Panel Discussion: Regulatory & Pharma Expectations in the Adoption of NAMs: IQ MPS Affiliate Perspective
- How pharma teams are collaborating within IQ MPS Affiliate to progress simple and complex in vitro NAM platforms toward regulatory acceptance
- Review insights from recent FDA publication on submitted NAM case examples and reviewer feedback – what works and what can be improved (need for well-articulated context-of-use)
- Where AI-enabled validation initiatives like VICT3R can strengthen confidence by benchmarking prediction accuracy against real clinical outcomes
- Gain practical guidance for integrating in vitro and in silico NAMs into toxicology packages without over-claiming translatability
- What industry needs from consortia, regulators, and data-sharing frameworks to accelerate adoption of novel platforms covering diverse mechanisms of injury