Certainty 2025: Model Informed Drug Development at Scale
Building on the successful Certainty events around the globe in 2024, this year’s focus is how the model informed drug development community is scaling its efforts and impacts around the globe. At Certainty 2025 we are highlighting the latest science, technologies, case studies and value that MIDD is delivering across the industry. This year we have added a development and preclinical focused track that highlights data flows and insights from lead optimization through the preclinical phase.
our schedule
7:30 – 8:30
Breakfast & Badge Pick Up
8:30 – 8:45
Welcome & Certara Update
8:45 – 9:15
Chris Bouton
What's Next for Predictive Science
9:15 – 10:00
The Innovation Circle: Driving Outcomes in R&D
10:00 – 10:30
Morning Break - Demo Bar
10:30 – 1:00
User Group Meetings
P21 Live: Digital Data Flow Optimization
Discovery: Intelligent Lead Optimization with Chemaxon and D360
Modeling & Simulation from Strategy to Approval
1:00 – 2:00
Lunch & Demos
2:00 – 3:30
User Group Meetings
P21 Live: Digital Data Flow Optimization
Discovery: Intelligent Lead Optimization with Chemaxon and D360
Modeling & Simulation from Strategy to Approval
3:30 – 4:00
Afternoon Break
4:00 – 5:00
David Fajgenbaum, MD
Keynote Presentation
5:00 – 5:15
Close of Day
8:00 – 9:00
Breakfast & Badge Pick Up
9:00 – 10:30
User Group Meetings
P21 Live
Phoenix
QSP Summit
PBPK Modeling Workshop
Discovery
10:30 – 11:00
Morning break
11:00 – 12:30
User Group Meetings Continued
P21 Live
Phoenix
QSP Summit
PBPK Modeling Workshop
Discovery
12:30 – 2:00
Lunch
2:00 – 3:30
User Group Meetings Continued
P21 Live
Phoenix
QSP Summit
PBPK Modeling Workshop
Discovery
3:30 -3:45
Close of day
Based on attendee feedback, Certainty 2026 will feature more in-depth UGMs and Workshops on Pinnacle 21, QSP, Phoenix, Discovery, PK/PD, and PBPK. Choose the interactive sessions that best suit your interests over the 2-days:
P21 Live: Digital Data Flow Optimization
Follow the flow of data from protocol all the way to submission in this track focused on the Pinnacle 21 technology. We’ll look more closely at P21 capabilities, from mapping specs and APIs to the progress of our solution for metadata management.
Phoenix User Meeting
Phoenix users can explore how empirical PK/PD methods work alongside in silico approaches by attending Modeling & Simulation from Strategy to Approval on Day 1 of Certainty. On Day 2, you’ll get an interactive look at new features, our roadmap, and AI’s expanding role in modeling and reporting.
QSP Summit
Attendees of the QSP Summit are also encouraged to attend Modeling & Simulation from Strategy to Approval on Day 1 of Certainty. On Day 2, we will explore how QSP is transforming MIDD through computational modeling, AI integration, and mechanistic insights. Sessions will feature case studies across disease areas, and forward-looking discussions on regulatory adoption and the future of predictive modeling.
Discovery: Intelligent Lead Optimization with Chemaxon and D360
With the explosion of new modalities, informatics is expanding its scope as AI closes gaps between chemistry, safety, and efficacy. Join this track to explore how predictive modeling is reshaping compound design and enabling a clearer view downstream in drug discovery.
PBPK Modeling Workshop
Attendees of PBPK Modeling Workshop are also encouraged to attend Modeling & Simulation from Strategy to Approval on Day 1 of Certainty. On Day 2, we’ll showcase how PBPK informs decisions for first-in-human dosing to formulation, drug–drug interactions, and special population optimization. Expert talks and case studies will offer practical insights to strengthen confidence in model-informed development.
Modeling and Simulation from Strategy to Approval
Learn how empirical PK/PD methods like NCA and popPK are complementing in silico approaches like PBPK and QSP to answer the most daunting challenges in development, from optimal first-in-human dosing to presenting clin pharm evidence effectively in your NDA or BLA. Attendees of the Phoenix User Meeting, QSP Summit, and PBPK Modeling Workshop are encouraged to attend this session on Day 1 of Certainty.
