Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 113
Appendix B Speaker Biographies Margaret A. Anderson, M.A., joined FasterCures in June 2004 as Chief Operating Officer. She came to the organization after 5 years at the Acad- emy for Educational Development (AED) in Washington, DC. At AED, she was Deputy Director and a Team Leader in the Center on AIDS and Com- munity Health. In that capacity, she assisted the Senior Vice President in managing a 70-person domestic and international staff. Her responsibilities included financial and budget oversight; management of a team, projects, and staff; and strategic planning. She managed a portfolio that consisted of grants and contracts from the Centers for Disease Control and Preven- tion (CDC), the Ford Foundation, and the Annie E. Casey Foundation. Project activities included a Diffusion of Effective Behavioral Interventions (DEBI) project, which provided curriculum development and training on eight proven effective HIV prevention interventions; an anti-HIV/AIDS stigma project; an annual health summit for community health agencies; and more than 20 other CDC task order projects. Between 1995 and 1998, Ms. Anderson was Program Director for the Society for Women’s Health Research. At the Society, she managed grant-funded programs including the start-up planning for the multiyear campaign Some Things Only a Women Can Do, aimed at increasing women’s awareness of and participation in clinical trials; the Get Real: Straight Talk about Women’s Health campaign for college campuses, focused on improving young women’s health; the Vive La Difference video and facilitator’s guide, which provide information about sex-based biology; and the annual Scientific Advisory Meeting. Prior to joining the Society, Ms. Anderson was a health science analyst at the American Public Health Association (APHA) from 1992 to 1995, where 

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS she managed a programmatic portfolio on HIV/AIDS and other sexu- ally transmitted diseases, infectious diseases, women’s health, and public health infrastructure issues. From 1987 to 1991, she was an Analyst and Project Director at the Congressional Office of Technology Assessment. Ms. Anderson currently serves as a member of the Whitman-Walker Clinic Institutional Review Board and has held numerous committee and coali- tion memberships for federal agencies and professional associations in the biomedical and public health arena. She holds a bachelor’s degree from the University of Maryland and a master’s degree in science, technology, and public policy from The George Washington University’s Elliott School of International Affairs. Mark L. Batshaw, M.D., is the “Fight for Children” Chair of Academic Medicine and Chief Academic Officer at the Children’s National Medical Center (CNMC) in Washington, DC, and Professor and Chairman of Pedi- atrics and Associate Dean for Academic Affairs at The George Washington University School of Medicine and Health Sciences, also in Washington, DC. Dr. Batshaw is a graduate of the University of Pennsylvania and the University of Chicago Pritzker School of Medicine. Following pediatric residency at the Hospital for Sick Children in Toronto, he completed a fellowship in developmental pediatrics at the the Johns Hopkins Medical Institutions. Dr. Batshaw is Director of the National Institutes of Health (NIH)–funded Rare Diseases Clinical Research Center at CNMC and con- tinues to pursue his research on innovative treatments for inborn errors of metabolism, including gene therapy. He has published more than 150 articles, chapters, and reviews on his research interests and on the medical aspects of the care of children with disabilities. Enriqueta C. Bond, Ph.D., is President of the Burroughs Wellcome Fund. She received her undergraduate degree from Wellesley College, her M.A. from the University of Virginia, and her Ph.D. in molecular biology and biochemical genetics from Georgetown University. She is a member of the Institute of Medicine (IOM), the American Association for the Advance- ment of Science, the American Society for Microbiology, and the APHA. Dr. Bond chairs the National Academies’ Board on Capacity Develop- ment of African Academies of Science and serves on the Report Review Committee for the National Academies. She serves on the board and executive committee of the Research Triangle Park Foundation, on the board of the National Institute for Statistical Sciences, on the board of the Northeast Biodefense Center and the New England Center of Excel- lence in Biodefense and Emerging Infectious Diseases, and on the council of the National Institute of Child Health and Human Development. Prior to being named President of the Burroughs Wellcome Fund in 1994,

OCR for page 113
 APPENDIX B Dr. Bond had served on the staff of the IOM since 1979, becoming IOM Executive Officer in 1989. Russell (Rusty) Bromley is Chief Operating Officer of the Myelin Repair Foundation (MRF). Since joining MRF in September 2003, he has been instrumental in the creation and evolution of the MRF Accelerated Research Collaboration™ model. His principal responsibilities include development and execution of the MRF research plan, identification and protection of resulting intellectual property, and development of relationships with a broad range of academic and commercial organizations. Prior to joining MRF, Mr. Bromley was CEO of LabVelocity, Inc., and spent 17 years with American Hospital Supply Corporation and Baxter Healthcare, where he was President of the Burdick and Jackson division. Mr. Bromley holds a degree in biochemistry from Rice University. C. Thomas Caskey, M.D. (member, IOM Forum on Drug Discovery, Devel- opment, and Translation), is Director and Chief Executive Officer and Chief Operating Officer of the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases (IMM) at the University of Texas Health Science Center at Houston. Dr. Caskey was founding director of Houston-based Cogene Biotech Ventures and Cogene Ventures, venture capital funds supporting early-stage biotechnology and life sciences com- panies. He has received numerous academic and industry-related honors. He is a member of the National Academy of Sciences and the IOM. He has served as President of the American Society of Human Genetics; the Human Genome Organization; and The Academy of Medicine, Engineering and Science of Texas (TAMEST). Dr. Caskey served as Senior Vice President for Human Genetics and Vaccines Discovery at Merck Research Laboratories from 1994 to 2000 and as President of the Merck Genome Research Insti- tute from 1998 to 2000. His genetic research documented the universality of the genetic code, discovered the mechanism of peptide chain termina- tion, identified the genetic basis of 10 major heritable diseases, opened understanding of triplet repeat diseases (Fragile X, myotonic dystrophy, and others), developed the STR method of DNA-based personal identification (now used worldwide) for forensic studies, and developed a viral vector vac- cine for HIV. Dr. Caskey received the Distinguished Texas Geneticist Award from the Texas Genetics Society in 1998 and serves on Texas Governor Rick Perry’s Council on Science and Biotechnology, which makes funding recommendations for the $200 million Texas Emerging Technology Fund. He earned his medical degree from Duke University School of Medicine and his undergraduate degree from the University of South Carolina. He is board certified in internal medicine, clinical genetics, metabolic diseases, and molecular diagnostics.

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS Gail H. Cassell, Ph.D. (Co-chair, IOM Forum on Drug Discovery, Devel- opment, and Translation), is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a depart- ment that ranked first in research funding from NIH during the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female gradu- ates of the twentieth century. She obtained her Ph.D. in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases (NIAID). She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, CDC, and served as chair of the board. She recently served a 3-year term on the advisory board of the Director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Prepared- ness. Currently she is a member of the Science Board of the U.S. Food and Drug Administration (FDA). Since 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agendas. She has served on several edito- rial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the IOM and is currently serving a 3-year term on the IOM Council, the institution’s governing board. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to bio- medical research and public health. For 9 years she was chair of the Public and Scientific Affairs Board of the American Society for Microbiology. She has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and brief- ings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences. She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently she is a member of the Executive Committee of the Board of Visitors of

OCR for page 113
 APPENDIX B Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing. Timothy Coetzee, Ph.D., is Executive Director of Fast Forward, LLC, a venture philanthropy of the National Multiple Sclerosis (MS) Society. In this capacity, he is responsible for the Society’s strategic funding of biotechnology and pharmaceutical companies, as well as partnerships with the financial and business communities. Prior to assuming his current position, he led the Society’s translational research initiatives on nervous system repair and protection in MS, as well as its programs to recruit and train physicians and scientists in MS research. Dr. Coetzee received his Ph.D. in molecular biol- ogy from Albany Medical College in 1993 and has since been involved in the field of MS research. He was a research fellow in the laboratory of Society grantee Dr. Brian Popko at the University of North Carolina at Chapel Hill, where he received an Advanced Postdoctoral Fellowship Award from the Society. After completing his training with Dr. Popko, Dr. Coetzee joined the faculty of the Department of Neuroscience at the University of Connecticut School of Medicine, where he conducted research that applied new technolo- gies to understanding how myelin is formed in the nervous system. He is the author of a number of research publications on the structure and function of myelin. Dr. Coetzee joined the National MS Society’s Home Office staff in fall 2000. Peter Corr, Ph.D. (member, IOM Forum on Drug Discovery, Development, and Translation), is Co-founder and General Partner of Celtic Therapeu- tics Management Company, LLLP. He retired from Pfizer Inc. in January 2007, where he was Senior Vice President for Science and Technology with strategic responsibility for advancing the company’s human health business through licensing and business development, science, technology, and medical outreach and advocacy, including global medical professional relations and science policy. In 2002 and 2003, he also headed world- wide pharmaceutical research and development for Pfizer. Dr. Corr was a member of the Pfizer Human Health Leadership Team, an executive body responsible for managing Pfizer’s global human health business, and the Pfizer Leadership Council. He previously served as Executive Vice Presi- dent, Pfizer Global Research and Development, and President, Worldwide Development. Before joining Pfizer in 2000, he held leadership positions in industry as Senior Vice President, Discovery Research, at Monsanto/Searle, and then as President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis until the merger with Pfizer in 2000. Dr. Corr, who received his doctorate from Georgetown University School of Medi- cine, spent 18 years as a researcher in molecular biology and pharmacol-

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS ogy at both the basic science and clinical levels at Washington University in St. Louis. When he left the university, he was Professor, Department of Medicine (Cardiology), and Professor, Department of Pharmacology and Molecular Biology. His research has been published in more than 160 sci- entific manuscripts. Dr. Corr is the recipient of numerous awards, includ- ing membership in the Alpha Omega Alpha National Medical Honorary Society, an Established Investigator Award from the American Heart Asso- ciation, and a Research Career Development Award from NIH. He received the Washington University School of Medicine Teacher of the Year Award on several occasions and, in 1990, the Washington University Distinguished Faculty Award. In 2004, he was named a William Pitt Fellow at Pembroke College, Cambridge University, Cambridge, UK. In addition to his work at Pfizer, Dr. Corr was Chairman of the Science and Regulatory Executive Committee of Pharmaceutical Research and Manufacturers of America (PhRMA); Chairman of the PhRMA Foundation Board of Directors; and Chairman of the Hever Group, representing chief scientific officers across the European and U.S.-based pharmaceutical industry. He is a Governor of the New York Academy of Sciences (and immediate past Chairman of the Board of Governors) and a member of the Board of Regents of Georgetown University. Additionally, he serves on the boards of C-PATH Institute in Tucson, Arizona; the International Partnership for Microbicides; CBio, an Australian biotechnology firm; Global Edit, Inc.; and the African Leader- ship Congress. He is a Trustee of the Joyce Theatre Foundation in New York City, and a member of the IOM Committee on Conflict of Interest in Medical Research, Education and Practice, as well as the IOM Forum on Drug Discovery, Development, and Translation. Timothy Coté, M.D., M.P.H., has served as Director of FDA’s Office of Orphan Product Development since September 2007. He received a bachelor’s degree from Syracuse University, a medical doctorate from the Howard University College of Medicine, and a master’s in public health from Harvard School of Public Health. He has completed residencies and is board certified in both preventive medicine and anatomic pathology. Dr. Coté began his federal service in 1989 with CDC’s Epidemiology Investiga- tion Service (EIS) and has since continued as an officer in the U.S. Public Health Service Commissioned Corps, assigned to wide variety of positions at CDC, NIH, the U.S. Department of Agriculture, and FDA. Most recently he served as CDC Chief of Mission in Kigali, Rwanda, where he implemented the President’s Emergency Plan for AIDS Relief. He has authored or co- authored more than 60 publications on infectious and neoplastic diseases. Stephen Groft, Pharm.D. (member, IOM Forum on Drug Discovery, Devel- opment, and Translation), is Director, Office of Rare Diseases, at NIH. He

OCR for page 113
 APPENDIX B started his career as a commissioned officer in the U.S. Public Health Service as a pharmacist in the Indian Health Service, with assignments in South Dakota and Oklahoma. From 1982 to 1986, he served in the Office of Orphan Products Development (OOPD) at FDA, and from 1986 to 1989, he was with the Department of Health and Human Services as Executive Director of the National Commission on Orphan Diseases. As Director of NIH’s Office of Rare Diseases, he has devoted particular attention to efforts to stimulate research on these diseases and develop information for the rare disease community. The office has cosponsored approximately 725 scientific workshops and symposia with the NIH Research Institutes and Centers and patient support groups. Dr. Groft received both his bachelor of science in pharmacy (1968) and doctor of pharmacy (1979) degrees from Duquesne University. Marlene E. Haffner, M.D., Ph.D. (member, IOM Forum on Drug Discovery, Development, and Translation) has been involved in patient access and therapies for those in need for her entire medical and public health career. She began her career on the Navajo Reservation, where she was responsible for the provision of comprehensive care to the 100,000 Navajo Indians. For 20 years she directed the OOPD at FDA. While in that position, she was involved in the development of orphan product programs around the globe, including the European Union, Japan, Australia, and Taiwan. Dr. Haffner is a graduate of The George Washington University School of Medicine and the Johns Hopkins University Bloomberg School of Public Health. She is trained in internal medicine, dermatology, and hematology. Her passion is making a difference in the health of people so their lives can be healthier and more productive. Since 2007 Dr. Haffner has been Executive Direc- tor, Global Regulatory Intelligence and Policy, at Amgen, Inc., where, in addition to her work in regulatory policy, she maintains her interest and involvement in orphan drugs, rare diseases, and access by patients to needed therapies. victoria Hale, Ph.D., is Founder and Chair of the Board of Directors of OneWorld Health. She established her expertise in all stages of bio- pharmaceutical drug development at FDA’s Center for Drug Evaluation and Research and at Genentech, Inc., the world’s first biotechnology com- pany. She presently maintains an Adjunct Associate Professorship in Bio- pharmaceutical Sciences at the University of California at San Francisco (UCSF); is an Advisor to the World Health Organization (WHO) for build- ing ethical review capacity in the developing world; and has served as an expert reviewer to NIH on the topic of biodiversity. Dr. Hale’s recent honors include being elected to membership in the IOM in 2007; being named a John D. and Catherine T. MacArthur Foundation Fellow in 2006;

OCR for page 113
0 BREAKTHROUGH BUSINESS MODELS and being selected as an Ashoka Fellow for work in leading social innova- tion, also in 2006. In 2005, The Economist named Dr. Hale the recipient of its Social and Economic Innovation award, and Esquire magazine named her “Exec of the Year.” That same year, OneWorld Health was awarded the Social Responsibility Award at the prestigious Pharmaceutical Achievement Awards competition and received the Skoll Award for Social Entrepreneur- ship. In 2004, Dr. Hale was named one of the Most Outstanding Social Entrepreneurs by the Schwab Foundation for Social Entrepreneurship. Also in 2004, Dr. Hale and OneWorld Health were included in the Scientific American 50, the magazine’s annual list recognizing outstanding acts of leadership in science and technology. Sharon Hesterlee, Ph.D., is Vice President, Translational Research, for the Muscular Dystrophy Association. She received her Ph.D. in neuroscience in 1999 from the University of Arizona, where she studied neural develop- ment and received funding from a Flinn Foundation Training Grant. From 2000 to 2006, she served as the Muscular Dystrophy Association’s Direc- tor of Research Development. In that position, she developed and oversaw an $8 million translational research program aimed at increasing industry participation in drug development for rare diseases. She has been involved in the planning of several meetings to identify and remove barriers to therapy development for neuromuscular diseases and serves on numerous advisory boards, including the Department of Health and Human Services’ Federal Advisory Committee for muscular dystrophy. In 2006 Dr. Hesterlee was appointed Vice President of Translational Research, and in addition to overseeing that program, she is currently directing major collaborations in the areas of Duchenne muscular dystrophy, Friedreich’s ataxia, spinal muscular atrophy, and amyotrophic lateral sclerosis (ALS). Chaitan Khosla, Ph.D., is Professor of Chemistry, Chemical Engineering, and Biochemistry at Stanford University. He received his Ph.D. in 1990 at the California Institute of Technology. After completing postdoctoral studies at the John Innes Centre in the United Kingdom, he joined Stanford in 1992. His research interests focus on the interface of chemistry, engineer- ing, and medicine. Over the past decade he has studied polyketide synthases as paradigms for modular biosynthesis and has sought to exploit their prop- erties for engineering novel antibiotics. More recently, he has investigated the chemical underpinnings of Celiac Sprue pathogenesis, with the goal of developing therapeutic alternatives for this widespread but overlooked dis- ease. He has co-authored more than 200 publications and is the recipient of several awards and honors, including a Camille and Henry Dreyfus New Investigator Award (1991), a National Science Foundation Young Investi- gator Award (1994), a David and Lucile Packard Fellowship for Science

OCR for page 113
 APPENDIX B and Engineering (1994), the Allan P. Colburn Award from the American Institute of Chemical Engineers (1997), the Eli Lilly Award in Biological Chemistry (1999), the Pure Chemistry Award (2000) from the American Chemical Society, and the Alan T. Waterman Award from the National Science Foundation (1999). He is also the recipient of a Distinguished Alumnus Award from his undergraduate (Indian Institute of Technology) and graduate (Caltech) alma maters. He is a member of the American Academy of Arts and Sciences and a Fellow of the American Association for the Advancement of Science. David P. Meeker, M.D., is Executive Vice President, Therapeutics, Bio- surgery and Transplant, at Genzyme. He joined Genzyme in 1994 as Medical Director to work on the Cystic Fibrosis Gene Therapy program. Subsequently, as Vice President, Medical Affairs, and prior to his promotion to Senior Vice President in 1998, he was responsible for the development of therapeutic products, including products in the current lyosomal storage disease (LSD) portfolio. In 2000 he assumed the position of Business Unit Leader for Genzyme’s LSD and Thyrogen® programs in Europe. In March 2003 he was promoted to President of the Global LSD Business Unit. Dr. Meeker has overseen the global launches of Aldurazyme®, Fabrazyme®, and Myozyme®. In May 2008, he was promoted to Executive Vice President and now oversees the Biosurgery and Transplant Business Units in addition to Therapeutics. Prior to joining Genzyme, Dr. Meeker was Director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic Foundation. He has authored more than 40 articles and multiple book chapters. He is currently a member of the Board of Penwest Pharmaceuticals Inc. and a member of the Scientific Advisory Board of Prize4Life, an organization dedicated exclusively to promoting research and development objectives in ALS. Dr. Meeker attended Dartmouth College and received his M.D. from the University of Vermont Medical School. He completed an internal medi- cine residency at Beth Israel Hospital in Boston and a pulmonary/critical care fellowship at Boston University. He completed the Advanced Manage- ment Program at Harvard Business School in 2000. Carol Mimura, Ph.D., is Assistant Vice Chancellor for Intellectual Property and Industry Research Alliances (IPIRA) at the University of California at Berkeley (UC Berkeley). IPIRA is the portal for industry access to Berkeley’s preeminent faculty and research capabilities. Dr. Mimura holds a bachelor of science degree from Yale University in molecular biophysics and bio- chemistry and a Ph.D. in biology (biochemistry and microbiology concen- tration) from Boston University. She was an NIH-sponsored postdoctoral fellow and research scientist at UC Berkeley in biochemistry and in chemical biodynamics. She served on the board of directors of the Children’s Hospi-

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS tal Research Institute in Oakland, California, and as a member of the board (the Chancellor’s alternate) of BayBio, the regional voice of biotechnology in northern California. She is 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 and a consultant to Cor Therapeutics and Genomyx, and wrote for the Genetic Engineering News. Her scholarly publications include articles on the sucrose phospho- transferase 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 Immu- nity, Analytical Biochemistry, Biochimica and Biophysica Acta, Journal of Cellular Biochemistry, FEMS Microbiological Reviews, Advances in Enzy- mology, and Abstracts of the American Society for Microbiology. She also authored an article in the fall 2006 Journal of the Association of the Uni- versity Technology Managers, “Technology Licensing for the Benefit of the Developing World: UC Berkeley’s Socially Responsible Licensing Program,” which was reprinted in Industry and Higher Education (August 2007). Michael R. Mowatt, Ph.D., is Director, Office of Technology Develop- ment, at NIAID. He has directed NIAID’s Office of Technology Development (OTD) since 2001. He has more than 12 years of experience in technology transfer, intellectual property management, and the development of part- nership agreements. Dr. Mowatt leads a staff of nearly 30 professionals in support of NIAID’s research mission to conduct and support basic and applied research to better understand, treat, and ultimately prevent infec- tious, immunologic, and allergic diseases. In addition to managing the intellectual property portfolio of NIAID and promoting the development and commercialization of NIAID’s inventions, OTD is responsible for nego- tiating and managing transactional agreements, including Material Trans- fer Agreements, Cooperative Research and Development Agreements, and other collaboration agreements that enable NIAID to execute successful and effective research and R&D programs around the world. He and his staff have negotiated a wide variety of agreements with NIAID partners, which include universities, nongovernmental organizations, other U.S. government agencies, and philanthropic organizations such as the Bill and Melinda Gates Foundation, as well as commercial concerns ranging from large pharmaceutical companies with bureaucracies that rival that of the U.S. government to small biotechnology companies. Dr. Mowatt joined OTD in 1995 after completing postdoctoral training in molecular and cellular biol- ogy and parasitology in the Laboratory of Parasitic Diseases at NIAID and in the Laboratory of Molecular Parasitology at the Rockefeller University in New York City. He received a Ph.D. in microbiology and immunology at the University of Michigan in 1985 and a B.S. in microbiology at the

OCR for page 113
 APPENDIX B University of Notre Dame in 1980. He has authored more than 30 original scientific papers, reviews, book chapters, and book reviews in the disci- plines of molecular and cellular biology, immunology, and parasitology. In addition to the daily challenges of promoting and negotiating partnerships between the private sector and NIAID, Dr. Mowatt has overseen the tripling in size and restructuring of his office to support the growing and evolving needs of NIAID’s biodefense and emerging infectious diseases research initiatives. Douglas E. Onsi, J.D., is a Venture Partner of HealthCare Ventures. Prior to joining HealthCare Ventures in 2007, he served as Vice President, Campath Product Operations and Oncology Portfolio Management, and as Vice President, Business Development, at Genzyme Corporation. Before joining Genzyme, Mr. Onsi was Chief Financial Officer and Vice President, Business Development, of TolerRx, Inc. Prior to joining TolerRx, he held a senior business development position at LeukoSite, Inc., which was merged with Millennium Pharmaceuticals, Inc. He has also practiced corporate law at Bingham Dana, LLP. Mr. Onsi received his J.D. from the University of Michi- gan Law School and his B.S. in biology from Cornell University. Anne R. Pariser, M.D., is Medical Team Leader for the Inborn Errors of Metabolism team in the Division of Gastroenterology Products, Office of New Drugs, at the Center for Drug Evaluation and Research, FDA. She has been at FDA since 2000 as a Medical Officer and Medical Team Leader, and has been responsible for clinical reviews for drugs and biologic products for a wide variety of indications. In recent years, she has worked almost exclusively with rare diseases such as LSD, urea cycle disorders, and many others. She is actively involved in working within FDA and with industry, patient groups, and other stakeholders for the development of drugs and biologic products for rare diseases, and her work focuses on regulatory decisions and policy affecting the clinical development and approval of these products. Anne quinn young, M.P.H., is Program Director at the Multiple Myeloma Research Foundation (MMRF), where she oversees all communication efforts for the foundation and for its sister organization, the Multiple Myeloma Research Consortium (MMRC). In this role, she works closely with founder and CEO Kathy Giusti to communicate the organizations’ success in breaking down barriers to drug development and building col- laborations with industry and academia to deliver much-needed new and effective treatments to patients. In addition, she oversees the organization’s extensive educational programming for and outreach to patients and health care providers, which includes a number of continuing medical educa- tion (CME)–accredited programs. Ms. Quinn Young currently serves on

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS the Cancer Leadership Council (CLC) and as principal investigator on a multiyear grant from CDC focused on reaching underserved populations and their health care providers with critical information on how best to treat multiple myeloma. Prior to joining the MMRF, she was a consultant in the Healthcare Practice of Datamonitor, a global market research and business intelligence company, where she focused predominantly on oncol- ogy. Ms. Quinn Young previously worked in health care public relations at Burson-Marsteller and Chandler Chicco Agency, where she developed disease awareness campaigns for a number of disorders following a post- graduate internship at the Department of Justice, Antitrust Division. She holds a master of public health degree from the Mailman School of Public Health of Columbia University and graduated cum laude from Dartmouth College with a B.A. in government. Laurie M. Ryan, Ph.D., is Program Director, Alzheimer’s Disease Clini- cal Trials, for the Division of Neuroscience, National Institute on Aging, NIH. She received her bachelor of arts degree in human development from St. Mary’s College of Maryland in 1986 and went on to obtain her master’s degree in psychology from Loyola College in Maryland in 1991. During that time, she worked at NIH for the National Institute of Neurologi- cal Disorders and Stroke in the Neuropsychology Service of the Clinical Epilepsy Branch, where she was mentored by Dr. Paul Fedio. Following completion of her master’s degree, she attended Louisiana State University (LSU) in Baton Rouge for doctoral training in clinical psychology, with specialty training in neuropsychology, under the mentorship of Dr. W. Drew Gouvier. During her doctoral training at LSU, she maintained an active research program focused on the nature and sequelae of mild traumatic brain injury (TBI). Dr. Ryan went on to complete a neuropsychology- focused internship at the Medical University of South Carolina/Department of Veterans’ Affairs Medical Center in Charleston, South Carolina. During her internship, she broadened her research experience to include disorders affecting geriatric populations, such as dementia. Her primary research project focused on identifying distinctive neuropsychological correlates of Alzheimer’s dementia that distinguish it from vascular dementia. She completed her internship and obtained her Ph.D. in 1997. She then went on to the Thomas Jefferson University/Jefferson Medical College in Phila- delphia to complete her 2-year postdoctoral fellowship in clinical neuro- psychology. During her fellowship, she continued to gain both clinical and research experience. She was involved with research projects addressing the neurocognitive and emotional changes associated with focal epilepsy and epilepsy surgery, and neurocognitive functioning in aging and dementia. In 1999, Dr. Ryan joined the Defense and Veterans Brain Injury Center

OCR for page 113
 APPENDIX B (DVBIC) at the Walter Reed Army Medical Center in Washington, DC, as clinical neuropsychologist. In January 2003, she became Assistant Direc- tor for Research and Senior Neuropsychologist for DVBIC, where she was responsible for overseeing clinical research development and implementa- tion across sites, with a particular focus on clinical trials. In September 2005, Dr. Ryan accepted her current position with NIH. As Program Director, she is responsible for the management and development of the clinical trials portfolio for Alzheimer’s and other dementias. This portfolio currently includes 23 trials plus the Alzheimer’s Disease Cooperative Study (ADCS), a large clinical trials consortium. The interventions under study include both pharmacologic and nonpharmacologic approaches and both prevention and treatment strategies. Anthony So, M.D., serves as Professor of the Practice of Public Policy Studies at Duke University’s Terry Sanford Institute of Public Policy, where he started the Program on Global Health and Technology Access in 2004. The program focuses on issues of globalization and health, particularly innovation and access to essential medicines. Dr. So’s research on the ownership of knowl- edge and how it is best harnessed to improve the public’s health ranges from conceptualizing a technology trust and patent pools to reengineering the value chain from R&D to the delivery of health technologies for developing countries. Previously Dr. So served as Associate Director of the Rockefeller Foundation’s Health Equity program, where he co-founded a cross-thematic program on charting a fairer course for intellectual property rights; shaped the foundation’s work on policy on access to medicines in developing coun- tries; and launched a multicountry program in Southeast Asia, “Trading Tobacco for Health,” focused on enabling countries to respond on their own terms and for the long term to the challenge of tobacco use. Prior to joining the foundation, Dr. So served as Senior Advisor to the Administra- tor at the Agency for Health Care Policy and Research, U.S. Department of Health and Human Services, and from 1995 to 1996, he served as Secretary Donna Shalala’s White House Fellow. A general internist by training, he also earned his M.P.A. from Princeton University as a Woodrow Wilson Scholar and completed a fellowship in the Robert Wood Johnson Clinical Scholars Program at the University of California at San Francisco/Stanford. He pres- ently serves on the Board of Directors for Community Catalyst, a U.S.-based national advocacy organization working to ensure quality affordable health care for all; sits on the Advisory Board for TropIKA, a new web-based research and policy portal from the Special Programme for Research and Training in Tropical Diseases (TDR); and is a member of the Advisory Board for Universities Allied for Essential Medicines, a student organization com- mitted to improved access to medicines in developing countries, particularly by ensuring a socially responsible role for universities.

OCR for page 113
 BREAKTHROUGH BUSINESS MODELS Craig M. Sorensen, Ph.D., is currently Senior Director, Strategic Research Alliances, at Vertex Pharmaceuticals Incorporated, where he is responsible for establishing strategic research collaborations and alliances worldwide in both core and emerging scientific areas to address global health problems. Dr. Sorensen holds a B.S. in microbiology and in biochemistry from the Uni- versity of Illinois and a Ph.D. in immunology and pathology from Washington University in St. Louis. After receiving his graduate degree, he was an Assis- tant Professor of pathology at Washington University Medical School in St. Louis, Missouri. After leaving academia, he held various research and business strategic planning positions in the biotechnology/biopharma indus- try before joining Vertex in 2001. Dr. Sorensen is a member of Sigma Xi and serves on the NIH Immunology IRG Special Emphasis Panel. Nancy Sung, Ph.D. (member, IOM Forum on Drug Discovery, Development, and Translation), 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 inter- faces 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 areas 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 the BWF staff, she 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 those discoveries 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. Sharon Terry, M.A., is President and CEO of the Genetic Alliance, a net- work focused on transforming health by promoting an environment of openness centered on the health of individuals, families, and communi- ties. She is founding Executive Director of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). She codirects a 33-laboratory research consortium and manages 52 offices worldwide for PXE International. Ms. Terry is a co-founder of the Genetic Alliance BioBank. She serves as a member of many of the major

OCR for page 113
 APPENDIX B governmental advisory committees on medical research and services, and is liaison to the Secretary’s Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children and the National Advisory Council for National Human Genome Research Institute (NHGRI), NIH. She is on the steering committees of the Genetic Association Information Network of NHGRI, the Collaboration, Education and Test Translation (CETT) program, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Stakeholders Group, and the Google Health Advisory Board. She serves on the boards of the Biotechnology Institute, DNA Direct, the National Coalition of Health Professional Education in Genetics, and the Coalition for 21st Century Medicine. She is Chair of the Coalition for Genetic Fairness, which was instrumental in the passage of the Genetic Information Nondiscrimination Act. She is a member of the IOM Round- table on Translating Genomic-Based Research for Health. She is also Chair of the Social Issues Committee of the American Society of Human Genetics. In 2005, she received an honorary doctorate from Iona College for her work in community engagement and haplotype mapping, and in 2007 she received the first Patient Service Award from the University of North Carolina Insti- tute for Pharmacogenomics and Individualized Therapy. Diana R. Wetmore, Ph.D., is Vice President of Alliance Management for Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT). Since joining CFFT in 2003, she has managed the strategic planning process for the CF Foundation– supported therapeutics pipeline, identified and launched multiple new dis- covery and development projects with industry collaborators, and provided ongoing project management support for CFFTs discovery and development projects. Some of the projects directed by Dr. Wetmore include the CFFT dis- covery collaborations with EPIX Pharmaceuticals, SGX Pharmaceuticals, and FoldRx, and development collaborations with PTC Therapeutics, Transave, and Mpex. Additional projects managed in her group include the CFFT Specimen Bank with ProMedDx, the MetaMiner CF informatics platform with GeneGo, and the CF Biomarker validation initiative. As a business- oriented scientist, Dr. Wetmore has had a successful career managing complex multidisciplinary drug discovery projects and teams. She obtained her Ph.D. in biochemistry at the University of Calgary in Canada, where her inter- est was in studying the contributions of ligand binding to protein folding and stability. Prior to joining CFFT, she held positions in the pharmaceuti- cal and biotechnology industries. At Dupont Merck Pharmaceuticals (now Bristol Myers Squibb), she was part of the crystallography group and studied protein–protein and protein–ligand interactions using calorimetric methods. During her 5-year tenure at Scriptgen Pharmaceuticals, now Anadys, she led the bifunctional drug design group before becoming Senior Director of R&D Project Management. At Geneprot, Inc., she served as Chief Technical Officer