Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program

Affiliations

• ¹ Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.
• ² Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
• ³ Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
• ⁴ Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA.
• ⁵ Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
• ⁶ Department of Clinical Pharmacology, Genentech, member of the Roche group, South San Francisco, California, USA.
• ⁷ GlaxoSmithKline, Philadelphia, Pennsylvania, USA.
• ⁸ Faegre Drinker Biddle & Reath, LLP, Washington, DC, USA.
• ⁹ Bristol Myers, Inc., Woodbury, Connecticut, USA.
• ¹⁰ Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
• ¹¹ Ain Shams University, Cairo, Egypt.
• ¹² Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
• ¹³ DMPK, IVIVT, GlaxoSmithKline, Ware, UK.
• ¹⁴ Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA.
• ¹⁵ Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.