日期： 2026 年 3 月 26 日, 星期四
时间： 3-4pm (JST) and 10-11am (CET)
概述
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 Science从药物早期发现到报批和上市后，Fran 在全球战略性和运营性药物开发方面拥有超过 25 年的经验。她在战略性药物发现和开发方面拥有广泛的知识，尤其侧重于发展策略和模型引导的药物开发 (MIDD) 的应用。
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. Piet 于Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet 曾在伦敦国王学院师从诺贝尔奖获得者 Sir James Black，接受了临床医学的博士培训。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 是英国药理学会的当选委员，在定量药理学和药物开发领域发表了超过 250 篇同行评议的论文。
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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