ADC First-in-Human Dose Selection

日期： 2026 年 2 月 17 日, 星期二

时间： 11am - 12pm EST

Part 1 of a 3-Part CHI Series

Services: Pharmacometrics, Model-Based Meta-Analysis, Modeling and Simulation Services, Drug Development Services, regulatory

产品： Certara IQ™, Phoenix®, D360™

CHI ADC Webinar

Antibody drug conjugates (ADCs) present distinct challenges in first-in-human (FIH) dose selection due to their structural complexity, narrow therapeutic windows, and evolving regulatory expectations. As the ADC landscape continues to mature, sponsors must integrate translational science, mechanistic modeling, and regulatory strategy to confidently define safe and informative starting dose ranges and set development teams up for successful entry into the clinic.

In the first webinar of our 3-part CHI ADC series, Certara leaders Fran Brown, Piet van der Graaf, and Helen-Marie Dunmore will guide attendees through the current ADC landscape, key lessons from recent successes and failures, and best practice approaches to FIH dose range selection. The session will demonstrate how mechanistic modeling approaches, including physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP), can be applied alongside translational PK and PD to support regulatory-ready FIH packages.

Attendees will gain practical insight into aligning scientific rigor with nonclinical regulatory expectations to reduce early development risk, enable confident first-in-human transitions, and support more informed dose selection decisions for ADC programs.

Key Learning Objectives:

Understand why ADCs differ from other modalities, including the nuances that impact first-in-human development
Learn from recent ADC successes and failures, and how drug–antibody ratio (DAR) and narrow therapeutic windows influence FIH dose decisions
Recognize ADC-specific dose selection challenges that extend beyond traditional small-molecule and biologic approaches
Set teams up for a successful first-in-human transition through the right nonclinical strategy and informed dose selection
See how PBPK, QSP, and translational PK/PD can be applied to define safe starting doses and efficacious dose ranges
Align FIH dose strategies with nonclinical regulatory expectations to build stronger, submission-ready packages

Who should attend?

This webinar is intended for professionals involved in oncology and ADC drug development, including leaders and scientists in clinical pharmacology and pharmacometrics, translational and early development, clinical and regulatory strategy, as well as those supporting QSP, toxicology, PBPK/DDI, market access, and portfolio or program strategy.

演讲嘉宾：

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 Pharmacology

Piet 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 Solutions

Helen-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.

CHI ADC 网络研讨会：开局稳健·收官强劲：抗体-药物偶联物（ADC）研究成功之道

CHI ADC Webinar

Key Learning Objectives:

Who should attend?