Nonclinical Scientist
RTI
Potomac, Maryland, United States
Dr. Yang is a former US Food and Drug Administration (FDA) Pharm/Tox reviewer and a board-certified toxicologist (DABT). Working as a Senior Toxicologist at RTI, she provides and guides regulatory support, strategy, and submissions for clients' drug development projects. With over 10 years of FDA experience, Dr. Yang has expertise in evaluating nonclinical data submitted to Investigational New Drug (IND) Applications and New Drug Applications (NDA). Dr. Yang designs, contracts, and monitors nonclinical programs that support IND submissions and provides resolution of toxicology and regulatory issues during the nonclinical development of pharmaceutical candidates.
Within the FDA, she has held leadership positions, including the Toxicology Working Group/Cardiotoxicity Interest Group and Pharm/Tox Reviewers Education Committee. Dr. Yang has served on multiple international committees and co-chaired multiple continuing education courses, symposia, and workshops within the FDA and at annual Society of Toxicology meetings. She has published over 45 peer-reviewed research articles and book chapters and has experience reviewing NIH grant proposals.
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The Importance of and Preparing the Target Product Profile (TPP)
Wednesday, March 6, 2024
12:15 PM – 1:15 PM East Coast USA Time