日期： 2026 年 9 月 30 日
时间： 11:30 AM – 2:00 PM
地点： CIC Cambridge, 1 Broadway, Cambridge, MA 02142
Regulators around the world are converging on the same conclusion: MIDD should be a core part of how evidence is built and evaluated across drug development. ICH M15 has established the first harmonized global framework for MIDD, and FDA’s Operation TrialBlazer guidances, including new recommendations for QSP-based dose selection in first-in-human trials, reflect a broader momentum toward formalizing modeling’s role in regulatory decision-making. Taken together, these developments signal growing confidence in MIDD approaches as trusted contributors to the evidence package, not just supporting analyses.
This session brings together three of Certara’s most recognized scientific leaders across Quantitative Systems Pharmacology (QSP), Physiologically-Based Pharmacokinetics (PBPK), and Pharmacometrics for a candid, cross-disciplinary discussion on this momentum, and how sponsors can capitalize on it by building modeling strategies that give them the best chance of success with regulators.
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Piet van der Graaf
Senior Vice President and Head of Quantitative Systems PharmacologyPiet van der Graaf, PharmD, PhD 现任 Certara 公司应用生物模拟高级副总裁，莱顿大学系统药理学教授，以及辛辛那提儿童医院医疗中心儿科教授。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。
Karen Rowland Yeo, PhD
高级副总裁，客户与监管战略部Karen 是 Certara UK Limited 旗下 Simcyp 事业部的客户与监管战略高级副总裁。Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.
Adekemi Taylor, PhD
VP Regional Lead USA, Division 1, Quantitative Science ServicesAdekemi 专注于定量药理学策略与分析（涵盖群体药代动力学、PK/PD、疗效与安全性暴露-效应反应及浓度-QTc 模型构建），以支持监管申报、研究设计与整体药物开发。
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