April 14 - 15, 2026
our schedule
7:15 – 8:15
Breakfast & Badge Pick Up
8:15 – 8:25
Sheila Rocchio
Welcome to Certainty 2026
Kick off Certainty 2026 with a look at the state of the industry, an overview of what to expect during the event and the key insights to take back with you.
Speaker: Sheila Rocchio, CMO, Certara
8:25 – 8:50
Amin Rostami, Piet van der Graaf, Mirjam Trame
Evolution of evidence generation with PBPK and QSP champions
Join the leaders spearheading PBPK and QSP science & strategy for an insightful discussion that will explore:
- Critical regulatory shifts and their impact on MIDD
- The evolution of MIDD to MIE (Model-Informed Evidence) and how it’s being used
- Recentering the patient experience by leveraging findings from virtual trials
- How AI can be most effective and where it won’t permeate scientific processes
Speakers:
Amin Rostami, PhD, FCP, FAAPS, FJSSX, FBPS, Senior Vice President of R&D and Chief Scientific Officer (CSO), Certara
Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology, Certara
8:50 – 9:15
Matt Rizk, Leif Pedersen
Fireside chat: Moving from models to decisions earlier
This insightful conversation will showcase Merck’s approach to integrating Certara solutions & scientific expertise to improve decision-making at every phase of drug development. The discussion will also examine how AI is solving fragmented workflows and how this leads to exponential growth in productivity.
Speakers:
Matt Rizk, PhD, Associate Vice President, Translational Sciences & Outsourcing Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck
Leif Pedersen, President, Chief Commercial Officer, Certara
9:15 – 9:35
Josh ApgarÂ
Achieving faster time to insights with AI
It’s clear that AI used in tandem with sophisticated modeling is shifting the drug development timeline, from generating insights to making confident decisions at a rapid pace.
This presentation will demonstrate how:
- Real power comes from combining AI regulatory-grade modeling software AND scientists: not replacing everything that exists
- Certara is incorporating AI to support decision-making as a core tech provider, and by empowering scientists-in-the-loop
- The future is more connected as AI architectures bring data, models, and expertise together for achieve quality decisions faster.
Speaker:
Joshua Apgar, PhD, VP, Head of QSP Software, Certara
9:35 – 9:55
Amin Rostami, Piet van der Graaf, Matt Rizk, Chris Bouton,Leif Pedersen
Panel Discussion: From vision to action
This panel will examine the challenges being faced by our industry today, and how to operationalize innovative technology & science for faster, better decision-making. Panelists will share where they expect strategy and processes to evolve in the next year. Â
Panelists:
Amin Rostami, PhD, FCP, FAAPS, FJSSX, FBPS, Senior Vice President of R&D and Chief Scientific Officer (CSO), Certara
Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology, Certara
Matt Rizk, PhD, Associate Vice President, Translational Sciences & Outsourcing Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck
Chris Bouton, PhD, Chief Technology Officer, Certara
Leif Pedersen, President, Chief Commercial Officer, Certara
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
7:30 – 8:30
Breakfast & Badge Pick Up
8:30 – 9:00
Sean McGee
From protocol to submission: an optimized digital workflow
Like a decathalon, a clinical study is a series of challenges. Selecting the right endpoints. Drafting a protocol. Setting up data collection. All this needs to happen before the first patient visit. From there, it’s wave after wave of data validation and analysis, reporting and table-creation, and the million-and-one checkpoints of submission.
How much time, cost, and pain might be saved by relying on a suite of interconnected solutions, each purpose-built for its task? Find out in this fast-paced demonstration of Certara capability from protocol to submission. In 30 minutes, you’ll see how our increasingly AI-driven technology supports your organization right from start, when a study is little more than a justified hope. Sean McGee will present solutions for endpoint selection, optimal trial design, data standardization, analysis, reporting, and more. Live 5-plus years of the trial life in a half-hour, all with Certara by your side.
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
1:00 – 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
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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
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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
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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
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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
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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.
