Beyond the Lab: FDA’s Vision for Modeling a Future Without Animal Testing скачать в хорошем качестве

Beyond the Lab: FDA’s Vision for Modeling a Future Without Animal Testing

The FDA has released a new roadmap outlining a path toward reducing—and ultimately replacing—animal studies in pharmaceutical development with new approach methodologies (NAMs), beginning with monoclonal antibodies. This evolving regulatory landscape presents exciting opportunities and both scientific and operational implications for drug developers. In this webinar, experts from Simulations Plus provide an overview of the FDA’s roadmap, discuss its relevance to current development practices, and examine what is achievable today with modeling and simulation (M&S) tools in support of this transition. Presenters share practical approaches for integrating M&S into development programs, with a particular focus on biologics and monoclonal antibodies. Topics include: • Key elements of the FDA’s roadmap and their impact on development strategies • Incorporating model-informed approaches into early- and late-stage development • Case studies demonstrating the use of M&S in lieu of animal studies • Regulatory considerations and alignment with MIDD initiatives This session is intended for professionals involved in preclinical and clinical development who are seeking to understand how in silico tools can contribute to scientifically sound and regulatory-aligned alternatives to animal testing. WEBINAR PANELISTS: Sandra Suarez-Sharp (moderator), President, Regulatory Strategies Center of Excellence, Simulations Plus Susie Zhang, Vice President, Regulatory Strategies, Simulations Plus Scott Siler, Chief Scientific Officer, QSP, Simulations Plus Viera Lukacova, Chief Scientist, PBPK, Simulations Plus Timothy McGovern, Co-Founder, Principal Consultant at White Oak Regulatory Tox, LLC 00:46 Agenda 1:56 Speaker Introductions 5:18 Introductory Comments with Tim McGovern 5:45 What does traditional nonclinical testing look like? 7:41 Roadmap to reducing animal testing 12:28 Regulatory perspectives 15:35 Panel Discussion 1:01 Closing Statement