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Conference: 2nd Model-Informed Drug Development Summit

Date: November 18 - 19, 2026

Location: Wyndham Boston Beacon Hil, Boston, MA

Certara is an Expertise Partner of the summit.

Certara is proud to support the 2nd Model-Informed Drug Development Summit, where clinical pharmacology, pharmacometrics, QSP, and regulatory leaders gather around the questions now shaping MIDD in practice: turning model-informed evidence into decisions regulators accept, preparing for ICH M15, and scaling quantitative methods beyond a single program. As the FDA MIDD Pilot Program, Project Optimus, and ICH M15 raise the bar on what sponsors are expected to bring, Certara’s modeling, simulation, and regulatory expertise offers a practical route through the dosing, evidence, and submission questions teams are working through right now.

Meet Certara at the Summit

Joshua Apgar, PhD

VP, Head of QSP Software

Dr. Apgar is the VP, Head of QSP Software at Certara, and co-founder of Applied BioMath (acquired by Certara in Dec 2023). Prior to this, Josh was a Principal Scientist in the Systems Biology Group of the Department of Immunology and Inflammation at Boehringer Ingelheim Pharmaceuticals. His work leveraged physics-based models to: translate in vitro and in vivo data, assess target feasibility, understand drug mechanism of action, and predict human doses. The ultimate goal of this work was to reduce late stage attrition in drug development through a deep and quantitative interrogation of drug pharmacology and disease pathophysiology.

Josh received his PhD from MIT in Biological Engineering where he worked on experiment design for Systems Biology, focusing on the identification of tractable experiments that could allow for the estimation of unknown parameters and reveal complex mechanisms in signal transduction networks. Before that Josh worked at Avaki to develop a highly scalable software platform to support High Performance Computing, and Enterprise Information Integration in the Life Sciences, and Engineering.

Katie Williams, PhD

Global Portfolio Lead, Modeling & Simulation

Where to hear Certara insights and expertise

Speaking session:

Wednesday, Nov 18
2:30 PM - 3:00 PM
What we’re seeing in MIDD: regulatory momentum, ICH M15, and what it means for your next submission.

Scientific poster:

Details coming soon — check back here for the Certara research being presented during the summit’s dedicated poster session.