Dr. Hirsch is a former FDA scientist with expertise in breast cancer signaling pathways and regulatory review of the product quality/chemistry manufacturing and controls (CMC) section of Investigational New Drug (IND) applications for monoclonal antibody products intended for oncology indications. She worked at the Division of Monoclonal Antibody (DMA) of the Office of Biotechnology Product (OBP), CDER FDA from 2005 until 2014.

Whiling working at FDA, she split her time between independent and collaborative research in the cancer field and working on the regulatory review of the IND product quality sections from PIND to Phase III products. Products reviewed include monoclonal antibodies, scFv, antibody drug conjugates, and radiolabeled monoclonal antibodies.

Dr. Hirsch is one of the authors of the book chapter of “Antibody-Drug Conjugates as Therapeutic Agents in Oncology: Overview and Perspectives” in Frontiers in Anti-Cancer Drug Discovery, Volume 2, 2013.

She is also the author of “Recent and Emerging Trends and Concerns Related to the Manufacturing and Testing of Monoclonal Antibodies Intended for Clinical Use” in Comprehensive Biotechnology, Second Edition, 2011.

Dr. Hirsch obtained her Ph.D. in Tumor Biology from the Department of Oncology, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC; and her Bachelor’s in Biology from University of Virginia, Charlottesville, VA.