Appendix B


Participant Biographies

Barry S. Coller, M.D. (Workshop Co-Chair), is the David Rockefeller Professor of Medicine; Head, Laboratory of Blood and Vascular Biology; Physician-in-Chief of The Rockefeller University Hospital; and Vice President for Medical Affairs at The Rockefeller University. He also serves as the founding Director of the Rockefeller University Center for Clinical and Translational Science and the Principal Investigator of the University’s CTSA from the National Center for Research Resources of NIH. From 1993 to 2001, Dr. Coller was the Murray M. Rosenberg Professor of Medicine and Chairman of the Samuel Bronfman Department of Medicine at Mount Sinai School of Medicine in New York City. Dr. Coller received his B.A. degree, magna cum laude, from Columbia College in 1966, and his M.D. from New York University School of Medicine in 1970. He completed his residency in internal medicine at Bellevue Hospital in New York City and advanced training in hematology and clinical pathology at NIH. He joined the faculty at Stony Brook in 1976 as an Assistant Professor of Medicine in the Division of Hematology. During his years at Stony Brook he was the Clinical Director and Head of the Hematology Division, and Associate Director for Biomedical Research of the Biotechnology Center for Advanced Technology. He was awarded the title of Distinguished Service Professor of Medicine and Pathology at Stony Brook in 1993. Dr. Coller is a member of Phi Beta Kappa, Alpha Omega Alpha, the American Society for Clinical Investigation, the Association of American Physicians, the IOM of the National Academies, and the National Academy of Sciences. He is a Fellow of the New York Academy of Medicine,



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Appendix B Participant Biographies Barry S. Coller, M.D. (Workshop Co-Chair), is the David Rockefeller Pro- fessor of Medicine; Head, Laboratory of Blood and Vascular Biology; Physician-in-Chief of The Rockefeller University Hospital; and Vice Presi- dent for Medical Affairs at The Rockefeller University. He also serves as the founding Director of the Rockefeller University Center for Clinical and Translational Science and the Principal Investigator of the Univer- sity’s CTSA from the National Center for Research Resources of NIH. From 1993 to 2001, Dr. Coller was the Murray M. Rosenberg Professor of Medicine and Chairman of the Samuel Bronfman Department of Medicine at Mount Sinai School of Medicine in New York City. Dr. Coller received his B.A. degree, magna cum laude, from Columbia College in 1966, and his M.D. from New York University School of Medicine in 1970. He com- pleted his residency in internal medicine at Bellevue Hospital in New York City and advanced training in hematology and clinical pathology at NIH. He joined the faculty at Stony Brook in 1976 as an Assistant Profes- sor of Medicine in the Division of Hematology. During his years at Stony Brook he was the Clinical Director and Head of the Hematology Division, and Associate Director for Biomedical Research of the Biotechnology Center for Advanced Technology. He was awarded the title of Distin- guished Service Professor of Medicine and Pathology at Stony Brook in 1993. Dr. Coller is a member of Phi Beta Kappa, Alpha Omega Alpha, the American Society for Clinical Investigation, the Association of American Physicians, the IOM of the National Academies, and the National Acad - emy of Sciences. He is a Fellow of the New York Academy of Medicine, 81

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82 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE the American Association for the Advancement of Science, and the Ameri- can Academy of Arts and Sciences, and a Master of the American College of Physicians. Dr. Coller served as President of the American Society of Hematology in 1997-1998 and as the founding President of the Society for Clinical and Translational Science from 2008 to 2010. He is a member of the Advisory Council of the National Heart, Lung, and Blood Institute and the national Principal Investigators’ CTSA Consortium Steering Com- mittee. Dr. Coller’s research interests have focused on hemostasis and thrombosis, in particular platelet physiology. He developed a monoclonal antibody that inhibits platelet function and a derivative of that antibody (abciximab; ReoPro; Centocor/Eli Lilly) was approved for human use by FDA in 1994. It is now in clinical use throughout the United States, Europe, Scandinavia, Australia, and portions of Asia to prevent ischemic complications of percutaneous coronary interventions such as angioplasty and stent insertion. More than 4 million patients have been treated with abciximab. He also developed an assay to assess platelet function, and automated derivatives of that assay to monitor therapy with abciximab, aspirin, and clopidogrel (Plavix™) have been approved for human use by FDA (VerifyNow; Accumetrics). Dr. Coller is the recipient or a co-recipient of 14 U.S. patents. Elaine K. Gallin, Ph.D. (Workshop Co-Chair), is currently a partner at QE Philanthropic Advisors, a consulting firm established in 2010 that serves nonprofits specializing in biomedical research, science and math education, and international health. From 1999 through February 2010, Dr. Gallin served as the Doris Duke Charitable Foundation’s (DDCF’s) first Program Director for Medical Research. In that capacity, she led the creation and management of a portfolio of grant programs that commit - ted more than $185 million to supporting clinical research. Dr. Gallin also designed and led DDCF’s $65 million African Health Initiative. Launched in September 2007, this initiative supports large-scale health services delivery projects designed to provide integrated primary health care linked to rigorous operations and implementation research in several sub- Saharan African communities. Before joining DDCF, Dr. Gallin spent two decades working for the U.S. government, first as a research physiologist and then as research administrator where she last served as the Deputy Director of the Office of International Health Programs in the U.S. Depart- ment of Energy overseeing health research programs in countries of the former Soviet Union. During this period, she also spent a sabbatical year working in the Science Committee of the U.S. House of Representatives as a Congressional Science Fellow. Dr. Gallin has participated in numerous professional committees and review panels including several for the IOM and NIH. She was a founding member and the first Vice Chair of HRA (an

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83 APPENDIX B alliance of not-for-profit, nongovernment research funders). Dr. Gallin is currently a member of the Sickle Cell Disease Advisory Committee at the National Heart, Lung, and Blood Institute, the Forum on Drug Discovery, Development, and Translation at the IOM, the Scientific Advisory Board for the Avon Foundation, and the President’s Council of Cornell Women. Dr. Gallin received her B.S. from Cornell University and her Ph.D. from the City University of New York and completed postdoctoral fellowships in Physiology at Johns Hopkins University Medical School and Columbia University Medical School. Kathryn (Kate) N. Ahlport, M.S.P.H., is the Executive Director, HRA. In the 6 years since she joined the Alliance, Kate Ahlport has overseen the transformation of an informal network of 15 funders into an indepen- dent, 501(c)(3) national consortium of 49 not-for-profit, nongovernmental funders of health research and training, the HRA. HRA member orga- nizations work together to maximize the impact of investment in bio- medical research and training to improve human health by fostering open communication and collaboration among members, by providing com- prehensive data and analysis about the funding of biomedical research and training by member organizations, by identifying gaps in funding and facilitating innovative grantmaking, and by addressing issues key to accelerating research discovery and its translation. As the chief executive officer, Kate is responsible for administration, programs, and all other functions and activities of the Alliance, serving also as a member of the HRA Board of Directors. Prior to joining the Alliance, Kate served as Vice President of the Moses Cone-Wesley Long Community Health Founda - tion in Greensboro, North Carolina, formed as part of the merger of two community hospitals. Ms. Ahlport’s career has also included the manage- ment of acute health care facilities, jointly and wholly owned outpatient health care services, and a managed care plan. Ms. Ahlport received her M.S.P.H. degree in health care administration from UNC School of Public Health and is ABD in the doctoral program in health behavior at UNC. She is a Diplomate of the American College of Healthcare Executives and has served as an adjunct lecturer in the Department of Health Policy and Administration at the UNC School of Public Health. Ms. Ahlport has been involved in numerous statewide and community health and civic initia - tives throughout her career. Michael Brennan, Ph.D., is the Senior Advisor for Global Affairs at the AERAS Global TB Vaccine Foundation. He develops strategies for the timely introduction of new TB vaccines into low-income countries, and he works closely with national regulatory authorities that are respon- sible for clinical trial approval and new product licensure. Brennan also

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84 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE heads projects on the development of correlates and biomarkers for TB vaccines. Prior to joining AERAS, he spent more than 20 years at FDA, where he was an associate director at the Office of Vaccines Research and Review and was also head of the TB vaccine program. In 2001, he worked in Geneva assisting the World Health Organization (WHO) in its devel - opment of a new Tuberculosis Vaccine Initiative. Brennan has published more than 90 scientific articles on vaccines and infectious diseases, and his early research paved the way for widespread whooping cough immuni- zations. An authority on vaccine development and regulatory review, he sits on several international advisory committees, including the Stop TB Partnership, WHO, and NIH. He received a Ph.D. from Albany Medical College. Robert Califf, M.D., graduated from Duke University, summa cum laude and Phi Beta Kappa, in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He performed his internship and residency at the University of California, San Francisco and his fellowship in cardiology at Duke University. He is board certified in internal medicine (1984) and cardiology (1986) and is a Master of the American College of Cardiology (2006). He is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Insti - tute (DTMI), and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. For 10 years he was the founding Director of the Duke Clinical Research Institute (DCRI), the premier academic research organization in the world. He is the editor-in-chief of Elsevier’s American Heart Journal, the oldest cardio- vascular specialty journal. He has been author or co-author of more than 800 peer-reviewed journal articles and a contributing editor for www. theheart.org, an online information resource for academic and practicing cardiologists. He was recently acknowledged as one of the 10 most cited authors in the field of medicine by the Institute for Scientific Information (ISI). Dr. Califf led the DCRI for many of the best-known clinical trials in cardiovascular disease. With an annual budget of over $100 million, the DCRI has more than 1,000 employees and collaborates extensively with government agencies, the medical products industry, and academic partners around the globe in all therapeutic areas. In cooperation with his colleagues from the Duke Databank for Cardiovascular Disease, Dr. Califf has written extensively about the clinical and economic outcomes of chronic heart disease. He is considered an international leader in the fields of health outcomes, quality of care, and medical economics. Dr. Califf’s role as Director of the Duke Translational Medicine Institute, which is funded in part by an NIH CTSA, includes service as co-chairman of the Principal Investigators Steering Committee of the CTSA. Dr. Califf has

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85 APPENDIX B served on the Cardiorenal Advisory Panel of the FDA and the Pharma- ceutical Roundtable of the IOM. He served on the IOM committees that recommended Medicare coverage of clinical trials as well as the removal of ephedra from the market and on the IOM’s Committee on Identifying and Preventing Medication Errors. He is currently a member of the IOM Forum on Drug Discovery, Development, and Translation and a subcom - mittee of the Science Board of FDA. He was the founding director of the coordinating center for the Centers for Education and Research on Therapeutics (CERTs), a public-private partnership among the Agency for Healthcare Research and Quality, FDA, academia, the medical products industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products. He is now the co-chairman of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership focused on improving the clinical trials system. 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. 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 Hospi- tal; 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 physi - ologic 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 last decade, most recently as Senior Vice President for Discovery Research and Clinical Investigation. Andrew M. Dahlem, Ph.D., was named Vice President and Chief Oper- ating Officer for Lilly Research Laboratories (LRL) and LRL Europe in February 2007. He has previously served as Vice President of Toxicology, Drug Disposition, Pharmacokinetics, and Lilly Research Laboratories in Europe since January 2003 and a member of Lilly senior management. Dr. Dahlem received a bachelor of science degree in wildlife biology from The Ohio State University in 1982 and a doctor of philosophy degree

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86 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE in toxicology from the University of Illinois at Urbana-Champaign in 1989. Dahlem joined Lilly in 1990 as a senior pharmacologist. He became head of biochemical toxicology in 1992. He was named Director of Drug Disposition and Biochemical (investigative) Toxicology in 1993. He was promoted to Executive Director for Toxicology and Drug Disposition in 1998, and he assumed responsibility for LRL in Europe in 1999 and for discovery operations in 2000. In December 2001 he was promoted to Vice President. Dr. Dahlem serves as adjunct professor of toxicology in the College of Veterinary Medicine at Purdue University, the University of Illinois at Urbana-Champaign, and at The Ohio State University. He is also a member of the Ohio State University College of Pharmacy Cor- porate Council and the Illinois Professional Science Master’s Board. Dr. Dahlem currently serves on the board of directors for Indigo Biosystems, the YourEncore board of advisors, and is a member of the Indiana State Museum Foundation Board. He is a member of the IOM Forum on Drug Discovery, Development, and Translation and the Translational Research and the Critical Path for Tuberculosis Drug Regimens for the Gates Foun - dation. He is a member and past president of Indianapolis/Cincinnati Discussion Group of the American Association of Pharmaceutical Sci - entists. He is also a member of the International Society for the Study of Xenobiotics, the Society of Toxicology, and the American Association for the Advancement of Science. David L. DeMets, Ph.D., is currently professor and former Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. Since receiving his Ph.D. in 1970 from the University of Minnesota, he has been active in the design, conduct, and analysis of clinical trials in several disease areas. He spent 10 years (1972-1982) at the National Heart, Lung, and Blood Institute at NIH. In 1982, he joined the University of Wisconsin-Madison and developed the Department of Biostatistics and Medical Informatics. He has co-authored or edited four texts, Fundamentals of Clinical Trials, Data Monitoring in Clinical Tri- als: A Case Studies Approach, Data Monitoring Committees in Clinical Trials: A Practical Perspective, and Statistical Methods for Clinical Trials. He has served on numerous NIH and industry-sponsored Data Safety and Moni - toring Committees for clinical trials in diverse disciplines. He served on the board of directors of the American Statistical Association, as well as having been President of the Society for Clinical Trials and President of the Eastern North American Region (ENAR) of the Biometric Society. In addition he was Elected Fellow of the International Statistics Institute in 1984, the American Statistical Association in 1986, the Association for the Advancement of Science in 1998, the Society for Clinical Trials in 2006, and the American Medical Informatics Association in 2008.

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87 APPENDIX B Lawrence Deyton, M.D., M.S.P.H., described by FDA Commissioner Margaret Hamburg as “the rare combination of public health expert, administrative leader, scientist, and clinician,” became the Center for Tobacco Product’s first director on August 19, 2009. Prior to joining FDA, Dr. Deyton was Chief Public Health and Environmental Hazards Offi- cer for the U.S. Department of Veterans Affairs. Previously, Dr. Deyton served for 11 years in leadership positions in the NIAID at NIH, 6 years in the Office of the Assistant Secretary for Health at HHS, and as a leg - islative aide with the House of Representatives Subcommittee on Health and the Environment in the 1970s. He was a founder in 1978 of the Whitman Walker Clinic, a community-based AIDS service organization in Washington, DC. He is a graduate of the University of Kansas, the Harvard School of Public Health, and the George Washington University School of Medicine. Dr. Deyton’s postdoctorate medical training was at USC/Los Angeles County Medical Center. He is board certified in internal medicine and continues to care for patients on a regular basis. Uros V. Djekic, Ph.D., is a Senior Regulatory Scientist and Policy Analyst at CBER’s Office of Blood Research and Review. Dr. Djekic focuses on regulatory review of blood donor screening assays and HIV diagnostics while simultaneously developing policy at the center and agency levels. He is a member of FDA’s Transparency Task Force which evaluates cur- rent agency practices, regulations, and policies in order to facilitate trans - parency and improve public health. In 2008, he matriculated to the FDA CFP during which he developed and implemented a variety of policies related to approval and use of CBER-regulated in vitro diagnostics as well as initiated and drafted guidance documents. Dr. Djekic was instrumen- tal in contributing to the Blood Products Advisory Committee discus - sion on home-use HIV test kits. During his tenure at the Pharmaceutical Research and Manufacturers of America (PhRMA) Division of Scien- tific and Regulatory Affairs, Dr. Djekic drafted a variety of pamphlets on potential bioterrorist agents, provided analyses of bioequivalence of generic drugs, and contributed to discussions relating to preparedness response to emerging and reemerging infections. Dr. Djekic completed his Ph.D. and postdoc at the University of Alabama at Birmingham. The former focused on HIV replication and primer selection, while the latter investigated the underlying principles of inflammation in the lung with a neutrophilic component. Mary Dwight, M.D., is Vice President of Government Affairs for the Cystic Fibrosis Foundation. Dr. Dwight directs the Foundation’s public policy agenda and grassroots activities. She has been a catalyst for accel - erating efforts to remove barriers to clinical drug development. Dwight

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88 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE also leads the strategic development of the Foundation’s efforts to enable and expand access to CF care, integrating the organization’s public pol- icy, advocacy, strategic communications, and medical research and care delivery programs. Prior to coming to the Foundation, Dwight was a Vice President at Spitfire Strategies where she crafted successful policy strategy for clients such as the David and Lucile Packard Foundation, the Robert Wood Johnson Foundation, First Focus, and the Juvenile Diabetes Research Foundation. Dwight began her career with Representative Diana DeGette (D-CO), a member of the House Energy and Commerce Commit- tee. Dwight graduated cum laude from Williams College. Steven K. Galson, M.D., M.P.H., is Vice President of Global Regulatory Affairs at Amgen as of October 2010. He was the Senior Vice President for Civilian Health Operations and Chief Health Scientist at Science Applica - tions International Corporation. In October 2009, he completed 23 years of government service, most recently—for 2 years—as Acting Surgeon General of the United States. Previously, he served as Director of FDA’s CDER from July 2005, where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Service (PHS) career as an epide - miological investigator at CDC after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency (EPA); the Department of Energy, where he was Chief Medical Officer; and the Department of Health and Human Services. Prior to his arrival at FDA, he was Director of EPA’s Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances. Dr. Galson joined FDA in April 2001 as CDER Deputy Director. He is the recipient of numerous awards, including the Surgeon General’s Medallion and three Secretary of Energy Gold Awards. Dr. Galson has been a board member of the National Board of Medical Examiners and a peer reviewer for medi- cal journals. He holds a B.S. from Stony Brook University, an M.D. from Mt. Sinai School of Medicine, and an M.P.H. from the Harvard School of Public Health. He is board certified in preventive medicine and public health and occupational medicine. Kathy Giacomini, Ph.D., is Professor and Co-Chair of the Department of Bioengineering and Therapeutic Sciences at UCSF. Dr. Giacomini received her Ph.D. in pharmaceutical science from the State University of New York at Buffalo and completed a postdoctoral fellowship at Stanford Uni- versity. She is considered a leader in the field of pharmacogenomics of membrane transporters, having led the discovery and functional char- acterization of genetic variants in over 100 membrane transporters that

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89 APPENDIX B play a role in drug response in ethnically diverse populations. Her studies link genetic variants to clinical drug response. Dr. Giacomini has co- authored over 150 manuscripts, mentored over 20 Ph.D. students and several junior faculty, and has received many awards for her research including the Dawson Award of the American Association of Colleges of Pharmacy, and, most recently, the Scheele Award of the Swedish Academy of Pharmaceutical Scientists. In 2007, she was inducted into the IOM of the National Academies. William Greenlee, Ph.D., is President and Chief Executive Officer of The Hamner Institutes for Health Research (formerly CIIT Centers for Health Research) and Chief Executive Officer of the Health Research and Educa- tion Foundation in Research Triangle Park, NC. He received his B.S. and M.S. degrees in chemistry from San Jose State University and a Ph.D. degree in pharmacology from the University of Rochester. After complet - ing a postdoctoral fellowship at CIIT in 1980, Dr. Greenlee was appointed Assistant Professor of Toxicology at the Harvard School of Public Health and held a joint appointment in the Program in Cellular and Developmen- tal Biology at the Harvard Medical School. He later returned to CIIT as a member of the senior scientific staff and in 1988 was appointed Head of the Department of Cellular and Molecular Toxicology. He was recruited to Purdue University in 1991 as Professor and Head of the Department of Pharmacology and Toxicology. From 1995 to 1999, Dr. Greenlee was Professor and Chair of the Department of Pharmacology and Molecular Toxicology at the University of Massachusetts Medical School in Worces- ter, Massachusetts. Dr. Greenlee is widely recognized for his research and education contributions in molecular toxicology and has published benchmark studies on the molecular basis of dioxin actions in humans. He has served on editorial boards of several journals and government advi- sory panels. In 2009, Dr. Greenlee was recognized as one of the 50 most powerful NC Business Leaders by Business Leader magazine and received the Benjamin Rush Award from Dickinson College for exceptional lead- ers in business or government who uphold humanistic values and whose accomplishments exemplify the value of a liberal arts education. Gigi Hirsch, M.D., brings nearly 30 years of clinical and business experi- ence in the health care industry to MIT’s Center for Biomedical Innova - tion (CBI). She joined CBI in March 2006 as Senior Advisor, and became Executive Director in 2007. Her current efforts at CBI are focused largely on leading NEWDIGS, a unique collaboration focused on transforming the global health care innovation system to deliver greater value to all stakeholders and to ensure its sustainability. Dr. Hirsch has held a number of leadership roles that leverage her broad clinical background (internal

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90 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE medicine, emergency medicine, and psychiatry) along with her passion for innovation, entrepreneurship, and improving patient care. Prior to joining CBI, she served as Director of Academic and Professional Rela- tions in a biopharmaceutical company (Millennium Pharmaceuticals) and was founder and CEO of a boutique entrepreneurial venture (MD IntelliNet) that spun out of an academic research and consulting firm that she founded in partnership with Boston’s Beth Israel Hospital. Dr. Hirsch completed her residency training in internal medicine and psychiatry, and practiced full-time emergency medicine for nearly 5 years at Brigham and Women’s Hospital in Boston. She was an instructor in psychiatry at Harvard Medical School from 1992 to 1997. She previously held appoint - ments in internal medicine at Harvard Medical School and Brown Uni- versity after receiving her medical degree at the University of Cincinnati in 1981. Story C. Landis, Ph.D., has been Director of NINDS since September 1, 2003. As the Director of NINDS, Dr. Landis oversees an annual budget of $1.5 billion and a staff of more than 900 scientists, physician-scientists, and administrators. The Institute supports research by investigators in public and private institutions across the country, as well as by scien- tists working in its intramural laboratories and branches in Bethesda, Maryland. Since 1950, the Institute has been at the forefront of U.S. efforts in brain research. Dr. Landis joined NINDS in 1995 as Scientific Director and worked with then-institute director Zach W. Hall, Ph.D., to coordinate and reengineer the Institute’s intramural research programs. Between 1999 and 2000, under the leadership of NINDS Director Gerald D. Fischbach, M.D., she led the movement, together with NIMH Scientific Director Robert Desimone, Ph.D., to bring some sense of unity and com- mon purpose to 200 laboratories from 11 different NIH Institutes, all of which conduct leading-edge clinical and basic neuroscience research. A native of New England, Dr. Landis received her undergraduate degree in biology from Wellesley College in 1967 and her master’s degree (1970) and Ph.D. (1973) from Harvard University, where she conducted research on cerebellar development in mice. After postdoctoral work at Harvard Uni - versity studying transmitter plasticity in sympathetic neurons, she served on the faculty of the Harvard Medical School Department of Neurobiol- ogy. In 1985 she joined the faculty of Case Western Reserve University School of Medicine in Cleveland, Ohio, where she held many academic positions including Associate Professor of Pharmacology; Professor and Director of the Center on Neurosciences; and Chairman of the Depart- ment of Neurosciences, a department she was instrumental in estab- lishing. Under her leadership, Case Western’s Neuroscience Department achieved worldwide acclaim and a reputation for excellence. Throughout

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91 APPENDIX B her research career, Dr. Landis has made many fundamental contributions to the understanding of developmental interactions required for synapse formation. She has garnered many honors and awards and is an elected fellow of the Academy of Arts and Sciences, the American Association for the Advancement of Science, and the American Neurological Association. In 2002, she was named the President-Elect of the Society for Neurosci- ence. In October of 2009, she was elected to the membership of the IOM. H. Clifford Lane, M.D., is Deputy Director, Clinical Research and Special Projects, NIAID, NIH. Dr. Lane, a native of Detroit, Michigan, received his M.D. degree from the University of Michigan in 1976. He then completed an internship and residency at the University of Michigan Hospital, Ann Arbor, Michigan. In 1979, Dr. Lane came to NIH as a clinical associ- ate in the Laboratory of Immunoregulation (LIR) at NIAID. In 1985, he was appointed Deputy Clinical Director, NIAID, and in 1989 he became the Chief of the Clinical and Molecular Retrovirology Section (CMRS) of the LIR, a position he still holds. In 1991, Dr. Lane became Clini- cal Director of NIAID and, in 2006, Director of the Division of Clinical Research and Deputy Director for Clinical Research and Special Projects. In the laboratory, Dr. Lane’s early work involved studies aimed at dissect- ing the normal immunoregulatory mechanisms controlling the human immune response to specific antigen challenge. Within a brief time, the AIDS epidemic emerged and Dr. Lane became one of the first investi- gators to study immunopathogenic mechanisms of HIV disease, ulti- mately making seminal observations that helped establish the field of HIV immunopathogenesis. In the clinical arena, Dr. Lane has studied innovative approaches to therapy and has used experimental therapeutic interventions as a means of furthering our understanding of HIV patho- genesis. As Clinical Director of NIAID he has led efforts to identify and reduce barriers to clinical research. Dr. Lane is a member of the IOM, the American Federation for Clinical Research, the American Society for Clinical Investigation, the Association of American Physicians, the Ameri- can Association of Immunologists, the American College of Physicians, the Infectious Diseases Society of America, and the Clinical Immunology Society. He has served on the editorial boards of The Journal of Clinical Immunology and AIDS Research and Human Retroviruses. He is currently on the editorial boards of PLoS Medicine, the Journal of Acquired Immune Deficiency Syndromes, Clinical Immunology and Immunopathology, and AIDS Patient Care and STDs. Juan J. L. Lertora, M.D., Ph.D., has been Director, Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education, NIH Clinical Center since July 2006. Previously, he was Professor of Medicine

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92 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE and Pharmacology and Section Head of Clinical Pharmacology at Tulane University School of Medicine in New Orleans, Louisiana (1981-2006). He was Program Director, Tulane-Louisiana State University-Charity Hospital General Clinical Research Center (1998-2005) and Principal Investigator, Tulane-LSU Adult AIDS Clinical Trials Unit (1996-2005), both funded by NIH. Dr. Lertora is a graduate of the Faculty of Medicine, National Uni- versity of the Northeast, Corrientes, Argentina, and the Graduate School, Department of Pharmacology, Tulane University. He received a Merck Sharp and Dohme International Fellowship in Clinical Pharmacology at Tulane, completed training in internal medicine at the University of Connecticut, and a clinical pharmacology fellowship at the University of Iowa. He was Assistant Professor of Medicine and Pharmacology, Clinical Pharmacology Center, Northwestern University in Chicago (1977-1981) and received a Faculty Development Award from the Pharmaceutical Manufacturers Asso- ciation Foundation (now the PhRMA Foundation). Dr. Lertora serves on the editorial board of Clinical Pharmacology and Therapeutics, the FDA Advisory Committee for Pharmaceutical Sciences and Clinical Pharmacology, and the Board of Directors of the American Society for Clinical Pharmacology and Therapeutics (2007-2011). He is Adjunct Professor of Medicine at Duke University. Dr. Lertora conducted phase I-II safety and efficacy clinical trials and studied pharmacokinetics-pharmacodynamics, drug metabolism, pharmacogenetics, and drug interactions of antiretroviral drugs. Previ- ous research included erythropoietin’s role in the anemia of chronic renal disease, the dose-related cardioselectivity of practolol, the antiarrhythmic- inotropic actions of NAPA (N-acetylprocainamide), the cardiovascular actions of NAPADE (desethyl-N-acetylprocainamide), CYP2E1, and chlorzoxazone metabolism, and pharmacokinetics of ribavirin and peg- interferon alfa-2a in HIV-infected patients. Xavier Luria, M.D., is a qualified medical doctor, postgraduate fellow in internal medicine, and postgraduate qualifications in pharmaceutical medicine, in biostatistics, and in clinical pharmacology, drug develop - ment, and regulation. Dr. Luria worked in Barcelona (Spain) as an internal medicine physician, as assistant of physiology, and assistant in gastro- intestinal and psychosomatic disorders. In 1987, he joined a pharmaceuti - cal company as a medical doctor in clinical research and in 1990 became Head of Clinical Research. In 1995 he was nominated Medical Direc- tor with responsibility for international clinical development, biometry, pharmacovigilance, and global medical affairs. He has been a member of working groups in the Spanish (Farmaindustria) and European phar- maceutical industry associations (EFPIA). He participated in a number of ICH initiatives and was also a member of the DIA Steering Committee Europe until 2004. He has been involved in a number of activities with

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93 APPENDIX B FDA, Japanese health authorities, and European national regulatory bod- ies. He has contributed as a speaker in several training courses and con - ferences and as a lecturer in some university master’s degree programs. He joined the EMA, London, in December 2005 as Head of Safety and Efficacy of Medicines. Emma Meagher, M.D., was born in Dublin, Ireland. She graduated with her medical doctorate degree from the Royal College of Surgeons in Ireland and following completion of a residency in internal medicine she was appointed as Senior Registrar/Lecturer of Cardiovascular Medicine at Mater Hospital, University College Dublin, Ireland. She joined the fac - ulty at the University of Pennsylvania in 1995 and is currently Associate Professor of Medicine and Pharmacology and Director of the Translational Research Training Programs at the University of Pennsylvania School of Medicine. In addition she serves as a Co-PI on the Penn CTSA and is the Executive Chair of the University of Pennsylvania IRB. Annette Mollet, Ph.D., received her M.Sc. in pharmacy in 1989 from the University of Basel. She worked on her thesis in developmental neuro- biology at the Swiss Federal Institute of Technology (ETH) in Zurich, where she received her Ph.D. in 1994. During that time she taught phar- macology and toxicology at the School of Oral Hygiene in Zurich. Dr. Mollet worked at F. Hoffmann-La Roche in the Clinical R&D depart- ment until 1996. Subsequently she conducted clinical trials in the field of AIDS and anticoagulation therapeutics and worked as a medical and product manager responsible for oncology at Roche Pharma (Schweiz). Dr. Mollet’s present position is Head of Education and Training at the ECPM at the University of Basel. She became a member of the Expert Committee for the Evaluation and Registration of Radioactive Drugs at the Swissmedic (Swiss Agency for Therapeutic Products) and the BAG (Swiss Federal Office of Public Health) in 1993 and was elected president in 2008. Since 1999, Dr. Mollet has been a member of the board of the Swiss Association of Pharmaceutical Professionals (SwAPP) and special - ized in pharmaceutical medicine in 2000. She chaired the commission for specialty training and continuous education (CPD) of SwAPP until 2009. Dr. Mollet is also involved in the creation of a European Specialist title in Pharmaceutical Medicine and a Master title in Drug Development Sci- ences within the IMI joint undertaking, PharmaTrain. Carl Peck, M.D., obtained a B.A. in mathematics and chemistry from the University of Kansas in 1963 and an M.D. in 1968. Following training in internal medicine, he undertook a research fellowship in clinical pharma - cology at the University of California, San Francisco (1972-1974). From

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94 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE 1974 to 1980, Dr. Peck was employed at the Letterman Army Institute of Research, San Francisco, California, as Chief of the Army Blood Preser- vation Research Program. In 1980, Dr. Peck became Director of the Divi - sion of Clinical Pharmacology and Professor, Departments of Medicine and Pharmacology, Uniformed Services University, Bethesda, Maryland. Dr. Peck joined FDA as Director, CDER, in October 1987. He was promoted to Assistant Surgeon General in the Public Health Service in October 1990. Retiring from FDA in late 1993, Dr. Peck was appointed “Boerhaave” Pro- fessor of Clinical Drug Research at Leiden University in The Netherlands. In 1994 Professor Peck joined the faculty of the Georgetown Univer- sity Medical Center as the founding Director of the Center for Drug Development Science. In 1999, Dr. Peck received the FDA Distinguished Alumnus Award. Sweden’s University of Uppsala conferred an honorary doctorate degree (Doctor Honoris Causa) to Dr. Peck in January 2002 in recognition of “outstanding contributions to the science of drug develop - ment.” Dr. Peck founded NDA Partners LLC in 2003 and, in 2004, CDDS moved to UCSF, located in the UC-Washington Center. Throughout his career, he has mentored more than 40 postdoctoral fellows and gradu- ate students and co-founded the American (2007) and Chinese (2009) Courses in Drug Development and Regulatory Science (ACDRS, CCDRS). Dr. Peck’s research interests center on optimizing informativeness, effi- ciency, speed, and economy of drug development and regulation using advanced concepts and techniques of clinical pharmacology, trial designs, and pharmacostatistical modeling and simulation to generate causal evi- dence of effectiveness and safety. He is an author of more than 150 origi - nal research papers, chapters, and books. Munir Pirmohamed, Ph.D., qualified in medicine in 1985, undertook a Ph.D. in pharmacology in 1993 and was appointed consultant physician at the Royal Liverpool University Hospital in 1996. He was awarded a Personal Chair in Clinical Pharmacology at the University of Liverpool in 2001, and in 2007, was appointed to the NHS Chair of Pharmacogenetics. He is Director of the Wolfson Centre for Personalised Medicine, Deputy Director of the Medical Research Council CDSS in Liverpool, and Head of the Department of Molecular and Clinical Pharmacology at the University of Liverpool. Professor Pirmohamed is a Member of the Commission on Human Medicines and Chair of its Pharmacovigilance Expert Advisory Group. His main area of research is in pharmacogenetics and drug safety. Adverse reactions to drugs are a major cause of illness in the popula- tion. The research aims to maximize the benefits of drugs and minimize their harms. This is being achieved through the use of different strategies ranging from improvements in prescribing to the development of genetic

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95 APPENDIX B and other tests for predicting and monitoring individual susceptibility to toxicity. Theodore F. Reiss, M.D., was born in New Jersey. He attended the Uni- versity of Pennsylvania, with majors in history and biology, and Vander- bilt Medical School, where he served his medical internship. His medical residency was performed at Columbia University and he performed his clinical training in pulmonary and critical care and his research training in airway pharmacology at UCSF. Thereafter, he joined Merck Research Laboratories, where he worked for 18 years, ultimately serving as Vice President, Clinical Research. He was responsible for development across a number of therapeutic areas including bone/muscle, gastroenterology, urology, and most importantly respiratory and allergy, where he led the team responsible for the development of the leukotriene antagonist montelukast. He also made significant scientific contributions to other therapies, notably alendronate and aprepitant. In 1998 he received the Merck Directors’ award, the company’s highest award for scientific achievement, for his work on montelukast. Following his time at Merck, he served as Corporate Vice President, Global Integrated Drug Develop- ment, at Covance and has taught translational science and drug devel- opment at the University of Pennsylvania School of Medicine. He cur- rently serves as Research Professor of Medicine at Vanderbilt University School of Medicine and is a candidate for a master of bioethics at the University of Pennsylvania. Vicki L. Seyfert-Margolis, Ph.D., is Senior Advisor within Science Innova- tion and Policy for the FDA Commissioner’s Office. Dr. Seyfert-Margolis focuses on initiatives in regulatory science, personalized medicine, and scientific computing and informatics. Previously, she served as Chief Scientific Officer at Immune Tolerance Network (ITN), a nonprofit con- sortium of researchers seeking new treatments for diseases of the immune system. At ITN, she oversaw the development of more than 20 centralized laboratory facilities and the design and execution of biomarker discovery studies for over 25 Phase II clinical trials. As part of the biomarker efforts, she established construction of a primer library of 1,000 genes that may be involved in establishing and maintaining immunologic tolerance and co- discovered genes that may mark kidney transplant tolerance. Dr. Seyfert- Margolis was also an adjunct associate professor with the Department of Medicine at UCSF. Prior to academia, she served as Director of the Office of Innovative Scientific Research Technologies at NIAID, NIH, where she worked to integrate emerging technologies into existing immunology and infectious disease programs. Dr. Seyfert-Margolis completed her Ph.D. in immunology at the University of Pennsylvania’s School of Medicine.

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96 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE Dr. Seyfert-Margolis co-authored an article in the New England Journal of Medicine July 15, 2010, issue titled “Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis.” Ellen V. Sigal, Ph.D., is Chairperson and Founder of Friends of Cancer Research (“Friends”), a cancer research thinktank and advocacy organiza- tion based in the Washington, DC, metropolitan area. Friends is dedicated to accelerating the nation’s progress toward prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues. For more than 14 years, Friends has pioneered innovative public-private partnerships, organized critical policy forums, educated the public, and brought together key communities to develop collaborative strategies in the field of cancer research. 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 NIH Foundation Board chairing its Public-Private Partnerships Committee, the American Asso - ciation for Cancer Research Foundation Board, and the Research!America Board. Dr. Sigal is a member of the Stand Up To Cancer (SU2C) Advocate Advisory Council, and she is one of two Council members nominated to the SU2C Scientific Advisory Committee. She holds leadership posi- tions with a broad range of cancer advocacy and public policy organiza - tions, and leadership positions with academic health centers including the M.D. Anderson Cancer Center External Advisory Board, the Duke University Cancer Center Board of Overseers, and the Sidney Kimmel Comprehensive Cancer Center Advisory Council. She serves on the C-Change Research Committee and the Entertainment Industry Founda- tion Oversight Committee for the Biomarker Discovery Project. Dr. Sigal was recently named to the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors as a representative of patients and health consumers. During her more than 20-year commitment to cancer research, Dr. Sigal has served in a number of critical public positions. She served on the NCI Board of Scientific Advisors from 2003 to 2009, and the NIH Director’s Council of Public Representatives from 2003 to 2006. She was a Presidential Appointee to the National Cancer Advisory Board from 1992 to 1998, where she chaired the Budget and Planning Committee that oversees the federal cancer budget. In 1998, Dr. Sigal was named Vice Chairman of the Board of The March, a national grassroots advocacy group that brought thousands of volunteers to Washington to liaise with Congress and to set a new advocacy agenda for cancer research and treat- ment. She is a past member of the American Society of Clinical Oncology Foundation Board. Dr. Sigal has also been instrumental in harnessing the

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97 APPENDIX B energies of Hollywood on behalf of cancer research, serving as President of the Creative Community Task Force for Cancer Research. Ralph Snyderman, M.D., served as Chancellor for Health Affairs and Dean of the School of Medicine at Duke University from 1989 to July 2004 and led the transition of this excellent medical center into an inter- nationally recognized leader of academic medicine. During his tenure, the medical school and hospital achieved ranking among the nation’s best. He oversaw the development of the Duke University Health Sys - tem, one of the most successful integrated academic health systems in the country, and served as its first President and Chief Executive Officer. Dr. Snyderman has played a leading role in the conception and develop - ment of Prospective Care, a novel approach to personalized health and an evolving model of national health care delivery. He was among the first to envision and articulate the need to move the current focus of health care from treatment of disease events to personalized, predictive, preventative, and participatory care. His approach, termed Prospective Care, embraces strategic health planning rather than reactive responses to late-stage chronic disease. Dr. Snyderman has been widely recognized for his contributions to the development of more rational, effective, and compassionate models of health care. He was awarded the first Bravewell Leadership Award for outstanding achievements in the field of integrative medicine in 2003. Dr. Snyderman received the 2007 Leadership in Person- alized Medicine Award in November 2007 from the Personalized Medicine Coalition for his efforts in advancing predictive and targeted therapies on a national scale. In May 2008, he received the prestigious Industrial Research Institute’s Medal for his outstanding accomplishments in tech- nological innovations that contribute to the development of industry and to the benefit of society. In November 2008, Dr. Snyderman received Frost & Sullivan’s North American HealthCare Lifetime Achievement Award for his pioneering spirit and contributions to medicine. In March 2009, he received the Triangle Business Journal’s Healthcare Lifetime Achievement Award. In February 2010, Procter & Gamble named Dr. Snyderman an honorary member of the Victor Mills Society for his leadership and impact on innovation. In April, he was awarded the Clinical Research Forum’s 2010 Leadership in Academic Health Centers award. Dr. Snyderman was recognized as a Bioscience Leader Emeriti by the North Carolina Associa - tion for Biomedical Research in 2010, honoring North Carolina research leaders for their outstanding leadership in research and development and in the transformation of the state through scientific discovery and innova- tion. Dr. Snyderman has played a prominent role in the leadership of such important national organizations as the Association of American Physi - cians, the IOM, and the Association of American Medical Colleges. He is

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98 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE a member of the IOM and the American Academy of Arts and Sciences. He served as Chair of the AAMC in 2001-2002 and President of AAP in 2003-2004. He chaired the IOM’s National Summit on Integrative Medi- cine and the Health of the Public held in February 2009. Dr. Snyderman accepted his first faculty appointment at Duke in 1972 and, by 1984, he was the Frederic M. Hanes Professor of Medicine and Immunology. His research contributed to the understanding of how white blood cells respond to chemical signals to mediate host defense or tissue damage and he is internationally recognized for his contributions in inflamma- tion research. In 1987, Snyderman left Duke to join Genentech, Inc., the pioneering biomedical technology firm, as Senior Vice President for Medi- cal Research and Development. While at Genentech, he led the develop - ment and licensing of several major biotechnology therapeutics. He is the recipient of numerous other honors, including the CIBA GEIGY Award in 1992, the highest prize in inflammation research; the 1993 Bonazinga Award for Excellence in Leukocyte Biology Research; and the award of designation as the American College of Rheumatology Master in 2005. Snyderman was honored with the Lifetime Achievement Award from the Arthritis Foundation in 1997. In 1995, Downstate Medical Center of the State University of New York awarded him with their Distinguished Alumni Achievement Award and, in 1996, an honorary doctor of science degree. In 2003, he received the Ellis Island Medal of Honor presented to outstanding Americans who have distinguished themselves among their specific ethnic groups and have made significant contributions to our country. Snyderman received the George Eastman Medal from the Uni- versity of Rochester School of Medicine in May 2003 and, in 2004, received an honorary doctor of science degree from Washington College. A gradu- ate of Washington College in Chestertown, Maryland (1961), Snyderman received his M.D., magna cum laude, in 1965 from the Downstate Medical Center of the State University of New York. He served his internship and residency in medicine at Duke and later worked as a Public Health Officer doing research in immunology at the NIH (1967-1972). His bibliography exceeds 375 manuscripts as well as numerous books. Henrietta N. Ukwu, M.D., FACP, FRAPS, is Senior Vice President, Global Regulatory Affairs, PPD Inc. Dr. Ukwu is a physician-internist and infectious disease specialist. She completed her fellowship in infec - tious diseases at Vanderbilt University, Nashville, Tennessee; her res- idency in internal medicine at Baptist Hospital, Nashville, Tennessee; and her internship in internal medicine at Meharry–Hubbard Hospital, Nashville, Tennessee. Dr. Ukwu holds medical and surgical degrees from the University of Jos, Nigeria. Dr. Ukwu, an internist and infectious dis - ease physician, is a biopharmaceutical industry executive and industry

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99 APPENDIX B thought leader with extensive global regulatory experience across many biopharmaceutical therapeutic platforms and all regions. Currently, she is Senior Vice President and Head of Global Regulatory Affairs for PPD Inc. Dr. Ukwu recently authored Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Products Development and Registration—a landmark first-of-its-kind textbook for regulatory and biopharmaceutical industry professionals. Beginning her pharmaceutical industry career at Merck & Co. in 1992, Dr. Ukwu became Vice President and Head of Vaccine World- wide Regulatory Affairs in 1998, and Vice President of Global Regulatory Policy in 2002. She joined Wyeth Pharmaceuticals in 2004 as Vice Presi - dent of Global Regulatory Affairs, with responsibility for all therapeutic areas across all platforms—vaccines, biologics, and pharmatherapeutics. In 2009, she became Vice President of Worldwide Regulatory Affairs for Pfizer Inc. Dr. Ukwu has led regulatory efforts for vaccines, biologics, and pharmatherapeutics platforms in the United States, Canada, Europe, Asia Pacific, Latin America, Middle East, Africa, and the WHO. She has been responsible for overseeing strategic product development and registra - tion plans, regulatory interactions with boards of health, human subject protection for clinical/preclinical development, rigorous regulatory stan - dards, and successful registration of new drugs/biologics. She has been involved in many product development activities and has directly led the successful original regulatory development, filings, and approvals of 14 new products. Dr. Ukwu has built strategic regulatory teams, led major initiatives to drive regulatory excellence, and made significant contri - butions to developing and enriching the regulatory profession. Under Dr. Ukwu’s leadership, PPD’s global regulatory affairs organization, which encompasses global regulatory development, global regulatory consulting, and strategic intelligence, global chemistry, manufacturing and controls, global medical writing, global devices/diagnostics, and global regulatory operations is strengthening its focus on the provision of strategic regulatory intelligence and expertise to enable Bio-Pharma to successfully navigate today’s dynamic and complex global regulatory landscape. A fellow of both the American College of Physicians (ACP) and RAPS, Dr. Ukwu is an adjunct professor at the Graduate School of Phar- macy, Division of Quality Assurance and Regulatory Affairs, at Temple University in Pennsylvania. She has received numerous awards for her outstanding contributions to medicine, science, and industry, including recent recognition as one of 100 most inspiring leaders by PharmaVoice, July 2011. She has authored professional and scientific publications and has given many lectures, keynote speeches, and presentations. Melinda Wharton, M.D., M.P.H., was appointed Deputy Director of the National Center for Immunization and Respiratory Diseases at CDC in

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100 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE August 2006. Dr. Wharton is a Captain in the U.S. Public Health Service (USPHS). She holds an M.D. from Harvard Medical School and an M.P.H. from the Johns Hopkins School of Hygiene and Public Health. She com - pleted internship and residency in internal medicine at the University of Michigan Medical Center and her infectious diseases fellowship at the Duke University Medical Center. Dr. Wharton was commissioned as a CDC epidemic intelligence service officer in 1986 and was assigned to the Tennessee Department of Health and Environment in Nashville. In 1989, she joined CDC as a Medical Epidemiologist in the Epidemiology Program Office. She joined the National Immunization Program (NIP) in 1992, holding chief positions in the Infant Immunization Section, the Sur- veillance, Investigations, and Research Branch, and the Child Vaccine Pre- ventable Diseases Branch, Epidemiology and Surveillance Division. She also served as Director of the Epidemiology and Surveillance Division. In January 2004, she became Acting Deputy Director of NIP. Dr. Wharton has authored or co-authored more than 80 scientific journal articles, book chapters, and CDC publications, including Morbidity and Mortality Weekly Report articles. Leslie D. Wheelock, M.S., R.N., is the Director of the Office of Scientific Professional Development (OSPD) in the Office of the Chief Scientist at FDA. The OSPD manages FDA-wide scientific training and professional development programs to include the CFP, professional development activities, scientific exchanges, and scientific achievement award. Prior to her position as OSPD Director, she was the Director of the Division of Manufacturers Assistance and Training at the CBER, FDA, for 6 years. Previously, Leslie worked for the FDA’s CDER, where she was as an Associate Director for Safety Outreach and Communication co-leading FDA’s Mid-Progress Review for Healthy People 2010 Focus Area Chapter 17, Medical Product Safety. At CDER, she also worked as a Regulatory Health Education Specialist Team Leader serving as the Program Man - ager for CDER’s Competency Based Training Program, which received the federal government’s 2000 W. Edward Deming Outstanding Training Award. Before joining FDA in 1997, Leslie was Nurse Director of the Clini- cal Research Department at the Washington Cancer Institute, Washington Hospital Center, and she also worked as a Clinical Nurse Specialist and Clinical Nurse Educator at the NIH Clinical Center supporting the NCI’s Intramural Research Program. As an oncology nurse, she held certifica - tions from the Oncology Nursing Society as an Oncology Certified Nurse (OCN) and Advanced Oncology Certified Nurse (AOCN). Leslie earned a B.A. in biology from Hood College and M.S. in nursing from the Uni- versity of Maryland. She additionally has graduate education in adult

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101 APPENDIX B learning and human resource development from Virginia Polytechnic Institute and State University. Jonathan S. Wiest, Ph.D., obtained a bachelor’s degree in analytical chem- istry from the University of Wisconsin-Milwaukee in 1980. He worked as a production chemist synthesizing oligonucleotides for P-L Biochemicals until he began graduate school in 1982 at the Medical College of Ohio in Toledo. Dr. Wiest received a Ph.D. in biochemistry in 1988 and then did a postdoctoral fellowship at the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina. He rose to the rank of Senior Staff Fellow and then assisted in establishing a Cancer Research Institute in western Colorado. In 1996 he became an assistant professor at the University of Cincinnati, Department of Environmental Health, School of Medicine. Dr. Wiest joined the Center for Cancer Research at the NCI as the Associate Director for Training and Education in November 2001. In 2007 Dr. Wiest was appointed by the NCI Director to serve as the Acting Director for the Cancer Prevention Fellowship Program and in early 2008 the NCI Director also appointed Dr. Wiest to lead the forma- tion of the Center for Cancer Training (CCT) as the director. The CCT is charged with coordinating the major training activities in the NCI in both the intramural and extramural communities. In 2003, Dr. Wiest received the NIH Director’s Award for Mentoring as well as the NCI Outstanding Mentor award. In November 2007 he received an NIH Award of Merit for mentoring. The major focus of his research involves genetic alterations in lung tumorigenesis. He is involved in studies to identify tumor suppres - sor genes and altered signaling pathways in lung cancer. Carolyn Wilson, Ph.D., received her Ph.D. in genetics from George Washington University while working in the laboratory of Dr. Robert Gallo for her dissertation research. For her postdoctoral fellowship, she worked in the laboratory of Dr. Maribeth Eiden identifying viral and cel - lular factors influencing viral entry. She joined the Division of Cellular and Gene Therapies (DCGT) at CBER, FDA, in 1993. As a researcher- reviewer in DCGT, she reviewed INDs and developed policy and guid- ance documents in two novel product areas: gene therapy and xenotrans- plantation. More recently, Dr. Wilson has served as the Associate Director for Research (ADR) at CBER. As ADR, Dr. Wilson ensures that CBER’s research is relevant, high quality, and provides CBER with the appropriate scientific expertise, tools, and data to support regulatory decision making and policy development. Dr. Wilson still maintains her own laboratory program studying retroviruses which are either used as vectors for gene therapy clinical trials or are of concern in the xenotransplantation setting.

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102 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE Alastair J. J. Wood, M.D., was Professor of both Medicine and Pharmacol- ogy, Assistant Vice Chancellor, and Associate Dean at Vanderbilt Medical School before being appointed Emeritus Professor of Medicine and Emeri- tus Professor of Pharmacology in 2006. His current academic appoint - ments are Professor of Medicine and Professor of Pharmacology at Weill Cornell Medical College, New York. He is a Partner at Symphony Capital LLC, a New York–based Private Equity Company. Dr. Wood is a member of the IOM, the American Association of Physicians (AAP), the Ameri - can Society for Clinical Investigation (ASCI); Honorary Fellow, American Gynecological and Obstetrical Society (AGOS); and Fellow of the Ameri - can College of Physicians. Dr. Wood served on the New England Journal of Medicine (NEJM) Editorial Board and was the NEJM Drug Therapy Editor for many years. He authored the chapter in Harrison’s Principles of Internal Medicine on adverse drug reactions from the 9th through the 15th editions. He was the chairman of the FDA’s Nonprescription Drugs Advisory Com- mittee until 2006 and chaired the 2005 FDA Advisory Committee on Cox-2 inhibitors. He previously served as a member of the Cardiovascular and Renal Advisory Committee of the Food and Drug Administration, and the FDA’s Nonprescription Drugs Advisory Committee. His research interests have been focused on understanding the mechanisms for interindividual variability in drug response and toxicity. His research has resulted in over 300 articles, reviews, and editorials.