Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012) / Chapter Skim
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Appendix F: Committee and Staff Biographies
Appendix F: Committee and Staff Biographies
Pages 387-394
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From page 387... ...
and has served as member or chair of a number of IOM and National Research Council committees, most recently serving as chair of the Committee on Accelerating Rare Diseases Research and Orphan Product Development. A pediatric pulmonologist by training, Dr.
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From page 388... ...
Prior to becoming the director of Clinical and Translational Research at CHOP, he was the program director of the General Clinical Research Center and principal investigator of its Pediatric Pharmacology Research Unit, funded by the National Institute of Child Health and Human Development. He is codirector of the University of Pennsylvania-CHOP Clinical Translational Science Award.
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From page 389... ...
He has been active in national and international rheumatic disease organizations, including the Canadian Arthritis Network, the Childhood Arthritis and Rheumatology Research Alliance, the International Hemophilia Prophylaxis Study Group, the Pediatric Rheumatology Collaborative Study Group, the Pediatric Rheumatology International Trials Organization, and the International Myositis Assessment Collaborative Study Group. Pat Furlong, B.S.N., is the founding president and chief executive officer of Parent Project Muscular Dystrophy, the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne)
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From page 390... ...
Among other current activities, she is the principal investigator for the Duke/North Carolina Consortium of the National Heart, Lung, and Blood Institute-sponsored Pediatric Heart Network. She also serves on the Child Health Oversight Committee of the Clinical and Translational Sciences Award program at the National Institutes of Health and Pediatric Hypertension Treatment Working Group
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From page 391... ...
She provides advice on operational, transactional, and enforcement issues in areas ranging from product research, development, and marketing approval to labeling and promotion, good manufacturing practice requirements, clinical trials registration, adverse event monitoring and reporting, licensure, distribution requirements, and market exclusivity and related protections. Milap C
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From page 392... ...
His early studies focused on treatment for persistent pulmonary hypertension of the newborn and developmental cardiovascular physiology and pharmacology. From 1997 to 2001, he chaired the American Academy of Pediatrics Committee on Drugs and participated in the drafting of the Food and Drug Administration Modernization Act, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act.
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From page 393... ...
Among earlier projects, she has directed three studies of the development and use of clinical practice guidelines, two studies of palliative and end-of-life care, and congressionally requested studies of employment-based health insurance and Medicare coverage of preventive services. Past positions include associate director of the Physician Payment Review Commission, executive director for Health Benefits Management at the Blue Cross and Blue Shield Association, and assistant professor of public administration at the Maxwell School of Citizenship and Public Affairs, Syracuse University.
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