Vincent Duan, Ph.D.

Vincent Duan, Ph.D.

Vincent Duan, Ph.D.

Principal Consultant

Vincent Duan, Principal Consultant, at Parexel, has recognized U.S. FDA drug review experience with a particular focus on clinical pharmacology/ biopharmaceutics and regulatory strategy across therapeutic areas including gastroenterology & inborn errors, reproductive & urology, dermatology, pulmonary, allergy & rheumatology, anesthesia & analgesia, and endocrinology. Vincent provides strategic guidance to clients on the drug development and regulatory submission, and coordinates with other disciplines in providing drug product development strategies with the goal of anticipating regulatory challenges and leveraging Parexel’s multidisciplinary expertise.

Work Experience

Before joining Parexel, Vincent was a drug reviewer in the Office of Clinical Pharmacology and later in Biopharmaceutics at the Office of Pharmaceutical Quality in the U.S. Food and Drug Administration (FDA). He is proficient in the drug regulatory aspects, technical understanding, and drug review evaluation of new drug products pertaining to Pre-INDs, INDs, NDAs, ANDAs, and BLAs. Vincent is familiar with 505(b) (2) development and drug-device combination products. He also has expertise with issues around dissolution, BCS classifications, Biowaiver, BA/ BE, dose selection, drug-drug interactions (DDIs), PBPK,PKPD modeling, exposure-response, clinical trial design, specific populations and pediatric plans.

Education

Vincent received his Ph.D. in Biomedical Science at the State University of New York at Buffalo, and his B.S. in Pharmacy at China Pharmaceutical University in Jiangsu Sheng, China. He also received the U.S. FDA Commissioner’s Fellowship in Clinical Pharmacology. Vincent has published more than twenty first-author or co-authored manuscripts and conference abstracts as well as multiple book chapters. Vincent is fluent in English and Chinese.

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