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Institute of Medicine (US). Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary. Washington (DC): National Academies Press (US); 2012.

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Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.

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Appendix CParticipant Biographies

Carolyn Compton, M.D., Ph.D. (Workshop Co-Chair), is the President and CEO of C-Path. She was most recently the Director of the Office of Bio repositories and Biospecimen Research (OBBR) and the Executive Director of the Cancer Human Biobank (caHUB) project at NCI. In these capacities, she had leadership responsibility for strategic initiatives that included the Innovative Molecular Analysis Technologies for Cancer program, the Biospecimen Research Network program, and the NCI Community Cancer Centers project. She is an adjunct professor of pathology at the Johns Hopkins School of Medicine. She received her M.D. and Ph.D. degrees from Harvard Medical School and the Harvard Graduate School of Arts and Sciences. She trained in pathology at Harvard’s Brigham and Women’s Hospital and is boarded in both anatomic pathology and clinical pathology. She came to NCI from McGill University, where she had been the Strathcona Professor and Chair of Pathology and the Pathologist-in-Chief of McGill University Health Center from 2000 to 2005. Prior to this, she had been a professor of pathology at Harvard Medical School, the Director of Gastrointestinal Pathology at Massachusetts General Hospital, and the Pathologist-in-Chief of the Shriners Hospital for Crippled Children, Boston Burns Unit, for 15 years. During this time she served as Chair of the Pathology Committee of the Cancer and Leukemia Group B for 12 years. Her research interests are in colon and pancreatic cancer as well as epithelial biology and wound healing. Dr. Compton has held many national and international leadership positions in pathology and cancer-related professional organizations. She is a Fellow of the College 95 of American Pathologists and a Fellow of the Royal Society of Medicine. Currently, she is the Chair of the American Joint Committee on Cancer (AJCC), serves on the Executive Committee of the Commission on Cancer of the American College of Surgeons, and serves as the Pathology Section Editor for Cancer. She is a past Chair of the Cancer Committee of the College of American Pathologists and was Editor of the first edition of the CAP Cancer Protocols (Reporting on Cancer Specimens) used as standards for COC accreditation. Among her awards are the ISBER Award for Outstanding Achievement in Biobanking, the NIH Director’s Award, the NIH Award of Merit, and the CAP Frank W. Hartman Award. She has published more than 500 original scientific papers, reports, review articles, books, and abstracts.

Louis J. DeGennaro, Ph.D. (Workshop Co-Chair), is Executive Vice President and Chief Mission Officer, LLS. As Chief Mission Officer, Dr. DeGennaro’s current responsibilities include oversight of all LLS mission functions: Public Policy, Patient Services, and Research with the goal of effectively deploying resources in pursuit of the LLS mission to cure leukemia, lymphoma, and myeloma and to improve the quality of life for patients and their families. The Society’s mission budget exceeds $100 million annually. Dr. DeGennaro has more than 25 years of research, drug development, and executive management experience in academic and private- sector settings. He received his Ph.D. in biochemistry from the University of California, San Francisco, and did his postdoctoral research at Yale University School of Medicine. His previous academic appointments include research group leader, Max Planck Institute in Munich, Germany, where his laboratory was among the first to clone genes expressed exclusively in the nervous system; and associate professor of neurology and cell biology, University of Massachusetts Medical School. Dr. DeGennaro’s private-sector positions include senior director of molecular genetics at Wyeth Pharmaceuticals, Princeton, New Jersey, where his department contributed to the development of pantoprazole (Protonix®) to treat acid reflux disease, Effexor (Venlafaxine®) for anxiety and depression, and Mylotarg® for leukemia; executive vice president for research and development, SynX Pharma, Inc., in Toronto, Canada, where he was responsible for the development of a point-of-care diagnostic test for congestive heart failure; and research manager at Streck, Inc., Omaha, Nebraska, where he helped develop an FDA-cleared diagnostic test for AIDS/HIV.

Margaret Anderson, M.S., is Executive Director of FasterCures/The Center for Accelerating Medical Solutions, defining the organization’s strategic priorities and positions on key issues, developing its programmatic portfolio, and managing its operations. Prior to her appointment as Executive Director, she was FasterCures’ COO for 5 years. Ms. Anderson previously served as deputy director of the Academy for Educational Development (AED), where she was also a team leader in the Center on AIDS & Community Health. Prior to AED, she led programs and studies at the Society for Women’s Health Research, the American Public Health Association, and the Congressional Office of Technology Assessment. She currently serves on the boards of the Alliance for a Stronger FDA, the Council for American Medical Innovation, and the Coalition for the Advancement of Medical Research, and has held numerous committee and coalition memberships for federal agencies and professional associations in the biomedical and public health arena. Ms. Anderson holds a bachelor’s degree from the University of Maryland and a master’s degree in science, technology, and public policy from George Washington University’s Elliott School of International Affairs.

Robi Blumenstein, L.L.B., M.B.A., is President of CHDI Management. Mr. Blumenstein organized CHDI Management in 2002 to provide management services to nonprofit organizations engaged in Huntington’s disease research. Mr. Blumenstein began his career as a lawyer at Torys, a law firm in Toronto, before moving into merchant banking, where he was responsible for structuring and negotiating transactions and supervising investment analysis. He was a principal at First City Capital Corporation, CIBC Capital Partners, and MMC Capital. Mr. Blumenstein was a director of Life Times Nine, a short subject film that was nominated for an Academy Award in 1973. Mr. Blumenstein graduated from the University of Toronto with a B.A. (1975) and an L.L.B. (1978) and has an M.B.A. from Harvard Business School (1984).

Joshua Boger, Ph.D., is the Founder of Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX). He retired as Vertex’s Chief Executive Officer in May 2009, after more than 20 years with the company. He continues to serve on the Vertex Board. Prior to founding Vertex in 1989, he worked for more than a decade in pharmaceutical research at Merck, where he developed an international reputation as a leader in the application of computer modeling to the chemistry of drug design and was a pioneer in the use of structure-based rational drug design as the basis for drug discovery programs. He holds a bachelor of arts in Chemistry and Philosophy from Wesleyan University, Middletown, Connecticut, and master’s and doctorate degrees in Chemistry from Harvard University. He is the author of more than 50 scientific publications; holds 32 issued U.S. patents in pharmaceutical discovery and development; and has lectured widely in the United States, Europe, and Asia on various aspects of drug discovery, development, and commercialization. Among a large number of nonprofit affiliations, he is the Chair of the Board of Trustees at Wesleyan University, Chair of the Board of Fellows of the Harvard Medical School, Chair of NEHI (the Network for Healthcare Innovation, Cambridge), and Vice-Chair of the Boston Museum of Science.

James Bradner, M.D., is an Instructor in Medicine and Staff Physician in Hematologic Malignancies at Dana-Farber Cancer Institute, as well as an assistant professor in medicine at Harvard Medical School. The research focus of his laboratory concerns the discovery/optimization of prototype drugs targeting cancer gene regulation. Clinically, The Bradner Group strives to deliver novel therapeutics for human clinical investigation in hematologic diseases. Dr. Bradner is a member of the American Society of Clinical Investigation, the American Society of Hematology, the American Chemical Society, and the American Association of Cancer Research. His recent research has been published in Nature, Cell, Nature Chemical Biology, and the Journal of the American Chemical Society. He has authored 16 U.S. patent applications, licensed to five pharmaceutical companies, and is a scientific founder of Acetylon Pharmaceuticals, SHAPE Pharmaceuticals, and Tensha Therapeutics.

ShaAvhrée Y. Buckman-Garner, M.D., Ph.D., FAAP, is the Director of the Office of Translational Sciences (OTS), CDER, FDA. OTS is comprised of the Office of Biostatistics, Office of Clinical Pharmacology, and provides oversight to CDER research involving human subjects as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. OTS also provides oversight for the CDER Computational Science Center. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman-Garner received her M.D. and Ph.D. degrees with an emphasis on molecular cell biology from Washington University School of Medicine. Dr. Buckman-Garner completed pediatric specialty training at Baylor College of Medicine.

William W. Chin, M.D., is the Executive Dean for Research at Harvard Medical School (HMS). In this role, Dr. Chin spearheads efforts to design and implement the vision for research at HMS, with special emphasis on interdisciplinary and translational research that crosses departmental and institutional boundaries. Dr. Chin is a Harvard-trained endocrinologist and longstanding faculty member. He was professor of medicine, HMS; Chief, Division of Genetics and Senior Physician, Brigham and Women’s Hospital; and Investigator, Howard Hughes Medical Institute. His impressive career is exemplified in part by his extensive bibliography of nearly 300 papers, chapters, and books, most of which were generated during his 25 years at HMS. As a pioneering molecular endocrinologist at HMS, Dr. Chin embraced the early use of emerging DNA technology to make important discoveries regarding the structure, function, and regulation of hormone genes. His investigations often demonstrated a translational research theme, connecting basic laboratory discoveries to their physiologic relevance in animal models and humans. He has been honored with numerous awards for research, mentorship, and leadership. Prior to HMS, Dr. Chin was at Eli Lilly & Co., where he had worked for the past decade, most recently as senior vice president for Discovery Research and Clinical Investigation. He is a graduate of Columbia College and HMS.

Kristen Doyle, J.D., M.S.T.C., is responsible for overseeing the legal issues that arise as part of CPRIT’s operations, including grant award contract negotiations, intellectual property and revenue sharing agreements, conflicts of interest and confidentiality, and regulatory/compliance issues. Prior to joining CPRIT, Ms. Doyle was a partner at an Austin-based law firm and served as Vice President of the Board of Directors for the Central Texas Chapter for LLS. Ms. Doyle has spent the majority of her legal career practicing administrative law, with an emphasis in the field of energy and regulatory law. She received her undergraduate degree in public policy, magna cum laude, from Indiana University and her doctorate of jurisprudence from the University of Texas at Austin School of Law. She has been recognized four times as a Super Lawyers Texas Rising Star by Texas Monthly and named to the 2010 edition of The Best Lawyers in America. She is a frequent speaker on administrative law and legislative policy issues. Ms. Doyle joined CPRIT in July 2009.

Jens Eckstein, Ph.D., comes to SR One from TVM Capital, where he was a venture partner, entrepreneur-in-residence, and appointed CEO and President of SelectX Pharmaceuticals. Prior to that, he was a general partner in TVM’s Boston life sciences practice, where he focused on earlier-stage investments. He was a member of the Board of Directors for CoNCERT Pharmaceuticals, Enanta Pharmaceuticals, SelectX Pharmaceuticals, Rapid Micro Biosystems, and Anchor Therapeutics and was an advisor to Sirtris Pharmaceuticals. Dr. Eckstein was the founder of Akikoa Pharmaceuticals, a biotechnology start-up company focusing on hearing loss, and North Haven Systems, a life science IT company. Prior to joining TVM Capital, he led drug discovery programs at Enanta Pharmaceuticals, Inc., and Mitotix, Inc. He is the author of numerous scientific publications and holds several issued and pending patents. He was managing editor of Frontiers in Biosciences “Current Topics in Lead Discovery” and served as an editorial board advisor for IDrugs. He is an advisor to the Alzheimer Research Forum (ARF), founding member of the Cure Dystonia Initiative Advisory Council (CDIAC), and a Kauffman Fellow.

Ellen G. Feigal, M.D., M.S., is the Senior Vice President, R&D at CIRM. Prior to joining CIRM in January 2011, Dr. Feigal was Executive Medical Director, Global Development, at Amgen, where her primary focus was in clinical development of therapeutics in hematology/oncology. She also led the scientific/clinical interface with patient advocacy organizations, formalized the company’s policy on expanded access to therapies for those with limited or no treatment options, and led the cross-functional teams to the company’s first collaborative research and development agreement with NCI. From 2007 until joining CIRM, Dr. Feigal was adjunct professor and founding Director of the American Course on Drug Development and Regulatory Sciences, University of California, San Francisco (UCSF), School of Pharmacy. The course, developed under her leadership as a collaborative effort with FDA, UCSF’s Department of Bioengineering and Therapeutic Sciences, its Center for Drug Development Sciences, and the European Center of Pharmaceutical Medicine at the University of Basel, was launched in 2007. It is taught in Washington, DC, with a separate parallel course in San Francisco. Prior to joining Amgen in 2008, she worked in clinical research and drug development in positions at the federal government, nonprofit and for-profit institutes, and companies. She was Chief Medical Officer, Insys Therapeutics, from 2007 to 2008, Director of Medical Devices and Imaging at C-Path, and Vice President of Clinical Sciences and Deputy Scientific Director at the Translational Genomics Research Institute from 2004 to 2007. She directed NCI’s Division of Cancer Treatment and Diagnosis from 2001 to 2004, served as Deputy Director from 1997 through 2001, and as senior investigator in the Cancer Therapy Evaluation Program, NCI, from 1992 to 1997. Dr. Feigal earned a B.S. in biology from UC Irvine, an M.S. in molecular biology and biochemistry from UC Irvine, and an M.D. from UC Davis. She completed her residency in internal medicine at Stanford University and her fellowship in hematology/oncology at UCSF. She was on the faculty at UCSF and UC San Diego before joining NCI.

Jesse L. Goodman, M.D., M.P.H., became Chief Scientist, FDA, in 2009. He has broad responsibility for and engagement in leadership and coordination of the Agency’s cross-cutting scientific and public health efforts. From 2003 to 2009, he was Director of FDA’s Center for Biologics Evaluation and Research (CBER), which oversees medical and public health activities critical to U.S. and global preparedness concerning the development, evaluation, safety, quality, and availability of biologics. A graduate of Harvard, he received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training at the Hospital of the University of Pennsylvania and at UCLA (where he was also Chief Medical Resident). Prior to joining FDA, he was professor of medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed the multihospital infectious diseases research, training, and clinical programs, and where his NIH-funded laboratory first isolated and characterized Anaplasma phagocytophilum, the infectious agent causing a new tick-borne disease, human granulocytic ehrlichiosis. He has authored numerous scientific papers and edited the book Tick-Borne Diseases of Humans, published by ASM Press in 2005. Dr. Goodman has been elected to the American Society for Clinical Investigation and to the IOM of the National Academy of Sciences, where he is a longstanding member of the Forum on Emerging Threats. He is an active clinician and teacher who is board-certified in internal medicine, oncology, and infectious diseases; is Staff Physician and Infectious Diseases Consultant at both the National Naval and Walter Reed Army Medical Centers; and is adjunct professor of medicine at the University of Minnesota.

Michael Gutch, Ph.D., M.B.A., had experience as both a corporate and private venture capital investor prior to joining MedImmune Ventures (MV) in September 2011. Before MV, Dr. Gutch was a Director with H.I.G. BioVentures, a life science–focused investment fund, and prior to that was a Principal with Lilly Ventures, the corporate venture capital arm of Eli Lilly & Co. While at Eli Lilly & Co., Dr. Gutch was also in the Corporate Financing and Investment Banking group, where he focused on mergers, acquisitions, and licensing transactions. Dr. Gutch earned his Ph.D. in cellular and molecular pathology from the State University of New York at Stony Brook and was a postdoctoral research fellow at both UCSF and the Cold Spring Harbor Laboratories. He earned his M.B.A. in finance from Indiana University. Dr. Gutch currently serves as a member of the Board of Directors for Southeast BIO, the Johns Hopkins Alliance for Science & Technology Development, and the Business Advisory Board for the Alzheimer’s Drug Discovery Foundation.

Kathy Hudson, Ph.D., M.S., is the Deputy Director for Science, Outreach, and Policy at NIH, the world’s largest biomedical research agency, with an annual budget of $31 billion. In this position, Dr. Hudson works closely with and oversees the activities of the Associate Directors for Communications and Public Liaison, Legislative Policy and Analysis, and Science Policy. In addition, Dr. Hudson works with NIH leadership to develop and implement new strategic and scientific initiatives and is the NIH liaison with the U.S. Department of Health and Human Services. She represents the NIH—and the NIH Director—in high-level collaborations and negotiations with other federal agencies, such as FDA, CDC, and the White House Office of Science and Technology Policy, as well as with private research institutions, patient voluntary organizations, and professional societies. In December 2011, NCATS was established as a new component of NIH with a mandate to streamline the way translational research is done. At that time, Dr. Hudson was designated Acting Deputy Director of NCATS. In that role she leads the many activities of bringing the Center into being and getting its programs under way.

Thomas R. Insel, M.D., graduated from Boston University, where he received a B.A. from the College of Liberal Arts and an M.D. from the Medical School. He did his internship at Berkshire Medical Center, Pittsfield, Massachusetts, and his residency at the Langley Porter Neuro-psychiatric Institute at the University of California, San Francisco. Dr. Insel joined the National Institute of Mental Health (NIMH) in 1979, where he served in various scientific research positions until 1994, when he went to Emory University, Atlanta, as professor, Department of Psychiatry, Emory University School of Medicine, and Director of the Yerkes Regional Primate Research Center. As director of Yerkes, Dr. Insel built one of the nation’s leading HIV vaccine research programs. At the time of the workshop, he was the Acting Director of NCATS. He currently serves as the Founding Director of the Center for Behavioral Neuroscience, a science and technology center funded by the National Science Foundation (NSF). The Center has developed an interdisciplinary consortium for research and education at eight Atlanta colleges and universities. Dr. Insel first joined NIMH in 1979 as a clinical associate in the Clinical Neuropharmacology Branch and went on to hold several administrative and leadership posts. During his 15 years at NIMH before heading to Emory in 1994, he conducted research in obsessive-compulsive disorder (OCD), initiating some of the first treatment trials for OCD using serotonin reuptake inhibitors. Dr. Insel oversees NIMH’s $1.3 billion research budget, which provides support to investigators at universities throughout the country in the areas of basic science; clinical research, including large-scale trials of new treatments; and studies of the organization and delivery of mental health services.

Thomas A. Kalil is currently serving as Deputy Director for Policy for the White House Office of Science and Technology Policy and Senior Advisor for Science, Technology and Innovation for the National Economic Council. From 2001 to 2008, Mr. Kalil was Special Assistant to the Chancellor for Science and Technology at UC Berkeley. He was responsible for developing major new multidisciplinary research and education initiatives at the intersection of information technology, nanotechnology, microsystems, and biology. He also conceived and launched a program called “Big Ideas @ Berkeley,” which provides support for multidisciplinary teams of Berkeley students who are interested in addressing economic and societal challenges such as clean energy, safe drinking water, and poverty alleviation. In 2007 and 2008, Mr. Kalil was the Chair of the Global Health Working Group for the Clinton Global Initiative, where he developed new public- and private-sector initiatives in areas such as maternal and child health, under-nutrition, and vaccines. Mr. Kalil was also a Senior Fellow with the Center for American Progress (CAP), where he co-authored A National Innovation Agenda, one of the four pillars of CAP’s Economic Plan for the Next Administration. He was also a member of the Scientific Advisory Board of Nanomix and has served on three committees of the National Academy of Sciences, including the Committee to Facilitate Interdisciplinary Research. Previously, Mr. Kalil served as the Deputy Assistant to President Clinton for Technology and Economic Policy and the Deputy Director of the White House National Economic Council (NEC). He was NEC’s “point person” on a wide range of technology and telecommunications issues, such as the liberalization of Cold War export controls, the allocation of spectrum for new wireless services, and investments in upgrading America’s high-tech workforce. He led a number of White House technology initiatives, such as the National Nanotechnology Initiative, the Next Generation Internet, bridging the digital divide, e-learning, increasing funding for long-term information technology research, making IT more accessible to people with disabilities, and addressing the growing imbalance between support for biomedical research and for the physical sciences and engineering. He was also appointed by President Clinton to serve on the G-8 Digital Opportunity Task Force (dot force). Prior to joining the White House, Mr. Kalil was a trade specialist at the Washington offices of Dewey Ballantine, where he represented the Semiconductor Industry Association on U.S.–Japan trade issues and technology policy. He also served as the principal staffer to Gordon Moore in his capacity as Chair of the SIA Technology Committee. Mr. Kalil received a B.A. in political science and international economics from the University of Wisconsin–Madison and completed graduate work at the Fletcher School of Law and Diplomacy. He is the author of articles and op-eds on S&T policy, the use of prizes as a tool for stimulating innovation, nanotechnology, nuclear strategy, newborn health, vaccines, the impact of mobile communications in developing countries, U.S.–Japan trade negotiations, U.S.–Japan cooperation in science and technology, the National Information Infrastructure, distributed learning, and electronic commerce.

Gerald Kovacs, Ph.D., is Director of the Division of CBRN Countermeasures in the Office of BARDA in the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. At BARDA, Dr. Kovacs focuses on addressing the major scientific and regulatory challenges of developing medical countermeasures (vaccines, therapeutics, and diagnostics) against CBRN threats. Dr. Kovacs is responsible for the development, implementation, and oversight of programs authorized by the Project BioShield Act of 2004 and the Pandemic and All Hazards Preparedness Act of 2006. Since joining BARDA in 2005, Dr. Kovacs has expanded BARDA’s portfolio of CBRN programs from 4 to more than 60. He has led five candidates through Phase 2 clinical testing and has delivered five first-in-class medical countermeasures to the Strategic National Stockpile. From 2003 to 2005, Dr. Kovacs was instrumental in establishing the Office of Biodefense Research Affairs (OBRA) at the National Institute of Allergy and Infectious Diseases. At OBRA, he formed the team that developed a novel smallpox vaccine for use in immune-compromised individuals. He completed clinical studies in healthy, atopic, and HIV-infected subjects, and delivered more than 1 million doses of vaccine to the U.S. government. Prior to his career in public service, Dr. Kovacs was a principal research scientist at Wyeth Vaccines. During that period, he led programs in herpes simplex, arainfluenza, respiratory syncytial, and papilloma virus vaccine development. He also led Wyeth’s post–9/11 efforts in the development of a second-generation smallpox vaccine. Dr. Kovacs received his doctorate degree from the Department of Biochemistry and Biophysics at Texas A&M University and subsequently trained as a postdoctoral fellow at Harvard Medical School and NIH. He is also a graduate of the Federal Executive Institute.

Martin Lehr, M.A., joined Osage University Partners in 2009 and focuses on novel biopharmaceutical products, medical devices, diagnostics, and research tools. Prior to joining Osage, Mr. Lehr conducted research in the areas of DNA repair at the Sloan-Kettering Institute and in thrombin activation at the Children’s Hospital of Philadelphia. Mr. Lehr is on the Advisory Board of the Sid Martin Biotech Incubator at the University of Florida, is an advisor to the University City Science Center’s QED Program, and is a mentor to the University of Pennsylvania’s Life Science Management program. He serves as Secretary of the BioBreak organization and is an organizer of Philly BioBreak, a group dedicated to fostering a thriving life science community in the Greater Philadelphia Area. Mr. Lehr holds an M.A. in biotechnology from Columbia University and a B.A. in economics from the University of Pennsylvania.

Freda C. Lewis-Hall, M.D., has been appointed Chief Medical Officer and Senior Vice President, Pfizer Inc. Dr. Lewis-Hall will be the senior physician in the company, responsible for enterprise-wide medical, patient safety, regulatory affairs, and quality assurance as well as outreach to doctors and other medical professionals. Dr. Lewis-Hall will report to Mr. Kindler and serve on Pfizer’s Executive Leadership Team, its most senior leadership group. She will shape Pfizer’s regulatory and medical policy during a time of fast-changing expectations for health care companies and a wave of new therapies in development, especially as information technologies change the ways companies develop medicines, clinicians prescribe them, and patients and payers value them. Prior to joining Pfizer, Dr. Lewis-Hall was Executive Vice President, Medicines Development of Vertex Pharmaceuticals, where she was responsible for clinical and nonclinical development as well as both medical and regulatory development; she also served as Senior Vice President of Medical Affairs at Bristol-Myers Squibb; Vice President of Research and Development at Pharmacia; and Product Team Leader at Eli Lilly & Co. Dr. Lewis-Hall is a Fellow of the American Academy of Psychiatry. She received her bachelor of arts and sciences from Johns Hopkins University and her medical doctorate from Howard University Hospital and College of Medicine.

Peder Maarbjerg, J.D., currently serves as Assistant Director for External Coordination at ARPA-E and is responsible for legislative and public policy outreach. Prior to joining ARPA-E, Mr. Maarbjerg served as Senior Policy Fellow at the U.S. Nuclear Infrastructure Council, where he researched legislative and policy trends, with a focus on administrative law and budget policy. Previously, Mr. Maarbjerg was the Appropriations and Legislative Director for a senior member of the U.S. House of Representatives, Energy and Water Appropriations Subcommittee. He is also a member of the Federal Energy Bar. Mr. Maarbjerg received his B.A. in anthropology and history from Union College, New York, and his J.D. cum laude in environmental law from the University of Baltimore.

Elizabeth Mansfield, Ph.D., is Director of the Personalized Medicine Staff in the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), CDRH, FDA, where she is developing a program to address companion and novel diagnostic devices. She was previously a Senior Policy Analyst in OIVD, managing policy and scientific issues. Dr. Mansfield formerly served as the Director of Regulatory Affairs at Affymetrix, Inc. (2004–2006). She previously served in other positions at FDA, including Scientific Reviewer and Genetics Expert. Dr. Mansfield received her Ph.D. from Johns Hopkins University, and completed further postdoctoral training at NIH.

Barbara M. McGarey, J.D., is Deputy Associate General Counsel for Public Health, NIH Office of the General Counsel (OGC), U.S. Department of Health and Human Services. Ms. McGarey serves as chief counsel for NIH in Bethesda, Maryland, and supervises the NIH Branch of the Public Health Division, OGC. The NIH Branch is the in-house counsel to NIH, providing legal advice on NIH research, policy development, grants and contracts, patents, and hospital and other facility operations. Ms. McGarey has served in this capacity since September 2001. Ms. McGarey has extensive knowledge and experience on the funding and regulation of biomedical research, with an emphasis on intellectual property law. Her prior positions include General Counsel to the NIH Foundation (2000–2001), Deputy Director of the NIH Office of Technology Transfer (1993–2000), and staff attorney and Acting Branch Chief in the Public Health Division, OGC (1987–1993). She began her legal career through the Honors Program at the U.S. Department of Justice in the Civil Division, Office of Consumer Litigation (1985–1987). Ms. McGarey graduated with honors from Catholic University Law School in 1985, where she served on the Catholic University Law Review staff and was a founding co-editor of the Journal of Contemporary Health Law. Prior to law school, Ms. McGarey received a bachelor of science from Cornell University, and worked as a cardiac surgery intensive care unit nurse.

Carol Mimura, Ph.D., is Assistant Vice Chancellor for Intellectual Property and Industry Research Alliances (IPIRA) at the University of California, Berkeley (UC Berkeley). IPIRA is the portal to Berkeley for industry access to Berkeley’s preeminent faculty and research capabilities. Dr. Mimura has a bachelor of science degree from Yale University in molecular biophysics and biochemistry and a Ph.D. in biology (bio chemistry and microbiology concentration) from Boston University. She was an NIH-sponsored postdoctoral fellow and research scientist at UC Berkeley in biochemistry and chemical biodynamics. She served on the board of directors of the Children’s Hospital Research Institute in Oakland, California, and as a board member (the Chancellor’s alternate) of BayBio, the regional voice of biotechnology in northern California. She was a former Executive Director of UC Berkeley’s Office of Technology Licensing. Prior to her positions at UC Berkeley, Dr. Mimura was an analyst at Technology Forecasters, a consultant to Cor Therapeutics and Genomyx, and wrote for the Genetic Engineering News. Dr. Mimura’s scholarly publications include articles on the sucrose phosphotransferase system in Streptococcus mutans and the histidine permease in Salmonella typhimurium in the Journal of Biological Chemistry; the Proceedings of the National Academy of Sciences; Infection and Immunity; Analytical Bio chemistry; Biochimica and Biophysica Acta; the Journal of Cellular Bio chemistry; FEMS Microbiological Reviews; Advances in Enzymology; Abstracts of the American Society for Microbiology; and an article in the Fall 2006 Journal of the Association of the University Technology Managers, “Technology Licensing for the Benefit of the Developing World: UC Berkeley’s Socially Responsible Licensing Program,” Vol. XVII, No. 2, Fall 2006, which has been reprinted in Industry and Higher Education (Vol. 21, No. 4, August 2007).

Garry Neil, M.D., is Corporate Vice President, Corporate Office of Science and Technology (COSAT) at Johnson & Johnson World Headquarters in New Brunswick, New Jersey. In this role, Dr. Neil leads a team that catalyzes sustained growth for Johnson & Johnson by identifying and launching emerging technologies that underpin the creation of future businesses. Dr. Neil has broad experience in science, medicine, and pharmaceutical development. He has held a number of senior positions within Johnson & Johnson, most recently Group President, Johnson & Johnson Pharmaceutical Research and Development. Under his leadership a number of important new medicines for the treatment of cancer, anemia, infections, central nervous system and psychiatric disorders, pain, and genitourinary and gastrointestinal diseases, gained initial or new and/or expanded indication approvals.

Robert O’Neill, Ph.D., is currently Senior Statistical Advisor at CDER, FDA. Previously, he was for 20 years the Director of the Office of Biostatistics (OB) in the Office of Translational Sciences in CDER, which provides biostatistical and scientific computational leadership and support to all programs of CDER. Prior to October 1998, he was Director of the Office of Epidemiology and Biostatistics, responsible also for the postmarket safety surveillance of new drugs. From 1989 to 1990, Dr. O’Neill was a visiting professor at the Department of Research, University Medical School, Basel, Switzerland, where he developed and presented numerous lectures and created a course series for European pharmaceutical scientists, “Topics in Therapy Evaluation and Review (TITER),” which was the model for the European Course in Pharmaceutical Medicine (ECPM), a degree-granting graduate program. He is a fellow of the American Statistical Association (1985), a member of several professional societies, a past Member of the Board of Directors of the Society for Clinical Trials, the 2002 recipient of the Marvin Zelen Leadership Award in Statistical Science, and the 2004 Lowell Reed Lecture Awardee from the American Public Health Association.

Jason J. Paragas, Ph.D., serves as Associate Director for Science, Integrated Research Facility (IRF), Division of Clinical Research, National Institute of Allergy and Infectious Diseases (NIAID). He is also at DTRA as Special Assistant to the Director, Dr. Alan Rudolph. He received his Ph.D. from Mount Sinai School of Medicine, New York University, studying the genetics requirements for influenza and vesicular stomatitis virus assembly. After his thesis work he was a National Research Council Fellow at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), where he later became a principle investigator. While at USAMRIID, Dr. Paragas developed cell-based antiviral discovery efforts in BSL-3 and -4 biocontainment, biotelemetry studies for nonhuman primates in BSL-3 and -4, and basic science investigations of Ebola and monkeypox virus pathogenesis. In response to the SARS outbreak, he identified a potential antiviral and developed a nonhuman primate model for the infection. He has also been involved in the DoD Cooperative Threat Reduction projects in the former Soviet Union, where he worked in Uzbekistan, Kazakhstan, Russia, and the Republic of Georgia. He led the development of the Threat Agent Detection and Response capability for the Republic of Georgia. This program was able to detect the first cases of avian influenza virus in the country. He was recruited by Dr. Jahrling to build a new group, Emerging Viral Pathogens section at NIAID. Since then he has been working as the Associate Director of Science, IRF, Division of Clinical Research, where he has responsibility for developing the scientific program, liaising between the builders and scientific program, and developing projects to support the IRF mission. Projects of particular note have involved developing medical imaging for infectious diseases, infectious disease systems biology, next-generation research informatics, and a novel risk management strategy for BSL-4.

Sudip Parikh, Ph.D., is Vice President of Health Policy at Battelle Memorial Institute and Managing Director of the Battelle Centers for Public Health Research and Evaluation. Dr. Parikh leads Battelle’s engagement in health and life science policy and directs a diverse team of laboratory scientists; social, behavioral, and health services researchers; epidemiologists; statisticians; and survey and field data collection professionals. Prior to joining Battelle, Dr. Parikh served as Science Advisor and Professional Staff to the U.S. Senate Appropriations Committee, where he was responsible for negotiating the discretionary budgets of NIH, CDC, AHRQ, the Centers for Medicare & Medicaid Services, and BARDA. Dr. Parikh received his Ph.D. from the Scripps Research Institute in La Jolla, California, and his B.S. from the University of North Carolina at Chapel Hill.

Lili M. Portilla, M.P.A., has worked in the area of technology transfer at NIH since 1989. She has extensive experience in negotiating and developing commercialization strategies for complex, multiparty collaborations and public–private partnerships. Ms. Portilla has broad knowledge of Federal and NIH technology transfer policy and law pertaining to biotechnology and commercialization issues. On December 23, 2011, Ms. Portilla was named Director of the Office of Strategic Alliances for the recently formed NCATS. From February to December 2011, Ms. Portilla served on a detail as Acting Director of the Technology Transfer and Partnerships at the NIH Center for Translational Therapeutics (NCTT), an intramural component of the National Human Genome Research Institute (NHGRI). NCTT is now the intramural program of NCATS. From January 2008 to 2011, Ms. Portilla served as Senior Advisor to the Director of the National Center for Research Resources (NCRR) and provided advice to NCRR staff on all facets of technology transfer, intellectual property, and public–private partnership issues. Prior to her position at NCRR, Ms. Portilla served for 7 years as Director of the National Heart, Lung, and Blood Institute (NHLBI), Office of Technology Transfer and Development (OTTAD). Ms. Portilla has also published several papers on public–private partnerships. She received a masters in public administration in 1992 from American University, Washington, DC, and a bachelor in business administration, double major in finance and Spanish literature in 1986 from Stephen F. Austin State University, Texas.

Jane Reese-Coulbourne, M.Ch.E., is the Executive Director of the Reagan-Udall Foundation for the FDA (Foundation). Created by Congress, the Foundation supports the mission of FDA by identifying, funding, and supporting public–private partnerships and projects that will provide the highest caliber science and technology to enhance the safety and effectiveness of FDA-regulated products. Ms. Reese-Coulbourne’s background includes experience in patient advocacy, industry, and government. As an employee of the Procter & Gamble Company for more than 10 years, she worked in production operations, chemical engineering, government regulation, new technology, and product/brand start-ups. Later working with other Fortune 500 companies, she consulted in strategic planning, reengineering/restructuring, new technology plans and start-ups, and total quality management in unionized manufacturing and utility operations. Her diagnosis of breast cancer led to her interest in health research and patient advocacy, serving as Executive Vice President of the National Breast Cancer Coalition, and then as a consultant to the Director of NCI, as well as to leaders in not-for-profit advocacy organizations, foundations, and biotechnology/pharmaceutical companies. Ms. Reese-Coulbourne holds a B.S. in chemistry from the University of Mary Washington and an M.S. in chemical engineering from the University of Virginia.

Stephen Seiler, J.D., is a biotechnology entrepreneur and Founder of AesRx, LLC. Previously, Mr. Seiler had been Chief Executive Officer of several public and private biotech companies that he successfully led through restructurings and refinancing and/or trade sales. These companies include Idera Pharmaceuticals, Access Pharmaceuticals, and Effective Pharmaceuticals. Mr. Seiler was Executive Vice President, Planning, Investment and Development, at Elan Corporation plc from 1995 to 2001. He was part of a senior management team that transformed Elan from a small drug delivery company (1996 revenues, $200 million) into a fully integrated specialty pharmaceutical company (2000 revenues, $1.5 billion). From 1986 to 1995, Mr. Seiler worked as an investment banker in New York and London including founding and heading the Pharmaceutical Industry investment banking group for Paribas Capital Markets. Mr. Seiler is a member of the Board of Associates of the Whitehead Institute for Biomedical Research. He received a J.D. (honors) from Georgetown University, where he was an editor of the Georgetown Law Review and a B.A., summa cum laude, from the University of Notre Dame, where he was elected to Phi Beta Kappa.

Ellen V. Sigal, Ph.D., is Chairperson and Founder of Friends of Cancer Research (Friends), a cancer research think tank and advocacy organization based in Washington, DC. Friends is a leader in developing partnerships and advocating for policies that will get treatments and therapies to patients in the safest and quickest way possible. Friends works with federal health agencies, congressional leadership, academic research centers, and private-sector industry producing real results. Dr. Sigal is Vice Chair of the inaugural board of directors of the Reagan-Udall Foundation, a partnership designed to modernize medical product development, accelerate innovation, and enhance product safety in collaboration with FDA. She serves on the Board of FNIH, where she chairs its Public–Private Partnerships Committee. In 2010, Dr. Sigal was appointed to a 6-year term on the Board of Governors of PCORI as a representative of patients and health consumers. She also holds leadership positions with a broad range of cancer advocacy groups, public policy organizations, and academic health centers including the American Association for Cancer Research Foundation Board, Research!America Board, M.D. Anderson Cancer Center External Advisory Board, Duke University Cancer Center Board of Overseers, and The Sidney Kimmel Comprehensive Cancer Center Advisory Council.

Nancy Sung, Ph.D., is a Senior Program Officer with the Burroughs Wellcome Fund (BWF), having joined its staff in 1997. She oversees grantmaking of $13–$15 million annually in the areas of translational research and interfaces in science. This portfolio includes programs ranging from individual bridging awards for postdoctoral fellows to midcareer awards for clinical investigators to institutional awards for interdisciplinary training programs that bridge the physical/mathematical and biological sciences. She has also shaped BWF’s funding and activities in the area of clinical research policy and workforce development. Dr. Sung earned her undergraduate degree from the University of Pennsylvania and a Ph.D. in microbiology and immunology from the University of North Carolina at Chapel Hill. Prior to joining BWF’s staff, Dr. Sung was a visiting fellow at the Chinese Academy of Preventive Medicine’s Institute of Virology in Beijing, with the support of WHO and NIH-NCI. Dr. Sung is founding chair of the Health Research Alliance, a growing consortium of private foundations and voluntary health agencies with a shared interest in fostering basic science discoveries and removing barriers that prevent them from being translated into clinical studies and then into better health. She has served as a member of several IOM panels including the Clinical Research Roundtable. For 2011–2012, she is on sabbatical from BWF, serving in the National Science Foundation’s Office of International Science and Engineering on its East Asia–Pacific portfolio.

Douglas C. Throckmorton, M.D., is Deputy Director for Regulatory Programs, CDER, FDA. In this role, he shares responsibility for overseeing the regulation of research, development, manufacture, and marketing of prescription, over-the-counter, and generic drugs in the United States. From aspirin to cancer treatments, CDER works to ensure that the benefits of approved drug products outweigh their known risks. Dr. Throckmorton is board-certified in internal medicine and nephrology, having received his training at the University of Nebraska Medical School, Case Western Reserve University, and Yale University. Prior to coming to FDA he practiced medicine at the Medical College of Georgia in Augusta.

Scott R. Ulrey, M.B.A., has been Deputy Director, Contracts Management Office, at DARPA since 2006 and held previous positions as division director and contracting officer at DARPA since 1989. He has more than 27 years of DoD acquisition experience, including tenure as head of the contracts section at the Special Programs Office, the White House Military Office, supporting White House classified acquisition programs. While at DARPA, Mr. Ulrey was the architect of the mechanics of Other Transactions issued pursuant to 10 U.S.C. § 2371 and personally trained the first military service and civilian representatives in developing their own Other Transactions. He is a recognized principal authority on Other Transactions and an expert in federal and DoD procurement contracts, grants, and cooperative agreements. Mr. Ulrey was also instrumental in the development of the first Other Transactions for Prototypes Program Solicitation for the Tier II+ program, later known as the Global Hawk program, issued pursuant to 10 U.S.C. § 2371, and Section 845, the National Defense Authorization Act for FY 1994, and negotiated multiple systems programs such as the Orbital Express satellite servicing program. An active contributor to the success of acquisition reform initiatives and to the acceptance of innovative acquisition instruments in the acquisition community, he continues to provide advice, assistance, and training on Other Transactions directly to federal and DoD contracting activities. He received a B.A. in English and history from George Mason University and an M.B.A. from the Florida Institute of Technology. He is a Certified Professional Contracts Manager and has received numerous awards including the Office of the Secretary of Defense Exceptional Civilian Service Medal and Civilian Career Service Award.

William L. Warren, Ph.D., is a Vice President and heads the VaxDesign Campus of Sanofi Pasteur. The VaxDesign campus specializes in biomimetic systems such as an in vitro human immune system (MIMIC® System) to accurately assess new drugs and vaccines in a more predictive and physiologic way. Dr. Warren is a member of the Research and Development Management Committee, External Innovation Executive Committee, the New Vaccines Advancement Committee, and the Global Leader Network at Sanofi Pasteur. Prior to this, he was CEO and founder of VaxDesign Corporation before it was acquired by Sanofi Pasteur. He was also a Managing Partner of Sciperio Inc., which is an innovative high-technology development company. He directed a diverse portfolio of R&D programs as a program manager at DARPA in the Defense Sciences Office. Dr. Warren was a principal member of the technical staff at Sandia National Laboratories, and received his B.Sc. honors and Ph.D. degrees in engineering science from The Pennsylvania State University. He is a Fellow of the American Institute for Medical and Biological Engineering, has authored more than 190 referred publications, is the editor of 3 conference proceedings, has given more than 200 scientific presentations, and holds more than a dozen patents or patent applications. He has received three R&D 100 awards from non-volatile memories, to micro-dispensing systems, to a surrogate human immune system; the 2011 BioFlorida Company of the Year; the 2011 Florida Companies to Watch; the 2009 Outstanding Collaborator Award from DTRA; the 2009 Governor’s New Product Award; the Schwartz Business Innovation Award; the Medical Marker Award; the Industry Week Innovation Award; the Discover Magazine Award; and several outstanding paper awards. He is on the board of directors and scientific advisory board of several companies and organizations, such as Florida’s Blood Centers.

Lt. Col. Daniel J. Wattendorf, M.D., USAF, joined DARPA as a Program Manager in the Defense Sciences Office in 2010. His interests focus on applying methodological advances in genomics and biotechnology to optimize health and prevent disease—specifically to achieve simple solutions that improve health care at the point of care, anywhere. He holds a bachelor of science in microbiology from Cornell University and a medical degree with distinction from George Washington University. He completed a residency in family medicine at the National Capital Consortium; a residency in clinical genetics at the National Human Genome Research Institute (NHGRI), NIH; a fellowship in clinical cytogenetics at Georgetown University; and a fellowship in health policy from the Office of the Director, NHGRI, NIH. Lt. Col. Wattendorf previously served as Director, Air Force Medical Genetics Center and program manager for an Advanced Concept Technology Demonstration integrating advanced diagnostics and informatics with surveillance systems to rapidly detect natural and hostile pathogens in the Office of the Air Force Surgeon General. In addition to his DARPA programs, he is a geneticist at the National Naval Medical Center and the Cancer Genetics Branch, NCI, NIH.

Myrl Weinberg, FASAE, CAE, is President of the National Health Council (NHC), the only organization of its kind that brings together all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations, the NHC’s core membership includes approximately 50 of the nation’s leading patient advocacy groups, which control its governance. Other members include professional and membership associations; nonprofit organizations with an interest in health; and major pharmaceutical, medical device, health insurance, and biotechnology companies. Ms. Weinberg’s extensive career has focused on health care delivery, medical research, long-term care, and related issues that affect people with chronic conditions. She has testified repeatedly before Congress and federal regulatory bodies and is a frequent speaker on the patient perspective in health policy. Before joining the Council, she held numerous senior managerial positions at the American Diabetes Association, including Vice President for Corporate Relations and Public Affairs.

Michael Weingarten, M.A., is Director for SBIR Development Center at NCI, 1 of 27 Institutes of NIH in Bethesda, Maryland. In this role, Mr. Weingarten leads a team of nine Program Directors who manage all aspects of the NCI SBIR and STTR Programs, including a portfolio of over $115 million in grants and contracts annually. The SBIR and STTR Programs are NCI’s engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. In his current role, Mr. Weingarten has implemented a set of key initiatives for optimizing the performance of the NCI SBIR Program at NIH. These include the establishment of a new model at NCI for managing the program—the SBIR Development Center. This Center is staffed with talented leaders from both industry and NIH who have expertise in the development and commercialization of technology in the cancer field to optimize the returns NCI achieves through this program. Under Mr. Weingarten’s leadership, the NCI SBIR Development Center has launched a range of new programs to facilitate the success of small businesses in the cancer space. One of these new initiatives is a brand new funding program for the NIH known as the SBIR Phase II Bridge Award, which more than triples the amount of funding available to applicants through the NCI SBIR Program. The Phase II Bridge Award helps small businesses “bridge” the funding gap known as the “valley of death” that currently exists between the end of the SBIR Phase II Award and the next round of financing needed to advance a promising cancer therapy or imaging technology. This new award also incentivizes partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners. Now in its fourth year, the NCI has made 12 Bridge Awards for a total of $31 million in NCI funding. These awards support projects in cancer imaging, molecular diagnostics, and drug development, including two projects that have advanced to Phase II clinical trials. Third-party investors, including venture capitalists and other strategic partners (e.g., big pharma), have provided more than $72 million in funding for these same projects. This provides NCI a leverage of more than 2 to 1 for every dollar it invests. For small businesses, raising funds from investors or strategic partners can still be a very difficult task. For this reason, NCI SBIR has launched an annual investor forum where potential investors can get a first look at the most promising NCI SBIR companies that are developing the next generation of cancer therapeutic, diagnostic, or imaging technologies. At the last forum in 2010, 6 out of the 14 presenting companies were successful in raising $225 million in private-sector funds. To put this into context, the amount of funds raised by NCI SBIR companies at the NCI Investor Forum was twice the value of the entire NCI SBIR budget. Prior to joining NIH, Mr. Weingarten was the manager of partnership development activities for NASA’s Technology Transfer Program which included the SBIR Program. In his 12 years with NASA Headquarters in Washington, DC, Mr. Weingarten played a major role in the creation and design of NASA’s Technology Transfer Program—a network of 10 NASA research centers and six regional technology transfer centers. Mr. Weingarten has a bachelor’s degree in political science from Northwestern University, Chicago, Illinois, and a master’s degree in political science from Columbia University, New York, New York.

David Wholley, M.A., manages The Biomarkers Consortium for FNIH. He has also served as Director of the Genetic Association Information Network (GAIN), a public–private partnership dedicated to helping discover the genetic basis of common disease, and led the development of a major public–private partnership in drug safety with the biopharmaceutical industry and FDA. Prior to joining FNIH in 2006, Mr. Wholley’s career spanned nearly 25 years in health care technology business management, including extensive experience in product development, sales, marketing, corporate strategy, and partnership and project development. Mr. Wholley has held senior management roles in several venture-funded technology start-up companies, including head of Global Marketing and Development for First Genetic Trust, Inc., which developed software for large-scale collaborative genetic research and personalized medicine. During a 16-year career at IBM, he co-led the corporate strategy team that guided IBM’s formation of its Life Sciences industry organization and its first product, DiscoveryLink database integration software, in 2000. Mr. Wholley holds an M.A. from Rutgers University and a certificate in business administration from the Stern School of Business at New York University.

R. Sanders (Sandy) Williams, M.D., is President of the Gladstone Institutes, an independent, nonprofit research enterprise in San Francisco’s Mission Bay. Gladstone is focused on finding solutions to some of the world’s most relentless illnesses, including heart disease, neuro degenerative disorders, and life-threatening viruses such as HIV. Dr. Williams is a physician scientist who earned a bachelor’s degree from Princeton University and an M.D. from Duke University. He completed a residency in internal medicine at the Massachusetts General Hospital; a cardiology fellow ship at Duke; and conducted laboratory research at Duke, Oxford University, and the Cold Spring Harbor Laboratory. Prior to joining Gladstone in 2010, Dr. Williams directed cardiovascular medicine and research at the University of Texas Southwestern Medical Center, and then served as Dean of Medicine and Senior Vice Chancellor at Duke. In this latter role, he also was founding Dean of the Duke-NUS Graduate Medical School in Singapore. Dr. Williams is an elected Member of the IOM of the National Academy of Sciences, and is active at the interface of academia and industry in biomedicine. He currently serves as a Director on the boards of Bristol-Myers Squibb and the Laboratory Corporation of America.

Copyright © 2012, National Academy of Sciences.
Bookshelf ID: NBK114620


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