here - WIRB-Copernicus Group
Transcription
here - WIRB-Copernicus Group
Deadline T actics , page 5 ; P artners in M us ic and L ife, 1 7 ; M arie S turk en’ s L ife of A rt, 2 0 ; J ae K o’ s S h iro at G F S , 2 2 . A ll- S tar T rib ute: Dawn R ob ins on performs with Candleligh t Concerts for E pileps y, M arch 2 8 . E v ents : page 1 0 . STANDING UP 5 , 201 ch 25 r © Ma FOR Business Meetings 35 Preview 10 Opportunities 26 Singles 28 Jobs 38 PH: 6 0 9 - 4 5 2 - 7 0 0 0 FAX: 6 0 9 - 8 4 4 - 0 18 0 WWW.PRINCETONINFO.COM HUMAN TEST SUB J ECTS WIrB copernicus, headed by cEO Donald Deieso, third from left, provides institutional review boards to pharmas planning to test new drugs on human subjects. Before the drug companies can try something on you, they have to get past the IrB. Diccon hyatt reports, page 30. PHOTO B princeton spring 2015 Genesis Celebrating Our Creative Community be osnide. my Y MARK CZ AJ KOWSKI Please take a sneak peek at the newest member of the Community News Service family. Genesis, a quarterly journal, is stapled inside this issue. firstbanknj.com 877.821.BANK (2265) A BANK SHOULD... AMAZING VALUE! Premier Checking CRANBURY BRANCH 609.642.1064 EWING BRANCH 609.643.0470 APY* HAMILTON BRANCH 609.528.4400 LAWRENCE BRANCH 609.587.3111 0.75% *The APY is accurate as of 3/20/15 and is subject to change without notice after the account is opened. Minimum daily balance of $500 required to open account and avoid monthly service fee. Fees may reduce earnings. FDIC insured. US1_PreChk_A March 25, 2015 What It’s Like to Be on an Institutional Review Board W hen institutional review boards meet to discuss the ethics of human subjects in studies, they rely on the perspective of non-scientists to make sure that the test subjects will be able to understand what they are signing up for. Each IRB has six scientists and three non-scientist members. The main qualification for being one of the three non-scientists is that you are not a scientist. Tanna MacReynold frequently serves on IRBs in addition to her role as senior director of IRB affairs at WIRB in Washington. “It’s very exciting. The members are quite the mix. We have physicians, pediatric oncology doctors, photographers, and engineers. I’m a non-scientist,” she says. It’s a paid job, but no one is an IRB member as a full-time career, since one person is usually on at most three IRBs a week. IRBs meet just once to approve a study or to require modifications. The members have two days to prepare for each meeting, each of which is about three hours long. “The scientists are there to present the scientific aspects of the study,” she says. “The scientists use the meeting as an opportunity to educate the nonscientists. We have a discussion about the rights and welfare of the subjects, and it’s one of the critical pieces for non-scientists to view it as a layperson, look at the consent form, make sure that we under- stand what is going on in the research, and go away as informed subjects.” After the discussion, the board holds a vote about whether to approve the study, and the majority wins. “I’ve been on a jury, and I would say it’s kind of similar,” MacReynold says. A board may approve a study, turn it down, or request changes or additional information. The researchers have an opportunity to respond, and can request another meeting for the IRB to reconsider. Since IRBs are supposed to be impartial, WIRB has to be careful to avoid conflicts of interest. MacReynold says this is easier at an independent review company like WIRB than it is at small individual institutions such as hospitals or universities where the people who are on IRBs often have direct ties to the research being conducted. Nevertheless, the for-profit IRB industry has attracted criticism because of the fear that IRBs will try to please clients instead of worry about the welfare of human subjects. MacReynold says the business personnel and the staff who run the IRBs are separate from one another. “Business discussions don’t ever come up in the boards,” she says. “Even as a staff person, I’m pretty much as removed from the business specs as possible. We don’t want to commingle those two things.” For-profit IRBs are kept honest by FDA regulations in addition to the company’s scruples. Both of WCG’s main IRB companies, Copernicus Group and WIRB, have been awarded ISO9000 certification by an independent auditor, with WIRB earning the certification on March 16. — Diccon Hyatt Forbes magazine recently dividand benefit would have to be established,” Deieso says. “And you ed 100 pharmaceutical companies’ couldn’t trust that decision to those total research budgets by the numthat had the greatest to gain, like ber of drugs approved, and found drug companies. Third parties were that on average, across all the cominstitutionalized to study those panies, each product brought to market accounted for $5.8 billion clinical trials,” he says. IRBs already existed at some in- in spending. Some companies were stitutions but weren’t mandated by spending as much as $11 billion on law until that point. Most organiza- research for every successful drug tions conducting research used that went out their doors, and even boards that were part of research the less costly drugs were north of institutions, or independent non- $100 million. The entire industry spends an astounding $150 billion profit IRBs. Western IRB — the largest com- a year on drug development. Deieso says he chose Princeton pany to be taken under the WCG umbrella — started off as one of the as the headquarters of the company latter. According to a company his- because it is near so many potential tory, WIRB was founded in Olym- clients — with Covance, Inventiv, pia, Washington, by Angela Bowen Bristol-Myers Squibb, Novo-Norin 1968 to oversee her endocrinol- disk and Johnson & Johnson close ogy research. The board began by, Princeton is a good location for companies that overseeing other want to cater to scientists’ projThere is an ongoing life sciences ects and incorpodebate among bioeth- companies. (It rated in 1977. also helps that icists about whether As research the move for regulations grew companies like WcG Deiso from his more strict in the should oversee the previous comearly 1980s, pany was a ethical performance WIRB became a for-profit comof companies that are short one — he was formerly in pany and greatly paying them. the same buildexpanded its oping as his curerations to inrent office at a clude international clients as well as many large drug companies. In company called Eduneering, where 1996 the company began offering he was CEO.) The companies that make up its services to institutions such as large universities. WIRB says it is WCG are also located at research hubs throughout the country. With the largest company of its kind. Arsenal bought up WIRB along its broad reach, WCG now overwith North Carolina-based Coper- sees about 11,000 clinical trials a nicus, the second-largest company year at 1,300 institutions and has in the field, in 2012, to form WIRB- about 550 employees around the Copernicus Group. The group soon world. Deieso says WCG compaacquired five other companies, all nies oversee IRBs at every major of them in the field of pharmaceuti- hospital where clinical research is done. cal services. “We didn’t start this from ground zero,” Deieso says. “We put togethn December WCG signed a er the largest and best companies with the finest reputations.” The deal to provide regulatory and ethother companies in the group are ics reviews to Cancer Treatment IRBNet, a web-based research Centers of America, a cancer remanagement application; Mid- search organization with hospitals lands Review Board, a Overland in Atlanta, Chicago, Philadelphia, Park, Kansas-based IRB company, Phoenix, and Tulsa. WCG has an Aspire Independent Review Board, oncology division that specializes a woman-owned IRB based in San in cancer research. “Cancer trials are becoming Diego; New England Independent Review Board, a Boston-based more and more complex,” Deieso IRB company; and ePharma Solu- says. Cancer treatments increastions, a clinical trial consulting ingly involve not just one drug, but “cocktails” of different drugs, in company. The common purpose behind all addition to new immunotherapy the WCG companies, Deieso says, treatments that turn the human imis to make drug development safer mune system against cancer cells. and less costly. And there is no Other research is exploring the gedoubt that such a service is badly netic underpinnings of cancer. All of this means more regulatory and needed. I ethical complexity when running a clinical trial. New areas of ethical complexity are arising all the time. For example, technology companies have created new ethics battlegrounds with their use of consumer data to run experiments. Facebook drew the ire of its users when it performed an experiment to see whether it could manipulate the emotions of its users by increasing the proportion of positive or nega- U.S. 1 For Sale-Princeton Office Professional 2000-12,500/SF rinceton off arrison, fully fit out medical, sale or lease, hi uality construction 3200/SF ext to indo arne ie enter, round oor corner, ample up rades, income potential P e e ont t O w n e r, B ro k e r i i i h 609-921-8844 • 609-731-6076 b b a r is h @ c p n r e a le s ta te .c o m Commercial Property Network, Inc. We Have a Place For Your Company Continued on following page BUILDING 29 SUITE(S) 1-4, 7,925 (+/-) SQ. FT. 73-’8” 37’-4” 33’-5” 25’-2” 8’-8” 20’ 6’-10” 25’-3” 26’-3” 11’-5” 16’-7” 13’-3” 12’ 9’ 9’ 10’-10” 45’ 11’ 12’ 11’ 10’-4” 10’-2” 11’-4” 5’-10” 9’-11” 17’-9” 10’-10” 31 ew Pr ice ! Love the lifestyle? 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The company’s The Bright Choice in Real Estate 609-921-3299 Fax entire executive team will work out glorianilson.com Beth Kearns of the new office. CEO Edmundo Sales Associate [email protected] Muniz says the new space offers Licensed in NJ & PA room to add new executives as well Cell: 609-847-5173 Princeton Office: 609-921-2600 as expand its business developglorianilson.com [email protected] ment, science, sales, marketing, medical regulatory writing, and consultancy staff. In a press release, the company says it plans to add an education center where the it can conduct scientific and product training for life science industry professionals. Where Green Meets Quality Certara was created in 2008 Owner Operated. Licensed & Insured. 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Although the experiment showed only a negligible effect on the 689,000 users chosen to participate, many ethicists objected to running the experiment without providing informed consent to the users. “I think the digital world is opening up a whole new frontier that we’re all coming to grips with and trying to understand,” Deieso says. “What most people don’t know is that when you register and log on to that software, in fine print it says that you have actually assented to letting them have your data.” Deieso wonders if the clicked-through but never-read user agreements truly give companies the right to experiment on users in this way. “It’s not like letting people with syphilis die, but it is intrusive,” he says. Another area of debate in the world of IRBs is “broad consent.” Traditionally, test subjects allow researchers to look at their data for particular experiments. But increasingly, researchers have been gathering DNA and other information of the people they study and building large databases that can be used for all kinds of research. A more traditional quandary that comes up in IRB deliberations is risk versus benefit. How much risk is acceptable in medicine? For example, Deieso says, face transplants are new and incredibly risky procedures, and the gain is only cosmetic. But various IRBs have allowed several surgeons to perform face transplants on people who were disfigured in accidents. “IRBs have taken a position that there were ample instances where the individuals were so disfigured that they chose to take their lives. It’s interesting from an ethical point of view because without the surgery, there is the risk that the in- Edited by Diccon hyatt holding company was named Certara, which is Latin for certitude. Later, Certara bought Simcyp. The UK-based company, founded in 2001, specializes in predicting how drugs would react not in a generic human body but in specific populations of patients. Biosimulation is the intersection of two disciplines: genetics and computing. With the knowledge of the human genome, makers of biosimulation software try to use computers to simulate how chemicals certara, the owner of three companies in the biosimulation business, is expanding to 100 Overlook center. would react with the human body. “The integration of those two relatively different disciplines harnesses synergistic power of both sciences that together explain how the human body works and how drugs work,” Muniz says. Tripos has been in the biosimulation business since 1979, when computer-aided drug discovery was just getting started. Today biosimulation is becoming a major part of drug development, with analysts predicting the biosimulation market to reach $1.7 billion by the end of 2017, compared to the overdividuals would terminate their lives, and that offsets some of the risks of the procedure.” The dilemma goes back to the roots of scientific medicine. Paracelsus observed in the 1400s that even medicine can be toxic in large enough amounts, famously saying “The dose makes the poison.” Deieso says ever since, pharmacology has been a balancing act to find the fine line between the two. “The The companies that make up WcG are located at research hubs throughout the country. WcG now oversees about 11,000 clinical trials a year. whole point of science is to determine that point,” Deieso says. The idea of a for-profit company being hired to provide an independent IRB is not without its critics. There is an ongoing debate among bioethicists about whether companies like WCG should oversee the ethical performance of companies that are paying them. Professors Trudo Lemmens and Carl Elliot have argued that commercial IRBs have “a fundamental conflict of interest” because their clients have a direct financial interest in obtaining drug approvals. B ut Ezekiel J. Emanuel, a bioethicist and Penn professor (and an advisor on Obamacare), says there is no evidence that for-profit IRBs perform poorly compared to their nonprofit counterparts. He notes that WIRB was the first organization to achieve the highest level of accreditation from the Association for the Accreditation of Human Research Protection Programs. He also says for-profit IRBs are subject to the same regulations all $68 billion drug research market. Biosimulation is used in addition to real-world clinical trials to predict the effects of drugs being researched in an effort to prevent costly failures of drugs late in the approval process. “If you can use the biosimulation to avoid doing a costly study, of course this work is encouraged by the regulators as long as science deems it appropriate,” Muniz says. “Doing a clinical study could be harmful to patients.” Muniz says Certara recently had a client that had a central nervous system drug that was in late stage development and about to be approved by the FDA. But first, the company had to conduct several studies of potential drug-drug interactions, each of which would have cost millions of dollars. Instead of testing the drugs on real patients, the company received approval to use computer simulations, and then provided the resulting data to the FDA. Biosimulation also provides a way around the mathematical reality that there are almost infinite potential drug combinations, and testing each one in a clinical trial would be impossible, Muniz says. “In a way, biosimulation is one of the most cost-effective ways of conducting clinical development, not only in terms of time, but in cost, and in terms of harming patients. When you conduct drug-drug interaction trials, you have to actually expose patients to potentially and oversight as nonprofit IRBs. But overall, the strategy of WCG is to deepen, rather than broaden its reach. Deieso says he has no plans to corner the market by buying more IRBs. “We’re happy with our growth,” he says. “We are much more focused now on expanding our services so our clients can benefit from more of a single solution that can accomplish more and more of what they do.” WCG is now “looking at ways to help researchers be administratively more efficient,” Deieso says. “In a drug trial there are hundreds and thousands of hands involved,” he says. “They may have hundreds of trial sites and can be conducted by 100 or more individual physicians and 100 or more staff, and thousands of subjects. Can you imagine how much paper is created?” One of WCG’s emerging services is to replace that massive paper trail with electronic records. WCG’s recent acquisition, Plymouth, Pennsylvania-based ePharma Solutions, is in the trial management arena. “We are very interested in moving clinical trials into the digital world,” Deieso says. Another area of expansion is WCG’s biosafety division. In July the company bought Alliance Biosciences, a Richmond, Virginiabased company that specializes in overseeing safety, the handling of dangerous materials, regulatory compliance, and lab design. “Our division has experts who specialize in the proper care and management of hazardous organisms — not just smallpox but Anthrax and the H1N1 flu.” While such samples are dangerous, Deieso says, they are also necessary to keep around in order to study or even to “weaponize” against diseases. Deieso says modified viruses could prove to be an extremely effective drug delivery mechanism. “Viruses are magnificent machines,” Deieso says. “They are able to mutate quickly. To capture that capability of a virus and turn it March 25, 2015 harmful drug-drug interactions. Obviously, if you had to do it, it would be for the good of humankind, but you would nevertheless have to expose patients to risk.” Doing the whole thing by number crunching would be preferable — so long as the simulation was accurate. Achieving accuracy requires not only immense computing power, but the expertise of staff. “One pharmo-kinetic model may have 10 to 20,000 lines of code,” Muniz says. currently Certara has about 10 people working in the recentlycreated Princeton headquarters, and about 350 worldwide. About 100 of those employees are scientists and medical doctors with advanced degrees. The company has only had a presence in Princeton since mid-2014. “This is a pharmaceutical corridor, and the concentration of pharmaceutical companies and biotech businesses is significant here,” Muniz says. “Being close to our clients would create significant interactions and easy communication.” Together, the companies that make up Certara have had a hand in developing hundreds of drugs over the years. Muniz says their clients have had 20 drugs approved in the last 18 months. Design with the aid of massive computing power has already revolutionized the aerospace industry, defense, and weather prediction. into good is a goal of clinical research.” Genetic research also poses lab safety challenges, Deieso says. Researchers must be careful not to release modified DNA into the environment. “This segment of the market is growing in a quite dramatic way,” Deieso says. Deieso’s background didn’t seem likely to point him for a career in biotech. He grew up in Elizabeth, and studied engineering at Manhattan College (and later environmental engineering for a doctorate at Rutgers) and music at Juilliard. He had always had an interest in engineering, going back to his father, who was an engineer. But he describes music as the true love of his life. He was an avid trumpet player in college and later served on the board of the New Jersey Symphony. “One of my greatest joys is just playing for myself and perfecting my skill,” he says. Deieso is married and lives in Princeton. His daughter Cara works at WCG as a senior vice president of marketing. Although he is still a lover of classical music, Deieso says he has discovered a passion for his work in drug research. “One thing that’s a shared trait at this company is the desire to make a contribution,” he says. “Everyone here, if you ask them what they do and why they are here, will say they want to transform healthcare. Most people here have stories about family members who have had healthcare adversity, or diseases they have succumbed to. This is one of those unique opportunities where you can use your energy to make a difference. That’s what drove me. I’ve become devoted to public health.” WIrB copernicus Group, 202 Carnegie Center, Suite 107, Princeton 08540; 609-9450101. Fax, 609-799-2216. Donald A. Deieso, CEO. www.wcgclinical.com. Simulation Game: Edmundo Muniz’s company integrates genetics and computing to assess how drugs could interact with the human body. Muniz hopes to bring healthcare, a relative latecomer to the game, into the same realm. Muniz grew up in the Dominican Republic. “That means I have to know how to dance, salsa and merengue very well, and I should know how to play baseball very well,” Muniz says. He is the son of an Exxon executive and a homemaker. Muniz recalls that by age 7, he knew he wanted to be in medicine. “I dissected all kinds of animals everywhere, which my mother would find under the bed and in the bathroom. It was a fantastic time. I fell in love with biology, which led me to choose medicine as a career. He earned a medical degree from the Autonomous University of Santo Domingo, and a Ph.D. in population planning and international health and a master’s in population planning from the University of Michigan’s school of public U.S. 1 33 OFFICE SPACE AVAILABLE OFFICE SPACE AVAILABLE 13 Roszel Road, Princeton, NJ 13 Roszel Road, Princeton, NJ health. After that, he completed a residency in epidemic intelligence services, investigating outbreaks of infectious disease. Muniz then joined Eli Lilly, where he worked for 11 years working in various senior executive roles including head of worldwide pharmacovigilance and epidemiology, the cardiovascular business unit leader, and vice president of oncology and clinical development. He later became president of Kirax Corporation and served there until 2014, when he became CEO of Certara and began to oversee its expansion. Adjacent Center Adjacent to to Carnegie Carnegie Center JunctionTrain Train Easy accessto to Princeton Princeton Junction Easyaccess Walking distance to Princeton Post Office Walking distance to Princeton Post Office available Verizon Fios & & Comcast Comcast available VerizonFios For tour,contact: contact: Formore moreinformation, information, or or to to schedule schedule aa tour, PeterM. M.Dodds Dodds Peter 609452-8880 452-8880X101 X101 609 [email protected] [email protected] Continued on following page For Lease: Warehouse, Flex, Showroom & Office Space Directly off Route 130 & 33. 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