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
7:15 – 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 – 10:50
Fran Brown
Strategy first: Modeling from preclinical to clinical
Modeling and simulation are most powerful when guided by strategy. By anchoring development around a single pivotal study, this session explores how starting with the end in mind, regulatory expectations, clinical differentiation, and investment realities, reshapes how evidence is generated and how Model-Informed Drug Development (MIDD) is applied from preclinical translation through clinical execution, with modeling serving as a unifying golden thread across decisions.
Rather than treating modeling as a series of technical milestones, this discussion presents MIDD as a lifecycle discipline, linking translational PK/PD, early clinical decision-making, competitive benchmarking through MBMA, and emerging AI-enabled and integrated evidence approaches.
The result: a more intentional, connected approach where quantitative methods turn limited data into confident, strategically grounded decisions, all the way to Phase 3 and beyond.
Speaker: Fran Brown, PhD, Global Head Drug Development Science, Certara Drug Development Solutions
10:50 – 12:00
Rachel Garner, Joyce James, Elliot Offman, Matt Zierhut
Driving confidence from early insight to Phase 3: Translational PK/PD and MBMA in practice
How does a strong translational strategy increase the probability of success?
In this real-world case discussion, Certara and Altimmune demonstrate how integrated PK/PD modeling connects preclinical insights to Phase 1 and Phase 2 decision-making. From defining exposure–response relationships and projecting human dose to modeling early efficacy signals such as weight-loss trajectories, this session highlights how a robust translational package reduces uncertainty, strengthens study design, and builds early confidence for Phase 3 success.
But early models only tell you what could happen.
Matt Zierhut will extend this foundation by showing how Model-Based Meta-Analysis (MBMA) leverages study-level data across a therapeutic class to establish quantitative benchmarks for efficacy, dose selection, and trial design. By contextualizing early clinical results against real-world competitive data, MBMA sharpens go/no-go decisions and ensures programs are positioned to compete, ultimately improving Phase 3 confidence.
Speakers:
Rachel Garner, PharmD, Vice President, Clinical Development, Altimmune
Joyce James, PhD, Corvid LLC, Early Development and Clinical Pharmacology Consultant for Altimmune
Elliot Offman, BSc Pharm, MSc, PhD, Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solutions
Matt Zierhut, PhD MBA, Vice President, MBMA Capability Lead, Certara Drug Development Solutions
12:00 – 1:00
Mirjam Trame, Nick Brown, Karthick Vishwanathan, Timothy Nicholas, Nastya Kassir
Role of AI in MIDD
This session will explore how artificial intelligence enhances Model-Informed Drug Development (MIDD) by accelerating insight generation while preserving mechanistic rigor and regulatory credibility. We’ll discuss how AI integrates with QSP, PBPK, MBMA, and real-world evidence to reduce uncertainty, strengthen decision-making, and improve probability of success across the development lifecycle.
Speakers:
Karthick Vishwanathan, Interim Head of the Clinical Pharmacology and Pharmacometrics Group, AstraZeneca
Mirjam Trame, PharmD, PhD, VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
Nick Brown, Director, Global Portfolio Leader for Certara.AI
Timothy M. Nicholas PhD, MS, Inflammation, Immunology, and Internal Medicine Pharmacometric Group Leader, Pfizer
Nastya Kassir, PharmD, PhD, FCP, Senior Director and Distinguished Scientist, Genentech
Alison Betts, PhD, Global Head of DMPK & Modeling, Takeda
1:00 – 2:00
Lunch & demos
2:00 – 2:30
Dr. Britta Wagenhuber, Matt Zierhut, Ananth Kadambi
Integrated evidence in action: Aligning mechanistic modeling, comparative analytics, and real-world data
This session explores how integrating mechanistic modeling, comparative analytics, and real-world data strengthens decision-making across the drug development lifecycle. It provides a practical, forward-looking perspective on how QSP informs disease understanding and translational strategy, MBMA benchmarks clinical outcomes and reduces uncertainty, and clinical and real-world evidence contextualize results for regulatory and payer decisions.
Using examples such as inflammatory bowel and metabolic diseases, the session demonstrates how these approaches can be applied independently yet aligned to support key decisions, including dose selection, phase transitions, competitive positioning, and early value strategy, ultimately advancing a more coordinated MIDD approach for regulatory and commercial success.
Speakers:
Dr. Britta Wagenhuber, VP, Head of QSP Consultancy, Certara
Matt Zierhut, PhD MBA, Vice President, MBMA Capability Lead, Certara Drug Development Solutions
Ananth Kadambi, PhD, Vice President of Real World Evidence & Modeling
2:30 – 3:00
Rajesh Krishna, Harold S. Bernstein, Mariam Ahmed
MIDD for pediatric rare disease “Too rare, too risky? Reframing the business case for pediatric innovation“
This panel explores how advances in clinical science are reshaping the risk–reward equation in pediatric drug development. Discussion will focus on how modeling and simulation approaches; including physiologically based pharmacokinetic (PBPK) modeling, quantitative systems pharmacology (QSP), and in silico trial design, can reduce uncertainty, optimize dosing strategies, and minimize the number of children exposed in early-phase studies. Panelists will also examine how these quantitative tools, combined with innovative trial designs and real-world data, are driving more efficient, predictable, and investable development programs for rare pediatric populations.
Rajesh Krishna, PhD, Senior Distinguished Scientist, Innovation Engines, Certara
Harold S. Bernstein, MD, PhD, President, Head of Research and Development, and Chief Medical Officer, Maze Therapeutics
Mariam Ahmed, Director and Quantitative Clinical Pharmacology Lead, Takeda Pharmaceuticals
3:00 – 3:30
Rajesh Krishna
Tiny populations, transformative science: The future of pediatric rare disease innovation
This session explores how breakthroughs in genetics, data science, and precision medicine are transforming care for children with rare diseases. Advances in CRISPR-based gene editing, RNA therapies, and AI-driven diagnostics are enabling targeted treatments for ultra-small patient populations through Model-Informed Drug Development (MIDD). Attendees will gain insight into innovative clinical trial models, evolving regulatory pathways, and the role of public–private partnerships in accelerating progress. The discussion will also address the critical next steps needed to ensure scientific advances translate into equitable, scalable, and sustainable solutions for children and families worldwide.
Rajesh Krishna, PhD, Senior Distinguished Scientist, Innovation Engines, Certara
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
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.
Presenter: Sean McGee, MS, Director of Product, Certara
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.
