Sarah Kennett
Genetech, a Member of the Roche
Sarah received a B.S. degree in Molecular and Cell Biology (Microbiology minor) from the Pennsylvania State University. She obtained her Ph.D. in Molecular Cancer Biology at Duke University and followed that with postdoctoral training in the Laboratory of Molecular Carcinogenesis at the National Institutes of Health (NIH).
Sarah joined FDA in 2005 as an Interagency Oncology Task Force Fellow in the Office of Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) where she reviewed early stage cell therapy products in addition to performing research. She joined the FDA Center for Drug Evaluation and Research (CDER), Office of Biotechnology Products (OBP), Division of Monoclonal Antibodies as a reviewer in 2007, became an Acting Team Leader in 2012, and was promoted to Review Chief in 2013. She became the Review Chief for OBP’s Division of Biotechnology Review and Research I when OBP was reorganized. While in OBP, Sarah has been involved in the review of and regulatory actions for a wide variety of antibody-related and other therapeutic protein products throughout their lifecycles and has been involved with numerous manufacturing facility inspections. She has experience with divergent product issues, such as those related to breakthrough products and biosimilars; has been involved with working groups and task forces for topics such as biosimilars, communications with sponsors, investigator-sponsor INDs, compounding pharmacy issues, and counterfeiting issues; and has recently been the OBP contact for FDA’s biological product representative for ICH Q12. Sarah joined Roche/Genentech at the end of 2017 as a Principle Regulatory Program Director for Biologics in Pharma Technical Regulatory and is located in Washington D.C.
Sarah joined FDA in 2005 as an Interagency Oncology Task Force Fellow in the Office of Cellular, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) where she reviewed early stage cell therapy products in addition to performing research. She joined the FDA Center for Drug Evaluation and Research (CDER), Office of Biotechnology Products (OBP), Division of Monoclonal Antibodies as a reviewer in 2007, became an Acting Team Leader in 2012, and was promoted to Review Chief in 2013. She became the Review Chief for OBP’s Division of Biotechnology Review and Research I when OBP was reorganized. While in OBP, Sarah has been involved in the review of and regulatory actions for a wide variety of antibody-related and other therapeutic protein products throughout their lifecycles and has been involved with numerous manufacturing facility inspections. She has experience with divergent product issues, such as those related to breakthrough products and biosimilars; has been involved with working groups and task forces for topics such as biosimilars, communications with sponsors, investigator-sponsor INDs, compounding pharmacy issues, and counterfeiting issues; and has recently been the OBP contact for FDA’s biological product representative for ICH Q12. Sarah joined Roche/Genentech at the end of 2017 as a Principle Regulatory Program Director for Biologics in Pharma Technical Regulatory and is located in Washington D.C.