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Addressing the Barriers to Pediatric Drug Development: Workshop Summary
National Medical Center in Washington, DC. A general pediatric academic development fellowship at Johns Hopkins followed. He has been active in the American Academy of Pediatrics (AAP), serving on the Task Force on Terrorism, the Committee on Drugs, and the Section of Clinical Pharmacology and Therapeutics. Dr. Gorman is currently chair of that section. He has worked with AAP to ensure that drugs are both tested and labeled for the pediatric patient.
Thomas Hassall, RPh, MS, holds a bachelor of science degree in pharmacy from the University of Iowa and a master’s degree in hospital pharmacy administration from the University of Minnesota. He served as a Commissioned Officer in the U.S. Public Health Service for 26 years, including 16 years at the Food and Drug Administration (FDA). Mr. Hassall’s FDA experience includes regulatory positions in the Division of Cardio Renal Drug Products, the Division of Gastrointestinal and Coagulation Drug Products, the Division of Over the Counter Drug Products, the Office of the Center Director, and the Office of Drug Evaluation IV (ODE IV). While in ODE IV he worked on the implementation of the pediatric exclusivity provisions of the Food and Drug Administration Modernization Act and promulgation of the “pediatric rule.” Mr. Hassall has 6 years of regulatory policy experience in the pharmaceutical industry, where he has continued his interest in pediatric drug development. He currently holds the position of Senior Director in Global Scientific, Medical, and Regulatory Affairs at Abbott.
Natasha D. Jarrett graduated from Oxford Brookes University with an honors degree in biology and has worked in regulatory affairs since 1997. Ms. Jarrett started her regulatory career at GlaxoWellcome, UK and subsequently moved to Hoffmann-La Roche in Hertfordshire, UK, where she worked on a range of local marketing and development projects. For the past 4 years, Ms. Jarrett has been working at Hoffmann-La Roche in the United States, with U.S. and global responsibility for a range of virology and dyslipidemia development projects. Ms. Jarrett is also the regulatory representative for U.S. pediatric strategy and development. She is currently Director, Regulatory Affairs at Hoffmann-La Roche, Nutley, NJ.
Michael Katz, MD, is Senior Vice President for Research and Global Programs, March of Dimes Birth Defects Foundation, Reuben S. Carpentier Professor, Emeritus of Pediatrics and Professor, Emeritus of Public Health at Columbia University. He is also consultant, emeritus to the New York–Presbyterian Hospital. He received an AB degree from the University of Pennsylvania, an MD degree from State University of New York, Downstate Medical Center, and an MS degree in tropical medicine