Are you prepared for the FDA’s phase out of animal tests for mAbs?

Summary

The FDA’s plan to phase out animal testing is a transformative step that paves the way for innovative, human-relevant preclinical approaches that are more predictive, efficient, and ethical. There is a long history at the FDA of using validated new approach methodologies (NAMs), including in silico tools and computational modeling as a framework for regulatory decision-making to support this transition effectively.

As a global leader in Model-Informed Drug Development (MIDD) strategies, Certara is ready to support the industry with a comprehensive offering of advanced modeling tools and development expertise that directly align with the FDA’s vision for the future of drug development.

Watch this webinar to learn how:

Use of NAMs can be integrated into your development programs. Learn the opportunities and considerations for the reduction in animal testing in pre-clinical safety studies made possible by the FDA’s roadmap.

PBPK and QSP models simulate monoclonal antibody behavior across diverse populations and disease states without relying on preclinical animal models.

Pharmacometric and PK/PD analyses inform dose selection, optimize trial design, and reduce uncertainty in first-in-human studies thru late-stage development.

Real-world evidence strategies complement modeling and simulation by providing context-rich insights into patient safety and efficacy, disease progression, and treatment outcomes.

"For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use.”

FDA Commissioner Martin A. Makary, M.D., M.P.H.
FDA Press Release

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Speakers:

Fran Brown, PhD

Senior Vice President, Certara Drug Development Solutions

Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing. She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).

Geoff Fatzinger

Vice President, Regulatory Strategy, Certara

Geoff brings 20+ years of expertise and a demonstrated record of regulatory and business accomplishments covering the United States, Europe, Asia Pacific (with in depth experience in Japan, China, and Korea), and Middle East having lived and worked in many countries championing regulatory affairs.

Hannah Jones, PhD

SVP, Head of Simcyp PBPK Modeling Services

Hannah has over 20 years of experience in global pharmaceutical organizations, possessing a particularly strong background in PBPK and PKPD modeling. She has over 70 publications in PBPK/PKPD modeling and other DMPK related topics, and considerable experience influencing drug research and development programs through modeling and simulation.

Patrick Smith, PharmD

SVP, Translational Science, Certara

Dr. Patrick F. Smith is SVP, Translational Science, Certara, where he leads a global team of drug development scientists and regulatory strategy that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. With more than 20 years of drug development experience, Patrick has worked across all phases of drug development with deep expertise in infectious diseases, oncology, and inflammation as well as novel early development program design and applying modeling and simulation to solve critical development problems.

Piet van der Graaf, PharmD, PhD

Senior Vice President and Head of Quantitative Systems Pharmacology

Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King’s College London. He has been awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >200 articles in the area of quantitative pharmacology and drug development.

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.