FDA, Health Canada & Leading Biopharma Organizations Unite at the 2nd Model-Informed Drug Development Summit

On Sep 8, 2026

Leading model-informed drug development experts to unite in Boston to explore pharmacometrics, AI, quantitative systems pharmacology, and evolving regulatory expectations

The 2nd Annual Model-Informed Drug Development Summit will bring together senior leaders from biopharma, regulatory agencies, and quantitative sciences functions to discuss how model-informed drug development (MIDD) is reshaping decision-making across discovery, clinical development, and regulatory strategy. The summit will feature perspectives from the FDA, Health Canada, and leading organizations including Eli Lilly, Sanofi, GSK, AbbVie, Novartis, Genmab, Gilead Sciences, Amgen, Johnson & Johnson Innovative Medicine, Astellas Pharma, Bristol Myers Squibb, Vertex Pharmaceuticals, EMD Serono, and Genentech.

Download the event guide here: https://ter.li/vpqssmsx

As MIDD approaches continue to gain traction across the industry, organizations are increasingly leveraging pharmacometrics, quantitative systems pharmacology (QSP), real-world evidence, and artificial intelligence to improve development efficiency, optimize dosing strategies, strengthen regulatory submissions, and reduce development risk. The summit arrives at a pivotal moment as companies work to implement the finalized ICH M15 guideline and adapt to evolving expectations surrounding AI-enabled modeling and quantitative decision-making.

Regulatory perspectives at this year’s summit will include contributions from both the FDA and Health Canada, offering attendees valuable insight into the evolving role of model-informed drug development in regulatory decision-making, implementation considerations surrounding the finalized ICH M15 guideline, and emerging expectations for quantitative and model-informed approaches across drug development.

The event’s agenda is designed to move beyond high-level discussions and provide practical case studies demonstrating how organizations are embedding MIDD into development programs. Attendees will hear how:

Eli Lilly is using MIDD to bridge indications and optimize dose selection across therapeutic areas.
Novartis is demonstrating the business impact and ROI of MIDD investment.
AbbVie is building internal confidence in modeling outputs and decision-making frameworks.
Sanofi is tailoring MIDD strategies across different stages of drug development.
GSK is applying model-informed extrapolation approaches in rare pediatric populations.

Register your place today: https://ter.li/aj18kkzq

In addition to regulatory and industry case studies, the summit will explore some of the most pressing questions facing the MIDD community, including the integration of AI into modeling workflows, validation of AI-assisted approaches, disease progression modeling, evidence generation for emerging modalities, and strategies for strengthening stakeholder confidence in quantitative decision-making.

Designed as an intentionally focused gathering, the summit will host more than 60 senior professionals working across clinical pharmacology, pharmacometrics, modeling and simulation, translational medicine, and quantitative sciences. Through dedicated networking sessions, interactive discussions, and practical workshops, attendees will have the opportunity to benchmark approaches, share implementation experiences, and build relationships with peers advancing MIDD across the industry.

The 2nd Annual Model-Informed Drug Development Summit will take place in Boston, Massachusetts, from November 17-19, 2026.

For more information and to view the full agenda, visit: https://ter.li/sv0ovraa