Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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Appendix B: Participant Biographies
Appendix B: Participant Biographies
Pages 81-102
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From page 81... ...
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.
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From page 82... ...
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.
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From page 83... ...
HRA member organizations work together to maximize the impact of investment in biomedical research and training to improve human health by fostering open communication and collaboration among members, by providing comprehensive 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.
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From page 84... ...
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.
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From page 85... ...
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.
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From page 86... ...
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.
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From page 87... ...
She has been a catalyst for accel erating efforts to remove barriers to clinical drug development. Dwight
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From page 88... ...
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.
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From page 89... ...
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 Education Foundation in Research Triangle Park, NC.
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From page 90... ...
Fischbach, M.D., she led the movement, together with NIMH Scientific Director Robert Desimone, Ph.D., to bring some sense of unity and common 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.
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From page 91... ...
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.
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From page 92... ...
, CYP2E1, and chlorzoxazone metabolism, and pharmacokinetics of ribavirin and peginterferon 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.
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From page 93... ...
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.
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From page 94... ...
Dr. Peck's research interests center on optimizing informativeness, efficiency, 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 evidence of effectiveness and safety.
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From page 95... ...
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 Development, at Covance and has taught translational science and drug development at the University of Pennsylvania School of Medicine.
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From page 96... ...
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.
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From page 97... ...
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.
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From page 98... ...
Henrietta N Ukwu, M.D., FACP, FRAPS, is Senior Vice President, Global Regulatory Affairs, PPD Inc.
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From page 99... ...
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.
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From page 100... ...
Before joining FDA in 1997, Leslie was Nurse Director of the Clinical 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)
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From page 101... ...
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.
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From page 102... ...
He was the chairman of the FDA's Nonprescription Drugs Advisory Committee 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.
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