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
8:00 – 9:00
Breakfast & Badge Pick Up
9:00 – 9:15
William Feehery, CEO
Welcome & Certara Update
9:15 – 9:45
Robert Aspbury, Chris Bouton
What's next for Modeling and Simulation?
9:45 – 10:15
Innovation Circle
10:15 – 11:00
Morning Break - Demo Bar
11:00 – 12:00
Keynote Speaker with Q&A
12:00 – 1:00
Lunch & Demos
1:00 – 2:30
User Group Meetings
1: P21 Live
2: Discovery
3: Modeling and Simulation from Preclinical to Approval
2:30 – 3:00
Afternoon Break
3:00 – 5:00
User Group Meetings Continued
1: P21 Live
2: Discovery
3: Modeling and Simulation from Preclinical to Approval
5:00 – 5:15
Close of Day
Customer Appreciation Event
Venue and time to be announced
8:00 – 9:00
Breakfast & Badge Pick Up
9:00 – 10:30
User Group Meetings
1: P21 Live
2: Discovery
3: QSP Summit
4: PBPK Modeling Workshop
5: Phoenix
6: Biotech ForumÂ
10:30 – 11:00
Morning break
11:00 – 12:30
User Group Meetings Continued
1: P21 Live
2: Discovery
3: QSP Summit
4: PBPK Modeling Workshop
5: Phoenix
6: Biotech ForumÂ
12:30 – 2:00
Lunch and Learns
2:00 – 3:30
User Group Meetings Continued
1: P21 LiveÂ
2: Discovery
3: QSP Summit
4: PBPK Modeling Workshop
5: Phoenix
6: Biotech ForumÂ
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
On Day 1, follow the flow of data from protocol all the way to submission. On Day 2, we’ll look more closely at the Pinnacle 21 technology itself, from mapping specs and APIs to the progress of our solution for metadata management.
Phoenix UGM
On Day 1, explore how empirical PK/PD methods work alongside in silico approaches like PBPK and QSP to tackle development challenges. 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
This dedicated Day 2 summit 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 UGM
With the explosion of new modalities, informatics is expanding its scope as AI closes gaps between chemistry, safety, and efficacy. Join this two-day track to explore how predictive modeling is reshaping compound design and enabling a clearer view downstream in drug discovery.
PBPK Modeling Workshop
This Day 2 exclusive session will 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.
Parallel learning tracks for every facet of development:
Seeing Further in Discovery and Non-Clinical Research
Drug discovery follows a Design-Make-Test-Analyze cycle, where each new set of assay results and in silico predictions inform the next generation of compound candidates. Learn how informatics and GPTs are accelerating this cycle, freeing scientists to focus on the innovative leaps required to advance new leads. Then, see how the combination of quantitative systems toxicology and on-demand visualization of SEND datasets can identify potential off-target effects and adverse events sooner. 
Ideal for: VP of R&D, Head of Chemistry, Head of Biology, Lead Toxicologist, Lead Pathologist
Latest Advances in MIDD: Insights, Examples and Perspectives
This track highlights innovative approaches in Model-Informed Drug Development (MIDD) to optimize drug development processes. Topics include the evolving regulatory landscape with the draft ICH M15 guidance, the application of Quantitative Systems Pharmacology (QSP) and Physiologically-Based Pharmacokinetic (PBPK) modeling for oncology therapies, and novel techniques for dose optimization. Experts will also discuss challenges in Phase II dosing and explore emerging technologies such as machine learning to enhance pharmacokinetic modeling accuracy.
Clinical Data Flow for Faster Analysis and Submission
Automating the flow of clinical data from source to CDISC deliverables accelerates both analysis and submission. Explore the technologies and meet the teams that will make this possible, as we examine metadata repositories, data transfer processes with automated error checking, and collaborative validation platforms. 
Ideal for: VP of Biometrics, Head of Data Standards, Head of Data Management, Heads of Biostatistics
Drug Development and Regulatory Strategy
Embracing Totality of Evidence throughout your drug development journey
Regulatory agencies are increasingly embracing the Totality of Evidence approach, reshaping drug development strategies and decision-making. Join experts from Certara’s Drug Development Solutions and Regulatory Sciences teams as they discuss this shift in regulatory philosophy, its impact on pharmaceutical development, and how companies can navigate both the challenges and opportunities it presents.
Ideal for all Executives and Leaders
