ELMASH GROUP- Limited Liability Company
Dr. Shacter regulated therapeutic proteins at the FDA for 18 years. She served initially as a primary product reviewer in CBER and later supervised the review of protein products as the Chief of the Laboratory of Biochemistry in CDER's Division of Therapeutic Proteins in the Office of Biotechnology Products. Prior to leaving the FDA earlier this year, Dr. Shacter oversaw the review of regulatory submissions for a wide range of novel and Biosimilar therapeutic proteins. She contributed significantly to FDA policies and expectations for the manufacture, control, and analytical characterization of innovative and Biosimilar protein products. Dr. Shacter received her Ph.D. in Biochemistry from Johns Hopkins University in 1982 and carried out basic research on cell regulation, inflammation, and cancer at the NIH and FDA for 30 years
research expertise in protein oxidation and structure-function relationships was applied regularly to the review of protein therapeutics.