May Freag
Senior Scientist, Nonclinical Safety & Pharmacology (NCSP) Takeda Pharmaceutical
Seminars
Wednesday 13th May 2026
Panel Discussion: Regulatory & Pharma Expectations in the Adoption of NAMs: IQ MPS Affiliate Perspective
3:00 pm
- 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
Wednesday 13th May 2026
Applying Liver MPS Technologies to Improve Preclinical DILI Prediction
1:30 pm
- Demonstrate how liver microphysiological systems improve mechanistic understanding and human relevance in assessing drug‑induced liver injury
- Present case studies where liver MPS provide earlier or more predictive detection of hepatotoxic liabilities compared with traditional in vitro assays
- Highlight translational biomarkers and functional readouts from MPS that strengthen decision‑making in preclinical safety assessment
