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2025 年 5 月 5 日

The Quantitative Systems Pharmacology (QSP) Summit 2025, hosted by Certara, marked another milestone in advancing the future of model-informed drug development. Now in its ninth year, this annual event brought together the thriving QSP community, uniting industry innovators, academics, and thought leaders under one roof to share insights, challenges, and visions for transforming pharmacology with QSP.

With over 100 attendees, the Summit highlighted the growing momentum behind QSP as a vital component of pharmaceutical R&D.

How QSP is Transforming Drug Development

QSP uses computational modeling and experimental data to bridge the gap between biology and pharmacology. By using a quantitative mathematical model, it examines interactions between drugs, biological systems, and diseases, effectively delivering a robust platform for predicting clinical outcomes. The summit spotlighted the extraordinary advancements and adoption of QSP solutions. QSP is no longer an emerging methodology; it is becoming the new standard in drug development. Thanks to increasing regulatory acceptance, cutting-edge AI advancements, and its application in solving complex biological puzzles, QSP is proving to be a game-changer. Users of QSP modeling showcased how QSP is reframing drug development while fostering collaboration and dialogue on its next steps.

Highlights from QSP Summit 2025

Scaling QSP for the Future

Piet van der Graaf, a leading figure in QSP, opened the summit with a deep exploration of how QSP is scaling to reshape the drug development journey. He shared data on the increased number of submissions leveraging QSP models to regulatory bodies like the FDA over the last decade. He also highlighted a pivotal paper by Pfizer estimating that Model-Informed Drug Development (MIDD)—enabled by approaches such as QSP, PBPK, and QST modeling—saves companies $5 million and 10 months per development program.

These figures, though impressive, barely scratch the surface. Beyond cost and time savings, QSP helps companies make crucial decisions earlier in drug development, such as eliminating programs with no realistic chance of success. QSP’s scalability was showcased through diverse case studies, including its applications in neurodegenerative and rare diseases. Each success story underscored QSP’s ability to drive efficiency while delivering precise, actionable insights.

The Power of Understanding Biology

QSP challenges researchers and drug developers to understand biology on a deeper level. It doesn’t simply accept assumptions; it identifies gaps and forces necessary questions to be asked. This rigor results in robust, validated models, prerequisites for effective and innovative pharmacology.

One standout application is hypothesis generation. QSP enables scientists to simulate clinical trial scenarios that are otherwise prohibitively expensive or impractical to test experimentally. This simulation capability not only builds confidence in efficacy projection but also ensures cost efficiency.

Another advantage is scalability. Each QSP model is a repository of knowledge, growing more valuable with every application. Learnings from one therapeutic area or modality can often be applied to others, multiplying cost savings and fostering innovation.

Beyond the First Application

A QSP model’s potential extends far beyond its initial application. Models developed for one reference indication can continue delivering value to subsequent indications, streamlining clinical dosage optimization and strategic decisions. Thanks to this long-term utility, regulators are increasingly endorsing QSP approaches as standard.

Reduce, Refine, and Replace Animal Testing

Further, QSP addresses the limitations of traditional animal models. By aligning with the FDA’s push to reduce, refine, and replace animal testing, QSP- a part of Certara’s Non-Animal Navigator solution– offers predictive, mechanistic alternatives that optimize preclinical safety evaluations.

Innovation on the Horizon

Perhaps most exciting is QSP’s role in enabling virtual patient populations and digital twins. These cutting-edge applications are particularly impactful for rare diseases and pediatric populations, where clinical trials are often unfeasible. Through QSP modeling, drug developers can explore personalized therapies and refine treatments with unprecedented precision, bypassing dose levels that would traditionally require live trials.

Looking to the Future

The success of the QSP Summit 2025 underscores the undeniable value of QSP in the pharmaceutical industry. This isn’t just a tool; it’s a paradigm shift. The collaborative energy and shared insights from the summit are paving the way for continued innovation, ensuring that QSP remains at the forefront of pharmacological science.

Certara is committed to leading this charge, providing the tools, expertise, and community required to drive these advancements forward. The momentum is clear—QSP is shaping the future of drug development in real-time.

Where to Find Us Next

QSP isn’t just the future of pharmacology. It’s happening now, and we invite you to be part of it. Join us at Certainty EU (October 1-2 | Barcelona, Spain) for the next chapter.

For more information about Certara’s QSP solutions and upcoming events, visit Certara’s QSP Services. Together, we’re transforming drug development.

Learn more about Quantitative Systems Pharmacology Consulting

Quantitative Systems Pharmacology (QSP) consulting services at Certara combine computational modeling and experimental data to address complex challenges in drug development.

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