Ercem Atillasoy, MD, Chief Regulatory and Safety Officer, has more than 25 years of experience leading drug, biologic, and infectious disease product development. At AlloVir, he oversees the company’s regulatory strategy and engagement, which has led to the unprecedented receipt of three FDA Regenerative Medicine Advanced Therapy designations for a single therapy with the company’s lead product candidate, posoleucel.
Prior to joining AlloVir, Dr. Atillasoy was at Merck Research Laboratories serving as Vice President and Therapeutic Area Head of Vaccines and Infectious Disease in Global Regulatory Affairs and Clinical Safety. He had responsibility and oversight for Merck’s extensive portfolio of infectious disease products, many of which have transformed human health. In addition, he oversaw engagement and strategy with regulatory agencies across the world, including those in the United States, Europe, Japan, and China.
Dr. Atillasoy joined Merck in 2001 and played an instrumental role in expediting development and approval of novel medicines and vaccines that have changed the world, including vaccines against viruses, such as Ebola (Ervebo®), human papillomaviruses that cause cancers (Gardasil® and Gardasil® 9), rotaviruses (RotaTeq®), those that cause pediatric illnesses (ProQuad®, Vaxelis™). Most recently, he had regulatory oversight for Merck’s lead investigational COVID-19-related vaccine and small molecule programs. Dr. Atillasoy has led regulatory filings and approvals for many antiviral agents, such as those against HIV (Isentress®, Delstrigo™, Pifeltro™), cytomegalovirus (Prevymis™) and hepatitis C (Zepatier®). In addition, Dr. Atillasoy oversaw the first IND filing for Keytruda® for melanoma, and he has supported approval of other oncology products that include Zolinza®, for cutaneous T cell lymphoma and Emend®. Earlier in his career, Dr. Atillasoy worked with the Medical Affairs Departments at Sandoz and Novartis Pharmaceuticals, where he supported licensure of anti-infective, dermatology, tissue engineered and cell therapy products, including Apligraf®.*
In addition to his professional accomplishments, Dr. Atillasoy was selected and currently serves as the industry representative to the FDA Dermatologic and Ophthalmologic Drugs Advisory Committee and served as Merck’s senior representative to the PhRMA Regulatory Steering Group and the BIO Vaccine Regulatory Advisory Committee. Dr. Atillasoy has published papers on a range of topics, including infectious disease, gene therapy, melanoma, dermatology, and tissue engineering.
Dr. Atillasoy is a graduate of the Yale University School of Medicine, where he was recognized as a Farr scholar, and continues to serve as a class officer. He completed his medical internship at Yale-New Haven Hospital and his dermatology residency at the University of Pennsylvania. He conducted research in carcinogenesis and gene therapy at the Wistar Institute. Dr. Atillasoy has received executive management and leadership training at institutions such as the Wharton School of the University of Pennsylvania and the UCLA Anderson School of Management. He maintains a voluntary Clinical Associate faculty position at the University of Pennsylvania. He graduated summa cum laude with a Bachelor of Arts degree in English from the City University of New York.
*Ervebo®,Gardasil® and Gardasil®9, RotaTeq®, ProQuad® Isentress®, Zepatier®, Zolinza®, Keytruda® and Emend® are registered trademarks of Merck and Co., Inc. Vaxelis™,Delstrigo™,Pifeltro™, and Prevymis™ are trademarks of Merck and Co., Inc. Apligraf® is a registered trademark of Organogenesis, Inc.