAGEN’s capabilities in companion diagnostics with Pfizer’s scientific excellence and global presence to develop an innovative diagnostictherapeutic combination with the potential to improve the standard of care for [non-small cell lung cancer] patients.” The companion diagnostic will be based on QIAGEN’s proprietary KRAS assay technology, which identifies mutation in the KRAS gene. Since EGFR inhibitors are OctOber 2011 • Drug Discovery News usually effective in patients without KRAS mutations, the new assay will aid in the identification of patients who will benefit the most from EGFR-inhibitor therapies. QIAGEN has already submitted an application for Premarket Approval for KRAS companion diagnostics to the U.S. Food and Drug Administration (FDA) for use with the other drugs that target metastatic colorectal cancers. Once clinical development is finished for the KRAS companion diagnostic for non-small cell lung 21 cancer, QIAGEN intends to submit a premarket approval application supplement to the FDA for full automation of the workflow, which will grant pathologists access and easy processing of lung tissue samples. “We see business benefits for Pfizer and QIAGEN, improved healthcare for patients and reduced costs for healthcare providers,” Little says of the partnership. “It really is a win-win-win situation.” ddn editcOnnect: e101114 The Seahorse XF Extracellular Flux Analyzer PROVIDING NEW ANSWERS TO AGING PROBLEMS • Simultaneously measures O2 consumption and H+ production rates, providing the most comprehensive measurement of cellular metabolism in a single assay Dr. Stephen Little, vice president of personalized healthcare at QIAGEN, notes that “in addition to more than 20 tests we already offer commercially, QIAGEN is co-developing companion diagnostics in more than 15 pharma partnerships.” nation to improve the standard of care for patients suffering from these blood cancers.” Development and use of the QIAGEN JAK2 assay during clinical trials is also included in the partnership, as is manufacturing and joint commercialization of the diagnostic product in parallel with Lilly’s compound. QIAGEN originally secured exclusive access to the JAK2 biomarker thanks to an agreement with Ipsogen, which it proposed to acquire in June. “QIAGEN’s strategy is to establish a broad range of [companion diagnostic] partnerships which are not only commercially valuable in themselves, but also have the potential to improve patient outcomes and minimize drug wastage,” says Little. “The Lilly partnership met all of these criteria.” QIAGEN’s partnership with Pfizer has a similar structure, except that the pair will be developing a companion diagnostic test for Pfizer’s non-small cell lung cancer compound. The investigational compound, dacomitinib (PF00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. QIAGEN and Pfizer will collaborate on the devel- • Measures every 14 seconds, giving you real-time kinetic results in minutes — 95% faster than other methods • Uses only 1% of cells needed by other methods • Assays adherent cells, suspension cells, tissue sections, and subcellular components, so you are no longer limited to trypsinized cells The XF Analyzer identifies mitochondrial dysfunction and subtle changes in neuronal cell metabolism early in pathogenesis, before the development of observable neurodegeneration. Learn how XF Analyzer results have helped advance several neurological drugs to Phase 2 clinical trials, and see for yourself why over 1,500 scientists have chosen the XF Analyzer for their bioenergetic research needs. See what’s possible. Scan this QR code to view videos and see what the XF Analyzer can achieve. Visit www.seahorsebio.com/neuro_product for more information and Special Offers! “ I understand that better biological tools are needed to bring ‘omic technologies to fruition, and the XF Analyzer is the best I have seen.” — David Ferrick, Ph.D., Chief Scientific Officer, Seahorse Bioscience 22 Drug Discovery News • October 2011 diagnostics For more information, visit www.DrugDiscoveryNews.com Irish blessing Queen’s University of Belfast and Almac agree to work on cancer tests By Kimberley Sirk CRAIGAVON, Northern Ireland—Pharmaceutical development company Almac and Queen’s University of Belfast joined forces in early September to co-develop tests for diagnosing and treating prostate, ovarian and breast cancer. “The initial focus is on the development of a prognostic test for prostate cancer, the development of technology to develop biomarkers from blood and the identification and development of novel drug targets” in the three cancers, says Prof. Richard Kennedy, the McClay Chair of Experimental Cancer Medicine at Queen’s University. Kennedy also now has a joint appointment at Almac. The research initiative, based at the Centre for Cancer Research and Cell Biology at Queen’s, will be led by Kennedy, one of Almac’s experts in personalized medicine—which tailors specific treatment to each cancer patient. Kennedy explains the research will involve using cutting-edge technology developed by Almac that will allow the partners to analyze patient tumors collected by Queen’s in quantity. “Almac provides technological and bioinformatics expertise required in the analysis of archived human tumor samples for target and biomarker identification,” Kennedy says. “The organization also has considerable expertise in the development of novel drug compounds through Almac Discovery, an independent member of the Almac Group focused on inno- Prof. Richard Kennedy with Enterprise Minister Arlene Foster and Prof. Patrick Johnston, the dean of the School of Medicine, Dentistry and Biomedical Sciences at Queen’s University. vative approaches to the treatment of cancer.” The two organizations, according to Kennedy, have enjoyed successful collaborations before now but this project is the first of its kind. “As well as having a large archived tumor bank, Queen’s University also has expertise in preclinical drug target and biomarker modeling as well as immunohistochemical biomarker development,” he says. “The university is also a leader in medicinal chemistry, particularly in fragment screening approaches.” In addition, Almac Group’s U.K. headquarters and Queen’s University are geographically close and have collaborated on projects in the past such as in the development of a prognostic test for stage II colon cancer and in the identification of a novel anti-angiogenic cancer therapy. The partners say that they will consider the pact successful if they are able to identify at least two commercially viable biomarkers and two drug targets that enter the Almac biomarker and drug development pipelines. The projects will be run under project management from Almac and have well-defined Go/No go criteria, goals and timelines. Kennedy also points out the regional economic development benefits of the partnership by pointing out that Almac has always demonstrated its commitment to education by funding several graduate student research positions. Full-time positions are also part of this collaboration. “There are 10 posts immediately linked to the program but also the possibility of expanding the number of jobs if the program is commercially successful,” he says. Economic development officials in Northern Ireland have expressed their support for the project, pointing out that academic and industry linkages are vital to economic growth, Short Courses: February 4–5 Conference: February 6–8 Exhibition: February 6–7 SLAS2012: Collaborate | Innovate | Dominate Collaborate with 5,000+ innovative scientists, engineers, researchers and technologists from academic, government and commercial laboratories around the globe to inaugurate the First Annual SLAS Conference and Exhibition in San Diego, CA, February 4–8, 2012. Stimulate your scientific creativity through 130+ outstanding educational presentations. Investigate new and emerging technologies from 275+ exhibitors. Calibrate your personal goals, accelerate your professional success and dominate the field of laboratory science and technology. Learn more and register for SLAS2012 at SLAS2012.org Enterprise Minister Arlene Foster (left) and Prof. Richard Kennedy (right), will lead a $6.9 million collaborative research initiative between Almac and Queen’s University to develop better tests for diagnosing and treating prostate, ovarian and breast cancer. strengthening the knowledge base and enhancing Northern Ireland’s reputation as an international research and development hub. Invest Northern Ireland (NI) and the McClay Foundation are partnering to fund the lab facilities and staff costs. Invest NI has committed financial support, which includes in part funding from the European Regional Development Fund under the Sustainable Competitiveness Programme for Northern Ireland. “The initial focus is on the development of a prognostic test for prostate cancer, the development of technology to develop biomarkers from blood and the identification and development of novel drug targets.” Prof. Richard Kennedy, McClay Chair of Experimental Cancer Medicine at Queen’s University The Almac Group provides a range of pharmaceutical services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology, to commercialscale manufacture. Almac provides services to more than 600 companies in the pharmaceutical and biotech sectors. While it is headquartered in Craigavon, Northern Ireland, it maintains a North American headquarters in Souderton, Pa., and has sites in California and North Carolina. The McClay Foundation, established in 2008 by Almac’s- founder, the late Sir Allen McClay in 2008, is a charitable trust which aims to advance the use of diagnostic tools and drugs in the prevention, control and cure of the disease and to support and encourage research and innovation in the field of healthcare across the globe, while promoting employment opportunities for the people of Northern Ireland. ddn EDITCONNECT: E101117 diagnostics For more information, visit www.DrugDiscoveryNews.com GE coNtINuED From PAGE 19 The company’s oncology portfolio already encompasses cellular research, medical imaging, laboratory diagnostics, biopharmaceutical manufacturing technologies and information technology. “We offer a portfolio of diagnostic technologies, such as X-ray, ultrasound and MRI, all of which are used for the diagnosis of cancer,” says Darby. “In December 2010, we acquired Clarient, a leading player in the fast-growing molecular diagnostics sector. Clarient’s technologies, combined with GE Healthcare’s strengths in diagnostic imaging, are expected to accelerate the development of new integrated tools for the diagnosis and characterization of cancer.” Other oncology portfolioboosting acquisitions by GE Healthcare that have brought the company to this moment include Amersham PLC in 2004, Biacore International AB in 2006, Wave Biotech LLC in 2007, MicroCal LLC in 2008 and Applied Precision in 2011. GE Healthcare also entered into a joint venture with Omnyx in 2009. The $1 billion investment will build on technologies and research already in progress, but it will also focus heavily on developing new oncology solutions—namely, in the identification of new biomarkers. “This is a key area of research for GE Healthcare,” Darby tells ddn. “Clarient pathologists recently identified a unique cancer diagnostic technology at GE Global Research that may give a clearer picture of the pathways driving specific tumors, and in turn may lead to more effective, personalized treatment recommendations. It is Clarient’s goal that by developing this sophisticated multiplexing technology, pathologists will be able to conduct more than 50 different stains on a single tissue section. GE Global Research’s ability to invent key technologies identified as critical by Clarient’s Medical Staff and Clarient’s ability to commercialize mean this game-changing breakthrough in science will be available for cancer patients in the very near future.” In addition to oncology, other key areas of research for GE Healthcare include investing in the development of stem cells as a tool for drug discovery research as well as cellimaging technologies. ddn editcOnnect: e101113 COLORECTAL coNtINuED From PAGE 19 Strait. The university has evolved into a multidisciplinary, comprehensive research center. The Sixth Affiliated GI Hospital of SYSU is the first GI hospital in China, focusing on treating malignant and benign gastrointestinal diseases—830 new GI cancer patients including 589 with CRC were diagnosed in the hospital last year. Within SYSU and its eight affiliated hospitals, more than 2,000 CRC patients are treated each year. Research scientists at the two universities will collaborate on the discovery, development and validation of biomarkers for screening high-risk populations to detect colon cancer at an early stage and for providing the most effective treatment strategy for patients, with the aim of improving patient outcomes and reducing cost. The agreement with SYSU forms the second hub in the Center for Sustainable Health’s Global Biosignatures Network (GBN), an effort to OctOber 2011 • Drug Discovery News harness scientific, academic, industry and healthcare system resources to make a major impact on 21st century healthcare practice. SYSU joins founding member Chang Gung University, which focuses on biomarker discovery and validation for oral and colorectal cancer. In his keynote address at the Arizona BioIndustry Association’s 2011 Expo earlier this month, Dr. Michael Birt, director of the Center for Sustainable Health at ASU’s Biodesign Institute, called for a shift in our health system to reward cost- effective prevention, early detection and intervention, saying this “has the potential to spur growth among bioscience organizations, reduce patient suffering, and lower healthcare costs. “By establishing biosignatures centers, we hope to build a global network that will provide the scale necessary to overcome scientific limitations while creating a global platform to share methods, results and experiences,” Birt told the conference. ddn editcOnnect: e101115 We’re fluent in the language of cGMP manufacturing for molecular diagnostics. If you need to source custom, GMP compliant (21 CFR Part 820) Probes, primers, or other oligos ASRs for LDTs Oligos or assay sets for pre-clinical trials Fill & Finish services Let’s talk! We fully understand the complex and demanding requirements of regulated medical device manufacturing. Request a free consultation to learn how our GMP & Commercial Services group can work with your development teams to design and deliver individual custom, GMP-compliant critical oligonucleotide components or fully finished diagnostic kits. Our extensive experience with cGMP manufacturing and our dedicated GMP team ensures ensu es results esults that will meet or exceed your sour sou rcing rrequirements. equirrements. equi sourcing Scientist to scientist, we speak your language. Scan this QR code to request a free consultation session or visit www.biosearchtech.com/IVDConsult © 2011 Biosearch Technologies, Inc. Products and technologies appearing in this ad may have trademark or patent restrictions associated with them. Please see www.biosearchtech.com/legal for full legal disclosure. 23 Society for Neuroscience 24 Drug Discovery News • October 2011 For more information, visit www.DrugDiscoveryNews.com Society for Neuroscience (SfN) 41st annual meeting November 12–16, 2011 Walter E. Washington Convention Center Washington, D.C. n Improved member directory launched this spring WASHINGTON, D.C.—April saw the Society for Neuroscience (SfN) launch a new “Enhanced Member Directory” (EMD) to give its members “a great new resource for finding colleagues around the world.” The EMD is accessible only to fellow SfN members, the society notes, “so you can share your fields of study, contact information and biographical information within a trusted community.” According to SfN, populating the EMD was the first step toward the launch of NeurOnLine, SfN’s membersonly online community that launched in the summer. Designed to engage members at all career levels, NeurOnLine “will keep you plugged in to the global SfN membership community,” the organization maintains. NeuroJobs gets a facelift WASHINGTON, D.C.—Early July saw SfN change up the technology platform for the NeuroJobs online professional development offering, giving it what the organization calls “a new look and enhanced features to help you find jobs even faster. New features include: advanced search options with “cloud filters,” an intuitive and visual way to sort and customize your job search results; saved job searches; enhanced job alerts, allowing users to establish a search and receive an automatic notification whenever a matching job is posted; Google Maps, so that job-seekers can now assess potential commutes right from the job detail screen; social media integration to more easily access NeuroJobs on Twitter, Facebook and LinkedIn and to post and find positions using all three networking sites; job application previews; and a searchable portfolio. THE BIG BRAINS Society for Neuroscience brings a wide range of perspectives to the nation’s capital with Neuroscience 2011 By Jeffrey Bouley WASHINGTON, D.C.— Billed as “the world’s largest forum for neuroscientists to debut research and network with colleagues from around the world,” the 41 st annual meeting of the Society for Neuroscience (SfN)—otherwise known as Neuroscience 2011—will take place Nov. 12 to 16 in Washington, D.C., at the Walter E. Washington Convention Center. With an expected attendance of more than 31,000 people, SfN will keep everyone engaged and interactive through lectures, symposia, workshops and social events focused on innovative neuroscience research. The meeting also will feature thousands of abstracts and provide networking and professional development opportunities. If figuring out what to attend and when to do it is a bit of a challenge—and it probably is for most people—the meeting section of the SfN website, located at www.sfn.org/ am2011/, features the Neuroscience Meeting Destination DC b r i e f s n A view of the Walter E. Washington Convention Center from 7th Street Northwest and Mount Vernon Place/New York Avenue. programs for those attending the meeting with their families in tow. Onsite childcare and youth programs are available for children between the ages of 6 months and 12 years, but spaces are limited, and it’s possible if you haven’t already reserved a spot, there may not be any more left. KiddieCorp can be reached by phone at (858) 455-1718 or by email at info@ kiddiecorp.com, and its website is at http:// www.kiddiecorp.com/. KiddieCorp is in its 25th year of providing such services at conventions, trade shows and special events, with the goal of providing children “with a program they want to attend, while providing you with that critical ‘peace of mind’ so you can attend sessions,” according to the company. This year’s theme is “Science Camp” and activities will include arts and crafts projects each day, group games, music and movement, board games, story time and dramatic play. Planner (NMP). The NMP can be used not only to search abstracts and sessions, but also to create your own itinerary for the annual meeting. To head off other potential complications for attendees, SfN has also contracted with KiddieCorp to provide childcare and youth Online funding directory available WASHINGTON, D.C.— A NeuroJobs Job Fair Destination DC new online offering appeared in mid-August courtesy of SfN, called the “SfN Directory of International Sources of Neuroscience Funding.” This resource is for members seeking information about international sources of funding for neuroscience. The online directory provides information about agencies, programs and opportunities for research grants, fellowships and other types of funding available by region and country. SfN will continue to update the directory as it learns about new opportunities, and SfN members are encouraged to submit updates and information about additional resources to [email protected]. At its full size, the main ballroom of the Walter E. Washington Convention Center can seat more than 2,700 for a banquet and 4,600 when set up as a theater. New at this year’s meeting will be SfN’s first NeuroJobs Job Fair, featuring employers from industry, nonprofit organizations and academia on-site, along with concurrent brains continued on page 26 For more information, visit www.DrugDiscoveryNews.com Society for Neuroscience October 2011 • Drug Discovery News 25 Blue and red plate specials Presidential Special Lectures Regardless of where you lie on the political or ideological spectrum, D.C. offers plenty of culinary choices Neurotrophins: From Axon Growth to Synaptic Plasticity M By Jeffrey Bouley any people think meat and STEAKHOUSES BLT Steak 1625 I St. N.W., Washington, D.C. This restaurant aims for an interpretation of the American steakhouse that combines bistro ambiance with steakhouse fare. The owners invite you to “Indulge in our signature warm popovers, along with specially selected steaks, fresh seafood and satisfying sides. Weekly blackboard specials highlight seasonal flavors and local ingredients.” You can choose from Japanese Kobe beef or less expensive American cut, and you can also enjoy lob- Saturday, Nov. 12, 5:15 p.m. to 6:25 p.m. Destination DC potatoes when they think of conservative folks, and they think field greens and organic grains when they think liberal. So, with the polarization so common in the nation’s capital these days, let’s have both ends of that culinary ideological spectrum—steakhouses on one end and veggie fare on the other—with a couple other cuisines tossed in to appeal to the moderates. The choices below—a few of them outside the D.C. city limits—are by no means the limit of your options within those categories, nor are they even endorsements (talk to my lobbyist about those), but they’ll give you a start on calming the stomach growls when you’re done with daily events, meetings and presentations at Neuroscience 2011. Mu-Ming Poo, Ph.D. University of California, Berkeley and Institute of Neuroscience, Chinese Academy of Sciences Dupont Circle is described as a cosmopolitan neighborhood and features many museums, historic homes, foreign embassies, ethnic restaurants, bookstores and private art galleries—as well as being one of the nightlife hubs. Dupont Circle is served by the Washington Metro Red Line at the Dupont Circle Metro station, which is a five-minute walk from the restaurant Cafe Green, listed in the vegetarian section of this article. VEGETARIAN CUISINE Mall, this place is known for such range as aged Angus rib-eye “cowboy” steak and an iced shellfish platter of lobster, shrimp, king crab and oysters, as well as a novel wine cube—which is designed to appear as if floating on water—boasting 3,500 bottles of exclusively American wine featuring more than 600 selections. Reportedly, this is a place that keeps busy with power brokers, so consider reservations, and if you’re there in the afternoon, there is a prix-fixe lunch. Smith & Wollensky Aroma 1919 I St. N.W., Washington, D.C. It’s not that Aroma is a vegetarian restaurant per se, but as with so many venues with Indian cuisine, veggies loom large and meat often takes a back seat—or at least less prominence than is the case with so many other places in the United States. Aroma prides itself on fine dining and authentic cuisine in a “serene, pleasant atmosphere” and counts entirely vegan soups and a vegetarian section among its menu options. The restaurant also has a location in nearby Arlington, Va. Amsterdam Falafel Shop 1112 19th St. N.W., Washington, D.C. This restaurant offers an outside patio, the bustling Wollensky’s Grill and quiet formal dining rooms, as well as private rooms that can seat as many as 450 people. The theme here is “simple, elegant food in 2425 18th St. N.W., Washington, D.C. Located in the Adams Morgan neighborhood, this establishment offers all-vegetarian offerings specializing in falafel. Reportedly, it also has an almost all-vegan toppings bar to create your own sandwich. Prices are reasonable and the eatery is open late into the night. Elizabeth’s Gone Raw Destination DC 1341 L St. N.W., Washington, D.C. M Street is Georgetown’s main shopping street, and tends to be known primarily for stores that are part of major chains or bear well-known names, though many smaller boutique and specialty shops can be found nearby as well. In addition to the stores and restaurants at street level, there are also many underground in the Georgetown Shops. ster, cheesecake, fresh fruits, cheese selections and more—but apparently you’d better make reservations well in advance. Charlie Palmer Steak 101 Constitution Ave. N.W., Washington, D.C. Although it’s not attributed, I imagine the quote on the website, “I’m a patriotic guy and someone has to supply the apple pie around here,” is probably from Charlie Palmer himself. Located near the National a refined setting.” Midday food options include the house hamburgers made from Smith & Wollensky’s own aged beef and served with crispy, hand-cut fries. Other options include split pea soup, fried calamari, an iceberg wedge salad topped with thick slices of ripe tomatoes and a Roquefort dressing. Lamb chops and roast chicken provide options for the meat-eaters who are beef-averse. This gourmet restaurant—for which reservations are required—serves an entirely raw, all-vegan menu for your dairy-, glutenand meat-free needs that also include desserts and organic wines. Elizabeth’s Gone Raw seeks to celebrate nature and the ingredients of Earth in their purest form. Even the water they serve has been through a reverse-osmosis treatment. Cafe Green 1513 17th St. N.W., Washington, D.C. This all-vegan, organic, full-service restaurant and bar has featured such items as raw pizza, vegan steak n’ cheese sandwich and hand-made gnocchi, all with an emphasis on using local, seasonal ingredients. Cafe Green also offers raw selections, smoothies and desserts. It’s open until midnight on Friday and Saturday and offers an extensive brunch menu on Sundays until 4 p.m. MONGOLIAN BARBECUE BD’s Mongolian Barbeque 7201 Wisconsin Ave., Bethesda Md. The website for this restaurant recounts the plate continued on page 27 Neurotrophins were first identified as target-derived factors that promote neuronal differentiation and survival. Over the past decades, they also were found to regulate neuronal differentiation, axonal and dendritic growth, synapse formation and plasticity, as well as cognition and behavior. This lecture provides a retrospective view of the evolving concepts in the study of neurotrophins, with some highlights on recent findings on the role of neurotrophins in axon development and synaptic plasticity. The Basal Ganglia: Binding Values to Action Ann M. Graybiel, Ph.D. Massachusetts Institute of Technology Sunday, Nov. 13, 5:15 p.m. to 6:25 p.m. This lecture will summarize evidence that neural activity in cortico-basal ganglia circuits can exhibit high levels of flexibility related to value-based decision-making and adaptive behavior, but also can become overly fixed despite the need for change. This interplay between flexibility and fixity, if imbalanced, may underlie dysfunctions leading to motor and neuropsychiatric problems in basal gangliabased disorders. Genes, the Environment, and Decisions: How Fixed Circuits Generate Flexible Behaviors Cornelia I. Bargmann, Ph.D. Rockefeller University Monday, Nov. 14, 5:15 p.m. to 6:25 p.m. How do genes and the environment interact to generate flexible behaviors? How are behavioral decisions modified by context and experience? Genetic variation, internal states and environmental conditions converge on common neuronal circuits to regulate behaviors in the nematode worm C. elegans. Analysis of these circuits shows the detailed wiring diagram of C. elegans is both incomplete and ambiguous, because modulatory inputs invisible in the anatomical wiring change the flow of information. The Epigenetic Basis of Common Human Disease Andrew P. Feinberg, M.D., MPH Johns Hopkins University School of Medicine Tuesday, Nov. 15, 5:15 p.m. to 6:25 p.m. Epigenetics is the study of heritable information other than the sequence of DNA. We are taking an integrated approach to catalyze the generalization of gene-specific to genomic epigenetics and to advance the focus from cancer to common disease. Doing this requires an integration of new conceptual, technological, epidemiological and statistical approaches. Epigenetic variation influenced by genetic variants could help mediate complex traits. We have identified sites of stochastic epigenetic variation in the genome that are stably linked to traits such as body mass index. ddn 26 Drug Discovery News • October 2011 Society for Neuroscience For more information, visit www.DrugDiscoveryNews.com Such sights to see You know about the Washington Monument, Lincoln Memorial and the rest, but here are some lesser-hyped places weakness and instability associated with any disability during those times. The memorial is located at 1850 West Basin Drive S.W. By Jeffrey Bouley WASHINGTON, D.C.—You could probably visit the capital every week for a conference like Neuroscience 2011 and still barely scratch the surface of what there is to see and do, even after a few years. The Smithsonian campus alone is one of those places that requires numerous visits, and then there are all the famous memorials and other attractions to be seen. But if you’ve been to the “must-see” places that grace all the tour guidebooks and news coverage—or if you’d prefer to avoid them— we offer a quartet of lesser-known things to see while you’re in town for the annual meeting of the Society for Neuroscience. Kramerbooks & Afterwords Duke Ellington Mural Destination DC A jazz legend looms large on the side wall of Mood Indigo, a shop specializing in vintage clothing, shoes and accessories and located adjacent to the Green Line Metro station at 13th St. N.W. and U St. N.W. You’ll be visiting the Shaw neighborhood of Washington, D.C., within the Mount Vernon Square historic district to view the Duke Ellington Mural, and Located roughly at 1214 U St. N.W. in Washington, D.C., this mural of jazz legend Duke Ellington is in what many deem to be DC’s jazz district and is right next to Ben’s Chili Bowl, a well-known eatery with some very late hours. you’ll be in an area that has been a hub of African-American cultural life since the late 19th century and the neighborhood that is said to have shaped and nurtured him. Ellington grew up just around the corner on Bates Street and began his career in the music halls and clubs that flourished along nearby 14th Street in the early 1900s. The painting was completed in 1997 by muralist G. Byron Peck, and is based on a photo of Ellington on the frontispiece of his autobiography, Music Is My Mistress. If you’re a bit hungry after making the trek to see it, stop into Ben’s Chili Bowl, a well-known casual eatery that boasts some very late hours and is famous not just for chili (meat and vegetarian) but also chili dogs and seafood. World War II Memorial While many people think of the memorial to Vietnam veterans, this more recent arrival to Washington, D.C., isn’t as well known. Located at 17th St., between Constitution Avenue and Independence Avenue, the World War II Memorial honors the 16 million people who served in the armed forces of the U.S. during that conflict, the more than 400,000 who died in it and all who supported the war effort from home. The memorial is noted for the fact that the Second World War is the only 20th century event commemorated on the National Mall’s central axis. The design of the memorial features 56 pillars and a pair of arches surrounding a plaza and fountain, and it was built on the former site of the Rainbow Pool at the eastern end of the Reflecting Pool, between the Lincoln Memorial and the Washington Monument. On the west side of the memorial is the Freedom Wall, which has a view of the Reflecting Pool and Lincoln Memorial behind it. Adorning the wall are 4,048 gold stars, each star representing 100 Americans who died in the war. In front of the wall is the message, “Here we mark the price of freedom.” Franklin Delano Roosevelt Memorial The only U.S. president to serve more than two terms is honored here—a man who was stricken with polio at age 39 and paralyzed from the waist down, as well as having to lead the nation during the Great Depression and World War II. Sculptures inspired by photographs show the president alongside his dog Fala, and there is also a bronze statue of Eleanor Roosevelt standing before the United Nations emblem— reportedly notable as being the only case of a presidential memorial depicting a first lady—to honor her dedication to the U.N. Other sculptures depict scenes from the Great Depression, such as listening to a fireside chat on the radio and waiting in a bread line. Because Roosevelt himself dealt with a physical disability, the memorial’s designers endeavored to create a memorial that would be accessible to visitors with physical impairments. Among other features, the memorial includes an area with tactile reliefs and Braille writing for people who are blind, although many criticized that feature because the Braille was beyond the reach of even most tall people. Another point of controversy with the memorial was the statue of FDR himself, because the designers didn’t show his wheelchair. Instead, the statue depicts the president in a chair with a cloak obscuring the chair, the given rationale being that FDR’s reliance Dedicated on May 2, 1997, by President Bill Clinton, the FDR Memorial is on a wheelchair was not pubmore than just the statue shown here, spreading over 7.5 acres and tracing licized or emphasized during 12 years of the history of the United States through a sequence of four his life, given the stigma of outdoor rooms, one for each of Franklin Delano Roosevelt’s terms of office. Destination DC Destination DC The national World War II Memorial opened to the public on April 29, 2004, and was dedicated by President George W. Bush on May 29, 2004, two days before Memorial Day. The memorial is administered by the National Park Service under its National Mall and Memorial Parks group. Want to catch up on some reading and refreshments? Here at 1517 Connecticut Ave. N.W., the vibe, as described once by The Washington Post, goes like this: “The action at Kramerbooks & Afterwords starts with breakfast and the morning papers at 7:30 a.m., and keeps throbbing until well after midnight, seven days a week, complete with indoor and sidewalk cafes, a full-service bar and live entertainment. The sounds are diverting, the smells are delicious, the sights are tempting.” Kramerbooks is a cultural landmark and the New York Times writes that “Many people do not consider themselves true Washingtonians until they have received a phone call that begins as an invitation for drinks after work and ends with ‘I’ll meet you at Kramer’s.’ Kramerbooks & Afterwords is definitely an institution.” Reportedly, the Afterwords Cafe, which opened in 1976, was the first bookstore/cafe in the country to feature cappuccino, espresso, a full bar and food. ddn EDITCONNECT: E101133 brains continued from page 24 career development workshops. The event is free for all meeting attendees and is, as SfN notes, “an opportunity for employers to meet hundreds of job seekers at Neuroscience 2011.” The NeuroJobs Job Fair will be held Saturday, Nov. 12, from 8:30 a.m. to 11 a.m., and from 1 p.m. to 4 p.m., closing at midday for the Neuroscience 2011’s “Dialogues” lecture. Speaking of that lecture, the speaker will be Dr. Robert J. Shiller, an American economist, academic and bestselling author, who will talk about economics and behavior under the title of “Animal Spirits: How Human Behavior Drives the Economy.” Shiller currently serves as the Arthur M. Okun Professor of Economics at Yale University and is a fellow at the Yale International Center for Finance of the Yale School of Management. Reportedly ranked among the 100 most influential economists of the world, Shiller’s work has addressed how psychological factors influence decisionmaking in the economic arena and the impact of group dynamics on financial markets, and SfN invites you to “join Dr. Shiller and leading neuroscientists for an exciting opportunity to examine the interplay between economics and the brain.” ddn EDITCONNECT: E101131 Plate continued from page 25 history of the Mongolian barbecue concept—a cuisine I first became acquainted with on a business trip to D.C. When the Mongols were doing their fighting and hunting centuries ago, BD’s notes, they would gather in large community groups to celebrate their adventures and their successes. “Communing in banquet-style pavilions, the Mongols would create a ‘feast’ for all to enjoy by combining slivers of meat and vegetables, sliced with their razor-sharp swords, then cooked on their overturned shields over a blazing fire,” the website notes. In the modern day, this means going to a restaurant and picking out your own noodles, rice, vegetables, meats, sauces and/or other fixings, and giving them over in a bowl to a chef who will stir-fry it on a big cooking surface where other patrons’ food is likely also cooking. It can be confusing for some at first, but many people like the control they get over their flavors, and BD’s regularly comes up as a recommended Mongolian barbecue destination. Tony Cheng’s Mongolian Restaurant 619 H St. N.W., Washington, D.C. Located in Chinatown, this restaurant gets mixed reviews at times regarding the price-to-quality ratio, but it remains a popular choice. In addition, there is a portion of the restaurant devoted to more traditionaly Chinese food options. Genghis Grill 7001F Manchester Blvd., Alexandria, Va. This restaurant touts not only its casual setting and “colorful, lively” atmosphere but also the notion that Mongolian barbecue is not really a cuisine but rather an “interactive style of exhibition cooking modeled after a centuries-old legend.” SEAFOOD The Oceanaire Seafood Room 1201 F St. N.W., Washington, D.C. Located in the Penn Quarter, Oceanaire goes for the “sleek and sophisticated” vibe, while offering the freshest seafood that it can manage to fly in daily from around the world. The menu is based on market availability so selections change each day. Legal Sea Foods 704 7th St. N.W., Washington, D.C. Calling itself a bipartisan favorite since 1995, Legal has a racetrackshaped bar at which you can dine or a main dining room underneath a hull-like ceiling—plus a neon sign outside—so this is less highbrow than Oceanaire and is just a block from the convention center, as well as being near the Verizon Center, International Spy Museum and National Portrait Gallery, among other locales. Sea Catch Restaurant 1054 31st St. N.W., Washington, D.C. This restaurant and raw bar is located in downtown D.C. in Society for Neuroscience Georgetown, just steps from M Street, and is reportedly the only restaurant overlooking the C&O Canal. Sea Catch offers what it calls “fresh seafood simply prepared in a casual, relaxed atmosphere.” DC Coast 1401 K St. N.W., Washington, D.C. Chef Jeff Tunks is said to be famous for his Chinese-style smoked lobster and pan-roasted rockfish with polenta cake and lobster corn broth, but the restaurant also offers such non-seafood fare as grilled New York strip steak with andouille October 2011 • Drug Discovery News 27 hash and marinated free-range chicken with roasted fingerling potatoes and grilled ramps. Now, if that list isn’t enough for you, and if you like to bump elbows with important people—or self-important people, depending on your outlook— you can always take a look at the “Power Dining” list of restaurants at the Destination D.C. website, at http://washington.org/visiting/ experience-dc/foodie-experience/ power-spots/. ddn EDITCONNECT: E101132 Destination DC For more information, visit www.DrugDiscoveryNews.com Located in the northwest portion of Washington, D.C., the Woodley Park neighborhood is bounded on the north by Woodley Road and Klingle Road, on the east by the National Zoo and Rock Creek Park, on the south by Calvert Street, on the southwest by Cleveland Avenue and on the west by 34th Street. 28 Drug Discovery News • October 2011 b r i e f s Sistemic added to the ranks of ARM SISTEMIC, U.K.—Sistemic Ltd. recently joined the Alliance for Regenerative Medicine (ARM), a nonprofit organization with the goal of advancing regenerative medicine by representing and supporting members in front of government agencies as well as the general public. More than 80 members are part of ARM, including research institutes, companies, foundations and investor groups. Sistemic’s contribution to the initiative will include access to its cell characterization knowledge, innovative tools and experience for the members of ARM as well as the community. Morrie Ruffin, managing director of ARM, said, “We are delighted that Sistemic have joined ARM and look forward to sharing information and understanding … we feel Sistemic has a great deal to offer the Alliance in helping to support and develop this sector.” For more information, visit www.DrugDiscoveryNews.com Lessons in lifestyle and lipids Shimadzu and the University of Tokyo to develop lipidomics technology for biomarker discovery By Lloyd Dunlap KYOTO, Japan—Shimadzu Corp. and the University of Tokyo have signed a joint research agreement aimed at developing technology for the comprehensive analysis of functional, membrane and other lipids for the purpose of discovering biomarkers for such lifestyle- related diseases as hypertension, diabetes, atherosclerosis, stroke and dyslipidemia. “We aim to explore some factors (markers/profiles) which are common to such lifestyle diseases and also analyze the separate factors that characterize these diseases,” says Shimadzu spokesperson Satoko Maeji. Lipid metabolism is also thought to be involved in and/or responsible for a host of additional diseases and conditions, ranging from myocardial infarction to congenital diseases such as Niemann-Pick disease, Gaucher’s disease and Tay-Sachs disease. Drug-induced phospholipidosis is one of the challenges in drug discovery, Maeji notes. The accumulation of phospholipids in various tissues causes failure in physiological functions. “You should choose the medicine which does not result in these side effects,” Maeji adds. Shimadzu, the University of Tokyo and Ono Pharmaceutical Co. Ltd. of Osaka, Japan, have jointly established a sponsored laboratory at the university, the Department of Lipidomics in the Graduate School of Medicine and VANCOUVER, British Columbia— Tekmira TGen Center for Proteomics named Waters Center of Innovation MILFORD, Mass.—Waters Corp. recently recog- nized the Center for Proteomics at the Translational Genomics Research Institute (TGen) as a Waters Center of Innovation. Dr. Konstantinos Petritits, head of TGen’s Center of Proteomics, and his team in particular were also recognized for their leadership in proteomics research and biomarker discovery and verification. The selection establishes TGen in the ranks of fewer than 20 partners worldwide that have been recognized as part of the Waters Centers of Innovation. “We are making steady progress in the development of diagnostic and prognostic biomarkers for lung, colon, breast and pancreatic cancer as well as other diseases. We’re thankful to Waters for their support of our programs, not just in terms of instrumentation, but in terms of their training, technical support and services,” said Petritis. lipid continued on page 30 Not just an expression Tekmira, Halo-Bio sign exclusive license agreement Pharmaceuticals recently announced the acquisition of an exclusive, worldwide license to HaloBio RNAi Therapeutics Inc.’s novel and proprietary RNAi technology, MV-RNA (multivalent RNA). Within this license and collaboration agreement, Tekmira and Halo-Bio will work together to design and develop MV-RNA molecules to gene targets specified by Tekmira, in addition to combining MV-RNA molecules with Tekmira’s lipid nanoparticle (LNP) technology for the development of therapeutic products. Halo-Bio’s MV-RNA technology consists of single macromolecules with the ability to mediate RNAi at multiple target sites, with MV-RNA being capable of targeting three sites on one gene or up to three separate genes simultaneously. Financial details of the agreement were not disclosed. Faculty of Medicine, which began operation in April of this year. The research is being coordinated by associate professor Yoshihiro Kita. The purpose of the department is to systematically and comprehensively analyze low molecular weight compounds, such as bioactive and membrane lipids, as the next area of research following genomics and proteomics. In addition, it also aims to clarify how these substances relate to sustaining life and to discover biomarkers for the onset of diseases, such as lifestyle-related diseases Clavis, Skyline team up on biomarkers for AML drug By David Hutton Mental Health (NIMH). “We are embarking on another large study of bipolar disorder with our colleagues at the University of Michigan, and these data give us hints on genetic variants to examine further with more in-depth technologies,” Richard Myers, director of the HudsonAlpha Institute, stated in a news release in late August. Given the complex nature of bipolar disorder and other psychiatric conditions, scientists need to examine variation in the genomes of large numbers of individuals and pool the information together, Myers said. “Bipolar disorder is severely disabling and often life-threatening,” Myers stated. “This study, which will continue into 2014, will increase our understanding of bipolar disorder and support identification of targeted therapies ROTTERDAM—Clavis Pharma and Skyline Diagnostics recently took the wraps off a deal to investigate gene expression biomarkers that may help determine which patients will benefit from a drug compound being developed for treating acute myeloid leukemia (AML). Under this agreement, Skyline will investigate gene expression biomarkers for selection of individual AML patients that may benefit from a new AML drug in development at Clavis. The drug, elacytarabine, is a novel elaidic acid derivative of cytarabine and currently undergoing a Phase III study for treatment of patients with relapsed/refractory AML. Financial terms have not been released. The research agreement is a service-for-fee agreement, and Clavis Pharma retains the right to exploit any and all results coming out of the research. Athos Gianella-Borradori, chief medical officer of Clavis, says the collaboration is key for Clavis and for elacytarabine. “Skyline Diagnostics’ expertise will be instrumental in searching for gene expression patterns that can be utilized in the further biomarker program of elacytarabine,” notes Gianella-Borradori. “This genomic approach adds to our currently ongoing patient selection based on protein markers and will deepen our insights into the potential for precise and highly effective personalized medicines. bipolar continued on page 32 express continued on page 30 The Huntsville, Ala.-based HudsonAlpha Institute of Biotechnology and the University of Michigan recently received a $7.8 million award from the National Institute of Mental Health to probe genetic contributors to bipolar disorder. On the hunt for genetic clues By Lori Lesko HUNTSVILLE, Ala.— Touted as the largest genetic study of bipolar disorder to date, 169 scientists from 11 countries have discovered a new genetic location contributing to susceptibility to the disorder, and found further evidence of a genetic link to the mental illness marked by mood swings, mania and depression. These findings were published Sept. 18 in the online journal Nature Genome. The scientific article has set the stage for interest in a new three-year study launched by researchers at the Huntsville, Ala.-based HudsonAlpha Institute of Biotechnology and the University of Michigan. The institutions are teaming up—this time using wholegenome sequencing to look for genetic contributors to bipolar disorder—thanks to a $7.8 million award from the National Institute of ComPanion DiagnostiC seRviCes ConsUltation | samPle PReP | analy te analysis | Data analysis | assay DeveloPment | CommeRCialiZation Scientist-driven solutions for companion diagnostic development Asuragen Inc., is a fully integrated companion diagnostic company focused on developing and commercializing personalized molecular diagnostic tests. By leveraging our comprehensive assay development expertise, CLIA and GLP testing services, cGMP manufacturing, regulatory experience, and commercialization capabilities within our Pharmacogenomic Services and Diagnostic Divisions, Asuragen is uniquely positioned as a premier companion diagnostic partner. 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PhaRmaCogenomiC seRviCes Co-Rx/Dx DeveloPment DiagnostiC DeveloPment Contact us today and start leveraging our deep scientific talent to speed your research and further your drug development programs. 877.777.1874 | [email protected] | www.asuragen.com R&D/PRe-CliniCal/CliniCal | BiomaRkeR DisCoveRy | Patient stRatifiCation | assay DeveloPment | ComPanion DiagnostiCs 30 Drug Discovery News • October 2011 omics & systems biology Think about the orphans Synageva BioPharma enters R&D partnership with Mitsubishi Tanabe Pharma to develop protein therapeutic for orphan disease target By Jeffrey Bouley LEXINGTON, Mass.—Synageva BioPharma Corp. recently announced that it has formed a research and development partnership with Osaka, Japan-based Mitsubishi Tanabe Pharma Corp. to develop a novel therapeutic for an undisclosed orphan disease. Under the terms of the deal, Mitsubishi Tanabe Pharma will make an upfront payment of $3 million and will contribute additional research funds, getting in return Synageva’s expertise in the rare disease space, its product development capabilities and the benefits of its proprietary protein expression platform, according to Sanj K. Patel, Synageva’s president and CEO. Partnering is a particular focus of Synageva’s efforts on both the business and science sides of the corporate equation, with the company noting on its website that it is “committed to becoming the leading innovator of therapies for patients with rare diseases. We intend to further our mission to reach these patients by establishing partner- lipid continued from page 28 and other metabolic disorders. Parallel with genomics and proteomics, lipidomics refers to the comprehensive analysis of lipids, which have been considered difficult to analyze in a comprehensive manner. Due to recent advances in mass spectrometry, there has been rapid progress in this field. By participating in this joint research, Shimadzu says it aims to develop instruments and software that are better tailored to the needs of research laboratories and contribute to pathological analysis and the development of basic technology for drug discovery. The University of Tokyo will use state-of-the-art technology for analyzing lipids to understand the mechanisms involved in diseases fundamentally based on lipid metabolism. Lipid mediators, including prostaglandins, leukotrienes, platelet-activating factor and many other bioactive lipid metabolites, are attracting great attention as disease-related or physiologically important molecules. Comprehensive analysis of known lipid mediators is a use- ships with organizations to license assets to partners or bring new assets into Synageva for development and commercialization.” That means everything from outlicensing to in-licensing and technology licensing to product development collaborations like this one with Mitsubishi Tanabe. Looking to such development collaborations, the company notes that “Synageva’s senior team has been involved in the development and commercialization of nearly all of the novel protein therapeutics marketed to date for rare disease markets.” Although neither company would comment on the current deal, Synageva’s Patel noted very specifically in the news release that “this agreement illustrates Synageva’s strategy to help fund our internal product development by selectively forming partnerships to create therapeutics for rare diseases not targeted by our pipeline products.” This suggests that the target isn’t related to Synageva’s current pipeline, and the only other thing Patel will say about the target is that the partnership “should result in a new treatment for a devastating condition.” It remains to be seen whether that “devastating condition” is one of Mitsubishi Tanabe’s current pipeline targets, which domestically in Japan focuses on immunology and inflammatory diseases, ful, unbiased method in disease mechanism studies, and the lipid mediator profile is a useful parameter that characterizes disease status as well. At the University of Tokyo, the scientific team has developed an original multiplex quantification method for trace amounts of lipid mediators using liquid chromatographytandem mass spectrometry (LCMS/MS). The goal is to develop more sensitive and rapid methods that cover more lipid mediators, which meet the demands of various large-scale studies and high-throughput screening approaches. Shimadzu will provide the LC-MS/MS system to the University of Tokyo for lipid biomarker discovery, says Maeji. This agreement specifies a research term for the Department of Lipidomics that extends until March 31, 2014. During this term, Shimadzu and the university will jointly research topics such as the development of a biological sample pretreatment system and a comprehensive method for analyzing lipids, and apply these to the discovery of lipid biomarkers. The department will assist with this effort. ddn EDITCONNECT: E101118 diabetes and lipid metabolism disorders and hepatic diseases, and in Europe and the United States is “centered on two products that have advanced to the development stage in the field of renal diseases,” according to Mitsubishi Tanabe’s website. Synageva is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for patients with lifethreatening rare diseases and unmet medical need, with its major product being SBC-102, which has been granted orphan designations by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, and fast-track designation by the FDA. SBC-102 is a recombinant human lysosomal acid lipase currently under clinical investigation for the treatment of patients with early-onset and late-onset lysosomal acid lipase deficiency—a progressive and often fatal lysosomal storage disorder also known as Wolman disease and cholesteryl ester storage disease. In addition to SBC-102, Synageva has other protein therapeutic programs targeting lysosomal storage disorders and other rare diseases that are in various stages of preclinical development. ddn EDITCONNECT: E101121 pth continued from page 1 biomarkers, enabling Thermo Fisher to offer its worldwide life science research and clinical diagnostics customers an enhanced solution for quantitative protein biomarker detection, according to a Thermo Fisher media release. “We began our collaboration about a year ago,” says Dr. James Ladine, global director of R&D with Thermo Fisher’s lab consumables division. The collaboration recently resulted in a paper in the Journal of Clinical Chemistry, which detailed the workflow and assay results for parathyroid hormone (PTH) in blood. “We showed 17 different PTH hormone variations,” Ladine notes, most resulting from ends having been truncated. “Other techniques just show a big, dumb number,” he says, and lump together forms of the hormone that may not be active. Sensitivity is 8 picograms per milliliter, which compares favorably with other assays, he says. The IBI portfolio includes its novel Mass Spectrometric Immunoassay (MSIA), featuring a patented sample preparation technique. This technology allows enrichment of low-abundance proteins in biological samples. The specificity of immuno-enrichment, coupled with For more information, visit www.DrugDiscoveryNews.com express continued from page 28 It is our goal and vision that this collaboration with the experts of Skyline will bring better therapies to the many patients suffering from difficult-to-treat leukemia.” According to Henk Viëtor, CEO of Skyline Diagnostics, Clavis proved to be an attractive collaborator because it is working on an AML compound and is investigating associated biomarkers. “Skyline’s expertise in companion diagnostics, gene expression analysis and hematological diseases makes this a perfect fit,” he says. Ole Henrik Eriksen, chief operating officer of Clavis, adds that this is the first time the companies have worked together. He says Skyline was an attractive partner because it has a large sample database and proprietary technologies that can potentially help Clavis identify patients who may benefit from treatment with elacytarabine. “Elacytarabine has been designed to target leukemia patients with low expression of hENT1 (human equilibrative nucleoside transporter 1),” notes Eriksen. “Elacytarabine is thought to be independent of hENT1, whereas it is believed that today’s standard therapy, cytarabine, requires hENT1 for entry into cancer cells. The goal is to demonstrate that the efficacy the sensitivity and quantitative capability of mass spectrometry, gives researchers a complete, higher-resolution view of the proteome. According to Thermo Fisher, the MSIA technology provides greater sensitivity and higher throughput than conventional ELISA and beadbased immunoassay formats. Ladine notes that there are two trends in biomarker assays like that for PTH—greater complexity and lower abundance. In terms of complexity, he cites PSA as an example of a “traditional marker” that is being seen as more complex than previously thought. “Complexity can involve truncation,” as with PTH, “splicing variances and different sites or extent of phosphorylation,” he says. IBI’s proprietary immunoenrichment technology involves 10 steps, Ladine notes, nine of which are now made by Thermo Fisher, and is based on a patented pipette tip that integrates a high-throughput, highbinding-capacity microcolumn activated with antibodies. This technology addresses one of the key challenges of biomarker discovery and validation—the isolation and analysis of very low-abundance proteins such as PTH in complex biological matrices. Conventional approaches involving depletion of interfering high-abundance proteins are timeconsuming and introduce analytical of elacytarabine is independent of the patient’s hENT1 status.” Elacytarabine is a lipid-conjugated derivative of cytarabine, the standard treatment for AML. In contrast to cytarabine, elacytarabine can enter cells without requiring membrane expression of transporter proteins, particularly hENT1, and therefore retain its effect independent of the hENT1 expression level. Clavis wants to strengthen its biomarker program by exploring whether mRNA expression of hENT1 and related genes is correlated to cytarabine response. Skyline Diagnostics will use its bioinformatics engine to search for and validate biomarkers that are relevant for elacytarabine. Its focus will be on hENT1 and related genes to see if there is a correlation with response to cytarabine. Viëtor notes that the current project will focus on expression of the hENT1 gene and related genes. The results of this study will determine if this technology can provide new insight and predict response. In the short term, success will be gauged on whether array technology can be used to determine efficacy using expression of hENT1 and related genes, and in the midterm, to determine the possibility to develop a companion diagnostic and design a development plan and platform. ddn EDITCONNECT: E101120 variability. Compared to other immunoenrichment approaches, IBI’s approach promises more effective capture of low-abundance proteins. A key challenge in proteomics research is the ability to differentiate between and accurately quantitate intact proteins and their variants. Traditional enzyme-linked immunosorbent assays (ELISA) are limited by the inability of the antibodies to discriminate between all variants and quantify their abundance, Thermo Fisher states. “The Intrinsic Bioprobes portfolio will enhance Thermo Fisher’s position in the rapidly emerging field of clinical proteomics,” says Chuck Kummeth, president of Thermo Fisher’s laboratory consumables business. “It is a simple, yet powerful approach to uncovering the proteomic basis of disease, and it better positions us to support our customers in their efforts to realize the promise of personalized medicine.” IBI was founded in 1996 by Randall W. Nelson, who has served as its president since then. He will continue to be involved with the business as a consultant. Thermo Fisher declined to comment on the possible integration of IBI’s staff or facilities or provide information on the dollar value of the acquisition. ddn EDITCONNECT: E101104 MagNA Pure 96 System Purify DNA and RNA from 96 samples in less than 1 hour! Increase your lab’s throughput with the MagNA Pure 96 System. Fully automate the purification of nucleic acids from 96 standard-volume samples in less than one hour – including setup time! L Perform a variety of purifications with one versatile instrument. Consistently isolate high-quality DNA, RNA, or viral nucleic acids (Figure 1) from a wide variety of sample materials of up to 1 ml; use the resulting samples in qPCR, genotyping, and other downstream applications. L Increase convenience, and reduce labor cost. Reduce hands-on time by using barcoded prefilled reagent trays and disposables, intuitive software, and preprogrammed purification protocols. Figure 1: High-quality nucleic acid yield, purity, and reproducibility using the MagNA Pure 96 System. In this experiment nucleic acids were isolated from serum samples, spiked with Parvo B19 virus at very low concentration, and analyzed on a LightCycler ® 480 Real-Time PCR Instrument. Black: standard curves, Green: Parvo B19 samples, Blue: negative controls. L Ensure data integrity. Easily manage data from sample to result (e.g., in a workflow with the LightCycler® 480 Real-Time PCR System) via connectivity to LIMS or a networked file server. Bring true high-throughput purification to your lab. Call 800 262 4911 or visit www.magnapure96.roche.com to learn more about how purifying 96 samples in 1 hour can improve your lab’s productivity. For life science research only. Not for use in diagnostic procedures. MAGNAPURE and LIGHTCYCLER are trademarks of Roche. © 2011 Roche Diagnostics. All rights reserved. MP96_DDN.indd 1 Roche Diagnostics Corporation Roche Applied Science Indianapolis, Indiana 1/13/2011 11:27:14 AM 32 Drug Discovery News • October 2011 bipolar continued from page 28 and approaches for treatment.” Bipolar disorder is a chronic mental illness that affects roughly 1 percent of the population. Often diagnosed before the age of 25, bipolar disorder is characterized by dramatic mood and behavioral changes that oscillate between mania and depression, according to the NIMH. Symptoms may seem like separate problems, so diagnoses have been impeded and therapy often delayed. omics & systems biology Doctors have suspected for decades that bipolar disorder is hereditary since individuals with an affected parent or sibling are more likely to develop bipolar disorder than the general population—but there was no way to prove it. The NIMH reports that children with a parent or sibling who has bipolar disorder are four to six times more likely to develop the illness, compared with children who do not have a family history of the disorder. The NIMH project encompasses information from more than 7,000 individuals to provide more accurate prediction of risk, Myers said. Myers’ colleague and friend, Michael Boehnke, director of the University of Michigan Center for Statistical Genetics Scientists, is one of the study’s lead investigators. “There’s a strong familial component,” says Boehnke, who is also director of the University of Michigan’s Genome Science Training Program. “It’s not necessarily the case that that strong familial component would translate to a genetic basis, but it’s entirely possible that it would.” For more information, visit www.DrugDiscoveryNews.com The first phase of the NIMH-funded project will include whole-genome sequencing of 2,000 individuals, half of whom have been diagnosed with bipolar disorder and half of whom have not. Scientists will look for similarities between those diagnosed with bipolar and the control population. An additional 5,000 individuals will be included in comparative studies addressed with separate funding. “We are working exclusively with bipolar I, the most severe type [of bipolar disorder],” said Myers. “It is not just a passing [depression]. Once this starts, it seems to set in and massively affect people as well as their families and people around them.” Analysis on samples previously collected will be one of the largest sequencing studies in the world, he said. Myers is leading the effort at the HudsonAlpha Institute, where the bulk of the experimental work will take place, while Boehnke will head the University of Michigan arm of the study, focusing on statistical analyses of the data. “Our research team combines strengths in high-throughput genetics and genomics and development and application of innovative computational and statistical methods to maximize the benefits of cuttingedge technologies,” Myers stated. Boehnke says the bipolar sequencing study may ultimately include collaborators and participant samples from other institutions. To be successful in the genetics of something as complex as bipolar disorder, it’s important to build collaborations “both within our own study in terms of samples for initial sequencing and follow-up genotyping and sequencing, and also for confirming results or disproving results across other studies,” Boehnke says. In 2009, Myers, Boehnke and a host of researchers from each institution published a genome-wide association study involving thousands of bipolar disorder cases and controls in the Proceedings of the National Academy of Sciences. But even though some loci have been linked to bipolar disorder, the overall number of known genetic contributors is still relatively small. Given what he referred to as the “incredible drop in sequencing prices, the incredible increase in sequencing throughput, the time seemed right for a large-scale sequencing study,” Boehnke says. By comparison, Myers said the Human Genome Project—which first sequenced a single person’s DNA ran from 1990 to 2003— involved thousands of scientists and technicians around the world and cost $2.5 billion. Along with clues about what causes the disease, those involved in the bipolar disorder study hope to unearth information for improving treatment. The NIMH study’s ultimate goal is to identify genes and pathways that contribute to the risk for bipolar disorder, says Chris Gunter, director of Research Affairs at the HudsonAlpha Institute. “We feel that completion of the grant study will provide new insights into disease mechanisms that have the potential to catalyze breakthroughs in bipolar disorder prevention, treatment and diagnosis,” Gunter tells ddn. “This could, of course, lead to collaborations between business and our academic groups.” ddn EDITCONNECT: E101119 For more information, visit www.DrugDiscoveryNews.com b r i e f s Adimab collaborates with Biogen Idec, Novo Nordisk LEBANON, N. H.—Adimab LLC entered into two collaborations with industry giants recently, signing one deal with Weston, Mass.-based Biogen Idec Inc. and another with Novo Nordisk A/S of Denmark. The terms of both deals are similar, stipulating that Adimab, a company focused on the development of yeast-based antibodies, will utilize its proprietary discovery platform to identify human antibodies against a pair of targets selected by Biogen Idec and another pair of targets chosen by Novo Nordisk. Adimab will receive upfront payments of unspecified values from both partners, as well as potential preclinical milestone payments. In addition, Adimab has the potential to receive clinical development milestones and product sales royalties from both collaborations as well. No specific financial details were disclosed for either collaboration. Biologics named strategic partner by Genentech CARY, N.C.—Genentech recently selected Biologics Inc. as its strategic partner to support their suite of services for Zelboraf (vemurafenib), which received U.S. Food and Drug Administration approval on Aug. 17 as an oral therapy treatment for patients with unresectable or metastatic melanoma with BRAFV600E mutation. In partnership with Genentech, Biologics is a key provider of clinical support, patient access and pharmacy services for patients taking Zelboraf. Biologics was selected by Genentech to administer the Patient Partners program, and will also provide adverse event monitoring and reporting, therapy adherence evaluations and side effect education and management for Zelboraf patients. Additionally, Biologics’ oncology pharmacy was selected as a strategic channel partner to dispense Zelboraf in the United States. No financial details for the partnership were disclosed. Galenea, CHDI Foundation form Huntington’s collaboration CAMBRIDGE, Mass.—Galenea Corp. and CHDI Foundation Inc. have come together to collaborate on the identification of synaptic dysfunctions linked to Huntington’s disease (HD) using Galenea’s proprietary synaptic transmission drug discovery platform. Galenea’s platform, which examines synaptic transmission on several levels, will hopefully offer insight into a new approach to discovering therapies for HD. The company’s Multiwell Automated Neuro TRansmission Assay (MANTRA) system is a highthroughput screening assay that monitors synaptic events at the cellular level through the use of primary neuronal cultures. Galenea’s system for establishing in-vivo EEG measures of behaviors in rodent disease models by monitoring brain and behavioral activities in parallel also allows for surveillance at the network level. October 2011 • Drug Discovery News 33 Acquisition is par for the course Par Pharmaceutical acquires rival Anchen Pharmaceuticals for $410 million By Lori Lesko WOODCLIFF LAKE, N.J.—Aimed at enhancing its R&D platform and significantly increasing its pipeline, Par Pharmaceuticals’ agreement to purchase privately held specialty drugmaker and rival Anchen Pharmaceuticals is the “most significant acquisition in Par’s history,” declares Paul V. Campanelli, Par’s executive vice president. If approved, Par will pay the acquisition price of $410 million, and is expected to reap the rewards of the Irvine, Calif.-based company’s extended release and niche generic products and other assets as early as year’s end. The transaction is expected to be immediately accretive to non-GAAP earnings in 2011, Par executives announced at a conference call held for investors and the media on Aug. 24. With Anchen onboard, “our new portfolio is expected to generate significant and positive future cash flow, including more frequent product launches every year,” Campanelli said in the call. “We look forward to Anchen launching from eight to 10 new products within the next two years, which will contribute significantly to Par’s revenues and gross product.” Par plans to finance the Anchen acquisition in part with a $350 million bank loan, to Stem cell breakthroughs within Cyte? BioTime’s ReCyte and OncoCyte subsidiaries ink pact with Cornell on vascular cells derived from hESCs be repaid over five years with an adjustable rate that is expected to average around 5 percent, according to Michael A. Tropiano, Par’s chief financial officer. Anchen is described as a profitable, fully integrated pharmaceutical company with five commercialized products including generic forms of the well-known drugs Cipro, Wellbutrin and Ambien. The California pharma has 27 abbreviated new drug approvals (ANDAs) on file with the U.S. Food and Drug Administration (FDA)— five of which are believed to be first-to-file —and approximately 26 additional products in development, according to Par. Founded in 2002, Anchen has 218 employees and more than 72,000 square feet of expandable manufacturing and warehouse facilities, with state-of-the-art equipment. J.B. Davis, senior vice president at Anchen, deferred all questions about the acquisition to Par. Anchen has demonstrated sound management in all aspects of its operations, including its legal department, which has handled patent challenges, said Campanelli. “Par has been evaluating Anchen for more than a year, and in that time, we have developed a very deep understanding of the organization, its assets and its culture,” Campanelli said. Campanelli stated during the conference call that it is too early to say whether all of Anchen’s employees would be kept on. A L A M E DA , C a l i f . — B i o T i m e I n c . announced in early October that it has entered into an exclusive license agreement with Cornell University for the worldwide development and commercialization of technology developed at the university for the differentiation of human embryonic stem cells (hESCs) into vascular endothelial cells. BioTime is a biotechnology company focused on regenerative medicine and blood plasma volume expanders that carries out much of its work in the human stem cell space. According to the companies, the new methods will provide an improved means of generating these cells on a large scale. BioTime will employ the technology in two of its subsidiaries: ReCyte Therapeutics Inc. and OncoCyte Corp. ReCyte targets age-related vascular disease, and OncoCyte will use the technology to find a way to deliver a toxic payload to cancerous tumors. The work at both spinoffs relies on the work of capillaries, which play a role in vascular health and also provide a par continued on page 35 cyte continued on page 37 By Kimberley Sirk Stem cells offer new hope for MS patients By Amy Swinderman CLEVELAND, Ohio— A group of researchers here are collaborating on a clinical trial that aims to treat or even reverse the debilitating effects of multiple sclerosis (MS) by harnessing the power of stem cell research. The trial—the first of its kind in the United States—is the work of a consortium of researchers from the Cleveland Clinic, University Hospitals’ Seidman Cancer Center and Case Western Reserve University (CWRU). Researchers are harvesting mesenchymal stem cells (MSCs)—or adult stem cells found in the bone marrow—of patients with MS, cultivating them in a CWRU lab and then Researchers are interested in mesenchymal stem cells because they have several properties that could possibly make them helpful in treating multiple sclerosis, says Dr. Jeffrey Cohen, lead investigator of the trial and director of the Experimental Therapeutics Program at the Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment. injecting them intravenously back onto the patients. The primary goal of these efforts is to test the safety and feasibility of using the body’s own stem cells to treat MS. More long-term, though, the researchers hope to find evidence that these transplanted cells can help moderate the overactive immune systems of MS patients—or to develop regenerative strategies to repair or even stop the debilitation seen in the more progressive stages of the disease. The researchers are interested in MSCs because they have several properties that could possibly make them helpful in treating MS, msc continued on page 34 34 Drug Discovery News • October 2011 msc continued from page 33 says Dr. Jeffrey Cohen, lead investigator of the trial. “One reason is that they have the ability, in a number of animal models of other human diseases, to increase repair in tissue damages—not just by replacing the cells themselves, but also by creating an environment that supports normal repair mechanisms that are already present in tissue,” says Cohen, who directs the Experimental Therapeutics Program at the RESEARCH & DEVELOPMENT Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment. “In addition, the anti-inflammatory effects of these cells are quite potent in modulating a number of immune mechanisms, may of which have been implicated in MS. Finally, these cells appear to have the ability to migrate through the blood into tissues that are inflamed and seek out areas of damage. This is much more convenient than directly injecting them into the brain.” The study is the clinic’s first foray into performing stem cell research For more information, visit www.DrugDiscoveryNews.com In Phase I of this clinical trial, researchers are testing the safety and feasibility of harvesting the mesenchymal stem cells of patients with MS, cultivating them in a lab and then injecting them intravenously back onto the patients, with the hope of moderating their overactive immune systems and limiting or even stopping the debilitating effects of the disease. R&D Systems Tools for Cell Biology Research™ Proteins Antibodies ELISAs Biomarker Testing Service R&D Systems Biomarker Testing Service Precious Samples. Critical Results. Trust the Expert. 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The researchers have enrolled four patients in Phase I studies so far. After a formal safety review, they hope to enroll a total of 24 patients by the end of 2012. Getting the trial off the ground hasn’t been easy. Researchers first had conversations about it in early 2007, but had to work earnestly for a few years to obtain funding. “This study is fully funded by grants, rather than industry,” Cohen notes. But the researchers’ main stumbling block, he says, was obtaining the necessary regulatory approval to proceed. “Even though there has been some experience with using these cells in other disease areas, the overall published experience has been very modest,” Cohen explains. “We hope to get the reassurance we need to move at a more rapid place.” The researchers have not yet considered a commercial partner to bring the results of their findings to market, he notes. Instead, they are focused more on furthering the science involved in using MSCs. “We’re less encumbered by commercial constraints, and more concerned with how a treatment would be offered more broadly down the road,” he says. “Even if the cells are not commercializDr. Jeffrey Cohen able, the data we are generating will surely help other people who have commercial plans underway.” The outcome of this trial is expected to be a significant advance in the field of MS research. About 10,000 people in the United States are diagnosed with MS annually, and there is no known cure. Cohen notes that medications currently approved for the treatment of MS focus on preventing disease activity, but do not address damage. They can also have adverse effects or be poorly tolerated. “There is a huge unmet need for therapies for MS patients,” Cohen says. MSCs have also been tested on and demonstrated potential in other conditions such as heart disease, stroke, spinal cord injury and nonhealing bone fractures, he adds. “MSC transplantation is a very effective treatment for conditions where anti-inflammatory actions are discovered,” Cohen says. “It’s being evaluated in a wide variety of conditions. The areas that have received the most attention are cancer, graft-versus-host disease, bone marrow transplants, coronary disease and peripheral vascular disease. There are also a number of smaller studies in diseases like irritable bowel syndrome. But the overall experience there is relatively modest.” ddn EDITCONNECT: E101125 For more information, visit www.DrugDiscoveryNews.com RESEARCH & DEVELOPMENT October 2011 • Drug Discovery News 35 Specificity counts in Merck deal Zymeworks Inc. to collaborate with Merck on developing bi-specific antibody therapeutics By Jeffrey Bouley VANCOUVER, British Columbia—Zymeworks Inc. recently granted Merck, through a subsidiary, a worldwide license to develop and commercialize bi-specific antibodies generated through use of the Azymetric platform toward certain exclusive therapeutic targets. Under the terms of the research collaboration with Merck, known as MSD outside the United States and Canada, Zymeworks will receive an upfront fee and is eligible to receive research, development and regulatory milestones with a potential value of as much as $187 million, as well as tiered royalty payments on sales of products. Both companies will collaborate to advance the technology platform and work on novel bi-specific antibodies, which are designed to bind to two different drug targets for broad use in clinical applications, such as oncology or autoimmune disease. Merck will work to progress the bi-specific therapeutic antibody candidates through clinical development and will have exclusive worldwide commercialization rights to products derived from the collaboration. “Zymeworks’ technology platform has the potential to provide a unique solution for engineering novel antibodies,” said Dr. Richard Murray, senior vice president of biologics research at Merck, in the news release about the deal. “At Merck, we continue to build upon our portfolio of novel technologies aimed at developing a new generation of biologic candidates designed to provide improved therapeutic properties.” “From the day we got started in the business of biologics, we had an eye out for Merck as a company we really wanted to do a deal with,” Dr. Ali Tehrani, CEO of Zymeworks, tells ddn. “An early thing I learned is that the world is not your playground in this business, and you need a focus—and part of that focus was thinking about companies we most wanted to do deals with. I admit that with the acquisition of Schering, I was nervous like a lot of people, but I think it brought them a lot of strengths and made them even more desirable a company with which to form a collaboration. Now we have that chance, bringing our Azymetric platform while they bring their drug expertise.” He also had noted earlier, in the news par continued from page 33 After searching for the ideal acquisition for some time, Par believes it got it right. “Anchen is the one we wanted and a terrific acquisition for Par Pharmaceuticals,” Patrick G. LePore, chairman, CEO and president of Par, told investors. “I can’t wait to work with the people from California. “This transaction accelerates the expansion of Par’s research and release about the deal, that this collaboration is “an important validation of our scientific leadership in the field of structureguided protein engineering and we look forward to working with Merck to realizing the full value of this novel platform technolo g y ac r o s s a r a n ge o f t h e r ap e u t i c indications.” Antibodies developed using the Azymetric platform, unlike native antibodies, consist of two different heavy chains engineered to potent drugs.” The timing for a deal like this now is right, he says, because there is no clear leader yet in the bi-specific space. “There is a race, and someone is going to come out as one of the leaders and maybe that someone will also ‘win’ the race,” Tehrani notes. “Who that will be depends on the right technology and platform and the right combination of teams to get there. I think that Merck placing a bet on us with this col- Zymeworks has long seen Merck as a prime candidate for a major collaboration partner, and now the company has the chance with the development and possible commercialization of bi-specific antibodies generated through use of the Azymetric platform toward certain exclusive therapeutic targets. Says Zymeworks CEO Dr. Ali Tehrani: “It’s nice to be inspired; the Merck term inspires the Zymeworks team.” exclusively assemble into a single molecule, thereby allowing bi-specific binding of two different antigens or drug targets, Zymeworks notes. Because they have two different but complementary heavy chain subunits, Azymetric antibodies are classified as “heterodimeric” antibodies—reportedly, similar to natural antibodies, heterodimeric antibodies retain long serum half-lives and the ability to induce effector function. “Antibody therapeutics are a very hot area, and if you’re in the business of drug development and you’re looking at biologics, antibodies are attractive, and have proved to be effective drugs,” Tehrani says. “Within the antibody space, there is a lot of interest in multivalent bi-specific molecules that can create opportunities for more efficacious and development infrastructure and reinforces our strategy to provide long-term sustainable growth,” LePore added. “Anchen has an excellent development track record and robust product pipeline, which, when combined with Par’s existing capabilities and pipeline, more than doubles our product opportunities. Anchen also shares Par’s highly entrepreneurial culture and costefficient approach to product development, which should allow for a seamless integration.” Par made a deal for another laboration shows that they are very committed to this race.” Zymeworks’ proprietary ZymeCAD structure-guided protein engineering technology and its novel Azymetric and AlbuCORE platforms are said to enable the development of highly potent bi-specific antibodies and multivalent protein therapeutics targeted across a range of indications. The company is growing its preclinical biotherapeutics pipeline through a combination of in-house research and development programs and strategic collaborations. Looking toward this most recent and highly sought-after collaboration, Tehrani says of Merck: “It’s nice to be inspired; the Merck term inspires the Zymeworks team.” ddn Merck Serono, F-Star, ink inflammatory disease deal LONDON— Merck Serono SA recently announced the signing of an inflammatory disease research deal with F-Star GmbH, a specialist in antibody engineering, which is worth up to $691.1 million. The partners will work with “up to three” targets selected by Merck Serono as the basis for the joint discovery of antibody fragments as well as bi-specific antibodies. F-Star will receive research funding as well as a technology access fee, and license fees and milestones will be paid out as the projects progress. While no additional financial details were released, Kevin FitzGerald, F-Star’s CEO, said in a press release that achieving the full $691.1 million value would require commercialization of products. “We certainly value our partnerships,” FitzGerald said. “They have real benefits that go beyond early- and midterm cash. They are a great validation for the technology, great internally in terms of motivating our people and showing pharma is interested in our technology.” F-Star’s modular antibody technology allows it to engineer additional antigen-binding sites in both antibodies and antibody fragments. Its Fcab antibody fragments enable the production of entities a third of the size of normal antibodies with the same functionality, but a longer half-life than antibody fragments usually have. Fcabs, according to FitzGerald, can be used as therapeutic products or as modules for generating mAb2 antibodies. F-Star’s mAb2, or bispecific, antibodies offer greater functionality than their conventional counterparts as well as the option of having two binding sites for the same disease antigen, dual targeting against a second antigen or using the additional binding site for the delivery of the antibody to a specific tissue. “We believe that F-Star’s modular antibody technology has the potential to offer important functional advantages over conventional antibodies and will potentially allow us to generate highly differentiated drugs,” Susan Herbert, head of portfolio development at Merck Serono, said in a press release. ddn EDITCONNECT: E101126 small generics company in May, agreeing to acquire India-based Edict Pharmaceuticals for up to $37.6 million. The company expects the deal to close by the end of the year and add to earnings in 2013. Par has also been moving into the branded pharmaceutical market by developing updated versions of off-patent drugs. Par has two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, which develop, manufacture and market generic drugs and proprietary pharama ceuticals. Par announced this summer that it plans to cut 100 jobs— about 15 percent of its workforce of 600—in the Strativa division. At that time, LePore said the company planned to focus on two Strativa products: Megace, which treats appetite loss and weight loss, especially in AIDS patients; and Nascobal, a vitamin B-12 nasal spray. Strativa also makes Zuplenz, an anti-nausea drug aimed at cancer patients undergoing chemotherapy or radiation, and Oravig, an anti-fungal medi- cine. Besides its headquarters in Woodcliff Lake, the company has locations in Suffern, Spring Valley and Hauppauge, N.Y. Par Pharmaceuticals conducts manufacturing in the United States and markets and/or licenses more than 85 prescription drug product. Par also has more than 50 currently marketed products, more than 30 products in active development and manufacturing plant capability of more than 2 billion tablets per year. ddn EDITCONNECT: E101122 36 Drug Discovery News • OctOber 2011 RESEARCH & DEVELOPMENT For more information, visit www.DrugDiscoveryNews.com Baxter acquires privately held Baxa, establishes investment arm Baxter International Inc. announced last month the signing of a definitive agreement to acquire privately held Baxa Corp., an Englewood, Colo.-based company focused on developing pharmacy technology to enhance the safety and efficiency of oral and IV dose preparation and delivery. At the same time, Baxter also announced its establishment of Baxter Ventures, a joint venture that will invest up to $200 million in equity in promising early-stage companies developing therapies that complement the company’s existing portfolio. Baxter will acquire Baxa for a total upfront cash consideration of $380 million. The closing is subject to customary closing conditions as well as the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. “With this agreement, Baxa will be able to play a greater role in delivering safe medication practices,” Greg Baldwin, Baxa chairman and CEO, said in a press release. “We are very DEERFIELD, Ill.— mately $150 million, and Baxter expects the acquisition of Baxa to be accretive to its future sales growth. The company also expects the acquisitive to be neutral to full-year 2012 earnings excluding dilution of approximately $0.03 to $0.05 per diluted share related to acquisition accounting and transaction-related expenses, and increasingly accretive in the following years. Baxa’s website states that its mission is “to be a great medical device company that continually improves and maximizes long-term value through lifetime partnerships with customers.” The company’s pharmacy products include automated compounding devices, dose management, pharmacy admixture tools, oral and enteral systems, automated filling systems and IV administration. Baxa also has a variety of nursing products, including supplies for neonatal feeding, oral and enteral systems and IV administration. Baxa’s product line includes the ExactaMix Compounder, devices that work to automate “bringing this expertise together with Baxter’s commercial capabilities and global reach will enable us to continue to meet our customers’ evolving needs and extend our position in IV nutrition and fluid delivery.” ROBERt M. DAVIs, pREsIDENt OF BAXtER’s MEDICAL pRODUCts BUsINEss pleased to find a partner that shares our commitment and sees the potential in our products, technology and people.” Baxa’s annual sales in 2010 were approxi- multi-ingredient nutritional solution compounding, as well as its DoseEdge Pharmacy Workflow Manager, which provides an integrated system for managing IV and oral dose The acquisition of Baxa gives Baxter “a comprehensive solution to fulfill the majority of patients’ nutritional requirements and increase efficiency in the pharmacy,” says Robert M. Davis, president of Baxter’s Medical Products business. preparation activities. “With these new offerings, Baxter will be able to provide a comprehensive solution to fulfill the majority of patients’ nutritional requirements and increase efficiency in the pharmacy,” said Robert M. Davis, president of Baxter’s Medical Products business, in a press release regarding the acquisition. “Bringing this expertise together with Baxter’s commercial capabilities and global reach will enable us to continue to meet our customers’ evolving needs and extend our position in IV nutrition and fluid delivery.” The acquisition is a strong one for Baxter based on the extremely complementary Where Else Can you Find Cutting-Edge Antibody Engineering Basic Science Combined with Updates of Clinical Progress for Antibody Therapeutics? IBC’s 22nd Annual International Conference IBC’s 9th Annual International Conference Annual Meeting of The Antibody Society December 4-8, 2011 • Hilton San Diego Bayfront Hotel • San Diego, CA Invaluable Scientific Collaborations, New Approaches to Your Research Programs and Important Industry and Science Updates ALL in ONE PLACE and FACE-TO-FACE. Register with Priority Code: D11171DDN to Receive 20% off Standard Rates Learn More About this Conference at: www.IBCLifeSciences.com/antibodyeng D11172ddnHP.indd 1 8/10/11 9:58 AM nature of the two companies’ businesses. Baxter’s areas of expertise include anesthesia, clinical nutrition, infusion systems/IV tubing, pharmaceuticals, solutions and drug delivery. When combined with the company’s drug delivery systems and nutrition products— such as Baxter’s multi-chamber, prefilled, premixed containers—Baxa’s products will boost the company’s portfolio and its strength in its areas of focus. Premixed medications and pharmacy automation serve to minimize issues in the medication process, in terms of reducing errors in dosage and administration and improving effectiveness. Baxter’s premixed multi-chamber containers include essential nutrients for a range of patients, and Baxa’s integration and automation technology give hospital pharmacists the ability to customize treatments for specific patient populations. Of Baxter Ventures, Robert L. Parkinson Jr., chairman and CEO of Baxter, said in a statement, “Baxter’s mission is to apply innovative science to develop therapies and medical technologies that save and sustain patients’ lives. As the company’s internal capabilities have advanced our late-stage pipeline, we have the capacity to further accelerate the early-stage development of essential therapies.” Baxter Ventures will invest globally and focus on innovative technologies with sustainable long-term growth. The company has continued to grow its internal investments in R&D and to pursue business development initiatives, collaborations and alliances as part of its long-term growth strategy. Baxter Ventures will report to Dr. Norbert Riedel, Baxter’s chief scientific officer. “Baxter Ventures will allow us to provide companies with promising, early-stage technologies with the capital and expertise needed to drive successful innovation,” said Riedel. “Through this additional investment, Baxter will expand its internal pipeline with the goal of further strengthening the company’s history of innovative ‘firsts’ in medical therapies.” ddn For more information, visit www.DrugDiscoveryNews.com cyte continued from page 33 route directly into tumors. Vascular endothelial cells form the tubular structure of capillaries and the innermost cells of larger arteries and veins in the body. When these cells become dysfunctional, they are believed to play a key role in numerous disease processes. The technology was developed at the Weill Cornell Medical College. The journal Nature Biotechnology published a story about the work in 2010. The ability to reprogram cell lifespan and manufacture young, healthy, patient-specific vascular endothelial cells may prove to be important in the field of regenerative medicine. BioTime has tested the Cornell technology when combined with BioTime’s ACTCellerate technology and has successfully produced highly purified monoclonal embryonic vascular endothelium. This high level of purity and scalability is expected to facilitate the manufacture of clinical-grade cells that may be used for transplantation therapies. “The technology invented by Drs. Shahin Rafii and Daylon James of the Weill Cornell Medical College is both elegant and useful,” said Dr. Joseph Wagner, CEO of OncoCyte, in a prepared statement. “The products derived from the combination of this technology with BioTime’s ACTCellerate and OncoCyte’s existing technologies to target and destroy malignant tumors may lead to an entirely new modality for the treatment of solid tumors.” BioTime’s license is worldwide and exclusive for the fields of cell therapy for ageand diabetes-related vascular diseases and cancer therapy. The license also covers products utilizing human vascular or vascular forming cells for the purpose of enhancing the viability of the graft of other human cell types, and cellbased research products. “In addition to obtaining exclusive worldwide licenses to the patent-pending Cornell technology, we have entered into a sponsored research agreement with Weill Cornell Medical College that will utilize the expertise of the scientists who developed the licensed technology,” said Dr. Steve Kessler, vice president of research and development of ReCyte, in a statement. Cornell and BioTime representatives did not answer questions posed to them for this story by press time. ddn EDITCONNECT: E101124 RESEARCH & DEVELOPMENT October 2011 • Drug Discovery News 37 BioTime receives NIH approval for four hESC lines ALAMEDA, Calif.—BioTime Inc. also recently announced that four human embryonic stem cell (hESC) lines— ESI-035, ESI-049, ESI-051 and ESI053—developed by a BioTime subsidiary have been approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry. The approval opens the door to the use of these cell lines in federally funded research. The lines were developed by ES Cell International Pte. Ltd. (ESI). The lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP), are free of animal feeder cells and have been assessed for pluripotency and karyotypic stability. In collaboration with the California Institute of Regenerative Medi- cine, BioTime has supplied researchgrade versions of these lines to dozens of researchers throughout California, including those in the University of California system. BioTime has agreed to provide the complete genome sequence to the public this fall to facilitate the development of products derived from these cell lines. One of the ESI cell lines is being evaluated by an undisclosed large pharmaceutical com- pany for potential use in its product development program. “As researchers work towards developing therapeutics for use in hard-to-treat diseases, we believe that our clinical-grade hESC lines will enable them to easily translate scientific progress into commercially successful therapeutic products,” said Dr. Michael D. West, president and CEO of BioTime, in a statement. ddn INTRODUCING Your gateway to the latest oncology news, trends and resources ■ ■ ■ ■ ■ Top cancer-related news and opinion stories Archive of all of ddn’s cancer-related news stories Interviews with key oncology leaders Links to various companies, research centers and organizations involved in the field of oncology and much more! Visit: www.ddncancer.com 38 Drug Discovery News • OctOber 2011 RESEARCH & DEVELOPMENT DIRt continued from PAge 1 “When Clostridia spores are injected into a cancer patient, they will only grow in oxygen-depleted environments, i.e., the center of solid tumors,” explains Nigel Minton, a professor at the University of Nottingham. “Unfortunately, because the outside of the tumor is oxygenated, tumors always regrow. We have done something about that by using this enzyme as a pro-drug therapy.” Although these findings about the bacteria strain—called Clostridia—have generated quite a bit of interest, scientists have been aware of its potential for many years. Clostridia are an ancient group of bacteria that evolved on the planet before it had an oxygen-rich atmosphere. Because they cannot grow in the presence of oxygen, they produce spores to survive. Medically speaking, Clostridia cannot grow in normal, healthy tissue. Their ability to germinate in necrotic tissue, however, has long been recognized. In the last 50 years, these characteristics have been probed by researchers for their potential to select and target tumors. In the 1950s, Parker, et al., showed that the injection of Clostridium histolyticum spores to the transplanted sarcomas of mice results in significant tumor lysis. Soon after, it was shown that a direct injection is not necessary, and that tumor colonization was readily Neuroscience D223-3 Isotype Control MZ CP 20 µm MZ { CP 20 µm Immunohistochemical detection of Reelin on frozen sections of mouse fetal brain (E18) with D223-3 (left) or isotypic control IgG (right). This data was kindly provided by Professor For more information, visit www.DrugDiscoveryNews.com International Corporation Kazunori Nakajima and Dr. Ken-ichiro Kubo (Department of Anatomy, Keio University School of Medicine, Tokyo). International Corporation obtained after intravenous administration of spores. Now, in a poster that was recently presented at the Society for General Microbiology’s Autumn Conference at the University of York, the Nottingham/Maastricht team has shown it has overcome the hurdles that have so far prevented this therapy from entering clinical trials. They have introduced a gene for a much-improved version of the enzyme into the C. sporogenes DNA. This improved enzyme can now be produced in far greater quantities in the tumor than previous versions, and is more efficient at converting the pro-drug into its active form. “When Clostridia spores are injected into a cancer patient, they will only grow in oxygen-depleted environments, i.e., the center of solid tumors,” says Nigel Minton, a professor of Applied Molecular Microbiology in the faculty of Medicine and Health Sciences at the University of Nottingham. “Unfortunately, because the outside of the tumor is oxygenated, tumors always regrow. We have done something about that by using this enzyme as a pro-drug therapy.” Their approach presents a paradigm shift in the treatment and control of tumors. Traditional cancer treatments—such as surgery, radiotherapy and chemotherapy—are reasonably successful in controlling the disease, but in certain types of tumors and circumstances, these approaches may be ineffective. Moreover, in the cancer community, the holy grail of treatment has become the ability to subject tumor cells to a toxic agent while at the same time excluding normal, healthy tissues from toxic exposure. Recent experiments have shown that although intravenously injected Clostridia spores are dispersed throughout the body, only those that encounter the hypoxic environment of a solid tumor go on to germinate and multiply. This predisposition of Clostridia spores to germinate selectively in the hypoxic regions of solid tumors makes them an ideal delivery vehicle for anticancer agents, according to Minton and his colleagues. Clostridia, Minton notes, is a “totally natural phenomenon,” requires no fundamental alterations and is “exquisitely specific.” “We can exploit this specificity to kill tumor cells, but leave healthy tissue unscathed,” he adds. Ultimately, the Nottingham/ Maastricht team hopes these findings will lead to a simple and safe procedure for curing a range of solid tumors. They hope to begin testing this strain in patients by 2013. “A successful outcome could lead to its adoption as a frontline therapy for treating solid tumors. If the approach is successfully combined with more traditional approaches, this could increase our chance of winning the battle against cancerous tumors,” says Minton. ddn editcOnnect: e101103 For more information, visit www.DrugDiscoveryNews.com b r i e f s Spaulding Clinical partners with Clinigene, Eurofins Optimed WEST BEND, Wis.—Spaulding Clinical Research LLC, a West Bend, Wis.-based clinical pharmacology, cardiac core lab and medical device manufacturer, recently announced a strategic partnership agreement with Clinigene International Ltd. The partnership provides both companies with the opportunity to interact with clients strategically and accelerate first-in-human to proof-of-concept clinical development. Spaulding also announced a joint partnership agreement with Eurofins Optimed Clinical Research for global clinical studies, which will facilitate collaboration on integrated clinical studies. The two companies both noted that a key focus of the partnership was securing a highquality partner that met their standards for both study conduct and participant safety. No financial details were disclosed for either partnership. Sinochem, DSM establish global anti-infectives joint venture BEIJING—Sinochem Group and Royal DSM have finished the transaction delivery to establish the 50/50 global anti-infectives joint venture, DSM Sinochem Pharmaceuticals Ltd., in Hong Kong. Per the terms of the agreement, the joint venture will have its headquarters in Hong Kong, and its board of directors will consist of six members, three of whom will represent DSM and three Sinochem. Sinochem Group has taken a 50 percent equity interest in the group for a total cash consideration of approximately $289.6 million on a cash- and debt-free basis. Pan Zengyi, vice president of Sinochem, said in a statement, “We are confident that this is a very positive step for Sinochem and DSM in their respective ambition to apply biotechnology broadly, to help the advancement of human health with environmentally sustainable processes.” SCRA MUSC Innovation Center chosen as VaxyGen HQ CHARLESTON, S.C.—VaxyGen Assay Services will be the latest tenant at the SCRA Medical University of South Carolina (MUSC) Innovation Center in Charleston, S.C., and will lease space for both laboratory and business operations. VaxyGen is a provider of contract custom testing services for the characterization of active components and their effects in the development of therapeutics and vaccines. The SCRA MUSC Innovation Center is one of three facilities built by SCRA in conjunction with its South Carolina university and civic partners. “This facility and, in general, the resources within the ‘MUSC/Charleston area’ are highly impressive and a tremendous asset to the life sciences area and, in particular, our company,” said David Dodd, VaxyGen’s CEO. October 2011 • Drug Discovery News 39 Building on a strong foundation ICON selected as a preferred provider for early-phase clinical development by Bristol-Myers Squibb By Jeffrey Bouley DUBLIN—Building on an existing strategic partnership for global clinical development, BristolMyers Squibb Co. (BMS) has chosen ICON PLC, a Dublinbased global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, as a preferred provider for full-service clinical pharmacology and exploratory clinical studies. In June 2010, BMS announced the signing of agreements with ICON and PAREXEL Intl., as two leading providers of clinical development services, for joint strategic, operational and capability support of the company’s clinical development program. Under the agreements, ICON and PAREXEL were to provide global support for the execution of BMS’s clinical studies to support its full development pipeline over the following three years. “These partnerships will increase the operational capability of our clinical development organization, and support our icon continued on page 41 ICON’s Clinical Pharmacology Unit in Manchester, United Kingdom, is one of three—along with two others in the United States—that will be brought to bear in ICON’s new role as a preferred provider for full-service clinical pharmacology and exploratory clinical studies for Bristol-Myers Squibb Co. Blueprint for Build it neurotherapeutics and they will come AMRI wins five-year, $43 million federal contract award Start-up research institute forms strategic alliance with LabCorp Clinical Trials to offer specialized biomarker and assay development services By Lori Lesko ALBANY, N.Y.—Chosen to provide chemistry and other drug discovery technologies for the National Institutes of Health (NIH) Blueprint Neurotherapeutics Network, Albany Molecular Research Inc. (AMRI) has won a fiveyear $43 million federal contract award—the largest government award in the company’s history and one of the largest ever given by the NIH. The award from the NIH and the National Institute of Neurological Disorders and Strokes (NINDS) in support of NINDS’ Medicinal Chemistry for Neurotherapeutics P r o g r a m ( M C N P) wa s announced Aug. 18. AMRI has been collaborating with NINDS since 2005 on novel treatments for spinal muscular atrophy, a degenerative neuromuscular disease. By Lloyd Dunlap KANNAPOLIS, N.C.—The David H. Mur- patients who suffer from devastating neurological and degenerative diseases, such as macular degeneration and Alzheimer’s disease.” Christopher Conway, senior director of business development for AMRI, says the award “represents the federal government’s awareness of the great need for treatment for muscle degeneration and nervous system disorders.” “There is substantial unmet dock Research Institute (DHMRI) has formed a strategic alliance with Esoterix Clinical Trials Services, a division of Laboratory Corporation of America Holdings (LabCorp), to provide LabCorp’s clients with access to enhanced assay development services. Assays developed at DHMRI for contracted research will be transferred to LabCorp laboratories worldwide to support global clinical studies. The agreement also provides a mechanism for downstream commercialization of companion diagnostics and other biomarker assays once clinical validation has been established. Launched in 2009 after a six-year development program engineered by David H. Murdock, the institute dif- amri continued on page 42 dhmri continued on page 42 AMRI has been collaborating with the National Institute of Neurological Disorders and Strokes since 2005 on novel treatments for spinal muscular atrophy, a degenerative neuromuscular disease. Shown here is a liquid handler in the company’s Singapore facility. “After a highly competitive, rigorous application process, AMRI was selected for this contract award because of our proven track record on projects of similar scope with a number of global pharmaceutical companies,” Thomas E. D’Ambria, AMRI chairman, president and CEO, said in a news release. “We are pleased to support NIH/NINDS’ efforts and provide our discovery resources to the neuroscience research community and to 40 Drug Discovery News • OctOber 2011 contract research services For more information, visit www.DrugDiscoveryNews.com Advantar partners with DavosPharma by daVid huttOn SAN DIEGO—Advantar Laboratories and DavosPharma have forged an alliance to accelerate clients’ development programs with chemistry and analytical services. Under the collaboration, the companies will provide U.S.-based biotech and pharmaceutical clientele with development, consultancy and program management support for preclinical and clinical trial materials as well as approved drugs and devices. According to Brandon M. Griffin, vice president of sales and marketing for Advantar, mutual client opportunities brought the companies together this year. “After various discussions evaluating the given chemistry and/or drug development approach of cli- ents, it was apparent that both teams had strong complimentary expertise and resources to leverage,” he says. “A collaborative approach simply made sense from the perspective of supporting clients more strategically and promoting that relationship.” Giff Marzoni, vice president of global API development at DavosPharma, explains thatAdvantar is one of about 50 laboratories and manufacturers with which DavosPharma has partnered. “We have known the principals at Advantar for many years, so we feel confident that we can offer Advantar’s analytical services to successfully meet our clients’ needs,” Marzoni says. The collaborative offerings include custom synthesis for APIs and advanced intermediates, formu- Discover an evolution in drug discovery and development Introducing Covance Discovery and Translational Services If you’re ready for the next evolution in drug discovery and development, join us to find better ways to effectively and efficiently bridge research gaps. Only Covance drives innovative pipeline development by integrating early nonclinical safety, efficacy, and Discovery services with expert capabilities in Biomarkers, Genomics, Immunology, and Antibodies. We also give you access to innovative scientists, state-of-the-art services, and technologies to optimize decision making throughout preclinical and clinical development. It’s time to transform challenges into opportunities. Join the evolution. lation development, cGMP drug manufacturing, investigational and compatibility studies, method development and validation projects, stability studies and regulatory support. Rich Kenley, CEO of Advantar Labs, says the alliance enables mutual clients to rapidly and confidently place their program with dedicated teams of experts to manage. “For time-critical studies, we are able to utilize DavosPharma’s infrastructure and broad network to provide more options and overall guidance to customers for their development needs than previously,” Kenley says. “This accomplishment puts our lab well ahead of many competing CROs with in-house project management, because they often lack specific area expertise or comprehensive tracking tools.” Marzoni notes that a key resource DavosPharma will add to the partnership is its technical staff. “Our chemists and chemical engineers have many years experience in dealing with FDA regulations, process development issues, and commercial manufacturing,” he says. “In my 33 years as a process chemist, I have taken four clinical candidates from the bench to fullscale commercial production.” Marzoni also says the Advantar team has a breadth of analytical and formulation development experience that DavosPharma will leverage for its customers. “Finding the right partner with the compliance, analytical resources and communication we need is no easy feat,” he says. “However, Rich and his team simply make it very easy to work with and get the job done right. They share our corporate vision in providing great science and exceptional support for every program awarded.” Griffin adds that the overall focus of the collaboration is to provide more reliable resources to customers at various stages of their drug development process. “Our customers will realize a reduced overall development risk,” he adds. “Also, access to more centers of excellence, more options to meet an individual customers needs, streamlined sourcing and manufacturing efforts and international access.” Griffin also notes that the collaboration will give Advantar customers access to trusted manufacturing partners and a more diverse customer base and more expertise in compliance with foreign regulations. Moreover, DavosPharma’s infrastructure and broad network will boost Advantar Lab’s efforts. “The resources of DavosPharma will create an ongoing opportunity for new business with both foreign and domestic customers,” Griffin notes. ddn editcOnnect: e101130 For more information, visit www.DrugDiscoveryNews.com conract research services October 2011 • Drug Discovery News 41 icon continued from page 39 ICON will now be bringing its skills in Phase I studies to its support of Bristol-Myers Squibb Co.’s development efforts, along with the Phase II, Phase III and central lab work it had been conducting previously. sors are looking for in a strategic partner. Performing the clinical development of BMS compounds from early phase through late phase will put the BMS/ICON relationship in a unique position for fully realizing efficiencies and leveraging expertise.” Previous to the early-phase preferred provider relationship status, ICON did a small amount of clinical pharmacology support for BMS, Rocci says, but this new addition to their work together “ provides both BMS and ICON with continuity in the development of a compound from early through late stage.” He also noted, in the official statement about the deal, that “we look forward to demonstrating the same value and efficiencies to BMS’s early-phase clinical programs. Our global network of clinical research units, scientists and project teams, underpinned by world-class technology, will drive significant cost savings and productivity.” ICON specializes in the strategic development, management and analysis of programs that support clinical development from com- ddn Market Research: CRO market trends pound selection to Phase I through IV clinical studies, and the company currently has approximately 7,800 employees, operating from 77 locations in 39 countries. The preferred status conferred by BMS follows news of another relationship Quality Assurance GMP Synthesis GMP Preparative EDITCONNECT: E101127 Let Regis guide you through a successful project Separations Find out why 90% of customers Analytical Method Development return to Regis for more services, from small-scale synthesis to Drug Discovery News (ddn), in partnership with the healthcare research team at investment bank Mizuho Securities USA, is conducting a reader survey on current trends on the contract research organization (CRO) market. Process Research Whether you work at the bench or for an academic institution— or anywhere in between—we are interested in finding out about your participation in and views on the CRO market. Commercial Stability Services commercial manufacturing. We offer proven, effective project management for cGMP custom manufacturing and related services. Manufacturing Talk to Regis about your next project. The survey contains 20 questions and takes about five minutes to complete. To participate, please use the link below: https://www.surveymonkey.com/s/P22WCHJ All information will remain confidential, and only aggregate results will be published. If you are interested in receiving a copy of the survey results, please indicate at the end of the survey. 800.323.8144 www.RegisTech.com/gmp CHROMATOGRAPHY GMP MANUFACTURING SFC SERVICES PHARMA SERVICES API FINE CHEMICALS R E G I S T E C H N O L O G I E S G M P C U S T O M M A N U FA C T U R I N G industry-leading position in productivity and innovation,” said Brian Daniels, senior vice president of global development for BMS at the time. “Working with ICON and PAREXEL, two leaders in clinical research, Bristol-Myers Squibb will enhance support for our robust pipeline and improve our ability to deliver innovative medicines to patients with serious disease.” Under this latest agreement with BMS, for preferred-provider status that adds early-phase development to the mix, ICON will provide a broad range of clinical pharmacology and exploratory clinical trial services, including study conduct in ICON’s Clinical Pharmacology Units located in San Antonio, Texas; Omaha, Neb.; and Manchester, United Kingdom. ICON will also provide all supporting scientific services, such as protocol design and development, project management, clinical monitoring, medical monitoring/pharmacovigilance, data management, biostatistics, pharmacokinetics and medical writing. There is a fairly direct line from the previous agreement to the current one, Mario L. Rocci Jr., president of ICON Development Solutions, tells ddn. “As often is the case, ICON’s performance in the Phase II to III and central lab partnerships certainly helped pave the way for our early-phase partnership. It’s a testament to the fundamental principle that if you do a good job for a client at a good price you will earn more business from them,” Rocci says. The combination of agreements is good for ICON’s short-term and long-term goals, Rocci notes, adding that “ICON is well-positioned for the strategic partnership model many pharmaceutical companies are seeking as they respond to the growing pressure to reduce development timelines and decrease overall development costs. This award is a very important indication that ICON’s fullservice clinical platform spanning the development continuum is in line with what spon- announced in late May of this year, when ICON launched a strategic partnership with Pfizer Inc. that will see ICON serve as one of two preferred providers of clinical trial implementation services for Pfizer. That partnership was touted as being part of Pfizer’s comprehensive program of change in research and development “to sharpen research focus, deliver differentiated innovation, and create a more flexible cost base through external partnerships for certain R&D services.” Intended to be fully implemented over an 18- to 24-month period, the partnership will reportedly enable Pfizer to focus internally on its core capability in clinical trial design, while leveraging the strengths and scale of ICON to implement clinical development programs with greater efficiency and rigor. Under that partnership agreement, Pfizer retains scientific ownership of the clinical development process and maintains strict oversight and quality standards relating to patient safety and regulatory compliance. Pfizer is leveraging ICON’s expertise in the areas of program initiation and management; site and country feasibility; data management and reporting set-up; program study drug logistics; scientific and medical communications; and quality assurance. ddn CONTRACT RESEARCH SERVICES 42 Drug Discovery News • October 2011 dhmri continued from page 39 ferentiates itself by stating that DHMRI is a place “where research begins with an idea, not a sample.” Murdock, once broke and homeless on the streets of Detroit, rose meteorically via a number of real estate transactions to rank 376th on Forbes Magazine’s list of the world’s billionaires. When Cannon Mills Plant #1 in Kannapolis closed, Murdock bought the land, demolished the mill and built the 5.8 million square- foot North Carolina Research Campus, of which DHMRI is a part. “DHMRI was created as a magnet or catalyst for NCRC,” says the institute’s CEO, Dr. Michael Luther. “The institute bridges the research gap between academics and industry by providing R&D solutions in a customer-focused, yet collaborative environment. The DHMRI catalyzes innovation at the public-private interface by driving and supporting R&D efforts with partners who are located both on and off campus. We work as a non-traditional CRO pro- viding answers from the bench to proof of principle.” Among the affiliated companies are Murdock interests Castle and Cooke and Dole Foods—and its new partner LabCorp. In addition to biomarker assay development, DHMRI provides a broad array of analytical, genomic, immunology and informatics services. The services available to clients include broad biomarker discovery and proof-of-concept assay development to support early- and late-stage drug discovery and devel- For more information, visit www.DrugDiscoveryNews.com opment. The institute uses transdisciplinary approaches to provide solutions for customers. Its capabilities and expertise range from profiling at the genetic, biochemical, cellular and in-vivo levels to clinical immune system monitoring using multiparameter flow cytometry and multiplexed protein analysis and quantitative gene expression. “With the addition of DHMRI’s discovery capabilities, LabCorp offers its clinical trials clients the most complete suite of biomarker development tools in the industry,” says Dr. David Johnston, senior vice president and global head of clinical trials at LabCorp. “Our collaboration with DHMRI exemplifies our strong commitment to providing cuttingedge services to our clients.” LabCorp’s core business provides a broad test menu ranging from routine blood analyses to reproductive genetics to DNA sequencing. The company conducts clinical trials testing through its Esoterix Clinical Trials Services division. ddn EDITCONNECT: E101129 Amri continued from page 39 THE FASTER WAY TO CLEANER 100 Ostro MRM of 5 Channels ES+ (3.88e6) % 0 0.0 100 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 LLE 10.0 11.0 12.0 MRM of 5 Channels ES+ (3.88e6) % 0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 Overlay of 5 individual phospholipids Enhance your laboratory’s productivity with Ostro™ Sample Preparation Products. Requiring little to no method development and using a simple protocol. Ostro plates remove more than 95% of phospholipids and are 15 times faster than traditional LLE. See how Ostro can increase sample throughput and reduce instrument downtime. Watch a short demonstration video at www.waters.com/cleaner ©2011 Waters Corporation. Waters, The Science of What’s Possible, and Ostro are trademarks of Waters Corporation. 9.0 10.0 11.0 12.0 min need for treatments in the area of nervous system disorders, which affect millions of Americans,” Conway tells ddn. “About 10 to 20 percent of candidate drugs for all disease indications survive the early phases of development and reach clinical trials. Some nervous system disorders are rare and present small markets for drug companies, and the process for developing new drug therapies is costly and carries high risk. With this NIH funding, investigators involved in this project gain access to the same resources and expertise that drug companies have, thus enabling AMRI to provide input in patients care.” For AMRI, the initial funding of up to $10 million applies to the first phase of the project, with the objective of delivering at least one Phase I clinical trial candidate and subsequent funding of up to $33 million to be spread over the remaining four years of the contract. “The investigators get access to the same resources and expertise that drug companies have,” says Jill Heemskerk, a program director in the NINDS Office of Translational Research and lead contact for the Blueprint Neurotherapeutics Network. “The investigators will retain intellectual property rights for any drugs they develop through the network. Our hope is that pharmaceutical companies will license the most promising drugs and invest in the clinical studies needed to bring them to market.” According to the SMA Foundation, an estimated 9,000 people in the United States have spinal muscular atrophy (SMA). SMA types I, II and III belong to a group of hereditary diseases that cause weakness and wasting of the voluntary muscles in the arms and legs of infants and children. The disorders are caused by an abnormal or missing gene known as the survival motor neuron gene 1, which is responsible for the production of a protein essential to motor neurons, the NIH reports. Muscular dystrophies are a group of more than 30 genetic diseases characterized by progressive weakness and degeneration of the skeletal muscles that control movement. ddn EDITCONNECT: E101128 For For more more information, information, visit visit www.drugdiscoverynews.com www.drugdiscoverynews.com ANNOUNCEMENTS October 2005 2011 • Drug Discovery News 43 NOVEMBER People & Promotions Roche Rainer Metternich, Ph.D. Head of Small Molecules Research BASEL, Switzerland—Taking over for Klaus Strein, who is retiring from Roche, Dr. Rainer Metternich is the company’s new head of small molecules research, a position in which he will lead some 800 scientists across Europe and the United States who work in medicinal chemistry, discovery technologies, process research and formulation. In addition, he will oversee the development of the Small Molecule Research division’s mid- and long-term vision and strategy and guide the group as it applies novel technologies to develop worldclass compounds. Rainer brings more than two decades of experience in the pharma industry, having worked for Novartis (formerly Sandoz), Schering AG and Merck & Co. Since returning to Europe in 2010, Rainer has been the chief scientific officer and chief business officer for Caprotec Inc., a German biotechnology company based in Berlin with expertise in chemical proteomics. iPierian Inc. Nancy Stagliano, Ph.D. Chief Executive Officer SOUTH SAN FRANCISCO, Calif.—As iPierian’s interim CEO, Dr. Peter Van Vlasselaer, transitions to his role as executive chairman of the board of directors, Dr. Nancy E. Stagliano has been tapped to officially fill the CEO position. Stagliano joins iPierian after serving as CEO and co-founder of CytomX Therapeutics, and she boasts a career as a biotech leader spanning all aspects of the industry, from discovery research and strategy to global medical affairs and corporate communications. She brings to iPierian a combination of business skills, based on her roles launching CytomX Therapeutics and Cynvenio Biosystems, along with deep expertise in drug discovery and development, including her role as a lead inventor on the patents for CytomX’s Probody platform. NIH Intramural Sequencing Center James C. Mullikin, Ph.D. Director BETHESDA, Md.—Dr. James C. Mullikin, who has been acting director of the NIH Intramural Sequencing Center (NISC)—which the NHGRI created in 1997 to develop its own genome sequencing capabilities and to collaborate with other NIH intramural researchers—has been named the permanent director of the NISC. Mullikin takes up the baton of NISC director from NHGRI Director Eric Green, who founded the multidisciplinary genome sequencing center 14 years ago. Mullikin has been with NISC since 2003, and for the past two years has served as acting director of the center during what the NHGRI describes as “a time of rapid changes in genome sequencing technologies.” He is also an associate investigator in NHGRI’s Genome Technology Branch and is head of the Comparative Genomics Unit. Prior to joining NHGRI in 2003, Mullikin worked at the Wellcome Trust Sanger Institute in the United Kingdom for five years, where he led the production informatics department. His group developed sample and data tracking systems, automated sequence-assembly tools for the Human Genome Project and sequence variation analysis methods for the SNP Consortium Project and the International Haplotype Map Project. During his final six months at the Sanger Institute, he was the acting director of informatics. National Human Genome Research Institute (NHGRI) Mark S. Guyer, Ph.D. Deputy Director BETHESDA, Md.—Dr. Mark S. Guyer, who has been serving as director of NHGRI’s Division of Extramural Research, has been named deputy director of the institute, only the third person to hold that post since the NHGRI was founded in 1988 as an office to lead NIH’s portion of the effort to sequence the human genome for the first time. Guyer will play a key role in implementing the institute’s new strategic plan, the fifth one that he has helped develop in his 23 years at NHGRI. In helping to guide implementation of the new strategic plan, Guyer will work to balance the institute’s ongoing commitment to basic genomic research, including developing new technologies for sequencing and analyzing genomes, with NHGRI’s commitment to expanding the use of genomic knowledge in medical care. Guyer has served in many capacities during the evolution of the organization from office to center to institute and has participated in all phases of NHGRI’s scientific activities, from genome sequencing to the creation of the ethical, legal and social implications program. The institute’s extramural program that Dr. Guyer currently directs annually distributes more than $350 million in research and training grants and cooperative agreements, and plans a wide range of scientific activities to advance genomics, including studying the societal implications of genomics research. PBS Biotech Inc. Lourie Zak Chief Financial Officer CAMARILLO, Calif.—PBS Biotech Inc., a supplier of innovative single-use bioreactors for the biotechnology market, has named Lourie Zak, a former executive director of finance at Amgen, as its new chief financial officer. For the past eight years, Zak held executive roles of increasing responsibility at Amgen, joining the company in 2003 as special projects lead on the process improvements team overseeing the finance integration of Tularik, a research firm acquired by Amgen. She also served for three years as european controller based in Breda, the Netherlands, for Amgen Europe. For the past four years, Zak was executive director of finance for Amgen’s Global Commercial Operations at the Thousand Oaks, Calif. headquarters. Missed our bi-monthly e-newsletter, ddn Online, or our daily website reports? Catch up on these additional stories, available at www.drugdiscoverynews.com. Simply enter the EditConnect codes below in the “EditConnect” function in the lefthand menu bar of our homepage. NEWS BRIEFS ddn launches Cancer Research Portal Recently, Drug Discovery News marked the debut of the ddn Cancer Research Portal, your gateway to the latest news, trends and resources in cancer-related drug discovery and development. EDITCONNECT: E09281106 Valeant ups the ante in faceoff with Paladin to acquire Afexa Valeant sweetens the pot with its friendly takeover offer of Afexa. EDITCONNECT: E09281101 Boehringer Ingelheim’s blood-thinning drug Pradaxa raises side effect concerns in New Zealand New Zealand drug regulators are now under fire after two patients using Pradaxa died and 36 others suffered severe bleeding. EDITCONNECT: E09141102 RXi Pharmaceuticals plans to split into two public companies One company will focus on the development of targeted cancer therapies and the other will focus on the development of RNAi-based therapeutics. BENCH PRESS MIT, Carnegie Mellon researchers link protein behavior to rapid-aging disease Using engineering approaches to study protein behavior, researchers at the Massachusetts Institute of Technology (MIT) and Carnegie Mellon University are gaining important clues about the genetic mutation that causes progeria. EDITCONNECT: E09281105 Sanford-Burnham researchers identify key protein involved in glucose metabolism Scientists at the Sanford-Burnham Medical Research Institute have unveiled a new blueprint for glucose uptake. EDITCONNECT: E09141103 Scripps scientists identify white blood cells responsible for growth, metastasis of tumors A particular kind of white blood cell known as neutrophils, bone marrow-derived cells that generally serve as “first responders” at sites of severe inflammation, seems to play a direct role in the growth and spread of tumors. EDITCONNECT: E09141104 Novartis hands out 2,500 pink slips According to at least one media report, Novartis has laid off 2,500 people over the past year. A one-two combo Researchers at Brigham and Women’s Hospital share findings about a new combination of targeted cancer therapies that seems to be effective in treating two types of cancer that thus far have lacked significantly effective treatments. EDITCONNECT: E09281103 EDITCONNECT: E09281104 EDITCONNECT: E09281102 Visit the ddn Blog at http://drugdiscoverynews.com/blog/ and catch news we haven’t posted elsewhere as well as some of our opinions, views and insights about pharmaceutical and biotech business news. Here are some recent posts: Hot trend for fall: Fat! Fat seems to hold the secret to extended lifespans—if you’re a worm, at least. Chief Editor Amy Swinderman shares some interesting findings about something a lot of people are trying to lose, but which has shown some surprising value in improving health. http://bit.ly/pWy6fQ Drunk on possibilities, sobered by reality It’s all well and good to gaze in wonder at the many drug candidates being explored for so many diseases right now, but let’s not forget how few of them will ever see approval, much less success. http://bit.ly/rmRTB2 Delving deeper into abuse-resistant opioids A Q&A with Nektar Therapeutics, a company that is working on the problem of opioid abuse by attaching a polymer to the opiate to slow the speed at which the drug moves across the blood-brain barrier. http://bit.ly/ncUKwA Resistance is futile (and unhelpful) Recently, scientists at the Scripps Research Institute have been able to successfully reengineer an antibiotic to kill the deadliest antibiotic-resistant bacteria, leading to hope that we can stay ahead of drug-resistance pathogens one day. Associate Editor Kelsey Kaustinen shares this work and highlights other efforts to combat drug-resistant pathogens. http://bit.ly/nIXmtF 44 Drug Discovery News • October 2011 Products & Services Covance SFN Satellite Symposium highlights recent advances in biomarkers of Parkinson’s disease Covance Alzheimer’s research: ApoE4/ Pan-ApoE ELISA Kit MBL International Corp. (MBLI) MBLI’s ApoE4/Pan-ApoE ELISA Kit measures the amount of human ApoE4 or Pan-ApoE specifically with high sensitivity using an affinity-purified polyclonal antibody against ApoE and a monoclonal antibody against ApoE4. It also measures the difference among the homozygotes (E4/E4) and the heterozygotes (E2/E4, E3/E4) of ApoE4 phenotypes, and non-ApoE4 zygotes (E2/E2, E3/E3, E2/E3) by taking a concentration ratio between ApoE4 and Pan-ApoE. MBL International Corp. 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RSVP at [email protected] with the subject line, “SFN Symposium.” Covance (888) 268-2623 www.covance.com Visit us at Neuroscience booth #1234 microRNA sequencing services LC Sciences RNA sequencing is a powerful new tool for discovery of novel microRNAs and other small RNAs in your total RNA sample. LC Sciences provides a turnkey solution for microRNA sequencing using the latest in RNA-Seq technology including all sample handling and library preparation, microRNA sequencing and advanced bioinformatics analysis. Detect and quantify rare microRNA sequences and sequence isoforms in your samples. LC Sciences (888) 528-8818 www.lcsciences.com Visit us at Neuroscience booth #2608 Breakthrough TUNE technology Molecular Devices Molecular Devices announces the addition of the TUNE detection cartridge to the SpectraMax Paradigm Multi-Mode Microplate Detection Platform. TUNE offers wavelength flexibility in a monochromator device and up to 10 times the sensitivity. The patent-pending Spectral Optimization Wizard in SoftMax Pro software reduces the assay set-up time by more than 50 percent with simultaneous scanning of excitation and emission spectrums. Seahorse Bioscience (800) 671-0633 www.seahorsebio.com Visit us at Neuroscience booth #400 For more information, visit www.DrugDiscoveryNews.com the comfort of PIPETMAN L by adapting to both right- and left-handed users. Gilson (800) 445-7661 www.gilson.com Second-generation multimode reader with versatility and appeal Berthold Technologies The TriStar2 LB942 offers new proprietary single optics, improved fluorescence performance, injector reservoirs at the front, two injector tips in measurement position and a full modularity of reading technologies. TriStar2 is equipped with or can have added a universal and low-noise detector; photo diode for absorbance reading, fluorescence and luminescence; up to three reagent injectors; and temperature control for cellular and temperature-sensitive assays. Berthold Technologies (865) 483-1488 www.berthold.com IVIS Spectrum CT for next-generation imaging Caliper Life Sciences The IVIS Spectrum CT offers premier optical imaging seamlessly integrated with fast, low-dose microCT. The IVIS Spectrum CT was designed to offer the ultimate range of applications for in-vivo and non-invasive imaging. The system enables integration of functional and anatomical data simultaneously for true multimodal quantitative imaging. Caliper Life Sciences (508) 435-9500 www.CaliperLS.com/SpectrumCT Visit us at Neuroscience booth #1415 The Thermo Scientific CV2000 automated aliquoting liquid handler is a newly developed, secondgeneration platform that enhances laboratory efficiency through workflow automation. The CV2000 can accurately dispense liquid volumes from 100-875 µL and process up to 1000 samples per hour. With its robotic arm and rotary height sensors, it fits easily into automated workflows to boost sample throughput. The system is compatible with a wide variety of sample management software, but can also be used as a stand-alone instrument. Fully compatible with multiple rack formats, the CV2000 system allows users to change the loading and dispensing routine to suit their needs. A unique tip preservation system allows the instrument to only discharge used tips, reducing waste while eliminating contamination. Capable of holding up to 300 samples and accommodating both 45 and 90 mL urine containers, the system can automate the process of aliquoting urine from primary samples to analyzer racks. Gilson has released PIPETMAN L, the latest innovation from Gilson PIPETMAN, the pipetting standard for nearly 40 years. PIPETMAN L is an adjustable volume pipette that features a Gilson patented volume locking system. This GLP feature, among other features, meets the current needs of intensive pipette users who desire accuracy and precision without sacrificing comfort. Once you lock the thumbwheel, the operating rod is no longer in contact with the counter assembly, which is responsible for changing the volume; as you pipette, the volume cannot be accidentally changed—a concern in some manual pipettes. PIPETMAN L boasts the most natural and patented tip ejection system that reduces forces through a pulley system offering low tip ejection forces with any brand of tip. An adjustable tip ejector button has further improved Cellular Dynamics International (CDI) (877) 310-6688 www.cellulardynamics.com Cell-based assay enables researchers to distinguish primary mitochondrial dysfunction from secondary cytotoxic events in a single well Promega Corp. Promega has launched the Mitochondrial ToxGlo Assay, a cell-based assay that enables researchers to quickly profile large compound libraries or medicinal modifications for their effects on mitochondria by allowing them to distinguish primary mitochondrial dysfunction from secondary cytotoxic events in a single well via a sequentialaddition, multiplexed assay chemistry. The Mitochondrial ToxGlo Assay is based on the differential measurement of biomarkers associated with changes in cell membrane integrity and cellular ATP levels during short xenobiotic exposure periods. The assay is easy to automate and can be scaled to meet throughput needs for 96- and 384-well plate formats. Horizontal Amersham ECL Gel System for protein electrophoresis GE Healthcare Automated aliquoting liquid handler Thermo Fisher Scientific Inc. Increase productivity without sacrificing comfort Gilson for use in vascular-targeted drug discovery, tissue regeneration and other life-science research. iCell Endothelial Cells are derived from human induced pluripotent stem (iPS) cells, actively proliferate, are capable of arranging themselves into tubular formations and exhibit biochemical properties of normal human endothelial cells. Because they are human cells, they better recapitulate human biology and therefore are better predictors of drug candidate responses than current cell models. CDI manufactures iCell Endothelial Cells in industrial quantities with more than 95 percent purity, which is ideal for vascular biology research, including revascularization of an organ for tissue regeneration. Promega Corp. (608) 274-4330 www.promega.com Molecular Devices (800) 635-5577 www.moleculardevices.com/Paradigm Kits measure cellular bioenergetics Seahorse Bioscience Seahorse Bioscience’s XF Extracellular Flux Analyzer is the industry standard for measuring cellular bioenergetics, simultaneously measuring the two major energy-producing pathways of the cell mitochondrial respiration and glycolysis in a microplate in real time. The XF Analyzer and kits determine in-vitro oxygen consumption, glycolysis, mitochondrial function and fatty acid oxidation, providing a full bioenergetics profile. Now it’s easy to determine the reserve respiratory capacity of resting and stressed primary neurons, astrocytes, glia and other neural cells in a microplate, opening the door to new understanding of cancer and aging as well as metabolic, cardiovascular and neurodegenerative diseases. Thermo Fisher Scientific Inc. (508) 742-5254 www.thermofisher.com iCell Endothelial Cells for vascular-targeted drug discovery Cellular Dynamics International (CDI) CDI has launched human iCell Endothelial Cells GE Healthcare’s horizontal Amersham ECL Gel System is designed for high-quality protein electrophoresis, enabling efficient, high-quality and reproducible protein separation. Offering high sensitivity and resolution, it works with standard protein detection protocols and is easy to integrate into the Amersham ECL Western blotting workflow. The core of the system is Amersham ECL Gel, a precast gel available in a variety of concentrations and well configurations. Gels are processed using Amersham ECL Gel Box, a dedicated electrophoresis unit with horizontal design, and significantly increased ease of use compared to vertical systems. Everything required to access and cut the gel is included in the cassette. At 1.4 mm thickness, it is thicker than most other precast and hand-cast gels, providing peace of mind when handling and reducing the risk of gel breakage in downstream processing. GE Healthcare (800) 526-3593 www.gelifesciences.com Sample traceability and enhanced security is facilitated with reliable plug-and-play technology WHEATON WHEATON introduces the new SingleScan Bar Code Reader, a tool to aid researchers in making sample traceability more efficient and accurate. A sophisticated 2D Data Matrix and 1D Linear Bar Code Reader capable of reading coded vials and ampules from a wide range of manufacturers and label printers, the new SingleScan Bar Code For For more more information, information, visit visit www.DrugDiscoveryNews.com www.DrugDiscoveryNews.com Reader offers enhanced reading performance in a compact unit. Researchers simply hold or place the vials, such as the CryoELITE Cryogenic vials, over the scanning element for rapid reading and precise identification. The SingleScan features a user-friendly, plug-and-play design that enables an easy set-up with no software installation required. Simply plug into the USB port and open the application file. The USB interface allows for an easy connection to any computer and enables multiple user/multiple software applications. Additionally, it inputs decoded bar code ID into any software application where the cursor is placed, making the SingleScan the easiest and most cost-effective way to manage and track biological samples. WHEATON (800) 225-1437 www.wheaton.com Software offers a better understanding of intracellular and intercellular relationships PerkinElmer Inc. PerkinElmer announces the release of Volocity 6.0, which represents a major advance in the power and simplicity of Volocity Quantitation. Define and measure cells, organelles or other biological structures, and the relationships between them, with greater ease. Measure distances in 3D between structures across a whole field or within biologically relevant compartments such as cells or nuclei. Enjoy more interactivity and even simpler workflows to obtain quantitative 3D answers more quickly and easily. Perform FRAP analysis on data that has not been acquired in Volocity software (requires FRAP plug-in and Volocity Quantitation). Faster and easier export of multiple, processed images for presentation and for use in other applications. PerkinElmer Inc. (781) 663-6900 www.perkinelmer.com High-throughput centrifuge boosts reliable lab performance Beckman Coulter Inc. The Allegra X-14, a new three-liter benchtop centrifuge from Beckman Coulter Inc., accepts a variety of tubes and adapters to provide reliable performance in a range of applications. Refrigerated and constant-temperature models are offered individually or in pre-bundled packages that provide everything needed for quick set-up in the laboratory. With a fixed-angle rotor, the X-14 provides a maximum speed of 10,200 rpm and delivers rcf of 11,400 X g. Swinging-bucket rotors can achieve a maximum speed of 4,300 rpm and rcf of 4,300 X g and, utilizing a wide selection of tubes, bottles and plates, accommodate a range of sample types and volumes. Depending on rotor and labware, the Allegra X-14 can process as many as 148 tubes per cycle. The refrigerated model offers a temperature range of 2° to 40°C, and features a robust cooling system that brings samples from room temperature to 4°C in less than four minutes, reducing wait time and enabling runs to be processed efficiently. The constant-temperature model is pre-set to 20°C. Allegra X-14 series units can be equipped with exclusive ARIES Smart Balance rotor technology, which automatically detects and corrects sample-load imbalances of up to 50 grams. This saves time by easing sample prep Products & Services requirements, eliminating mid-run interruptions and reducing wear by correcting imbalances before damage can occur. Beckman Coulter Inc. (800) 526-3821 www.beckmancoulter.com Stellaris FISH advances research in cancer, developmental biology and pathology Biosearch Technologies Inc. Biosearch Technologies’ Stellaris Fluorescence In Situ Hybridization (FISH) Probes are an RNA visualization method that allows simultaneous detection, localization and quantification of individual mRNA molecules at the subcellular level in fixed samples. Biosearch currently offers Stellaris FISH probes manufactured on a custom basis, including software for optimum probe design. In addition, premade probe sets for glyceraldehyde 3-phosphate dehydrogenase (GAPDH) in human and mouse applications are available. By enabling scientists to localize and count discrete molecules of mRNA using widefield fluorescence microscopy, Stellaris FISH probes can lead to streamlined studies in stem cell, cancer, pathology, developmental biology, transcription regulation and neuroscience research. Biosearch Technologies Inc. (800) 436-6631 www.biosearchtech.com Instant visualization at every stage reassures researchers throughout immunoblotting workflow Bio-Rad Laboratories Inc. Bio-Rad announces the launch of its ChemiDoc MP imaging system, the industry’s only stain-free enabled instrument capable of chemiluminescent, multiplex fluorescent and routine gel imaging. Using the stain-free detection option of the ChemiDoc MP system, researchers can quantify total protein for normalization purposes after transfer to the membrane. This stain-free total protein normalization method produces faster results and overcomes the potential errors associated with normalization using housekeeping proteins. The ChemiDoc MP system also integrates with Bio-Rad’s V3 Western Workflow, a portfolio of Bio-Rad products that shorten the protein separation and blot transfer steps from several hours to 30 minutes. In addition, the V3 Western Workflow offers researchers confidence in their Western blot results, providing them a way to visualize their proteins at every stage of the protocol. Using the ChemiDoc MP system, researchers can visualize protein separation on Criterion TGX Stain-Free precast gels, verify successful transfer with the Trans-Blot-Turbo transfer system by imaging the membrane using stain-free detection and validate the accuracy of Western blot results at every step. Bio-Rad Laboratories Inc. (800) 424-6723 www.bio-rad.com October 2005 2011 • Drug Discovery News 45 NOVEMBER adv e r t is e r ’ s ind e x Asuragen, Inc..................................................................29. BASi...............................................................................10. Beckman Coulter Genomics, Inc.......................................5. Beckman Coulter, Inc........................................................7. Bio-Rad Laboratories........................................................9. Biosearch Technologies...................................................23. BioTek Instruments, Inc...................................................17. Caliper Life Sciences........................................................3. Cosmo Bio USA, Inc........................................................20. Covance..........................................................................40. DiscoveRx Corporation....................................................27. Hamilton Robotics............................................................2. IBC Life Sciences...........................................................36. INDIGO Biosciences, Inc.................................................18. Invitrogen, Part of Life Technologies................................48. LC Sciences....................................................................32. MBL International Corporation........................................38. Molecular Devices, Inc....................................................11. National Disease Research Interchange (NDRI)..............15. OriGene Technologies, Inc.......................................... Cover. R&D Systems, Inc...........................................................34. Regis Technologies, Inc...................................................41. Roche Applied Science...................................................31. Seahorse Bioscience......................................................21. SLAS 2012.....................................................................22. Taconic...........................................................................47. Waters Corporation.........................................................42. phases for the analysis of intact proteins, phosphopeptides and glycans. All cHiPLC-nanoflex columns are designed and microfabricated to be robust and highly reproducible, providing superiorquality separations that are easy to obtain by users at all experience levels. AB SCIEX (877) 740-2129 www.absciex.com Bioprocess analyzer for reliable metabolite profiling and substrate analysis Roche The Cedex Bio Bioprocess Analyzer is a continuous random-access analyzer enabling a safe and reliable determination of chemical and biochemical parameters in aqueous solutions. Its comprehensive testing capabilities include photometric testing and electrolyte testing. The measurement of up to 14 parameters simultaneously (out of 28 programmable tests) is possible per sample. The analyzer is easy to operate, enabling continuous loading and unloading of diverse cup types as well as on board dilution of highly concentrated samples. drug compounds. Based on HP inkjet technology, the Digital Dispenser is the result of an agreement between Tecan and HP to commercialize this new technology for use in drug discovery research. The HP D300 provides fast and reliable performance across a large dynamic range, eliminating the need for slow, error-prone and wasteful serial dilutions. Using disposable dispense heads to help avoid the possibility of cross-contamination, the instrument offers non-contact digital dispensing from 13 pl to 5 μl, delivering any dose to any well and virtually eliminating waste of valuable compounds. Tecan +41 44 922 81 11 www.tecan.com IDBS announces multiple web-based advances IDBS HP D300 offers exceptional speed for drug discovery workflows Tecan IDBS has announced that it will launch a range of new products over the next six months that enhance its integrated enterprise software platforms. In July, IDBS released a web-based version of its E-WorkBook product to support searching and reviewing content while on the move. The next release of E-WorkBook Web will support editing of a wide range of content as well as web-based review and sign-off, enabling researchers to collect, calculate, store, search and use data across a wide range of browsers. This fall, IDBS will release ActivityBase 8 to enhance personal productivity and performance at a time of increasing data volumes, and further ease administration and deployment through a web-based interface. Registration of samples and administration can be carried out securely and remotely to make the process of high-capacity experimentation even more efficient. IDBS will also launch a high-capacity ‘omics analysis system that offers fast analysis of high-context ‘omics data, molecular analysis and research collaboration. Tecan announces the availability of the HP D300 Digital Dispenser, a simple, standalone instrument that uses HP Direct Digital Dispensing technology to rapidly deliver picoliter to microliter volumes of IDBS +44 1483 595 000 www.idbs.com Roche +49 8856 604830 www.roche.com AB SCIEX expands Eksigent Chip Column family for nano- and micro-LC proteomics analysis AB SCIEX AB SCIEX has extended its Eksigent line of column chips for the cHiPLC-nanoflex system. Five new chips expand the flexibility and application of the system for high-performance proteomics analysis including biomarker discovery, validation and verification. The extended offering adds higher flow micro-cHiPLC columns for peptide separation at increased throughput levels, as well as new www.asuragen.com www.basinc.com www.beckmangenomics.com www.beckmancoulter.com www.bio-rad.com www.biosearchtech.com www.biotek.com www.caliperLS.com www.cosmobiousa.com www.covance.com www.discoverx.com www.hamiltonrobotics.com www.ibclifesciences.com www.indigobiosciences.com www.invitrogen.com www.lcsciences.com www.mblintl.com www.moleculardevices.com www.NDRIresource.org www.origene.com www.RnDSystems.com www.registech.com www.roche-applied-science.com www.seahorsebio.com www.slas2012.org www.taconic.com www.waters.com 46 Drug Discovery News • October 2011 facts & Figures For more information, visit www.DrugDiscoveryNews.com Report examines benefits, factors of portfolio management P ortfolio management is quickly gaining strength as more and more pharma- ceutical organizations recognize its benefits and potential. However, as market research firm Cutting Edge Information (CEI) notes in its report, “Pharmaceutical Profile Management Strategy,” like many business operations, portfolio management has to be overseen and maintained correctly to truly benefit a company. One of the key factors in successful portfolio management, according to the report’s interviewees, is “a clear corporate strategy to drive the portfolio management process.” The most effective portfolio management functions, the report Portfolio Management Budgets Based notes, are those that work in on Number of Investigational Drugs tandem with corporate strategic planning toward achieving company goals. Without proper leadership and connection with the executive leaders, it becomes much less effective. Company size can also affect portfolio management effectiveness. Licensing is a viable option for mid-sized companies, although on average, only 8 percent of their portfolio investments are allocated to licensing activities, while an average 69 percent is allocated to marketed products with proven success. D at a s t a n d a r d i z at i o n serves as a significant help in ensuring that portfolio manage m e nt f u n c t i o n s r u n Portfolio Management Budgets Based smoothly, since the sheer volume of data that is amassed on Number of Marketed Drugs can make thorough analysis and comparison difficult and overwhelming. One of the interviewed companies struggled to institute “a web-based metrics and measurement tool for each of its brand teams to track product performance,” and after a year, it was implemented in all its subsidiaries, resulting in full integration and data outputs that are “fully comparable between products.” The corporate factor has to be present, though, as 45 percent of those interviewed say that the “chief reason for lessthan-satisfactory portfolio management is a lack of either buy-in or corporate culture,” while 62.5 percent believed that to be “the chief barrier” to success. For some, it might come down to a battle between executive unease at granting decision-making power to another business function and acknowledging the benefits a sharing of power could have. ddn Portfolio Management Budgets Per Company Reporting Relationships in Portfolio Management Departments Participating in Portfolio Management Activities ABOUT CUTTING EDGE INFORMATION Cutting Edge Information is a business intelligence firm providing primary and secondary research on a wide range of business subjects, with a specialization on the pharmaceutical research industry. For more information about this report, or other CEI reports, visit www.cuttingedgeinfo.com. Drug Discovery News (USPS 024-504) is published monthly by Old River Publications LLC, 19035 Old Detroit Road, Suite 203, Rocky River, OH 44116; 440-331-6600. Periodical postage paid at Cleveland, Ohio and additional mailing offices. Publisher assumes no responsibility for unsolicited material or prices quoted in the magazine. Contributors are responsible for proprietary classified information. ©2011 by Old River Publications. All rights reserved. Reproduction, in whole or in part, without written permission of the publisher is expressly prohibited. Back issues, when available, cost $7 each within the past 12 months; $12 each prior to the past 12 months. Back orders must be paid in advance by check. Drug Discovery News is distributed without charge in North America to qualified drug discovery research professionals. Paid subscriptions to those not qualified cost $65 annually to the U.S. and Canada and $150 to all other countries. All payments must be made in U.S. funds drawn on a U.S. bank. Publications mail agreement no. 41401058 return undeliverable Canadian addresses to PO Box 503, RPO West Beaver Creek, Richmond Hill, ON L4B 4R6. For subscription services, including subscription information, please call 215-785-5196. POSTMASTER: Send address changes to Drug Discovery News, PO Box 3100, Langhorne, PA 19047-8800. Tac transADMET_Ad_DDN 8/24/11 1:07 PM Page 1 The smarter the mouse... ...the better its ability to predict ADMET in humans. With the introduction of transADMET™, a portfolio of novel humanized mouse models, Taconic is helping to transform compound development by predicting with greater accuracy ADMET in humans. transADMET™ models are humanized or annulled for key proteins involved in drug metabolism and disposition, and have the potential to significantly improve the safety and efficacy evaluation of new drugs. transADMET™ models are offered in three panels: xenoreceptors, cytochrome P450s, and drug transporters. For further information, visit www.taconic.com/transADMET Smart. Very Smart. MORE INFO @ adv-connect.com Wolf goby fish (Luposicya lupus) seamlessly transitions into its environment. cell reprogramming transformed Introducing the CytoTune™-iPS Sendai Reprogramming Kit Setting a new standard in cell reprogramming, the CytoTune™-iPS Sendai Reprogramming Kit offers highly efficient, easy-to-use technology for generating induced pluripotent stem cells (iPSCs) with no viral integration. Experience Invitrogen™ innovation at www.invitrogen.com/cytotune Get the free mobile app for your phone at http://gettag.mobi For Research Use Only. Not intended for any animal or human therapeutic or diagnostic use. © 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. CytoTune is a trademark of DNAVEC Corporation. Printed in the USA. CO23755 0911 CO23755 One page ad DDN SPECS 10.625x13.875.indd 1 9/26/11 12:52 PM