Roger Berlin is an internationally recognized expert in global prescription and non-prescription pharmaceutical development. 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. 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 has 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.
Dr. Berlin is founder and principal of 1.618 Consulting LLC that provides strategic insights to Pharma/OTC companies, Foundations, and trade organizations. He serves on multiple boards.
Previously, Dr. Berlin was CEO and Director of Arno Therapeutics, a biopharmaceutical company that develops innovative products for the treatment of cancer. During his tenure one compound was advanced from Phase I to Phase II and two compounds were advanced through pre-clinical testing to IND filing and acceptance by the FDA.
Prior to his tenure at Arno he was President, Global R&D at Wyeth Consumer Healthcare, the $2.7 billion non-prescription division of Wyeth. He led a 400+ person organization comprised of diverse functions including clinical research, medical affairs, biostatistics, regulatory affairs, formulation and analytical development, project planning and new business development. Under Dr. Berlin's direction, the division pursued drug, dietary supplement and cosmetic projects and performed evaluations of multiple in-licensing candidates. Therapeutic areas included analgesia, sleep, urology, allergy, asthma, migraine, cough/cold, cholesterol reduction, nutrition, and gastroenterology. Numerous unique and first-ever claims and approvals resulted from these efforts including: 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 505B2 approval for a non-sedating antihistamine, the first NDA approval for a combination analgesic/sleep aid and potentially the first EMEA centralized approval for an OTC product. Under Dr. Berlin's leadership, a 300,000 sq. ft. pharmaceutical research laboratory was designed and constructed and numerous successful IT projects were undertaken, including an innovative search tool for non-structured internal and external data. Dr. Berlin served on the divisional senior leadership team, was an instructor for the corporate leadership training program, served on the Consumer Health Products Association scientific leadership group and was Wyeth's lead presenter for several key FDA advisory committee meetings.
Prior to joining Wyeth, Dr. Berlin served in a variety of leadership roles in prescription drug development at Merck. He was head of global clinical research operations, a group of approximately 225 that conducted clinical studies in all therapeutic areas worldwide. Dr. Berlin 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. In 1994, he developed and delivered the first external course for the Chinese regulatory authority that covered GCP, clinical study design and data interpretation. Previous to
Board Member - Atrogi AB 2017
Board Member - Sigrid AB 2017
Board Member - Philadelphia Chamber Music Society 2016
Board Member at rTerra, a renewable energy company. Dec 2009 - 2014
Chief Executive Officer at Arno Therapeutics.
Aug 2008 - May 2009 & Member of the Board
President - Global R&D at Wyeth Consumer Healthcare. Dec 1998 - Feb 2008
Executive Vice President - Worldwide R&D at
Wyeth Consumer Healthcare. April 1998 - Dec 1998
Senior Vice President R&D at Wyeth.
Sept 1994 - March 1998
Executive Director - Clinical Research Operations Worldwide at Merck. June 1992 - Sept 1994
Executive Director - Int. Liaison/Clinical & Regulatory Development at Merck. Sept 1991 - May 1992
Senior Director - Clinical Research at Merck.
Dec 1985 - August 1991
Harvard Business School. Advanced Management Program, Business.
1996 - 1996
Weill-Cornell Medical College. MD, Medicine.
1971 - 1975
City University of New York-Queens College.
BS, Biology. 1967 - 1971
MD, FACP, FACG
that assignment, Dr. Berlin was head of international regulatory liason, responsible for registration strategy development and execution in a wide variety of therapeutic areas. Before that, as head of global clinical gastroenterological research, Dr. Berlin was responsible for the development of an H2 receptor antagonist, Pepcid, and the first proton pump inhibitor, Prilosec. Under his leadership, his division pursued other projects in inflammatory bowel disease, gastrointestinal malignancy, and GI hormone blockade. During his time at Merck, Dr. Berlin served on many key leadership committees and groups and was involved in 3 inter-company collaborations, Yamanouchi, Astra and J&J•Merck, that all led to successful marketed products.
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. He serve(s)(d) on the boards of rTerra (renewable energy company), Arno Therapeutics, Atrogi AB, Sigrid AB,the Life and Healthcare Advisory board of JRG Ventures and 3D Communications, the clinical advisory board of Alevium, the board of trustees of BIO NJ and the advisory board for the Pharmaceutical MBA program at the U. of Health Sciences in Philadelphia. Dr. Berlin received research grants from NIH and the Bank of America-Giannini Foundation. He has published extensively, served as a reviewer to numerous journals and served on the national research committee of the American Gastroenterological Association. He was a Senior Fellow in the School of Population Health at the Thomas Jefferson U. School of Medicine.