Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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Appendix B: Participant Biographies
Appendix B: Participant Biographies
Pages 61-78
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From page 61... ...
In 1980, she joined the Department of Hematology and Vascular Biology at the Walter Reed Army Institute of Research and became Chief of the Department in 1992. She left the Army at the rank of Colonel in 1996 to become the Director of the Medical Oncology/Hematology Section at the Washington Hospital Center in Washington, DC.
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From page 62... ...
gail H Cassell, Ph.D., is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana.
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From page 63... ...
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 briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education, the accrediting body for U.S.
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From page 64... ...
House passed legislation allowing the importation of drugs from countries like Canada in the 108th Congress. A survivor of ovarian cancer, DeLauro has been a leading voice for increasing critical cancer research.
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From page 65... ...
She has championed legislation that would make child care more affordable, and has worked to improve public education by reducing class size and modernizing public schools. In 1999, DeLauro established "Rosa's Readers," a program designed to increase interest in reading outside the formal classroom environment.
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From page 66... ...
At Penn, in addition to her teaching and administrative duties, she serves as senior statistician for three multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research. In her role as Associate Dean for Clinical Research, she oversees the human subjects protections programs of the University of Pennsylvania School of Medi cine.
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From page 67... ...
Ellenberg's tenure at FDA, she played a leading role in the development of international standards for design and analysis of clinical trials performed by the pharmaceutical industry, developed productive programs for postmarketing safety surveillance of biological products, and coordinated the development of policy for the establishment and operation of clinical trial data monitoring committees.
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From page 68... ...
He is an active clinician and teacher who is board certified in internal medicine, oncology, and infectious diseases and is Staff Physician and Infectious Diseases Consultant at both the National Naval and Walter Reed Army Medical Centers, and is Adjunct Professor of Medicine at the University of Minnesota. Harry greenberg, M.D., received his B.A.
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From page 69... ...
During her tenure she was widely praised for her initiatives, decisive leadership, and significant public health measures she carried out despite severe budget constraints and while holding academic positions at Columbia University School of Public Health and Cornell University Medical College.
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From page 70... ...
He recently served as PresidentElect of the American Society of Clinical Pharmacology and Therapeutics and has previously served as a Vice President and Chair of its section on Pharmacoepidemiology, Drug Safety and Outcomes Research. He is the PhRMA representative to the International Conference on Harmonization (ICH)
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From page 71... ...
In 2008, Dr. Kramer was named Executive Director of the Clinical Trials Transformation Initiative, (CTTI)
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From page 72... ...
Michael Manganiello has more than 15 years of experience in patient advocacy and public health with a strong background in formulating policy, building coalitions, managing nonprofits, and organizing grassroots campaigns. Diagnosed as HIV positive in 1988, he was an early participant in NIH clinical trials that eventually led to treatments that have benefited many people today.
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From page 73... ...
McClellan was Deputy Assistant Secretary of the Treasury for Economic Policy from 1998 to 1999, supervising eco nomic analysis and policy development on a range of domestic policy issues. He subsequently directed Stanford's Program on Health Outcomes Research, and was a Research Associate of the National Bureau of Economic Research and a visiting scholar at the American Enterprise Institute.
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From page 74... ...
Client activities are both domestic and international. Recent projects include the development of a public–private partnership to build laboratory capacity for multidrug resistant TB across diverse international settings which he is currently leading, development of governance structures for the National Biosurveillance System for Human Health, development of a multi-institutional collaboration to revise FDA regulatory processes to more effectively establish laboratory data standards for national laboratory data exchange, and the evaluation of emerging diagnostics related to the gut microbiome from both the scientific and clinical perspectives.
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From page 75... ...
from the University of Rochester School of Medicine. He completed an internship and residency at Children's Hospital Medical Center in Boston, a teaching fellowship at Harvard Medical School, and a clinical and research fellowship in pediatric oncology at the National Cancer Institute.
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From page 76... ...
His teams completed the first efficacy pharmacogenetic clinical trial, identifying the responsive and non-responsive patients in a clinical trial of rosiglitazone for the treatment of AD.
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From page 77... ...
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 the U.S.
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From page 78... ...
She has served as president of the Association of Independent Research Institutes, as editor of the Journal of the Society of Research Administrators, as a reviewer for the National Institutes of Health and National Science Foundation, and as a consultant to several research organizations.
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