The regulatory landscape has shifted. ICH M15 is finalized, the EMA’s MIDD initiative is live, and the sponsors moving fastest aren’t waiting — they’re building mechanistic models that regulators trust and using them to make decisions that were previously impossible.
In this on-demand webinar, Karen Rowland Yeo and Piet van der Graaf — two of the most recognized voices in Physiologically Based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP) — lead a frank, case-study-driven conversation about what mechanistic modeling makes achievable today and what’s coming next.
The question is no longer whether mechanistic modeling works. It’s whether your organization is using it boldly enough. Watch on demand for a conversation about real decisions, real submissions, and what it takes to develop future novel medicines in today’s environment.
What You’ll Learn
- How to build a modeling strategy that regulators trust — the collaboration, transparency, and credibility-building practices that turn models into accepted regulatory evidence
- How to maximize patient benefit with first-in-human dosing for novel medicines while reducing unnecessary animal usage through comprehensive regulatory justification
- What’s working today in special populations and rare disease — including AI-enabled mechanistic Virtual Twins® for gene therapies — and how new approaches are changing what’s possible for underserved patient populations
- Where drug-drug interaction (DDI) modeling is heading beyond CYP-mediated interactions, including emerging GLP-1 interactions, and what they reveal about the future 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, Certara
Piet van der Graaf, PharmD, PhD — Senior Vice President and Head of Quantitative Systems Pharmacology, Certara
