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The Role of Toxicology in FDA-Approved Therapeutics with Julie Castañeda, PhD

From early discovery research to the release of a new drug onto the market, toxicology plays a pivotal role in the drug development process. Toxicology is involved in the milestone of each major step as a drug attempts to gain FDA-approval. Assessing the safety profile of a pharmaceutical product by extrapolating animal data to humans is the primary goal of toxicology review work performed by the U.S. Food & Drug Administration (FDA). This presentation will delve into the drug development process and highlight the role of toxicology in FDA-approved therapeutics. Case studies will be presented that explain how animal data aids in the prediction of safety and efficacy in humans. About the speaker: Julie Castañeda obtained her PhD in Molecular Toxicology from the University of California, Los Angeles in 2016, where she published various papers on the toxicological effects of marijuana on the human immune system. She later went on to work in the Early Discovery phase of drug development for the Inflammation-Oncology department at Amgen, where she researched COPD and asthma. Julie is currently an acting Pharmacology/Toxicology Team Leader at the U.S. Food and Drug Administration in the Division of Pharmacology/Toxicology for Immunology and Inflammation. She reviews investigational new drug (IND) applications and new drug applications (NDA) for various indications, including pulmonology, allergy, critical care, rheumatology, and transplant medicine. In the past year, Julie has also been involved in the process of approving new therapeutics for COVID-19. She is also a very active member of the American College of Toxicology since graduate school. Supported by the UCLA NIEHS Training Grant in Molecular Toxicology T32ES015457.