Integrate Pharmacometrics, QSP, AI & Real-World Evidence to Improve Development Strategy, Reduce Risk & Enhance Clinical and Regulatory Success
Model-informed drug development has crossed a critical threshold. With the ICH M15 guideline now finalized and regulators increasingly weighing model-informed evidence alongside traditional clinical data, quantitative approaches have moved from a supportive discipline into a core part of development strategy.
But guidance alone doesn't solve the practical questions teams face daily: how to integrate MIDD from day one, how to bring AI and machine learning into the workflow without losing regulator confidence, and how to demonstrate model credibility when data is limited.
The 2nd Model-Informed Drug Development Summit is where 60+ senior pharmacometricians, clinical pharmacologists, QSP scientists, translational leaders and regulatory experts come together to work through these questions directly, not in a convention space of a thousand people, but in a room intimate enough that you'll know every name by day three. Unlike the larger association meetings, this is a forum built for depth over volume: expert-led case studies, candid conversations around strategy, and connections that actually go somewhere after the event ends.
Across a workshop day and two conference days, expect practical, modality-agnostic conversations spanning AI-assisted modelling, the pharmacometrics-biostatistics interface, internal and regulatory stakeholder buy-in.
Good discussion around how to think about MIDD in a time of accelerating innovation.
Director PDKM, Amgen Inc., 2025 Attendee
The size of the meeting was great. The quality of the presenters and the Science was great too.
CSO Engineering & Technical, PhInc Modeling, 2025 Attendee
Great insights and cutting-edge scientific presentations and discussions.
Senior Director & Quantitative Pharmacology Portfolio Section Head Medical & Health, Merck KGaA, 2025 Speaker
The organizer, Lizie and Georgina were very helpful and supportive. The audience size was perfect for an in-depth discussion yet you still hear fresh perspectives, AI-ML aspect was a great addition. The session chairs, speakers, panelists were experts in the topics and presentations, the panel discussion was very interactive and gave everyone in the audience an opportunity to participate.
Vice President of Clinical Pharmacology C-Suite; Medical & Health, Third Arc Bio, 2025 Speaker
Explore the 2026 Full Event Guide
- Expert Speakers from Your Peers at Big Pharma, Emerging Biotechs & Regulatory Agencie
- Hands-On Workshops Covering AI Integration and Package Submission Readiness
- Case Studies Spanning Oncology, Autoimmune, Cell and Gene Therapy and Beyond
- Direct Regulatory Insight From the U.S FDA and Health Canada Perspectives
Official Partners
Attending Companies Include
Explore the Agenda
Preview strategy-led case studies on AI-enabled MIDD, pharmacometrics-biostatistics collaboration and ICH M15 in practice, alongside interactive discussions and hands-on workshops across three content-rich days.
Partner With Us
Position your organization as the go-to solution provider by showcasing your technologies, services and expertise to senior MIDD decision-makers actively evaluating modelling and simulation partners.
Join Biopharma Experts
Connect with pharmacometricians, clinical pharmacologists, QSP scientists and regulatory leaders through case studies, roundtables and structured networking designed for an intimate room, not a crowd.