Anna Kopec
Director, Investigative Toxicology Pfizer
Anna Kopec, PhD, leads the Investigative Toxicology group at Pfizer (Groton, CT) and served as the 2024 Chair of the IQ Microphysiological Systems (IQ MPS) Affiliate, part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium). Anna earned a dual‑major PhD in Biochemistry & Molecular Biology and Environmental Toxicology from Michigan State University, studying effects of xenobiotic exposures and investigating mechanisms linking coagulation and liver repair in models of liver injury. At Pfizer, Anna provides strategic guidance on the qualification and context‑of‑use-driven application of novel complex in vitro platforms.
Seminars
- 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)
- Discuss the value of a strong regulatory strategy: Suggestions for the qualification of alternative approaches leveraging toxicology data, statistical modelling, and AI – based on VICT3R experience
- 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
- Cross-pharma collaboration for in vitro NAM implementation in drug development
- Strategic global regulatory engagement and thought leadership
- Driving industry benchmarking, model qualification, and education