開催日: 2026年3月26日 (木曜日)
開催時間: 3-4pm (JST) and 10-11am (CET)
関連ソフトウェア： Certara IQ™, Phoenix®, Simcyp® PBPK Simulator
概要
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.
お申込みはこちら
Fran Brown, PhD
Vice President, Global Head, Drug Development Scienceグローバル医薬品開発における創薬早期から承認申請、市販後に至るフェーズの中で戦略策定とオペレーションに25年以上従事した経験を有します。戦略的な創薬および開発計画の幅広い知見を有し、開発戦略やモデルを活かした医薬品開発の活用に特に重点的に取り組んでいます。
Piet van der Graaf
Senior Vice President, Head of QSPPiet 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. CPTの創刊編集長であり、Pharmacometrics & Systems Pharmacology before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Pietはロンドン大学キングス・カレッジにてノーベル賞受賞者サー・ジェームズ・ブラックのもとで臨床医学の博士課程を修了し、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). 英国薬理学会のフェローに選出されており、これまで定量的薬理学および医薬品開発の分野にて250本以上の論文を発表しています。
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.
お申込みはこちら
