QSP at an Inflection Point: Scaling Impact

A defining highlight of the QSP Summit at Certainty was the Certara IQ demonstrations, which consistently drew strong engagement from attendees. Beyond enabling faster modeling, IQ stood out for its regulatory-ready foundation, bringing together models, data, and decision-making in a way that meets the demands of GxP environments and regulatory review. By connecting models, data, and decision-makers in a unified platform, IQ enables teams to:

• Rapidly explore “what-if” scenarios
• Build and reuse models with greater transparency
• Deliver insights in time to influence critical decisions
• Maintain traceability and auditability for GxP use

More importantly, Certara IQ signals a broader transformation: democratizing QSP so that all users can directly engage with mechanistic insights. The result is not just faster modeling, but better, more connected decisions across the organization.

Piet van der Graaf opens the QSP Summit, welcoming the entire QSP community and reflecting on how QSP has grown from being the new-kid-in-town to a must-have for drug development companies. Piet reminds us of why each of us is joined here at the summit – the patient. A moving video from Certara’s QSP modeler, Ellen Swanson, sharing her own patient story, reminded attendees of the deeper “why” driving their work. In Ellen’s own words, “Just increasing the length of life is not good enough.”

Vaishali Saharasrabudhe, Head of Pharmacometrics and Systems Pharmacology at Pfizer, emphasizes that integration of biology and pharmacology is key for building successful therapies. QSP is now firmly embedded within Model-Informed Drug Development strategies, delivering tangible value in the form of reduced timelines, lower costs, and improved probability of success. The evolution from siloed modeling efforts to integrated, end-to-end decision support reflects a broader shift toward quantitative, strategy-driven drug development.

Susana Zaph, Head of QSP at Sanofi, took the stage with a focus on the impact of QSP on rare diseases development. In rare diseases, where data is limited and variability is high, QSP-based Virtual Twin methods are enabling new ways to interpret clinical data and support extrapolation. By embedding diverse datasets into mechanistic models, these approaches help bridge gaps between populations and strengthen regulatory confidence.

Jae Kim, Chief Medical Officer at Septerna, built a case for QSP modeling as it makes an impact on emerging and innovative therapies. As new therapeutic modalities arise, mechanistic modeling is playing a critical role in linking pharmacology to clinical outcomes. QSP provides a quantitative narrative for dose selection and benefit-risk assessment, supporting stronger and more transparent regulatory interactions.

Benjamin Lee, Senior VP and Head of Translational Medicine at Crossbow Therapeutics, comes on stage to share a case study, where mechanistic modeling supports first in human dose selection for a T-cell engager (TCE). For complex therapies like TCEs, QSP is enabling more informed and efficient first-in-human strategies. By incorporating mechanistic understanding early, teams can move beyond overly conservative approaches toward dose selection that is both safer and closer to efficacious ranges.

Sarah DiBartolo, Associate Principal Scientist at Certara, shared the power of applying QSP modeling at as early as discovery stages. QSP is increasingly influencing decisions before molecules are even created. Discovery-stage biosimulation allows teams to evaluate pharmacological feasibility early, enabling faster prioritization, reduced risk, and more efficient allocation of resources.

Josh Apgar, VP and Head of QSP Software at Certara, followed with an overview of Certara’s AI-enabled QSP modeling tool, Certara IQ. The integration of AI into QSP workflows is transforming how quickly and effectively models can be built and applied. Platforms like Certara IQ are enabling collaborative, scalable, and decision-ready modeling environments, addressing execution of bottlenecks and expanding access beyond specialized experts.

Robert Bondi, Senior Director of PBPK/PD Modeling at Eli Lilly, helps wrap up the summit with the much-anticipated discussion on protein degraders. For emerging modalities like protein degraders, translational modeling is essential to understand how in vitro findings translate in vivo. Incorporating biological feedback mechanisms reveals key drivers of efficacy and highlights the importance of designing molecules that can overcome dynamic biological responses.

The closing panel brought together diverse perspectives on the future of QSP, with discussions spanning regulatory strategy, AI, and emerging methodologies.

The introduction of ICH M15 as a global standard for MIDD was recognized as a major milestone, signaling that QSP is now firmly embedded in regulatory science. Panelists emphasized that this creates both opportunity and responsibility:

• The need for clear, fit-for-purpose modeling strategies aligned with development goals
• The importance of transparency, reproducibility, and defined context of use
• A growing emphasis on quantitative planning as a cross-functional effort

AI was widely viewed as an accelerator, but not a replacement, for scientific thinking. The discussion highlighted a shift in focus:

• From building tools → to applying tools strategically to drive decisions
• From execution-heavy work → to higher-value scientific and strategic contributions

AI is already impacting areas like toxicology, target identification, and patient stratification, helping teams move faster while bridging data gaps.

Derek Leishman helped frame the bottom line: “A NAM without a model is an assay without ambition.” Panelists emphasized that New Approach Methodologies (NAMs) will deliver the most value when integrated into modeling frameworks.

• Models elevate NAMs from standalone assays to decision-making tools
• Combining NAMs with QSP/QST and traditional approaches enables more comprehensive, mechanistic understanding
• Integrated strategies are key to advancing both efficacy and safety insights

The QSP Summit at Certainty US reinforced a pivotal shift: QSP is no longer emerging but operationalizing at scale.

With growing regulatory alignment, advances in AI-enabled platforms like Certara IQ, and increasing integration across the drug development lifecycle, QSP is positioned to become a central pillar of modern R&D strategy. We can’t wait to bring together this amazing, growing group of QSP leaders and enthusiasts again next year.