As model-informed drug development (MIDD) becomes increasingly central to modern drug development strategy, organizations are under growing pressure to leverage quantitative approaches that accelerate timelines, reduce risk, and improve regulatory and clinical success. The 2nd Model-Informed Drug Development Summit, taking place November 17-19, 2026, in Boston, MA, brings together senior leaders in pharmacometrics, clinical pharmacology, quantitative sciences, translational medicine, and regulatory science to explore how modelling is transforming decision-making across the entire development lifecycle.

Designed as an intimate and highly interactive forum, this summit moves beyond traditional large-scale industry meetings to provide meaningful peer-to-peer networking, practical case studies, and candid discussions on the real-world challenges of implementing MIDD strategies. Attendees will gain insights from leading organizations including FDA, Health Canada, Sanofi, Eli Lilly, GSK, AbbVie, Novartis, Amgen, Genentech, Gilead Sciences, BMS, Astellas Pharma, Vertex Pharmaceuticals, Johnson & Johnson, and Genmab.

The agenda explores the latest industry developments, including implementation of the finalized ICH M15 guideline, the growing role of quantitative systems pharmacology (QSP), advances in AI-enabled modelling, and the use of real-world evidence to strengthen development decisions. Through case studies, panel discussions, workshops, and roundtable sessions, attendees will learn how to optimize dose selection, improve trial design, accelerate rare disease programs, validate model outputs, demonstrate return on investment from MIDD initiatives, and strengthen regulatory submissions.

In addition to the main conference, dedicated workshops will examine how to integrate pharmacometrics, QSP, machine learning, and AI into connected modelling ecosystems, while also addressing the challenge of building internal and external stakeholder confidence in modelling approaches.

With more than 60 senior industry leaders expected to attend, the summit offers a unique opportunity to benchmark strategies, share best practices, build valuable partnerships, and stay ahead of evolving regulatory and scientific expectations. Whether you are advancing innovative therapies, refining quantitative development strategies, or exploring the future role of AI in drug development, this event provides the practical insights and connections needed to maximize the impact of model-informed approaches across your organization.

To learn more about the event and register online click here.