FDA, Health Canada, and leading biopharma organizations to explore how artificial intelligence, quantitative modeling, and evolving regulatory expectations are reshaping drug development at the 2nd Annual Model-Informed Drug Development Summit
As pharmaceutical companies face increasing pressure to improve development efficiency, reduce late-stage risk, and accelerate decision-making, model-informed drug development (MIDD) is emerging as a critical component of modern R&D strategy. At the same time, advances in artificial intelligence and machine learning are expanding the potential of quantitative modeling, creating new opportunities to generate insights, optimize development programs, and support regulatory decision-making.
However, with growing innovation comes growing scrutiny. As organizations evaluate how AI-enabled approaches can be incorporated into established modeling frameworks, questions around validation, transparency, governance, and regulatory acceptance have become increasingly important. The recent finalization of the ICH M15 guideline has further accelerated industry focus on establishing robust, standardized approaches to model-informed decision-making.
Against this backdrop, the 2nd Annual Model-Informed Drug Development Summit will bring together leaders from biopharma, regulatory agencies, and quantitative sciences teams to explore how organizations can successfully implement and scale MIDD strategies across the drug development lifecycle. The summit will feature contributions 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
A Practical Agenda Focused on Industry Application
Designed to move beyond theoretical discussion, this year’s agenda focuses on how organizations are applying MIDD in practice and measuring its impact on development outcomes. Attendees will gain insight into how industry leaders are:
Optimizing dose selection and supporting indication expansion through model-informed approaches
- Integrating AI-enabled technologies into established modeling and simulation workflows
- Demonstrating the value and return on investment of MIDD capabilities
- Building organizational trust in quantitative evidence and decision-making frameworks
- Tailoring MIDD strategies across different stages of drug development
- Applying extrapolation approaches in rare disease and pediatric settings
- Preparing for evolving regulatory expectations following ICH M15
- Strengthening evidence generation strategies for emerging therapeutic modalities
Featured industry perspectives include:
- Eli Lilly on leveraging MIDD to bridge indications and optimize dose selection
- Novartis on demonstrating the strategic impact and value of MIDD investment
- AbbVie on building confidence in model-informed decision-making
- Sanofi on adapting MIDD strategies throughout the development lifecycle
- GSK on applying model-informed extrapolation approaches in rare pediatric populations
The program will also explore emerging topics including disease progression modeling, AI-assisted model development, validation of AI-enabled methodologies, and strategies for strengthening stakeholder confidence in quantitative evidence.
An Intentionally Focused Forum for Quantitative Sciences Leaders
Unlike broader drug development conferences, the 2nd Annual Model-Informed Drug Development Summit is designed specifically for senior professionals working across clinical pharmacology, pharmacometrics, modeling and simulation, quantitative systems pharmacology, translational medicine, and quantitative sciences. Through focused networking discussions and peer-to-peer knowledge exchange, attendees will have the opportunity to benchmark implementation strategies, share lessons learned, and engage directly with colleagues addressing similar scientific, operational, and regulatory challenges.
Register your place today: https://ter.li/aj18kkzq
An Intentionally Focused Forum for Quantitative Sciences Leaders
Unlike broader drug development conferences, the 2nd Model-Informed Drug Development Summit is designed specifically for senior professionals working across clinical pharmacology, pharmacometrics, modeling and simulation, quantitative systems pharmacology, translational medicine, and quantitative sciences. Through focused networking discussions and peer-to-peer knowledge exchange, attendees will have the opportunity to benchmark implementation strategies, share lessons learned, and engage directly with colleagues addressing similar scientific, operational, and regulatory challenges.
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