Chitrananda Abeygunawardana

VP, Regulatory Affairs at Venatorx Pharmaceuticals

Dr. Abey has nearly 25 years’ experience in pharmaceutical research, regulatory affairs and compliance. At Venatorx, Dr. Abey is responsible for developing and executing all regulatory strategies and tactics for Venatorx’s antibacterial and antiviral programs including interacting with health authorities and managing clinical trial applications worldwide.

Prior to joining Venatorx, Dr. Abey was Executive Director of Merck Global Regulatory Affairs and Clinical Safety (GRACS) where he led the development of Merck’s pneumococcal vaccine strategy, and developed the regulatory strategies to support new drug development and licensures. During his tenure at Merck, Dr. Abey was a key contributor in the development of strategies for multiple anti-infectives including vaccines, antivirals and antifungals, as well as immune-oncology, representing every stage of drug development from pre-clinical concept to life cycle management of approved products. Dr. Abey has extensive experience in formulating late stage clinical and regulatory strategy to maximize value through optimal labeling indications and content, and in leading discussions with the FDA (CBER, CDER, & CDRH) and representing Merck in discussions with other key ex-US Agencies (EMA, Health Canada, PMDA, PEI, CFDA, etc.). In addition, Dr. Abey has extensive expertise in analytical and manufacturing aspects of vaccines and biologics, cGMPs, devices, content labeling, and manufacturing investigations.

Dr. Abey received his Ph.D. in Chemistry from UMBC in Baltimore, Maryland and his B.S. in Chemistry from the University of Peradeniya in Sri Lanka. In addition, he was a member of the Research Faculty at Johns Hopkins School of Medicine.

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  • VP, Regulatory Affairs

    Current role

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