Emily Shacter


Dr. Shacter regulated therapeutic proteins at the US FDA for 18 years, serving last as the Chief of the Laboratory of Biochemistry in CDER’s Office of Biotechnology Products. Prior to leaving the FDA in 2012, Dr. Shacter supervised the review of regulatory submissions for a wide range of protein products. She contributed to FDA policies and expectations for the manufacture, control, and analytical characterization of novel therapeutic proteins and biosimilars.

Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins University in 1982 and carried out investigator-initiated laboratory research on cell regulation, chronic inflammation, protein oxidation, and cancer at the NIH and FDA for over 30 years.

She now works as an independent consultant through her business ThinkFDA LLC, providing strategic scientific and regulatory advice on FDA requirements for the development and approval of protein products, spanning novel proteins, biosimilars, and breakthrough therapies.