Building on the milestones of QSP Summit 2025, this track showcases how Quantitative Systems Pharmacology (QSP) is an increasingly adopted methodology in model-informed drug development. The QSP Summit at Certainty will unite industry innovators, academics, and thought leaders to explore how computational modeling is bridging biology and pharmacology to predict clinical outcomes, inform first-in-human dose decisions, and accelerate drug development timelines.
New for 2026, we will spotlight Certara’s revolutionary AI-enabled QSP platform that is enhancing predictive power, automating model building, and expanding the reach of mechanistic modeling.
Highlights include:
- Case studies demonstrating scalability across rare and neurodegenerative diseases.
- Strategies for reducing reliance on animal models via nonanimal safety evaluation tools, and innovative applications like virtual patient populations and Virtual Twin® methodology.
- Forward-looking discussions on how regulatory acceptance, AI integration, and rigorous mechanistic modeling are transforming QSP from a niche methodology into a foundational pillar across R&D.
Tuesday, April 14, 2026
Agenda
Don’t miss our Day 1 session, Modeling and Simulation from Strategy to Approval, where we show how empirical PK/PD (NCA, popPK) and in silico approaches (PBPK, QSP) work in complementary ways to tackle real-world development challenges, from first-in-human dosing to compelling NDA/BLA clin pharm evidence. View Certainty Agenda >
Wednesday, April 15, 2026
7:30 – 8:30
Breakfast & Badge Pick Up
8:30 – 9:00
Sean McGee
From Protocol to Submission: A Certara 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
9:00 – 9:15
Piet van der Graaf
Welcoming Remarks
9:15 – 9:45
Vaishali Saharasrabudhe, Pfizer
Keynote: Integrating Disease Biology, Pharmacology and Data to Inform Drug Development Decisions
9:45 – 10:15
Susana N. Zaph, Sanofi
Doing More with Less: QSP Modeling Strategies for Rare Disease Drug Development
10:15 – 10:30
Sarah DiBartolo
Portfolio Prioritization with Discovery-stage Biosimulation
10:30 – 11:00
Morning break
11:00 – 11:30
Jae Kim, Septerna
Coming soon
11:30 – 12:00
Benjamin Lee, Crossbow
Mechanistic Pharmacokinetic/Pharmacodynamic Modeling to Support First-In-Human Dose Selection for CBX-250, a novel TCR-mimetic T-cell Engager Bispecific Antibody
11:30 – 12:00
Tiernan O’Malley, Prime Medicine
Coming soon
12:30 – 1:00
Joshua Apgar
Certara IQ™: QSP at Scale
1:00 – 2:00
Lunch and learns
2:00 – 3:30
Afternoon session
2:30 – 3:30
Moderator: Piet van der Graaf
Panel Discussion
3:30 -3:45
Piet van der Graaf
Closing
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.
