Regulatory Considerations for Use of NAMs for Cardiovascular Drug Products

Day 2 of the 27th NIH Tissue Chip Consortium Meeting + CIVM Qualification Framework Public Workshop Jordan Pomeroy, a medical officer and clinical team lead at the FDA’s Division of Cardiology and Nephrology, delivers a detailed presentation on the evolving role of new approach methodologies (NAMs), including in silico modeling and microphysiological systems, in cardiovascular (CV) safety assessment during drug development. He emphasizes the complexity of cardiovascular toxicity mechanisms, the regulatory framework guiding CV safety testing, and the challenges of integrating NAMs into current drug development paradigms. FOLLOW C-Path: ►LinkedIn: / c-path ►Facebook: / cpathinstitute ►Twitter: https://twitter.com/CPathInstitute?re About Critical Path Institute C-Path is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org. #CPath #drugdiscovery #researchgrants #globalhealth #drugdevelopment #datasharing #researchfunding #raredisease #academicresearch #regulatoryscience #globalhealth #consortia #collaboration