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Pharmaceutical sciences / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / National Institutes of Health / Drug recall / Dermatologic and Ophthalmic Drugs Advisory Committee / Food and Drug Administration / Medicine / Health


Public Workshop Complex Issues in Developing Drug and Biological Products for Rare Diseases, Day 1 Participant List
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Company

M.D. / Development Novartis Pharmaceuticals Corporation / Genzyme / M.D. Deputy Center / M.P.H. / D. / M.P.H. Associate / /

Country

United States / Canada / /

Facility

Biology McGill University / University Marshall L. Summar / Operations Research University of North Carolina-Chapel Hill Robert Kowalski / Metabolism Children’s National Medical Center / /

IndustryTerm

Cystic Fibrosis Therapeutics / /

Organization

Department of Biostatistics / University of Washington / Acting Scientific Director Division / National Institute of Health / office of New Drugs / Public Policy National Organization for Rare Disorders Stephen C. Groft / office of Medical Products and Tobacco / Biomedical Statistics Seattle Children's Research Institute / EveryLife Foundation for Rare Diseases / Division of Clinical Evaluation and Pharmacology/Toxicology / University of North Carolina / Department of Statistics / University of Michigan / National Center / McGill University / office of New Drugs Center for Drug Evaluation / Rare Disease Program office of New Drugs / Preclinical Innovation National Center for Advancing Translational Sciences / U.S. Food and Drug Administration / Georgetown University / Biotechnology Industry Organization / Center for Drug Evaluation and Research / office of Antimicrobial Products / Safety office of New Drugs / Orphan Products Development office of Special Medical Products / /

Person

Andrew E. Mulberg / Sandra L. Kweder / John C. McKew / Edward M. Cox / C. Ellis F. Unger / Pediatrics Adjunct / Matthias Kretzler / Stephen C. Groft / Tissue Therapies / Pamela M. Williamson / Michael R. Kosorok / Diane Edquist / Cystic Fibrosis Therapeutics / List Mwango Kashoki / Marc K. Walton / Richard A. Moscicki / Washington D.C. Ellis / John Hyde / Gayatri R. Rao / Emil D. Kakkis / Seattle Children / Nicole Mayer Hamblett / Gene Therapies / List Anne Pariser / Marshall L. Summar / /

Position

Professor / Department of Biology / Deputy Director / Division of Gastroenterology and Inborn Error Products / President / Vice President / Chief Executive Officer / Global Head / Regulatory Affairs & Compliance / Co-Director / Head / Senior Vice President and Global Head / Regulatory Affairs / Associate Director / Office / Coordinating Center Director Development Network / Professor of Neurology / Pharmacology and Human Science Director / Professor of Medicine/Nephrology Research Professor / Director / Program / Acting Director / Study Endpoints and Labeling Development / Executive Officer and President / Deputy Director / Director / Director / Office / Associate Director / Medical Officer / Representative / Director Office / Chair / International Rare Diseases / Associate Professor / Ph. Associate Professor / Director Office of Drug / M.S. Chair / Chief / /

ProvinceOrState

Michigan / North Carolina / /

Technology

Bioinformatics / Biotechnology / /

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