CCST releaSeS inTeriM iP rePorT for STeM Cell inSTiTuTe
Transcription
CCST releaSeS inTeriM iP rePorT for STeM Cell inSTiTuTe
FELLOW strong force in IP study Today, policymakers turn to CCST more and more for impartial analyses of issues ranging from genetically modified foods to energy to education. However, as CCST Fellow and former Council Member Roger Noll notes, achieving this status as an independent source of advice has been a gradual process. "The first few years witnessed a long up-hill struggle to obtain the confidence of government officials, business leaders, and academics who are involved in science policy," said Noll. "With completion of the CaliforniaReportontheEnvironmentforScience and Technology (CREST), CCST demonstrated its competence across the entire spectrum of California policy issues." Noll has been a part of this process for many years. As a council member from 1995 through 2000, he helped oversee the production of CREST and witnessed CCST's transformation into an organization with greater recognition and credibility at the state and national levels. However, with recognition sometimes comes controversy. "Being an effective source of advice on science and technology presents formidable challenges, one of which is effective communication," said Noll. "Delivering the results of often difficult, arcane technical analysis in plain but accurate reports that are accessible to everyone is not easy. I believe that CCST's recent interim report on the intellectual property to be derived from California's stem cell research program, for example, has greatly elevated the debate not only about the governance of the program, but about the plausible role for stem cell research in stimulating new medical advancements." Noll is the Morris M. Doyle Centennial Professor of Public Policy in the Department of Economics at Stanford University. He also has a long affiliation with the Brookings Institution in Washington, D.C., where he has been a senior fellow, a visiting fellow, and a non-resident senior fellow. He has won a Guggenheim Fellowship, the Book Award of the National Association of Educational Broadcasters, and the Distinguished Service Award of the Public Utilities Research Center. He also received the 1994 Rhodes Prize for Undergraduate Teaching from Stanford University. This year, he has been an active participant in the study group that crafted the interim intellectual property (IP) report. While this subject remains an important one for the state, Noll is convinced that the real challenge for California lies in maintaining the competitiveness of its science and technology workforce overall. "To assure that California retains its leadership in high-technology industries, the state must improve its educational system," said Noll. "CCST has played a leadership role in science education, and I hope that it will not only continue in this role, but break the logjam in state governance that thus far has prevented adequate progress." on t r p e R y cil un olog o C n nia Tech r o d 05 lif an Ca nce r 20 e b e o Sci Oct 3/ ” est ter at n I s 8 te’ 98 d Sta in 1 sore d he on ed in t ablish It is sp ns ans. y o t g i . s / t m t o l r e u i n t hno tion nme nsti tor f n e 10 Tec aniza Gover dary i e-sec plicatios, um l d g o t n V a or te con iva d ap lyse nce profit nia Staostse ing pr licy an ing ana tives e i on for r p ad itia d Sc T po uct ST: is a nhe Calis majo by le ove S& s, cond s and inmy an . C C d r o e T ’ i t m ip “ n p e e Issu S c CC est of statenchor s to im progra g poli us eco adersh a n i osing endin igoro ical le qu y the o i e s r is op m b a v olog the n T’s m y pr com tain CCS rnia b and re ll main a’s tech i o i f i n l r w a o t tha Calif in C CCST Releases Interim IP report for stem cell Institute Roger Noll TheCCST ReportfocusesonCCSTactivitiesandhighlightsinnovativescienceandtechnologyresearchandapplicationsinCalifornia.TheReportiswrittenbyDanny DeCillis,whowelcomesinformationfromreadersaboutscienceandtechnologyatworkintheprivate,public,andeducationsectors.TheReportthanksCCSTmembersfor theirgenerousassistanceinprovidingmaterialforthisissue.IfyouwouldlikemoreinformationaboutCCSTinitiatives,[email protected],orvisit CCST’s website at http://www.ccst.us. Fax requests to (916) 492-0999 or telephone (916) 492-0996. In August, CCST released its interim report on a framework for intellectual property for the California Institute for Regenerative Medicine (CIRM). The long-anticipated report has generated considerable interest and has played an important role in the ongoing discussions concerning CIRM’s operations. “I want to commend the members of the California Council on Science and Technology for their thoughtful and timely report,” Assembly Member Gene Mullin said. “California is in a unique position to create an intellectual property policy that is as forward thinking as Proposition This report will begin “I want to commend the 71. those discussions.” members of the California The intellectual (IP) interim Council on Science and property report,PolicyFramework Technology for their thoughtful for Intellectual Property Derived from Stem Cell and timely report.” Research in California, released in partial Gene Mullin was response to Assembly Assembly Member Concurrent Resolutions California State Assembly (ACR) 252 and 24 authored by Assembly Member Gene Mullin. ACR 252, which was chaptered in September 2004, requested that CCST conduct an analysis on how and whether to implement a set of consistent statewide IP policies. FollowingtheNovember2004passageofProposition71(theStem Cell Research and Cures Initiative), which allocated $3 billion over 10 years to establish CIRM, CCST also agreed to prepare an interim report tailored specifically to CIRM’s needs and faster timetable. The IP Study Group, convened by CCST to recommend intellectual property guidelines for the state, released the interim report to begin a discussion and provide policymakers with a framework for consideration in the development of policies for the handling of intellectual property developed with state funds, especially in relation to stem cell research. “In this report our main objectives were to define the issues that needed to be addressed, in particular how to respond to heightened public expectations concerning financial returns from stem cell research,” said Stephen Rockwood, co-chair of the committee which produced the report. “Independent Citizens Oversight Committee (ICOC) members and state leaders must realize that this field of research is in its very early years. In all likelihood, the development of effective therapies from CIRM-sponsored research is at least ten to twenty years away.” OverallthecommitteerecommendedthatCIRMadoptanapproach to managing intellectual property that would be consistent with related federal policies. As there are no other states as yet which have established a comprehensive set of IP policies, the federal model was felt to be most appropriate. “Thereisconsiderableexperienceatthefederallevelfromagencies such as the National Institutes of Health which should be useful to California,” said co-chair Alan Bennett. “Fortunately, we have over twentyyearsofdiscussionandexperimentationatthatfederallevelto use as background for California in preparing its own set of policies.” These recommendations include permitting ownership of the intellectual property to reside with the grant recipients, with CIRM retainingrightstousetheresearch,andfocusingonmaximizingaccess to the research rather than controlling prices of the ultimate products of this research. “Theseissueshavebecomecontroversialinpartbecausesignificant publicexpectationsofroyaltyrevenueswerecreatedwhenProposition 71 was being promoted,” said Rockwood. “The considered opinion of thisgroupisthatthoseexpectationsarenotrealisticandnotconsistent with established practice at the federal level.” The interim IP report was originally structured to respond to ACR 24, which was drafted earlier this year and which requested that CCST prepare the interim report en route to completing the charge of ACR 252. However, ACR 24 continued to be amended through the summer, with the result that the interim report does not address all of the questions raised. “We will address ACR 24 in the final report,” said Rockwood. “It is our hope that the document at present may serve a useful purpose in informing and guiding what is surely just the start of a much longer discussion.” continued on page 2 Inside this issue Healthcare IT Has Big Promise for California Capitol Happenings 2005 S&T Legislation Update Teacher CPA Explores Serious Issue for California Reserch Pays Off in the Long Run Fellow Strong Force in IP Study page 3 page 4-5 page 4-5 page 6 page 7 page 8 5005 La Mart Dr, Ste 105 Riverside, CA 92507 California Council on Science and Technology Presorted Standard Nonprofit Organization U.S. Postage Paid Hesperia, CA Permit #164 IP Report continued from page 1 IP Study Group Recommendations The IP Study Group’s recommendations in the interim report are consistent with general principles likely to be recommended for statefunded research in the final report to be completed later this year. These general principles assert that the IP policy: • Is to be consistent with the Bayh-Dole Act. This principle can play out in many ways that are of benefit to the public. In particular, ownership of IP resides with the grantee, who is requiredtodiligentlydevelopIPforthepublic. Inaddition,thebalance of any net royalties must be used to support research and education activities. • Creates incentives for commerce in California from state-funded research to the greatest extent possible. • Encourages timely publication of results to diffuse knowledge widely, and provide guidance on the kinds of data that are desired to be placed in the public domain or available under open source, Creative Commons, or other broad-use licenses, including software and special databases. • Requires diligent development of IP into products that benefit the public. With these general principles in mind, the IP Study Group recommends that CIRM consider policies that accomplish the following: • Permit grantees to own IP rights from CIRM-funded research. • Require grantees (institutions, individuals, or both) to provide a plan describing how IP will be managed for the advancement of science and benefit to California. • Grant basic research funds without requiring grantees to commit to providing a revenue stream to the state. If, however, a revenue stream develops over time, revenues will be reinvested in research and education. • Generally make CIRM-developed research tools widely available to other researchers. • Require diligent efforts to develop CIRM-funded IPinto therapeutics and diagnostics that can benefit the public. • Retain within CIRM Bayh-Dole-like rights to step in if the owner of IP isnotundertakingappropriatestepstotransfertechnologytobenefit the public. • Leave license particulars to the owner who is in the best position to judge how best to ensure that discoveries are made widely available through commercialization or otherwise. • Reserve the right to use IP by or on behalf of CIRM. • Establish and maintain a CIRM database to track all IP generated through CIRM funding. The release of the interim IP report has garnered considerable media attention. The San Jose Mercury News, San Francisco Chronicle, San DiegoTribune,SacramentoBee,andLosAngelesTimeshaveallcoveredthereport’srelease,withseveralarticlesechoingpublicconcerns about the report’s suggestion that a strong royalty revenue stream is not realistic. “Last week, the council issued a report explaining why the state shouldn’t count on a quick shower of wealth from the $6-billion Propostion 71 investment in embryonic stem cell research. The report observed that an attempt by the Legislature to mandate a specific financial return from all commercial stem cell treatments derived from state grants would, in fact, discourage the commercialization of such treatments. It observed that useful research in biotech and other fields developed at a snail’s pace until the federal government abandoned a similar mandate in 1980.” Los Angeles Times September 1, 2005 IP Study Group Co-Chairs Stephen Rockwood and Alan Bennett “...it is unrealistic for the state to expect a huge payback on Proposition 71. The report examined federal policy over the last 25 years since the passage of the federal Bayh-Dole Act, which governs the use of federal funds at research universities. Bayh-Dole has been extremely goodatpushingbasicresearch...buthasestablishedlittle track record for financial payoffs to the government. Numerous people, including scientists affiliated with thefundingbodiescreatedbyProposition71,havecited Bayh-Dole as the proper model for stem cell research in California.” Capitol Weekly News September 22, 2005 2 CCST Report, October 2005 ind r ust y tur a e f e California is a leader in technological innovation. In this section, CCST Report focuses on how California’s major industries and universities are workingtomaintaincutting-edgeresearchprograms,andencouragestudentinterest in science and technology. Research Pays Off in the Long Run Medical breakthroughs do not occur overnight. In the life in the other drugs we have in the pipeline," said Graham. "It was sciences, development of a research finding into a new drug or FDAa long process. SYMLIN represents the culmination of 18 years of approved treatment typically takes at least a decade. Investments in research in diabetes." excess of several hundred million dollars are usually needed to bring During those 18 years, Amylin scientists helped both to improve a product to market. Consequently when a treatment does reach the understanding of the physiology of diabetes and to develop a the final stages of development, it is very good news for everyone new and effective treatment. involved. Amylin has been fortunate to obtain approval for its two diabetes Amylin Pharmaceuticals, a company founded in 1987, has finally medications. A company that stakes its future on the success of a begun seeing the fruits of its labors with the narrow group of drugs may soon flounder FDA approval of two diabetes medications, if clinical trials don't go well, or if those SYMLIN® (pramlintide acetate) injection products do not earn FDA approval. “The approval of SYMLIN, a in March 2005, and BYETTA® (exenatide) "A great deal of this depth comes injection in April 2005. The two drugs are the first-in-classtherapy,wasamajor from our approach to research, which first that Amylin has successfully brought to milestone for us. ... It was a long is to identify peptide hormones and market. characterize utility before determining "Successfully managing diabetes is a process. SYMLIN represented potential targets," added Graham. "We've daily struggle for millions of Americans," developed our own library of peptides and the culmination of 18 years of said Ginger L. Graham, president and chief characterized their functions; it's a resource executive officer, Amylin Pharmaceuticals, research in diabetes. ” we believe is unique in the industry." In Inc. "Often, current treatments do not many research processes, libraries of provide adequate blood sugar control. The uncharacterized compounds are screened development of SYMLIN and BYETTA offer against a known drug target. Ginger Graham significant new treatment opportunities for "For us, it has been a lengthy process, people with diabetes." President and CEO but our focus has paid off," said Graham. Amylin was founded after the discovery "Amylin has contributed much to the Amylin Pharmaceuticals of a peptide hormone, amylin, produced understanding of diabetes, and is now by the same cells of the pancreas that make bringing new treatment options to insulin. Since then, the company has built physicians and their patients. Through our continued efforts in a strong foundation on research and development in related areas. research and development, we look forward to advancing innovative Amylin's researchers concentrate primarily on investigating the new medicines with the potential to significantly change patient care potential utility of new peptide hormone candidates, leveraging in the years to come." highly focused expertise to develop drugs to treat diabetes, obesity, and cardiovascular disease. Because the drug development process is so lengthy, investors must typically wait years for returns on investment. Researchersmustconduct three phases of clinical trials to show that a drug's benefits outweigh its side effects, and that its therapeutic Byetta is the first in a new class of drugs to treat type 2 diabetes. It is a synthetic version of exendin-4, a naturallyaction works better than a placebo. occurring hormone. Depending on the complexity of the new drug and the nature of the disease Upcoming CCST events being treated, it may take thousands of patients and several years before statistically significant data emerge to confirm that a drug OCTOBER 19 – 20, 2005. Irvine works. The development program for SYMLIN involved over 5,000 patients in 12 years of clinical research. BYETTAclinical studies have Board and Council meeting and dinner program at included over 3,000 patients in the last 6 years. the Beckman Center. Keynote speaker is Molly Coye, With so much at stake, drugs in the pipeline are watched closely founder and CEO of the Health Technology Center at each stage. In August, positive clinical trial results for an as-yet (HealthTech). unapproved, long-acting formulation of BYETTA generated strong interest in Amylin's stock, despite the fact that the new formulation JANUARY 31 – FEBRUARY 1, 2006. Sacramento is still under investigation and will not be commercialized for some Board and Council meeting and dinner program. time. "The approval of SYMLIN, a first-in-class therapy, was a major milestone for us. It is the first new therapy approved for type MAY 23 – 24, 2006. Sacramento 1 diabetes since the discovery of insulin, over 80 years ago. It Council meeting and dinner program. validates our focus on peptide hormones as potentially useful human medicines, which in turn led to significantly higher interest CCST Report, October 2005 7 #T eachers California’s K-12 education system is the largest in the nation, with which will serve as the basis for an integrated document which will offer over six million students and three hundred thousand teachers. Building recommendationstothestateandtotheinstitutionsinvolvedinteacher an understanding of how to work within such a system in the face of production and professional development. The study, which is being significant shortfalls is no easy task. funded by the Stuart Foundation, is scheduled for completion in 2006. “Gaps in the collection, use, and availability of data seriously compromise efforts to plan and monitor the teacher workforce at both thestateandlocallevels,”saidMargaretGaston,executivedirectorofthe CenterfortheFutureofTeachingandLearning(theCenter). “Thisleaves PRINCIpAl INVeSTIGATORS policymakersandeducationofficialswithlittlein-depthunderstandingof thecurrentshortageofqualifiedteachers,theinequitabledistributionof fully qualified teachers, or a clear picture of future workforce needs.” Science Teacher Preparation Teacher Preparation in Private Herbert Brunkhorst Institutions AsCCST’s2002report,CriticalPathAnalysisofCalifornia’sScienceand College of Education Eugenia Mora-Flores TechnologyEducationSystemindicated,manystudentsaregraduating California State University, San Rossier School of Education without the basic skills needed to succeed in California’s high-tech Bernardino University of Southern California industries. That study called on industry, academic, and government leaderstoworktogethertooverhaulscienceandengineeringeducation, Recruitment of Qualified Science Teacher Professional toincreaseenrollmentinthesesubjects,andtoexpandthestate’sability Science and Mathematics Development to research S&T educational issues. Further research by the Center has Teachers Dan Walker underscored what appears to be a serious shortage of qualified math Mathematics and Science Teacher Pamela Clute andscienceteachers. Toformulaterecommendationsforaddressingthis Outreach and Educational Education Program (MASTEP) shortage, a great deal of groundwork needs to be done in order to define Partnerships College of Science University of California, Riverside and quantify the science and math workforce and skills gap and identify San Jose State University appropriatestrategiesforCaliforniatoenhanceitsproductionofscience Math Teacher Preparation Data Collection and Analysis-UC and math teachers. Judy Kasabian Patrick Callahan “We need reliable data to monitor the match between teachers’ Division of Mathematical Sciences Mathematician in Residence assignmentsandtheircredentials,understandwhatattractsteachersto El Camino College University of California Office of the theprofession,anddeterminewhatcontributestotheirdecisiontoleave President Math Teacher Professional it,”saidCCSTExecutiveDirector, Susan Hackwood. “Without such data, Data Gathering and Analysis Development itisverydifficulttoeffectivelydeterminewhatstrategiesmaybeeffective Using SRI Data Sets Yvonne Lux in boosting our science and math teacher workforce.” The Educational Research and Patrick Shields For their ongoing joint project, California’s Math and Science Teacher Leadership Institute Center for Education Policy Shortage:ACriticalPathAnalysis,CCSTandtheCenterhaveassembleda California Lutheran University SRI International teamofeightresearchersfromacrossthestatetoexaminedifferentaspects of science and math teacher production, retention, and professional development. Each member brings a different range of expertise to the table, as well as access to a wide variety of data sources. “While a variety of public and private institutions gather a great deal of data on teachers — including the California Department of Education, the California 2000 Commission on Teacher Credentialing, the California State Teachers’ Retirement System, and universities that prepare teachers — these data sources cannot provide some of the most basic information about the teacher workforce on a regular basis,” added Gaston. 1500 “Becausetheseagencieswereestablishedtoperform specific, independent functions that are not linked by a common plan for data use, they act in isolation and make decisions that often prevent their data from being used in analyses of the state’s overall teacher 1000 workforce.” CCST and the Center are drawing upon the cooperation of CCST’s constituent institutions to bring together as wide a range of data sources as possible, including some not normally made public. In 500 addition, with the assistance of the California Teacher Advisory Council (Cal TAC), CCST and the Center are conducting their own surveys of science and math teachers to obtain some of the missing pieces of the puzzleonwhyteachersstayintheteachingprofession 0 or go into other careers. Mathematics Life Science Physical Science “We are particularly excited about the prospect of leveraging Cal TAC members’ experience and ability Underprepared High School eachers T to tap into the science and math teacher workforce to gather new data for this study,” said Hackwood. Fully Cr edentialed Out-of-Field & Under prepared High School eachers T “Cal TAC will be playing an important role in the production of this analysis, and will make sure that we areaccuratelyreflectingtheexpertiseoftheclassroom Number of Out-of-Field and Underprepared High School Teachers in Mathematics and as well as the researchers.” Science, 2003-2004. Source: California’s Teaching Force 2004 Aswiththe2002CriticalPathAnalysis,theindividual researchers will produce separate standalone studies 6 CCST Report, October 2005 HEALTHCARE IT Has Big Promise for California America spends $1.7 trillion on healthcare each year, but the system remainshighlyinefficient. High-techtreatmentsabound,butsomeofthe simplerthings,suchaskeepingtrackofapatient’schart,canbechallenging. Healthcareinformationtechnology(HIT)isafieldthatoffersawiderange ofinformationtechnologyapplicationstohelpadministerhealthcaremore effectively, potentially saving more than $77 billion a year. Because of the importance of this issue to the state, CCST has focused attention this year on HIT, with the goal of identifying S&T areas where CCST could effectively assist the state in understanding and evaluating healthcare IT options. Under the leadership of CCST, Council Members Stephen Ryan, president of the Doheny Eye Institute, Francine Berman, director of the San Diego Super Computer Center, Alfonso Cardenas, ESTIMATeD INeFFICIeNCIeS ASSOCIATeD LACK OF A HeAlTHCARe IT SYSTeM WITH A • Without sharing patient records electronically, 30% of the time, physicians could not find information previously recorded in a paper chart • Thesamedrugor radiologyexam was ordered 11% of the time • Physicians were not aware of 1 in 4 prescriptions that a patient had been given • 1 in 7 admissions and 1 in 5 lab tests and radiology examswereorderedbecauseearlierresultscouldn’tbe retrieved • Typical physician receives test results from 5 or more locations • Cost of tracking down and obtaining information can range from $12 to $28 per visit Source:ElectronicMedicalRecords–GettingitRightandGoingtoScale, W.EdwardHammond,III,CommonwealthFundbackgroundpaper;via CalRHIO, January 2004. professor of computer science at UCLA, and CCST Board Member Steven Bruckman, executive vice chancellor for the California Community Colleges, the council meeting in October will focus on HIT systems. This meeting will be conducted in collaboration with the Institute of Medicine (IOM). “California trails other states that have already passed enabling legislation for the implementation of healthcare IT statewide,” said Ryan. “There are significant up-front costs involved, but overall, IT will ultimately reduce healthcare costs dramatically.” The costs in the early years are a disincentive – the RAND Corporation estimates implementation could cost $8 billion a year, and savings from efficiencies will not appear until later. One of the biggest HIT goals would be the creation of a statewide data exchange system and integration of the healthcare system. While there are many logistical obstacles to designing and implementing such a system, this integration could significantly improve the efficiency of healthcare. In one study, according to the California Regional Health Information Organization (CalRHIO), physicians could not find information previously recorded inpapercharts30%ofthetimeandweren’tawareof25%of prescriptions given to patients. In addition, data exchange systemsmaysignificantlyhelpmaintainconsistentmedical treatmentforvictimsofnaturaldisasters,suchasHurricane Katrina, which displaced hundreds of thousands of peopleanddestroyedcountlesspaperrecordsthatmaybe impossible to reconstruct. A variety of experts participating in the CCST/IOM meeting, include Roger Taylor, consultant with the RAND Corporation; Judy Ozbolt, scholar, Institute of Medicine; Jack Lewin, CEO and executive vice president of the California MedicalAssociation; Jeff Rose, CEO and founder, HealthAlliant; andRickCraft,projectlead,TelemedicineReferenceArchitectureProject, Sandia National Laboratories. The keynote speaker will be Molly Coye, founder and CEO of the Health Technology Center (HealthTech). As Coye points out, understanding how best to fix the state’s ailing system is partly a question of deciding where to invest limited resources and time. “Whatwedo[atHealthTech]isprovideobjectivetechnologyforecasts, innovative decision making tools, and expert learning networks,” said Coye. “This helps enable organizations to adopt the most effective technologies with the least amount of disruption.” Some of healthcare IT’s greatest promise lies in the integration of currently disparate data systems and the healthcare enterprise’s informationnetworks. However,suchstepsfaceseveralbarriers,including the lack of a trusted third party administrator for such a system and the lack of a viable business model. There exist, however, new technologies that can improve local efficiencies. “The first and simplest of these emerging technologies is wireless communication systems,” said Coye. “Thanks to significant improvementsinthepastfiveyears,real-time,efficientcommunications are now practical to implement. One such example is the Vocera system thatallowsstaffwearingasmalldevicetousespeechrecognitiontoreach any other individual in the hospital. The direct results of these wireless communication systems are faster and more direct response times, reduced phone tag, and greater capacity for multitasking.” HealthTech prepares its forecasts for over 45 partner organizations, including many hospitals both in California and elsewhere in the U.S. For each of these partners, different solutions may be appropriate. “Taking full advantage of IT systems is important, but the focus should be on obtaining the greatest return on investment,” said Coye. “An organization need only utilize those capabilities in their IT systems thatprovidethegreatestbenefittotheirbusinessprocesses.Sinceevery business is different, their utilization of a given IT system will vary according to their particular situation.” CCST’s healthcare IT committee will be helping California set priorities and develop an agenda and recommendations appropriate to the state. “Healthcareorganizationsinthestateshouldworkhardtolearnfromthe experiencesofearlyadopters,”saidCoye.“Inthisway,theycandetermine how the state can best focus its healthcare IT strategies overall.” 350 280 $ billions Teacher CPA explores serious Issue for California 210 140 70 0 2004200520062007200820092010201 1 2012201320142015201620172018 Inpatient Setting, Cumulative Savings - Cumulative Costs Outpatient Setting, Cumulative Savings - Cumulative Costs Inpatient Setting, Yearly Savings Ye - arly Costs Outpatient Setting, Yearly Savings Ye - arly Costs Net Potential Benefits (Savings - Costs) with adoption of Healthcare Information Technology at the National Level for the Inpatient and Outpatient Settings. Source: RAND CCST Report, October 2005 3 Capitol HAPPENINGS CCST’s mission is to focus California’s science and technology talent on important policy issues facing the state. However, there is little communication back to the S&T community on what is happening in the legislative and executive branches of state government that could impact, or be impacted by science and technology. “Capitol Happenings” is a section of the CCST Report that provides a brief summary and update on what is going on in state government, be it new action from the Governor’s Office, legislative committees or new legislation. Material for this article was contributed by Gus Koehler, principal consultant of Time Structures. GOVeRNOR Governor Schwarzenegger says California will be a national leader in addressing global warming. “The debate is over. We know the science. We see the threat posed by changes in our climate,” Schwarzenegger wrote in London’s Independent newspaper: “And we know the time for action is now.” The Governor set the goal of reducing greenhouse gas output 80% by 2050—eclipsing Britain’s goal for the same period and bringing praise from the British government’s chief scientific adviser. Aclimate change research conference held in Sacramento recently focused researchers, regulators and policymakers on how California could address human-induced climate change. The Governor also wants to increase the state’s total solar output fromabout101megawattsto3,000megawattsby2018,andheaimstohosta series of “conservation summits” for businesses across the state, “spreading the word that pollution reduction is good.” Governor Schwarzenegger’s administration will use high technology to track sexual predators. Sex offenders will soon be fitted with a transmitter that uses global positioning technology to track their every move. The satellite based system is part of a pilot program led by the California Department of Corrections and Rehabilitation with help from local law enforcement. California has a new Department of Technology Services (DTS) that will coordinatethestate’smassivedatasystemsandcomputernetworks.Thenew department, under the directorship of P. K. Agarwal, will bring together the state’s existing data centers to avoid duplication and improve efficiency. DTS will consolidate and modernize California’s information technology system. Leading California’s effort to combat obesity, Governor Schwarzenegger signed landmark legislation, SB 12 and SB 965 by Senator Escutia, and SB 281 by Senator Maldonado, to bring healthy food and drinks into California’s schools. ENeRGY The Governor’s reorganization plan to establish a Department of Energy received a negative evaluation by the Little Hoover Commission and doesn’t appear to be going anywhere soon. The Governor has also shelved his plan to reorganize the California Environmental Protection Agency (CalEPA). The California Energy Commission’s Public Interest Energy Research (PIER) program has contributed to several new technical briefs on energy efficiency in buildings including briefs on classroom lighting; small heating, ventilation and air conditioning systems; modular skylights; compact fluorescent downlights; hybrid lighting fixtures; and a brief describing Lawrence Berkeley National Laboratory’s Residential Commissioning Guide. The California Clean Energy Fund (CalCEF) plans to award a $1 million grant to establish and maintain the world’s leading university center on energy efficiency. The $30 million public benefit investment fund was created as part of the Pacific Gas and Electric bankruptcy settlement. An as yet to be named Northern California university will be awarded the grant to develop an international leadership position in the development of energy efficiency technologies and the removal of barriers to their rapid commercialization. “Advances in health care technology are essential to improving patient care for all Californians.” Wilma Chan Chair Assembly Committee on Health INFRASTRUCTURe The Earthquake Hazards Program has released details about new realtime maps on earthquake probabilities in California and U.S. Geological Survey public Web pages. Following Hurricane Katrina, these maps will help shape the growing interest in how to prepare California for major natural disasters. The Public Policy Institute of California released California 2025, a report of project findings regarding the state’s coming infrastructure challenges. The study is a major examination of the state’s infrastructure and the challenges California may face over the next 20 years. Presentations were made to legislative and administration staffers. A recent report published by the RAND Corporation, “California’s K-12 Public Schools: How Are they Doing?,” finds serious challenges ahead for California’s kindergarten to 12th grade (K-12) education system. The report suggests that California trails the nation in a number of indicators that measure school and student performance including school funding, teacher quality, school facilities, and academic and non-academic student achievement. The California Budget Project, and the Public Policy Institute of California have published a number of recent studies on employment, the minimum wage, the income gap between high and low income California, and healthcare costs. The new University of Southern California Public Policy Center has begun to make presentations and to publish briefs on healthcare and education issues. Improving healthcare access, cost and efficiency is a national challenge. Demonstrating California’s leadership, innovation and commitment to addressing this challenge, the California Public Employees’ Retirement System (CalPERS) and Blue Cross of California presented plans to implement a high-speed telecommunication pilot program to link 90,000 members in remote rural areas with healthcare specialists beginning January 2006. CalPERS will be the first employer purchaser in California to include telemedicine as a specific rural benefit. 2005 S&T LEGISLATION UPDATE 2005 is the first year of the Legislature’s two year session. CCST tracked 78 S&T related bills. Twenty-eight passed out of the Legislature and are either on theGovernor’sdeskorhavebeenchaptered.Thelargestnumberofenrolledbills involved energy, alternative fuels, and air emissions. Anumber of active bills are still moving through Senate orAssembly committees. Legislation that has beenenrolledandsenttotheGovernororchapteredisbolded. Furtherdetailson individuallegislationcanbeobtainedat:http://www.leginfo.ca.gov/bilinfo.html. Listed below are some of the S&T related legislation CCST is tracking. Note the significant number of bills dealing with healthcare information technology. HEALTH INFORMATION TECHNOLOGY AB 225 (Negrete McLeod) Encourages the use of e-health technology and clarifies that entities responsible for the administration of healthcare services can equip providers with hardware and software to promote electronic prescribing. AB 354 (Cogdill) Expands the definition of telemedicine to include "store and forward" technology for dermatology and opthamology, in which information is transmitted and reviewed at a later time by medical professionals, and allows Medi-Cal reimbursement for these services. AB 522 (Plescia) Clarifies policy on automated drug delivery systems, restricting access to licensed personnel in skilled and intermediate nursing facilities. Also prohibits Medi-Cal coverage of erectile dysfunction prescriptions for registered sex offenders. AB 1388 (Ridley-Thomas) Establishes two grant programs: 1) to demonstrate the benefits of using the state's telecommunications networks to deliver supplemental educational services; and 2) a grant program to demonstrate the use of telemedicine resources within a community. AB 1672 (Nation) Would require healthcare facilities, health insurers and healthcare service plans to record all healthcare information they obtain in an electronic record keeping system. SB 7 (Figueroa) Restricts disclosure of personal information, as specified, that is contained in public records and that would otherwise be public. 4 CCST Report, October 2005 SB 13 (Bowen) This bill permits state agencies to release personal information to the University of California or a nonprofit educational institution conducting scientific research only if the research proposal has been reviewed and approved by the Committee for the Protection of Human Subjects (the state's Institutional Review Board) for the Health and Human Services Agency. STEM CELL ACR 1 (Negrete McLeod) Urges the Independent Citizen's Oversight Committee to adopt robust conflict-of-interest procedures; maintain open meetings and public records; work to ensure that therapies are available to low-income residents; and report to the Legislature by January 1, 2006. SB 18 (Ortiz) Prohibits human oocytes or embryos from being acquired, sold, received, or otherwise transferred for valuable consideration for medical research or development of medical therapies; also requires the State Auditor to audit the California Institute for Regenerative Medicine and ICOC. SCA 13 (Ortiz) A proposed constitutional amendment that requires ICOC to operate subject to California open meeting laws; ensure that therapies developed through CIRM would be accessible to low-income residents; and ensure that ICOC members disclose potential conflicts of interest. This bill is inactive. SJR 17 (Ortiz) Asks Congress and the President of the United States to lift restrictions on federal funding for stem cell research; also requests that human cloning be prohibited. HEALTH AND MEDICAL RESEARCH AB 1062 (Saldaña) Expands informed consent laws, allowing medical research subjects the right to review all the laboratory reports or any other analysis regarding specimens taken from the subject. AB 1273 (Saldaña) This bill would declare that it is the intent of the Legislature to enact legislation that would create a statewide advisory panel on bioethics. SB 12 (Escutia) Requires the sale of all foods on elementary school grounds to comply with nutrition standards which restrict total fat and calories and provide for acceptable levels of specified nutrients. SB 281 (Maldonado) The California Fresh Start Program, which requires that fruits and vegetables be made more widely available to students and authorizes extra funding to support this. SB 849 (Berg) Would establish the Interagency Office of Environmental Health Tracking for the purpose of implementing the California Health Tracking Program, coordinating multiple health and environmental surveillance data collection efforts. SB 965 (Escutia) Restricts the sale of beverages to pupils at elementary and middle or junior high schools of certain specified beverages, requiring increased distribution of milk and fruit or vegetablebased drinks with no added sweeteners. AGRICULTURE AND FOOD AB 984 (Laird) Provides that the manufacturer of a genetically engineered (GE) plant is liable to any farmer, grain and seed cleaner, handler, or processor in cases where the plant has caused economic damage or loss. ENERGY, ALTERNATIVE FUELS, AND AIR EMISSIONS AB 838 (Saldaña) Provides tax credits for hybrid, alternative fuel, zeroemission, and ultra-low emission vehicles. AB 1007 (Pavley) Requires the State Energy Resources Conservation and Development Commission, in consultation with the State Water Resources Control Board, the Department of Food and Agriculture, and other relevant state agencies, to develop a state plan to increase the use of alternative transportation fuels by 2007. The plan should optimize public health and environmental benefits while minimizing costs to the state. AB 1660 (Pavley) Creates the California Energy-Efficient Vehicle Group Purchase Program in the Department of General Services to encourage the purchase of energy-efficient vehicles by local and state agencies through a group-purchasing program. SB 250 (Campbell) Adds hydrogen fuels to the list of fuels for which the Department of Food and Agriculture sets standards. SB 497 (Simitian) Requires the state to develop a strategy to better control emissions from vehicles used in construction, in a cost-effective manner. SB 757 (Kehoe) Would require public agency fleet operators to purchase alternative fuel vehicles and advanced transportation technologies where technologically feasible and cost-effective. SB 1003 (Escutia) Would enact the Liquefied Natural Gas Evaluation and Terminal Permitting Act, establishing a permitting process for the construction and operation of liquefied natural gas terminals. INFORMATION TECHNOLOGY SB 97 (Murray) Outlaws e-mail spam in California, makes unsolicited commercial email advertising a misdemeanor offense punishable by a $1000 fine and six months in jail. SB 1028 (Bowen) Bans "internet hunting," prohibiting the shooting or killing of any bird or mammal via the internet. AEROSPACE AND WORKFORCE ACR 7 (S. Runner) Congratulates and expresses the Legislature's appreciation for the achievements of SpaceShipOne and the efforts of the team of Paul Allen, Burt Rutan, and pilots Mike Melvill and Brian Binnie in making privately funded manned space flight a commercial reality. SCR 14 (G. Runner) Designated April 12, 2005 as California Space Day in recognition of the satellite industry's contributions to the state of California. CALIFORNIA COUNCIL ON SCIENCE AND TECHNOLOGY ACR 24 (Mullin) Expands the scope of the CCST Study Group developing intellectual property recommendations to include contracts, grants, and agreements developed under Proposition 71, the Stem Cell Research and Cures Initiative. CCST Report, October 2005 5 Capitol HAPPENINGS CCST’s mission is to focus California’s science and technology talent on important policy issues facing the state. However, there is little communication back to the S&T community on what is happening in the legislative and executive branches of state government that could impact, or be impacted by science and technology. “Capitol Happenings” is a section of the CCST Report that provides a brief summary and update on what is going on in state government, be it new action from the Governor’s Office, legislative committees or new legislation. Material for this article was contributed by Gus Koehler, principal consultant of Time Structures. GOVeRNOR Governor Schwarzenegger says California will be a national leader in addressing global warming. “The debate is over. We know the science. We see the threat posed by changes in our climate,” Schwarzenegger wrote in London’s Independent newspaper: “And we know the time for action is now.” The Governor set the goal of reducing greenhouse gas output 80% by 2050—eclipsing Britain’s goal for the same period and bringing praise from the British government’s chief scientific adviser. Aclimate change research conference held in Sacramento recently focused researchers, regulators and policymakers on how California could address human-induced climate change. The Governor also wants to increase the state’s total solar output fromabout101megawattsto3,000megawattsby2018,andheaimstohosta series of “conservation summits” for businesses across the state, “spreading the word that pollution reduction is good.” Governor Schwarzenegger’s administration will use high technology to track sexual predators. Sex offenders will soon be fitted with a transmitter that uses global positioning technology to track their every move. The satellite based system is part of a pilot program led by the California Department of Corrections and Rehabilitation with help from local law enforcement. California has a new Department of Technology Services (DTS) that will coordinatethestate’smassivedatasystemsandcomputernetworks.Thenew department, under the directorship of P. K. Agarwal, will bring together the state’s existing data centers to avoid duplication and improve efficiency. DTS will consolidate and modernize California’s information technology system. Leading California’s effort to combat obesity, Governor Schwarzenegger signed landmark legislation, SB 12 and SB 965 by Senator Escutia, and SB 281 by Senator Maldonado, to bring healthy food and drinks into California’s schools. ENeRGY The Governor’s reorganization plan to establish a Department of Energy received a negative evaluation by the Little Hoover Commission and doesn’t appear to be going anywhere soon. The Governor has also shelved his plan to reorganize the California Environmental Protection Agency (CalEPA). The California Energy Commission’s Public Interest Energy Research (PIER) program has contributed to several new technical briefs on energy efficiency in buildings including briefs on classroom lighting; small heating, ventilation and air conditioning systems; modular skylights; compact fluorescent downlights; hybrid lighting fixtures; and a brief describing Lawrence Berkeley National Laboratory’s Residential Commissioning Guide. The California Clean Energy Fund (CalCEF) plans to award a $1 million grant to establish and maintain the world’s leading university center on energy efficiency. The $30 million public benefit investment fund was created as part of the Pacific Gas and Electric bankruptcy settlement. An as yet to be named Northern California university will be awarded the grant to develop an international leadership position in the development of energy efficiency technologies and the removal of barriers to their rapid commercialization. “Advances in health care technology are essential to improving patient care for all Californians.” Wilma Chan Chair Assembly Committee on Health INFRASTRUCTURe The Earthquake Hazards Program has released details about new realtime maps on earthquake probabilities in California and U.S. Geological Survey public Web pages. Following Hurricane Katrina, these maps will help shape the growing interest in how to prepare California for major natural disasters. The Public Policy Institute of California released California 2025, a report of project findings regarding the state’s coming infrastructure challenges. The study is a major examination of the state’s infrastructure and the challenges California may face over the next 20 years. Presentations were made to legislative and administration staffers. A recent report published by the RAND Corporation, “California’s K-12 Public Schools: How Are they Doing?,” finds serious challenges ahead for California’s kindergarten to 12th grade (K-12) education system. The report suggests that California trails the nation in a number of indicators that measure school and student performance including school funding, teacher quality, school facilities, and academic and non-academic student achievement. The California Budget Project, and the Public Policy Institute of California have published a number of recent studies on employment, the minimum wage, the income gap between high and low income California, and healthcare costs. The new University of Southern California Public Policy Center has begun to make presentations and to publish briefs on healthcare and education issues. Improving healthcare access, cost and efficiency is a national challenge. Demonstrating California’s leadership, innovation and commitment to addressing this challenge, the California Public Employees’ Retirement System (CalPERS) and Blue Cross of California presented plans to implement a high-speed telecommunication pilot program to link 90,000 members in remote rural areas with healthcare specialists beginning January 2006. CalPERS will be the first employer purchaser in California to include telemedicine as a specific rural benefit. 2005 S&T LEGISLATION UPDATE 2005 is the first year of the Legislature’s two year session. CCST tracked 78 S&T related bills. Twenty-eight passed out of the Legislature and are either on theGovernor’sdeskorhavebeenchaptered.Thelargestnumberofenrolledbills involved energy, alternative fuels, and air emissions. Anumber of active bills are still moving through Senate orAssembly committees. Legislation that has beenenrolledandsenttotheGovernororchapteredisbolded. Furtherdetailson individuallegislationcanbeobtainedat:http://www.leginfo.ca.gov/bilinfo.html. Listed below are some of the S&T related legislation CCST is tracking. Note the significant number of bills dealing with healthcare information technology. HEALTH INFORMATION TECHNOLOGY AB 225 (Negrete McLeod) Encourages the use of e-health technology and clarifies that entities responsible for the administration of healthcare services can equip providers with hardware and software to promote electronic prescribing. AB 354 (Cogdill) Expands the definition of telemedicine to include "store and forward" technology for dermatology and opthamology, in which information is transmitted and reviewed at a later time by medical professionals, and allows Medi-Cal reimbursement for these services. AB 522 (Plescia) Clarifies policy on automated drug delivery systems, restricting access to licensed personnel in skilled and intermediate nursing facilities. Also prohibits Medi-Cal coverage of erectile dysfunction prescriptions for registered sex offenders. AB 1388 (Ridley-Thomas) Establishes two grant programs: 1) to demonstrate the benefits of using the state's telecommunications networks to deliver supplemental educational services; and 2) a grant program to demonstrate the use of telemedicine resources within a community. AB 1672 (Nation) Would require healthcare facilities, health insurers and healthcare service plans to record all healthcare information they obtain in an electronic record keeping system. SB 7 (Figueroa) Restricts disclosure of personal information, as specified, that is contained in public records and that would otherwise be public. 4 CCST Report, October 2005 SB 13 (Bowen) This bill permits state agencies to release personal information to the University of California or a nonprofit educational institution conducting scientific research only if the research proposal has been reviewed and approved by the Committee for the Protection of Human Subjects (the state's Institutional Review Board) for the Health and Human Services Agency. STEM CELL ACR 1 (Negrete McLeod) Urges the Independent Citizen's Oversight Committee to adopt robust conflict-of-interest procedures; maintain open meetings and public records; work to ensure that therapies are available to low-income residents; and report to the Legislature by January 1, 2006. SB 18 (Ortiz) Prohibits human oocytes or embryos from being acquired, sold, received, or otherwise transferred for valuable consideration for medical research or development of medical therapies; also requires the State Auditor to audit the California Institute for Regenerative Medicine and ICOC. SCA 13 (Ortiz) A proposed constitutional amendment that requires ICOC to operate subject to California open meeting laws; ensure that therapies developed through CIRM would be accessible to low-income residents; and ensure that ICOC members disclose potential conflicts of interest. This bill is inactive. SJR 17 (Ortiz) Asks Congress and the President of the United States to lift restrictions on federal funding for stem cell research; also requests that human cloning be prohibited. HEALTH AND MEDICAL RESEARCH AB 1062 (Saldaña) Expands informed consent laws, allowing medical research subjects the right to review all the laboratory reports or any other analysis regarding specimens taken from the subject. AB 1273 (Saldaña) This bill would declare that it is the intent of the Legislature to enact legislation that would create a statewide advisory panel on bioethics. SB 12 (Escutia) Requires the sale of all foods on elementary school grounds to comply with nutrition standards which restrict total fat and calories and provide for acceptable levels of specified nutrients. SB 281 (Maldonado) The California Fresh Start Program, which requires that fruits and vegetables be made more widely available to students and authorizes extra funding to support this. SB 849 (Berg) Would establish the Interagency Office of Environmental Health Tracking for the purpose of implementing the California Health Tracking Program, coordinating multiple health and environmental surveillance data collection efforts. SB 965 (Escutia) Restricts the sale of beverages to pupils at elementary and middle or junior high schools of certain specified beverages, requiring increased distribution of milk and fruit or vegetablebased drinks with no added sweeteners. AGRICULTURE AND FOOD AB 984 (Laird) Provides that the manufacturer of a genetically engineered (GE) plant is liable to any farmer, grain and seed cleaner, handler, or processor in cases where the plant has caused economic damage or loss. ENERGY, ALTERNATIVE FUELS, AND AIR EMISSIONS AB 838 (Saldaña) Provides tax credits for hybrid, alternative fuel, zeroemission, and ultra-low emission vehicles. AB 1007 (Pavley) Requires the State Energy Resources Conservation and Development Commission, in consultation with the State Water Resources Control Board, the Department of Food and Agriculture, and other relevant state agencies, to develop a state plan to increase the use of alternative transportation fuels by 2007. The plan should optimize public health and environmental benefits while minimizing costs to the state. AB 1660 (Pavley) Creates the California Energy-Efficient Vehicle Group Purchase Program in the Department of General Services to encourage the purchase of energy-efficient vehicles by local and state agencies through a group-purchasing program. SB 250 (Campbell) Adds hydrogen fuels to the list of fuels for which the Department of Food and Agriculture sets standards. SB 497 (Simitian) Requires the state to develop a strategy to better control emissions from vehicles used in construction, in a cost-effective manner. SB 757 (Kehoe) Would require public agency fleet operators to purchase alternative fuel vehicles and advanced transportation technologies where technologically feasible and cost-effective. SB 1003 (Escutia) Would enact the Liquefied Natural Gas Evaluation and Terminal Permitting Act, establishing a permitting process for the construction and operation of liquefied natural gas terminals. INFORMATION TECHNOLOGY SB 97 (Murray) Outlaws e-mail spam in California, makes unsolicited commercial email advertising a misdemeanor offense punishable by a $1000 fine and six months in jail. SB 1028 (Bowen) Bans "internet hunting," prohibiting the shooting or killing of any bird or mammal via the internet. AEROSPACE AND WORKFORCE ACR 7 (S. Runner) Congratulates and expresses the Legislature's appreciation for the achievements of SpaceShipOne and the efforts of the team of Paul Allen, Burt Rutan, and pilots Mike Melvill and Brian Binnie in making privately funded manned space flight a commercial reality. SCR 14 (G. Runner) Designated April 12, 2005 as California Space Day in recognition of the satellite industry's contributions to the state of California. CALIFORNIA COUNCIL ON SCIENCE AND TECHNOLOGY ACR 24 (Mullin) Expands the scope of the CCST Study Group developing intellectual property recommendations to include contracts, grants, and agreements developed under Proposition 71, the Stem Cell Research and Cures Initiative. CCST Report, October 2005 5 #T eachers California’s K-12 education system is the largest in the nation, with which will serve as the basis for an integrated document which will offer over six million students and three hundred thousand teachers. Building recommendationstothestateandtotheinstitutionsinvolvedinteacher an understanding of how to work within such a system in the face of production and professional development. The study, which is being significant shortfalls is no easy task. funded by the Stuart Foundation, is scheduled for completion in 2006. “Gaps in the collection, use, and availability of data seriously compromise efforts to plan and monitor the teacher workforce at both thestateandlocallevels,”saidMargaretGaston,executivedirectorofthe CenterfortheFutureofTeachingandLearning(theCenter). “Thisleaves PRINCIpAl INVeSTIGATORS policymakersandeducationofficialswithlittlein-depthunderstandingof thecurrentshortageofqualifiedteachers,theinequitabledistributionof fully qualified teachers, or a clear picture of future workforce needs.” Science Teacher Preparation Teacher Preparation in Private Herbert Brunkhorst Institutions AsCCST’s2002report,CriticalPathAnalysisofCalifornia’sScienceand College of Education Eugenia Mora-Flores TechnologyEducationSystemindicated,manystudentsaregraduating California State University, San Rossier School of Education without the basic skills needed to succeed in California’s high-tech Bernardino University of Southern California industries. That study called on industry, academic, and government leaderstoworktogethertooverhaulscienceandengineeringeducation, Recruitment of Qualified Science Teacher Professional toincreaseenrollmentinthesesubjects,andtoexpandthestate’sability Science and Mathematics Development to research S&T educational issues. Further research by the Center has Teachers Dan Walker underscored what appears to be a serious shortage of qualified math Mathematics and Science Teacher Pamela Clute andscienceteachers. Toformulaterecommendationsforaddressingthis Outreach and Educational Education Program (MASTEP) shortage, a great deal of groundwork needs to be done in order to define Partnerships College of Science University of California, Riverside and quantify the science and math workforce and skills gap and identify San Jose State University appropriatestrategiesforCaliforniatoenhanceitsproductionofscience Math Teacher Preparation Data Collection and Analysis-UC and math teachers. Judy Kasabian Patrick Callahan “We need reliable data to monitor the match between teachers’ Division of Mathematical Sciences Mathematician in Residence assignmentsandtheircredentials,understandwhatattractsteachersto El Camino College University of California Office of the theprofession,anddeterminewhatcontributestotheirdecisiontoleave President Math Teacher Professional it,”saidCCSTExecutiveDirector, Susan Hackwood. “Without such data, Data Gathering and Analysis Development itisverydifficulttoeffectivelydeterminewhatstrategiesmaybeeffective Using SRI Data Sets Yvonne Lux in boosting our science and math teacher workforce.” The Educational Research and Patrick Shields For their ongoing joint project, California’s Math and Science Teacher Leadership Institute Center for Education Policy Shortage:ACriticalPathAnalysis,CCSTandtheCenterhaveassembleda California Lutheran University SRI International teamofeightresearchersfromacrossthestatetoexaminedifferentaspects of science and math teacher production, retention, and professional development. Each member brings a different range of expertise to the table, as well as access to a wide variety of data sources. “While a variety of public and private institutions gather a great deal of data on teachers — including the California Department of Education, the California 2000 Commission on Teacher Credentialing, the California State Teachers’ Retirement System, and universities that prepare teachers — these data sources cannot provide some of the most basic information about the teacher workforce on a regular basis,” added Gaston. 1500 “Becausetheseagencieswereestablishedtoperform specific, independent functions that are not linked by a common plan for data use, they act in isolation and make decisions that often prevent their data from being used in analyses of the state’s overall teacher 1000 workforce.” CCST and the Center are drawing upon the cooperation of CCST’s constituent institutions to bring together as wide a range of data sources as possible, including some not normally made public. In 500 addition, with the assistance of the California Teacher Advisory Council (Cal TAC), CCST and the Center are conducting their own surveys of science and math teachers to obtain some of the missing pieces of the puzzleonwhyteachersstayintheteachingprofession 0 or go into other careers. Mathematics Life Science Physical Science “We are particularly excited about the prospect of leveraging Cal TAC members’ experience and ability Underprepared High School eachers T to tap into the science and math teacher workforce to gather new data for this study,” said Hackwood. Fully Cr edentialed Out-of-Field & Under prepared High School eachers T “Cal TAC will be playing an important role in the production of this analysis, and will make sure that we areaccuratelyreflectingtheexpertiseoftheclassroom Number of Out-of-Field and Underprepared High School Teachers in Mathematics and as well as the researchers.” Science, 2003-2004. Source: California’s Teaching Force 2004 Aswiththe2002CriticalPathAnalysis,theindividual researchers will produce separate standalone studies 6 CCST Report, October 2005 HEALTHCARE IT Has Big Promise for California America spends $1.7 trillion on healthcare each year, but the system remainshighlyinefficient. High-techtreatmentsabound,butsomeofthe simplerthings,suchaskeepingtrackofapatient’schart,canbechallenging. Healthcareinformationtechnology(HIT)isafieldthatoffersawiderange ofinformationtechnologyapplicationstohelpadministerhealthcaremore effectively, potentially saving more than $77 billion a year. Because of the importance of this issue to the state, CCST has focused attention this year on HIT, with the goal of identifying S&T areas where CCST could effectively assist the state in understanding and evaluating healthcare IT options. Under the leadership of CCST, Council Members Stephen Ryan, president of the Doheny Eye Institute, Francine Berman, director of the San Diego Super Computer Center, Alfonso Cardenas, ESTIMATeD INeFFICIeNCIeS ASSOCIATeD LACK OF A HeAlTHCARe IT SYSTeM WITH A • Without sharing patient records electronically, 30% of the time, physicians could not find information previously recorded in a paper chart • Thesamedrugor radiologyexam was ordered 11% of the time • Physicians were not aware of 1 in 4 prescriptions that a patient had been given • 1 in 7 admissions and 1 in 5 lab tests and radiology examswereorderedbecauseearlierresultscouldn’tbe retrieved • Typical physician receives test results from 5 or more locations • Cost of tracking down and obtaining information can range from $12 to $28 per visit Source:ElectronicMedicalRecords–GettingitRightandGoingtoScale, W.EdwardHammond,III,CommonwealthFundbackgroundpaper;via CalRHIO, January 2004. professor of computer science at UCLA, and CCST Board Member Steven Bruckman, executive vice chancellor for the California Community Colleges, the council meeting in October will focus on HIT systems. This meeting will be conducted in collaboration with the Institute of Medicine (IOM). “California trails other states that have already passed enabling legislation for the implementation of healthcare IT statewide,” said Ryan. “There are significant up-front costs involved, but overall, IT will ultimately reduce healthcare costs dramatically.” The costs in the early years are a disincentive – the RAND Corporation estimates implementation could cost $8 billion a year, and savings from efficiencies will not appear until later. One of the biggest HIT goals would be the creation of a statewide data exchange system and integration of the healthcare system. While there are many logistical obstacles to designing and implementing such a system, this integration could significantly improve the efficiency of healthcare. In one study, according to the California Regional Health Information Organization (CalRHIO), physicians could not find information previously recorded inpapercharts30%ofthetimeandweren’tawareof25%of prescriptions given to patients. In addition, data exchange systemsmaysignificantlyhelpmaintainconsistentmedical treatmentforvictimsofnaturaldisasters,suchasHurricane Katrina, which displaced hundreds of thousands of peopleanddestroyedcountlesspaperrecordsthatmaybe impossible to reconstruct. A variety of experts participating in the CCST/IOM meeting, include Roger Taylor, consultant with the RAND Corporation; Judy Ozbolt, scholar, Institute of Medicine; Jack Lewin, CEO and executive vice president of the California MedicalAssociation; Jeff Rose, CEO and founder, HealthAlliant; andRickCraft,projectlead,TelemedicineReferenceArchitectureProject, Sandia National Laboratories. The keynote speaker will be Molly Coye, founder and CEO of the Health Technology Center (HealthTech). As Coye points out, understanding how best to fix the state’s ailing system is partly a question of deciding where to invest limited resources and time. “Whatwedo[atHealthTech]isprovideobjectivetechnologyforecasts, innovative decision making tools, and expert learning networks,” said Coye. “This helps enable organizations to adopt the most effective technologies with the least amount of disruption.” Some of healthcare IT’s greatest promise lies in the integration of currently disparate data systems and the healthcare enterprise’s informationnetworks. However,suchstepsfaceseveralbarriers,including the lack of a trusted third party administrator for such a system and the lack of a viable business model. There exist, however, new technologies that can improve local efficiencies. “The first and simplest of these emerging technologies is wireless communication systems,” said Coye. “Thanks to significant improvementsinthepastfiveyears,real-time,efficientcommunications are now practical to implement. One such example is the Vocera system thatallowsstaffwearingasmalldevicetousespeechrecognitiontoreach any other individual in the hospital. The direct results of these wireless communication systems are faster and more direct response times, reduced phone tag, and greater capacity for multitasking.” HealthTech prepares its forecasts for over 45 partner organizations, including many hospitals both in California and elsewhere in the U.S. For each of these partners, different solutions may be appropriate. “Taking full advantage of IT systems is important, but the focus should be on obtaining the greatest return on investment,” said Coye. “An organization need only utilize those capabilities in their IT systems thatprovidethegreatestbenefittotheirbusinessprocesses.Sinceevery business is different, their utilization of a given IT system will vary according to their particular situation.” CCST’s healthcare IT committee will be helping California set priorities and develop an agenda and recommendations appropriate to the state. “Healthcareorganizationsinthestateshouldworkhardtolearnfromthe experiencesofearlyadopters,”saidCoye.“Inthisway,theycandetermine how the state can best focus its healthcare IT strategies overall.” 350 280 $ billions Teacher CPA explores serious Issue for California 210 140 70 0 2004200520062007200820092010201 1 2012201320142015201620172018 Inpatient Setting, Cumulative Savings - Cumulative Costs Outpatient Setting, Cumulative Savings - Cumulative Costs Inpatient Setting, Yearly Savings Ye - arly Costs Outpatient Setting, Yearly Savings Ye - arly Costs Net Potential Benefits (Savings - Costs) with adoption of Healthcare Information Technology at the National Level for the Inpatient and Outpatient Settings. Source: RAND CCST Report, October 2005 3 IP Report continued from page 1 IP Study Group Recommendations The IP Study Group’s recommendations in the interim report are consistent with general principles likely to be recommended for statefunded research in the final report to be completed later this year. These general principles assert that the IP policy: • Is to be consistent with the Bayh-Dole Act. This principle can play out in many ways that are of benefit to the public. In particular, ownership of IP resides with the grantee, who is requiredtodiligentlydevelopIPforthepublic. Inaddition,thebalance of any net royalties must be used to support research and education activities. • Creates incentives for commerce in California from state-funded research to the greatest extent possible. • Encourages timely publication of results to diffuse knowledge widely, and provide guidance on the kinds of data that are desired to be placed in the public domain or available under open source, Creative Commons, or other broad-use licenses, including software and special databases. • Requires diligent development of IP into products that benefit the public. With these general principles in mind, the IP Study Group recommends that CIRM consider policies that accomplish the following: • Permit grantees to own IP rights from CIRM-funded research. • Require grantees (institutions, individuals, or both) to provide a plan describing how IP will be managed for the advancement of science and benefit to California. • Grant basic research funds without requiring grantees to commit to providing a revenue stream to the state. If, however, a revenue stream develops over time, revenues will be reinvested in research and education. • Generally make CIRM-developed research tools widely available to other researchers. • Require diligent efforts to develop CIRM-funded IPinto therapeutics and diagnostics that can benefit the public. • Retain within CIRM Bayh-Dole-like rights to step in if the owner of IP isnotundertakingappropriatestepstotransfertechnologytobenefit the public. • Leave license particulars to the owner who is in the best position to judge how best to ensure that discoveries are made widely available through commercialization or otherwise. • Reserve the right to use IP by or on behalf of CIRM. • Establish and maintain a CIRM database to track all IP generated through CIRM funding. The release of the interim IP report has garnered considerable media attention. The San Jose Mercury News, San Francisco Chronicle, San DiegoTribune,SacramentoBee,andLosAngelesTimeshaveallcoveredthereport’srelease,withseveralarticlesechoingpublicconcerns about the report’s suggestion that a strong royalty revenue stream is not realistic. “Last week, the council issued a report explaining why the state shouldn’t count on a quick shower of wealth from the $6-billion Propostion 71 investment in embryonic stem cell research. The report observed that an attempt by the Legislature to mandate a specific financial return from all commercial stem cell treatments derived from state grants would, in fact, discourage the commercialization of such treatments. It observed that useful research in biotech and other fields developed at a snail’s pace until the federal government abandoned a similar mandate in 1980.” Los Angeles Times September 1, 2005 IP Study Group Co-Chairs Stephen Rockwood and Alan Bennett “...it is unrealistic for the state to expect a huge payback on Proposition 71. The report examined federal policy over the last 25 years since the passage of the federal Bayh-Dole Act, which governs the use of federal funds at research universities. Bayh-Dole has been extremely goodatpushingbasicresearch...buthasestablishedlittle track record for financial payoffs to the government. Numerous people, including scientists affiliated with thefundingbodiescreatedbyProposition71,havecited Bayh-Dole as the proper model for stem cell research in California.” Capitol Weekly News September 22, 2005 2 CCST Report, October 2005 ind r ust y tur a e f e California is a leader in technological innovation. In this section, CCST Report focuses on how California’s major industries and universities are workingtomaintaincutting-edgeresearchprograms,andencouragestudentinterest in science and technology. Research Pays Off in the Long Run Medical breakthroughs do not occur overnight. In the life in the other drugs we have in the pipeline," said Graham. "It was sciences, development of a research finding into a new drug or FDAa long process. SYMLIN represents the culmination of 18 years of approved treatment typically takes at least a decade. Investments in research in diabetes." excess of several hundred million dollars are usually needed to bring During those 18 years, Amylin scientists helped both to improve a product to market. Consequently when a treatment does reach the understanding of the physiology of diabetes and to develop a the final stages of development, it is very good news for everyone new and effective treatment. involved. Amylin has been fortunate to obtain approval for its two diabetes Amylin Pharmaceuticals, a company founded in 1987, has finally medications. A company that stakes its future on the success of a begun seeing the fruits of its labors with the narrow group of drugs may soon flounder FDA approval of two diabetes medications, if clinical trials don't go well, or if those SYMLIN® (pramlintide acetate) injection products do not earn FDA approval. “The approval of SYMLIN, a in March 2005, and BYETTA® (exenatide) "A great deal of this depth comes injection in April 2005. The two drugs are the first-in-classtherapy,wasamajor from our approach to research, which first that Amylin has successfully brought to milestone for us. ... It was a long is to identify peptide hormones and market. characterize utility before determining "Successfully managing diabetes is a process. SYMLIN represented potential targets," added Graham. "We've daily struggle for millions of Americans," developed our own library of peptides and the culmination of 18 years of said Ginger L. Graham, president and chief characterized their functions; it's a resource executive officer, Amylin Pharmaceuticals, research in diabetes. ” we believe is unique in the industry." In Inc. "Often, current treatments do not many research processes, libraries of provide adequate blood sugar control. The uncharacterized compounds are screened development of SYMLIN and BYETTA offer against a known drug target. Ginger Graham significant new treatment opportunities for "For us, it has been a lengthy process, people with diabetes." President and CEO but our focus has paid off," said Graham. Amylin was founded after the discovery "Amylin has contributed much to the Amylin Pharmaceuticals of a peptide hormone, amylin, produced understanding of diabetes, and is now by the same cells of the pancreas that make bringing new treatment options to insulin. Since then, the company has built physicians and their patients. Through our continued efforts in a strong foundation on research and development in related areas. research and development, we look forward to advancing innovative Amylin's researchers concentrate primarily on investigating the new medicines with the potential to significantly change patient care potential utility of new peptide hormone candidates, leveraging in the years to come." highly focused expertise to develop drugs to treat diabetes, obesity, and cardiovascular disease. Because the drug development process is so lengthy, investors must typically wait years for returns on investment. Researchersmustconduct three phases of clinical trials to show that a drug's benefits outweigh its side effects, and that its therapeutic Byetta is the first in a new class of drugs to treat type 2 diabetes. It is a synthetic version of exendin-4, a naturallyaction works better than a placebo. occurring hormone. Depending on the complexity of the new drug and the nature of the disease Upcoming CCST events being treated, it may take thousands of patients and several years before statistically significant data emerge to confirm that a drug OCTOBER 19 – 20, 2005. Irvine works. The development program for SYMLIN involved over 5,000 patients in 12 years of clinical research. BYETTAclinical studies have Board and Council meeting and dinner program at included over 3,000 patients in the last 6 years. the Beckman Center. Keynote speaker is Molly Coye, With so much at stake, drugs in the pipeline are watched closely founder and CEO of the Health Technology Center at each stage. In August, positive clinical trial results for an as-yet (HealthTech). unapproved, long-acting formulation of BYETTA generated strong interest in Amylin's stock, despite the fact that the new formulation JANUARY 31 – FEBRUARY 1, 2006. Sacramento is still under investigation and will not be commercialized for some Board and Council meeting and dinner program. time. "The approval of SYMLIN, a first-in-class therapy, was a major milestone for us. It is the first new therapy approved for type MAY 23 – 24, 2006. Sacramento 1 diabetes since the discovery of insulin, over 80 years ago. It Council meeting and dinner program. validates our focus on peptide hormones as potentially useful human medicines, which in turn led to significantly higher interest CCST Report, October 2005 7 FELLOW strong force in IP study Today, policymakers turn to CCST more and more for impartial analyses of issues ranging from genetically modified foods to energy to education. However, as CCST Fellow and former Council Member Roger Noll notes, achieving this status as an independent source of advice has been a gradual process. "The first few years witnessed a long up-hill struggle to obtain the confidence of government officials, business leaders, and academics who are involved in science policy," said Noll. "With completion of the CaliforniaReportontheEnvironmentforScience and Technology (CREST), CCST demonstrated its competence across the entire spectrum of California policy issues." Noll has been a part of this process for many years. As a council member from 1995 through 2000, he helped oversee the production of CREST and witnessed CCST's transformation into an organization with greater recognition and credibility at the state and national levels. However, with recognition sometimes comes controversy. "Being an effective source of advice on science and technology presents formidable challenges, one of which is effective communication," said Noll. "Delivering the results of often difficult, arcane technical analysis in plain but accurate reports that are accessible to everyone is not easy. I believe that CCST's recent interim report on the intellectual property to be derived from California's stem cell research program, for example, has greatly elevated the debate not only about the governance of the program, but about the plausible role for stem cell research in stimulating new medical advancements." Noll is the Morris M. Doyle Centennial Professor of Public Policy in the Department of Economics at Stanford University. He also has a long affiliation with the Brookings Institution in Washington, D.C., where he has been a senior fellow, a visiting fellow, and a non-resident senior fellow. He has won a Guggenheim Fellowship, the Book Award of the National Association of Educational Broadcasters, and the Distinguished Service Award of the Public Utilities Research Center. He also received the 1994 Rhodes Prize for Undergraduate Teaching from Stanford University. This year, he has been an active participant in the study group that crafted the interim intellectual property (IP) report. While this subject remains an important one for the state, Noll is convinced that the real challenge for California lies in maintaining the competitiveness of its science and technology workforce overall. "To assure that California retains its leadership in high-technology industries, the state must improve its educational system," said Noll. "CCST has played a leadership role in science education, and I hope that it will not only continue in this role, but break the logjam in state governance that thus far has prevented adequate progress." on t r p e R y cil un olog o C n nia Tech r o d 05 lif an Ca nce r 20 e b e o Sci Oct 3/ ” est ter at n I s 8 te’ 98 d Sta in 1 sore d he on ed in t ablish It is sp ns ans. y o t g i . s / t m t o l r e u i n t hno tion nme nsti tor f n e 10 Tec aniza Gover dary i e-sec plicatios, um l d g o t n V a or te con iva d ap lyse nce profit nia Staostse ing pr licy an ing ana tives e i on for r p ad itia d Sc T po uct ST: is a nhe Calis majo by le ove S& s, cond s and inmy an . C C d r o e T ’ i t m ip “ n p e e Issu S c CC est of statenchor s to im progra g poli us eco adersh a n i osing endin igoro ical le qu y the o i e s r is op m b a v olog the n T’s m y pr com tain CCS rnia b and re ll main a’s tech i o i f i n l r w a o t tha Calif in C CCST Releases Interim IP report for stem cell Institute Roger Noll TheCCST ReportfocusesonCCSTactivitiesandhighlightsinnovativescienceandtechnologyresearchandapplicationsinCalifornia.TheReportiswrittenbyDanny DeCillis,whowelcomesinformationfromreadersaboutscienceandtechnologyatworkintheprivate,public,andeducationsectors.TheReportthanksCCSTmembersfor theirgenerousassistanceinprovidingmaterialforthisissue.IfyouwouldlikemoreinformationaboutCCSTinitiatives,[email protected],orvisit CCST’s website at http://www.ccst.us. Fax requests to (916) 492-0999 or telephone (916) 492-0996. In August, CCST released its interim report on a framework for intellectual property for the California Institute for Regenerative Medicine (CIRM). The long-anticipated report has generated considerable interest and has played an important role in the ongoing discussions concerning CIRM’s operations. “I want to commend the members of the California Council on Science and Technology for their thoughtful and timely report,” Assembly Member Gene Mullin said. “California is in a unique position to create an intellectual property policy that is as forward thinking as Proposition This report will begin “I want to commend the 71. those discussions.” members of the California The intellectual (IP) interim Council on Science and property report,PolicyFramework Technology for their thoughtful for Intellectual Property Derived from Stem Cell and timely report.” Research in California, released in partial Gene Mullin was response to Assembly Assembly Member Concurrent Resolutions California State Assembly (ACR) 252 and 24 authored by Assembly Member Gene Mullin. ACR 252, which was chaptered in September 2004, requested that CCST conduct an analysis on how and whether to implement a set of consistent statewide IP policies. FollowingtheNovember2004passageofProposition71(theStem Cell Research and Cures Initiative), which allocated $3 billion over 10 years to establish CIRM, CCST also agreed to prepare an interim report tailored specifically to CIRM’s needs and faster timetable. The IP Study Group, convened by CCST to recommend intellectual property guidelines for the state, released the interim report to begin a discussion and provide policymakers with a framework for consideration in the development of policies for the handling of intellectual property developed with state funds, especially in relation to stem cell research. “In this report our main objectives were to define the issues that needed to be addressed, in particular how to respond to heightened public expectations concerning financial returns from stem cell research,” said Stephen Rockwood, co-chair of the committee which produced the report. “Independent Citizens Oversight Committee (ICOC) members and state leaders must realize that this field of research is in its very early years. In all likelihood, the development of effective therapies from CIRM-sponsored research is at least ten to twenty years away.” OverallthecommitteerecommendedthatCIRMadoptanapproach to managing intellectual property that would be consistent with related federal policies. As there are no other states as yet which have established a comprehensive set of IP policies, the federal model was felt to be most appropriate. “Thereisconsiderableexperienceatthefederallevelfromagencies such as the National Institutes of Health which should be useful to California,” said co-chair Alan Bennett. “Fortunately, we have over twentyyearsofdiscussionandexperimentationatthatfederallevelto use as background for California in preparing its own set of policies.” These recommendations include permitting ownership of the intellectual property to reside with the grant recipients, with CIRM retainingrightstousetheresearch,andfocusingonmaximizingaccess to the research rather than controlling prices of the ultimate products of this research. “Theseissueshavebecomecontroversialinpartbecausesignificant publicexpectationsofroyaltyrevenueswerecreatedwhenProposition 71 was being promoted,” said Rockwood. “The considered opinion of thisgroupisthatthoseexpectationsarenotrealisticandnotconsistent with established practice at the federal level.” The interim IP report was originally structured to respond to ACR 24, which was drafted earlier this year and which requested that CCST prepare the interim report en route to completing the charge of ACR 252. However, ACR 24 continued to be amended through the summer, with the result that the interim report does not address all of the questions raised. “We will address ACR 24 in the final report,” said Rockwood. “It is our hope that the document at present may serve a useful purpose in informing and guiding what is surely just the start of a much longer discussion.” continued on page 2 Inside this issue Healthcare IT Has Big Promise for California Capitol Happenings 2005 S&T Legislation Update Teacher CPA Explores Serious Issue for California Reserch Pays Off in the Long Run Fellow Strong Force in IP Study page 3 page 4-5 page 4-5 page 6 page 7 page 8 5005 La Mart Dr, Ste 105 Riverside, CA 92507 California Council on Science and Technology Presorted Standard Nonprofit Organization U.S. Postage Paid Hesperia, CA Permit #164