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Center for Drug Evaluation and Research
Food and Drug Administration
Dr. Baolin Zhang is a Senior Investigator and a Product Quality Reviewer at the Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). He has had 10 years regulatory experience in the quality review (Chemistry, Manufacturing and Control) of new therapeutic proteins under investigational new drug applications (INDs) and biologic license applications (BLAs). He also leads a research team in the conduct of FDA mission-oriented research addressing issues related to drug safety and efficacy. His scientific expertise lies in the areas of protein biochemistry, cell death regulation, cancer drug action and resistance mechanisms, and cancer biomarkers, as evidenced by over 60 peer-reviewed articles. He serves as an Editorial Board member or reviewer for numerous peer-reviewed journals. Prior to joining FDA in 2001, he was a Senior Research Scientist at University of Tennessee, College of Medicine. He had also served as Professor and Deputy Director at the Beijing Center for Biologics Development and Research, and Associate Professor at Nanjing University. He earned his Ph.D. in chemistry from Peking University in 1992. He has received many awards including the 2010 FDA/CDER Scientific Achievement Awards for Excellence in Laboratory Science and the 2011 FDA/CDER Excellence in Leadership and Mentoring.
cancer biomarkers, protein drug applications
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