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: 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
9:00 – 9:30
Piet van der Graaf
Welcoming remarks
9:30 – 10:00
Vaishali Saharasrabudhe, Pfizer
Keynote: Integrating disease biology, pharmacology and data to inform drug development decisions
10:00 – 10:30
Susana N. Zaph, Sanofi
Doing more with less: QSP modeling strategies for rare disease drug development
Rare‑disease drug development is challenged by small, heterogeneous patient populations that limit traditional trials. QSP mechanistically integrates limited data to characterize variability, support extrapolation, and inform decisions across drug development. This presentation explores examples of QSP models supporting rare disease programs.
10:30 – 11:00
Morning break
11:00 – 11:30
Jae Kim, Septerna
The case for QSP for innovative therapeutics — A sponsor’s perspective
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
CBX-250 has been developed as a novel TCR-mimetic (TCRm) bispecific T cell Engager (TCE) antibody that binds with high affinity to the CG1/HLA-A*02:01 peptide human leukocyte antigen (pHLA) complex. CBX-250 demonstrates potent tumor selective antileukemic activity, and this pharmacological effect is mediated through stimulation of T cells via the formation of a trimolecular (trimer) complex with CD3 on T cells and the CG1 pHLA target on cancer cells. Advancement of CBX-250 into the clinic was supported by a quantitative systems pharmacology (QSP) modeling approach to help guide selection of the starting dose, schedule, and route of administration for CBX-250 first in-human (FIH) studies as well as provide efficacious dose predictions.
Speaker: Benjamin Lee, MD, PhD, Senior Vice President, Head of Translational Medicine, Crossbow
12:00 – 12:30
Sarah DiBartolo
Portfolio prioritization with discovery-stage biosimulation
12:30 – 1:00
Joshua Apgar
Certara IQ™: QSP at scale
1:00 – 2:00
Lunch and learns
2:00 – 2:30
Robert Bondi, Eli Lily
Translational PKPD Modeling for Protein Degraders: Bridging the In Vitro–In Vivo Gap
This presentation demonstrates how translational PK-PD modeling can be used to understand and anticipate adaptive biological responses that limit the durability of protein degradation in vivo. By integrating experimental data with modeling, it highlights how repeat dosing can reshape target biology and why these dynamics are critical to interpreting long-term degradation.
Speaker: Robert Bondi, Senior Director, PBPK/PD Modeling, Eli Lilly
2:30 – 3:30
Piet van der Graaf, Anna Georgieva Kondic, Derek Leishman, Britta Wagenhuber
Panel discussion: What's next for QSP?
Moderator: Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology, Certara
Panelists:
Anna Georgieva Kondic, PhD, VP, Pharmacometrics, Translational Medicine & Clinical Pharmacology, BMS
Derek Leishman, VP, Quantitative and Translational Toxicology, Eli Lilly
Vaishali Saharasrabudhe, Head of Pharmacometrics and Systems Pharmacology in Translational Clinical Sciences, Pfizer
Dr. Britta Wagenhuber, VP, Head of QSP Consultancy, Certara
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.
