Tailwinds for MIDD: What to Know About the Changing Regulatory Landscape

Piet van der Graaf, PharmD, PhDは、サターラのApplied BioSimulation担当シニアバイスプレジデントであり、 Leiden University システム薬理学教授、 Cincinnati Children’s Hospital Medical Center 小児科教授を務めています。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。

Karen Rowland-Yeo is Senior Vice President of Client & Regulatory Strategy at Certara UK Ltd. She has over two decades of experience applying PBPK models in both global health and drug development and is currently focused on driving advancement of PBPK modeling in child and maternal health. Prior to her current role, Karen was Head of PBPK Consultancy Services at Certara UK Ltd, where she led a core team of scientists engaged in consultancy projects relating to the application of PBPK modeling in drug development and drove development of best practices while working directly with global regulators to gain acceptance of PBPK models. Karen has authored or co-authored more than 100 publications in peer-reviewed journals spanning clinical pharmacology, drug metabolism, and drug-drug interactions, and is frequently invited to speak at international meetings in the field. In 2023, Karen was awarded the Roger Jelliffe Individualized Therapy Award by the American College of Clinical Pharmacology (ACCP), in recognition of her contributions to personalized medicine through model-informed precision dosing. In 2024, she chaired the Scientific Program Committee for the ASCPT Annual Meeting and served as Deputy Editor-in-Chief of CPT:PSP; in October 2025, she took over the helm as Editor-in-Chief of Clinical Pharmacology & Therapeutics.

Adekemi氏は、薬理学的戦略および解析（母集団PK、PK/PD、有効性および安全性の暴露-反応、濃度-QTcモデリングを含む）を専門とし、薬事申請、試験デザイン、一般的な医薬品開発を支援します。