Dr. Roger G. Berlin
Dr. Roger G. Berlin is a recognized physician expert in global prescription and non-prescription pharmaceutical development. His experience spans multiple therapeutic areas, collaboration with commercial and government entities, extensive interaction with the FDA and with other regulatory authorities including the European Medicines Evaluation Authority.
Dr. Berlin is founder and principal of 1.618 Consulting LLC that provides strategic insights to Pharma/OTC companies, Foundations, and trade organizations and is currently Industry Representative Member of FDA’s Nonprescription Drugs Advisory Committee. He has conceived and executed integrated development strategies that have led to numerous NDA, sNDA and MRP approvals and resulted in products that were commercially successful due to unique claims.
Additionally, Dr. Berlin has also served in senior leadership roles in multiple functional areas; his background encompasses scientific research, due diligence, business development, crisis management, public advocacy, organizational and process evaluation and restructuring, and strategic analysis and implementation. He has served on boards of public and private companies and non-profit organizations and on multiple advisory boards. Notably, he was previously CEO and Director of Arno Therapeutics and prior to that, President, Global R&D at Wyeth Consumer Healthcare. Prior to joining Wyeth, Dr. Berlin served in a variety of leadership roles in prescription drug development at Merck. At Merck, Dr. Berlin was Head of Global Clinical Research Operations, a group of approximately 225 people that conducted clinical studies in all therapeutic areas worldwide.
Dr. Berlin holds a BS, Magna Cum Laude, in Biology from Queens College, CUNY, where he was elected to Phi Beta Kappa; an MD from Weill-Cornell Medical College; and he completed the Harvard Business School Advanced Management Program.