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Translational Medicine / 转化医学early phase trials

Udai Banerji

乌代·班纳吉

MBBS, PhD, FRCP

🏢The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust(英国癌症研究所暨皇家马斯登NHS基金会信托机构)🌐UK

Professor of Molecular Pharmacology; Head, Drug Development Unit分子药理学教授;药物开发部主任

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Udai Banerji, MBBS, PhD, FRCP is Professor of Molecular Pharmacology and Head of the Drug Development Unit at The Institute of Cancer Research (ICR) and The Royal Marsden Hospital, one of the world's leading early-phase oncology centers. Dr. Banerji is an internationally recognized expert in pharmacokinetic/pharmacodynamic (PK/PD) modeling in early-phase oncology drug development, having pioneered the use of pharmacologically guided dose escalation (PGDE) and pharmacodynamic endpoints as key readouts in phase I trials. His work on HSP90 inhibitors—including 17-AAG (tanespimycin) and subsequent generations—established paradigm-shifting approaches for using PD biomarkers (HSP70 induction, client protein degradation) to confirm target engagement and guide dose selection. He leads the ICR/Marsden Drug Development Unit, which conducts over 50 first-in-human and early-phase trials annually. Dr. Banerji has led phase I trials of PARP inhibitors, ATR inhibitors, MDM2 inhibitors, and multiple other DNA damage response agents, contributing foundational PK/PD and translational data to their clinical development. He is co-lead of the CRUK Drug Development Matrix, a national program integrating academic and industry early-phase trial capacity across the UK.

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🧪Research Fields 研究领域

PK/PD ModelingPK/PD建模
Phase I TrialsI期临床试验
HSP90 InhibitorsHSP90抑制剂
Pharmacodynamic Biomarkers药效动力学生物标志物
Drug Development药物开发
Translational Pharmacology转化药理学

🎓Key Contributions 主要贡献

Pharmacologically Guided Dose Escalation (PGDE)

Developed and applied PGDE frameworks integrating real-time PK data and pharmacodynamic biomarker readouts to drive dose escalation decisions in phase I trials, reducing empiricism and improving MTD identification accuracy.

PD Biomarkers for HSP90 Inhibitors

Established HSP70 induction and client protein (HER2, CDK4, AKT) degradation as pharmacodynamic readouts for HSP90 inhibition in clinical samples, providing proof of target engagement in first-in-human trials of 17-AAG and subsequent HSP90 inhibitors.

DNA Damage Response Inhibitor Early Development

Led phase I trials of PARP inhibitors, ATR inhibitors (AZD6738), and WEE1 inhibitors at the ICR/Marsden, generating translational datasets on DNA damage response biomarkers, PK/PD relationships, and synthetic lethality principles in patients.

ICR/Marsden Drug Development Unit

Built and leads one of Europe's most productive early-phase oncology units, running 50+ concurrent first-in-human and phase I trials with integrated translational science, including mandatory tumor biopsies and blood-based PD assays.

Representative Works 代表性著作

[1]

Pharmacodynamic endpoint biomarkers for the heat shock protein 90 (HSP90) inhibitor 17-allylamino-17-demethoxygeldanamycin (17-AAG) in human tumor biopsies

Clinical Cancer Research (2005)

Established the first validated pharmacodynamic biomarker panel for HSP90 inhibition in clinical tumor biopsies, enabling proof-of-target-engagement in phase I trials.

[2]

A phase I/II study of the ATR inhibitor AZD6738 in combination with carboplatin in patients with advanced solid tumors

Journal of Clinical Oncology (2021)

Phase I dose escalation trial of the ATR inhibitor ceralasertib with carboplatin, establishing MTD, PK/PD relationships, and early signals of efficacy in ATM-deficient tumors.

[3]

Pharmacokinetic-pharmacodynamic modeling in cancer drug development

Nature Reviews Cancer (2019)

Comprehensive review of PK/PD approaches in oncology drug development, covering model-based dose selection, biomarker integration, and optimal biological dose determination in phase I trials.

🏆Awards & Recognition 奖项与荣誉

🏆AACR Outstanding Investigator Award
🏆CRUK Senior Cancer Research Fellowship
🏆Royal College of Physicians Fellowship (FRCP)
🏆ICR/Marsden Distinguished Scientist Award

📄Data Sources 数据来源

Last updated: 2026-01-15 | All information from publicly available academic sources

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