Baolin Zhang
Food and Drug Administration (FDA), USA
Biography
Baolin Zhang is a Senior Investigator in the Office of Biotechnology Products of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA). Dr. Zhang has 14 years of FDA regulatory experience in product quality review (Chemistry, Manufacturing and Control) of therapeutic protein product applications under investigational new drug applications (INDs) and biologic license applications (BLAs). In addition to performing review, inspection, policy, and training activities, Dr. Zhang also leads a research team conducting FDA mission-related research aimed at improving drug safety and efficacy. Dr. Zhang’s scientific expertise lies in the areas of protein biochemistry, cell death and cell growth regulation, cancer drug resistance and biomarkers. He has published over 70 peer-reviewed articles in reputed journals, and presented at numerous scientific and regulatory conferences on the development of therapeutic proteins. Dr. Zhang earned his Ph.D. in chemistry from Peking University in China. He is a recipient of the FDA Scientific Achievement Award, the FDA/CDER Excellence in Mentoring Award, and the FDA/CDER Excellence in Leadership Award.
Abstract
Abstract : Integrating predictive biomarkers in the development of targeted cancer therapies