Modeling and simulation sit at the center of modern drug development, linking strategy, science, and regulatory decision-making from early translation through submission. This session highlights how model-informed drug development (MIDD) is applied across the lifecycle, from setting development strategy and enabling translational PK/PD, to informing dose selection through NLME and population PK, and accelerating insight with AI-enabled approaches.
Highlights include:
- A presentation and panel discussion on pediatric rare disease, exploring both the scientific innovation required to develop therapies for tiny populations and the evolving business case for pediatric investment.
- A panel discussion on the adoption of AI in MIDD.
- Presentations and case studies illustrating how quantitative methods turn limited data into confident decisions across diverse development challenges.
Tuesday, April 14, 2026
Agenda
7:30 – 8:30
Breakfast & Badge Pick Up
8:30 – 8:45
Welcome to Certainty
Our Certainty theme in 2026 is “Right from the start”. Together, we’ll delve into how the how AI enabled modeling and simulation supported by digital data flows is improving decision making at every stage of R&D and bringing the best new medicines to patients.
8:45 – 9:30
Sheila Rocchio, Matt Rizk
The Innovation Circle: Driving Outcomes in R&D
Ideas, actions, and collaborations driving productivity, insight generation and a faster, more flexible and patient centric approach to medicine discovery and development. This session will share insights from leaders in drug discovery and development responsible for driving digital transformation and integration to driver, faster and more agile decision making.
Panel Moderator: Sheila Rocchio
Panelists:
Matt Rizk, PhD, Associate Vice President, Translational Sciences & Outsourcing
Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck
9:30 – 10:15
Chris Bouton
Right from the Start: AI Enabled Science and Scientists: Introducing Certara Nexus for faster, model-informed decision making that regulators Trust
This session will showcase how AI is changing drug discovery and development focusing on insights and speed that democratize modeling and simulation insights earlier to speed the most promising new medicines to patients. An early look at new capabilities coming soon to the Certara portfolio will be demonstrated in this session.
Speaker: Chris Bouton, PhD, Certara CTO
10:15 – 10:30
Morning Break - Demo Bar
10:30 – 11:00
Fran Brown
Strategy First: Modeling from Preclinical to Clinical
11:00 – 11:30
Elliot Offman
Translational PK/PD in Practice: Altimmune
11:30 – 12:00
Coming soon
12:00 – 12:30
Rajesh Krishna
Tiny Populations, Transformative Science: The Future of Pediatric Rare Disease Innovation
12:30 – 1:00
Rajesh Krishna, Amitava Mitra
Too Rare, Too Risky? Reframing the Business Case for Pediatric Innovation
1:00 – 2:00
Lunch & Demos
2:00 – 2:30
coming soon
2:30 – 3:00
Mirjam Trame, Nick Brown, Birgit Schoeberl, Karthick Vishwanathan, Timothy Nicholas
Role of AI in MIDD
3:30 – 4:00
Afternoon Break
4:00 – 5:00
David Fajgenbaum, MD
Keynote Presentation
5:00 – 5:15
Close of Day
Wednesday, April 15, 2026
8:00 – 9:00
Breakfast & Badge Pick Up
10:30 – 11:00
Morning break
1:00 – 2:00
Lunch and learns
3:30 -3:45
Close of day
Reserve your spot
Reserve your spot for the Certainty US 2026 customer event for exclusive access to the Certara community of experts, industry leaders, and peers as we collectively explore the latest innovations and opportunities to bring greater certainty to drug discovery and development.