Pengyu Huang
Director & Head, In Vivo Pharmacology Simcere Pharmaceutical Group
Seminars
Wednesday 13th May 2026
Balancing Toxicology & Efficacy to Design Studies That Predict Real Clinical Value
4:30 pm
- Avoid costly pipeline pivots by distinguishing regulatory-driven toxicology studies from internal proof of-efficacy experiments that determine whether a program is worth advancing
- Improve Phase 1 success rates by integrating mechanistic efficacy insights upfront, not after GLP, ensuring safety signals are interpreted in the context of therapeutic promise
- Strengthen decision-making by aligning toxicology, pharmacology, and regulatory expectations early so resource-limited programs don’t over-optimize for approval while under-investing in efficacy
