Unlock New Possibilities with Mechanistic Modeling: With ICH M15 finalized and EMA’s MIDD initiative active, forward-thinking sponsors are already leveraging trusted PBPK and QSP models to enable groundbreaking decisions.
Join Karen Rowland Yeo and Piet van der Graaf, leading voices in PBPK and QSP, for a practical webinar. Through real case studies, they’ll reveal what’s achievable now and what the future holds.
Move beyond asking if modeling works. Ask instead: Is your organization bold enough? Discover how mechanistic modeling drives real-world decisions, submissions, and the development of tomorrow’s novel medicines.
What you’ll learn:
- Building regulator-trusted modeling strategies — discover how collaboration, transparency, and credibility-focused practices transform models into accepted regulatory evidence
- Optimizing first-in-human dosing for novel medicines — maximize patient benefit while minimizing unnecessary animal use through robust regulatory justification
- Advancing care for special populations and rare diseases — explore AI-enabled mechanistic Virtual Twins® for gene therapies and emerging approaches expanding possibilities for underserved patients
- The future of drug-drug interaction (DDI) modeling — move beyond CYP-mediated interactions to examine emerging GLP-1 pathways and what they signal for the next generation of mechanistic modeling
Who should watch:
Drug development and translational science leaders, PBPK and QSP scientists, regulatory strategy teams, innovation leaders and anyone who believes there’s more value in quantitative science than they’re currently capturing.
演讲嘉宾：
- Karen Rowland Yeo, PhD, Senior Vice President, Client & Regulatory Strategy
- Piet van der Graaf, PharmD, PhD, Senior Vice President and Head of Quantitative Systems Pharmacology
