The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based approaches, and both FDA and industry have committed to reduce animal use. In the webinar series, NURA will feature leaders in human-relevant nonanimal methods to demonstrate medical product safety and efficacy:
- September 10, 2024, at 1:00 p.m. (EDT): Case Study #1: The Utilization of Human-on-a-Chip Systems for Regulatory Submissions for Neurological Conditions. Speaker: James “J” Hickman, Ph.D., Founder and Chief Scientist at Hesperos, Inc., and the Founding Director of the NanoScience Technology Center, and a professor of nanoscience technology and electrical engineering at the University of Central Florida. In this webinar, Dr. Hickman will discuss how Hesperos’ clinically relevant functional readouts can be used in the regulatory process. Register.
- September 25, 2024, 10:00 a.m. (EDT): RosetteArray® Platform for Quantitative High-Throughput Screening of Human Developmental Neurotoxicity. Speaker: Randolph Ashton, Ph.D., Co-Founder and Chief Executive Officer (CEO) of Neurosetta. Dr. Ashton will present on the RosetteArray® platform that enables quantitative high-throughput screening of human developmental neurotoxicity (DNT) for chemical risk assessment. Register.
- October 10, 2024, at 1:00 p.m. (EDT): Case Study #2: Vanda Pharmaceuticals Inc. Uses NAMs in Lieu of Animal Study. Speaker: Sandra Smieszek, Ph.D., Head of Genetics at Vanda Pharmaceuticals Inc. Dr. Smieszek will discuss Vanda Pharmaceuticals’ use of NAMs in the regulatory process. Register.
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