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CMC

Michele Dougherty Image

Michele Dougherty, Ph.D.
CMC lead consultant; ex-FDA

Dr. Dougherty received her Ph.D. from Georgetown University in Tumor Biology and completed her post-doctoral training in the Laboratory of Cell and Developmental Signaling at the National Cancer Institute, where she defined novel mechanisms of c-Raf and B-Raf regulation and characterized the function of Kinase Suppressor of Ras 2, a scaffold protein for the ERK signaling pathway.

Dr. Dougherty joined the FDA in 2008 as a product quality reviewer in the Office of Biotechnology Products. During her 8 years with OBP, she developed expertise across the manufacturing and product quality lifecycle, including review of early phase INDs, BLAs, post-approval manufacturing changes, and participating in GMP inspections. She managed a diverse portfolio of products including monoclonal antibodies, anti-body drug conjugates, antibody cocktails, growth factors, enzymes, and biosimilar products. She held multiple leadership roles within OBP, including Team Lead and Review Chief. In 2017, she joined the Therapeutic Biologics and Biosimilar Staff in the FDA Office of New Drugs, where she was focused on supporting review of biosimilar products and participated in guidance and policy initiatives related to the biosimilar development pathway.

Dianne Hirsch, Ph.D.
Biologic CMC senior consultant; ex-FDA

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 included 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 Department of Oncology, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC; and her Bachelor’s in Biology from University of Virginia, Charlottesville, VA.

Zed Zheng, Ph.D.
CMC small molecule senior consultant

Dr. Zheng graduated from Tsinghua University with a Bachelor of Science degree in Chemistry and obtained his Ph.D. degree at Tohoku University Department of Engineering/ Chemistry. Dr. Zheng was trained as a postdoctoral scientist at Columbia University in New York City from 2002 to 2006 and conducted research on the mechanism and genetic factors of kidney diseases. Dr. Zheng held research scientist/faculty positions at Stony Brook University, Columbia University and Penn State University from 2006 to 2017. His projects involved knockout mice generations, identifying novel immunology pathways and bladder cancer biology. Dr. Zheng has over twenty years combined experience in small molecule and biologic product expression, purification, immunology and cancer immunotherapy/biology. Dr. Zheng has published more than twenty research papers.

Dr. Zheng is responsible for writing the CMC sections of regulatory dossiers of the small molecule drugs and biologic products to support their regulatory filings.