Date: Thursday, March 26, 2026
Time: 3-4pm (JST) and 10-11am (CET)
Products: Certara IQ™, Phoenix®, Simcyp® PBPK Simulator
Summary
Antibody–drug conjugates (ADCs) pose unique challenges for first-in-human (FIH) dose selection because of their structural complexity, narrow therapeutic margins, and increasing regulatory scrutiny. As the ADC field continues to evolve, sponsors need to combine translational science, mechanistic modeling, and regulatory considerations to establish safe and informative starting dose ranges and enable a successful transition into clinical development.
In this webinar, Certara experts Fran Brown, Piet van der Graaf, and Helen-Marie Dunmore will review the current ADC landscape, highlight key learnings from recent successes and failures, and discuss best-practice approaches for FIH dose range selection. The session will illustrate how mechanistic modeling methods, including physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP), can be used together with translational PK and PD to support the development of regulatory-ready FIH packages.
Participants will gain practical insight into how to align scientific rigor with nonclinical regulatory expectations in order to mitigate early development risk, enable confident first-in-human entry, and improve dose selection decisions for ADC programs.
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Fran Brown, PhD
Vice President, Global Head, Drug Development ScienceFran 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).
Piet van der Graaf
Senior Vice President and Head of Quantitative Systems PharmacologyPiet van der Graaf, PharmD, PhD is Senior Vice President Applied BioSimulation at Certara, Professor of Systems Pharmacology at Leiden University, and Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. Previously, he was the Director of the Leiden Academic Centre for Drug Research and held leadership positions at Pfizer in Discovery Biology, DMPK and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology 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 was awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >250 articles in the area of quantitative pharmacology and drug development.
Helen-Marie Dunmore, MSc
Senior Director, Toxicology, Certara Drug Development SolutionsHelen-Marie has 20+ years Regulatory nonclinical experience (IB/IND/CTA/MAA documentation and FDA/EMA/NCA meetings), Early and late-stage nonclinical program design and execution, carcinogenicity, impurity/excipient qualification, 3Rs, thought leader in advanced therapy modalities.
Here is how Helen-Marie can help you:
- Extensive expertise in managing complex non-clinical R&D projects across diverse therapeutic areas, including oncology, gene therapy, and rare diseases, leading to successful marketing authorization applications.
- Strong leadership in providing strategic non-clinical advice for first-in-human clinical trials and regulatory submissions, including guidance for FDA and EMA processes.
- Proven experience at MHRA in reviewing clinical trial applications and optimizing study designs, ensuring effective transition of therapies from research to clinical development.
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