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David Gortler, PharmD
Leadership Role

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David Gortler, PharmD

Senior Advisor to the FDA Commissioner (science, drug safety and FDA policy) at United States Food and Drug Administration

Dr. David Gortler served a member of the FDA’s Senior Executive Leadership Team. He served as senior advisor to Stephen M. Hahn, the 24th commissioner of the FDA on matters of drug safety (clinical and non-clinical), FDA science policy and FDA regulatory affairs.

Dr. Gortler’s executive schedule appointment was made during the early stages (first wave) of 2019-nCoV pandemic. The 2019-nCoV pandemic was the FDA’s most critical and scientifically ambitious emergency vaccine and emergency drug authorization challenges in modern public health history.

As a drug safety expert hired to advise the FDA commissioner, Dr. Gortler was also tasked with spearheading major public health initiatives. He also assisted with strategic scientific support to other members of FDA’s senior leadership team and to advance the commissioner’s policy priorities. These included, but were not limited to: assuring quality control of overseas drug supply, USA on-shoring of critical pharmaceuticals/ APIs, major new drug safety implementations, clarity in drug pricing, advanced human tissue microplating technology to reduce (or eliminate) animal testing, emergency drug and vaccine development and various urgent 2019-nCoV regulatory action items needed to support Operation Warp Speed vaccine development.

Dr. David Gortler is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic experience, as part of his nearly two decades of experience in drug development. He had previously served as an FDA medical officer/senior medical analyst, and was personally in charge of approving new drugs and labeling changes within the FDA’s Center of Drug Evaluation and Research (CDER). Prior to that, Dr. Gortler served as an investigational medicine research scientist and clinical trial principal lead at Pfizer Inc, as well as a scientific and drug safety advisor to Merck & Co, in addition to several other major pharmaceutical and medical device developers and manufacturers.

To date, Dr. Gortler has over two decades of hands-on, state-of-the-art knowledge and experience in drug development, drug safety, device safety, FDA regulatory affairs, pharmacovigilance, AERS/ FAERS/ MAUDE and VARES database research and analysis. His professional experiences in the above cover the complete triad of industry, academia and FDA regulation. He additionally has experience in complex scientific problem solving and managing large-scale critical FDA/regulatory projects, as well as supervising scientists and other employees in both the private sector and the federal government. Dr. Gortler has formal academic training in both clinical and basic science pharmacology, a postdoctoral basic science research fellowship in vascular medicine/molecular biology from The Yale University School of Medicine, and a clinical residency through The Columbia – New York Presbyterian hospital system.

He has additional specialized experience as an FDA and healthcare policy advisor, having worked under and/or advised multiple US Presidents and/or Presidential campaigns (W.Bush, Obama, Cruz, Trump).

Dr. David Gortler is an expert in drug development, drug safety, pharmacovigilance and FDA regulatory sciences, and has been quoted by the press on over 100 different occasions prior to his executive federal service, within his areas of expertise.

Dr. David Gortler was the first pharmacist to ever be appointed to serve on the FDA Senior Executive Leadership Team as Senior Advisor to an FDA commissioner.

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