Strategies That Make a Difference

Our Team

Roger G. Berlin MD, FACP, FACG

Medical, Clinical, and Innovation Strategies

Roger G. Berlin is an expert in global prescription and non-prescription pharmaceutical development. He has conceived and executed integrated strategies that have led to numerous NDA, sNDA and MRP (Mutual Recognition Procedure) approvals. His experience spans multiple therapeutic areas, collaboration with commercial and government entities, and extensive interaction with regulatory authorities including the FDA and the European Medicines Evaluation Authority.

Most recently, Roger was President, Global R&D at Wyeth Consumer Healthcare, the $2.7 billion non-prescription division of Wyeth. He led a 400+ person organization encompassing clinical research, medical affairs, biostatistics, regulatory affairs, formulation and analytical development, project planning and new business development. Under Roger’s leadership, the division pursued drug, dietary supplement and cosmetic projects and performed evaluations of multiple in-licensing candidates. Therapeutic focus areas included analgesia, sleep, urology, allergy, asthma, cough/cold, cholesterol reduction, nutrition, and gastroenterology. Key successes included a range of unique claims and approvals: the first analgesic speed of onset claim, the first OTC MRP, the first complete prevention/complete treatment claim for an OTC H2 receptor antagonist, the first NDA for an OTC triple combination, the first 505(b)(2) approval for a non-sedating antihistamine, and the first NDA approval for a combination analgesic/sleep aid.

Prior to joining Wyeth, Roger held a variety of Rx drug development leadership roles at Merck. He was head of global clinical research operations, a group of approximately 225 that conducted clinical studies in all therapeutic areas worldwide. He also provided senior level supervision of GI clinical research and headed a clinical and epidemiologic research collaboration with INSERM, the French equivalent of the NIH. Earlier, Roger was head of international regulatory, responsible for registration strategy development and execution in a wide variety of therapeutic areas. Before that, as head of global clinical gastroenterological research, Roger was responsible for the development of the H2 receptor antagonist, Pepcid, and the first proton pump inhibitor, Prilosec as well as projects in inflammatory bowel disease, gastrointestinal malignancy, and GI hormone blockade.

Dr. Berlin holds a BS in Biology from Queens College, CUNY, an MD from Cornell-Weill Medical College and attended the Harvard Business School Advanced Management Program.