CDER Food And Drug Administration
Baolin Zhang is a Senior Investigator and a Product Quality Reviewer in the Division of Therapeutic Proteins within 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). He 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 development, biomarkers, and potency assays for evaluation of therapeutic proteins. He has published over 70 original studies in prestigious journals, and presented at numerous scientific and regulatory conferences on the development of therapeutic proteins. Dr. Zhang serves as an Editorial Board member and as an ad hoc reviewer to numerous scientific journals. He has supervised and mentored many research fellows and regulatory staff. 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.
Integration of Predictive Biomarkers in Anticancer Drug Development
Thursday, 15 January 2015 at 08:30
Add to Calendar ▼2015-01-15 08:30:002015-01-15 09:30:00Europe/LondonIntegration of Predictive Biomarkers in Anticancer Drug DevelopmentPrognostic, Predictive, and POC: Biomarkers from Research to Clinic in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com
The regulatory approval of marketing new drugs requires evidence demonstrating the safety and efficacy of the drug for the intended patient population that is described in the drug label. When evaluating potential anticancer agents, there is a continued interest in using predictive biomarkers to select patients likely to respond or be resistant to a particular therapy. The ability to identify subsets of patients with molecularly defined cancers could significantly improve the outcome of cancer treatment. Several clinically validated biomarkers, such as HER2 and K-Ras mutation status have become an essential part of the clinical use of HER2/EGFR targeted therapies. However, the identification of clinically predictive biomarkers for solid tumors has proven challenging given that many initially promising biomarkers failed to translate into clinically useful applications. The complexity of the subject matter is also challenging when making regulatory decisions on either biomarker development or drug and biomarker co-development. This presentation describes recent FDA initiatives aimed at facilitating the development of biomarkers with case studies which highlight the major challenges in the discovery, qualification and regulation of predictive cancer biomarkers.
Add to Calendar ▼2015-01-15 00:00:002015-01-16 00:00:00Europe/LondonPrognostic, Predictive, and POC: Biomarkers from Research to ClinicPrognostic, Predictive, and POC: Biomarkers from Research to Clinic in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com