Clinical and Translational Biomarkers in Drug Development Banner

May 18-19

Translational Biomarkers in Drug Development

The Evolving Role of Biomarkers in Quantitative Systems Pharmacology

Lawrence J. Lesko, Ph.D., Clinical Professor and Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida College of Pharmacy

Application of Novel and Conventional Safety Biomarkers in the Development of Epigenetics Drug Candidates in Oncology

Madhu S. Mondal, Ph.D., DABT, Toxicology Project Leader, Drug Safety & Metabolism (DSM), AstraZeneca

Preclinical Early Biomarkers of Doxorubicin-Induced Cardiotoxicity

Varsha Desai, Ph.D., Research Biologist, National Center for Toxicological Research, US Food and Drug Administration

Talk Title to be Announced

Suso Platero, Ph.D., Senior Director, Translational Research Oncology, Janssen Pharmaceuticals

Biomarkers in Clinical Trials

A Novel Design for a Phase III Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker

Robert A. Beckman, M.D., Professor, Oncology, and Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center

Talk Title to be Announced

Rajiv Raja, Ph.D., Director, R&D, Translational Medicine and Genomics, MedImmune

Biomarker Validation and Qualification

Multi-Stakeholder Progress on Biomarker Qualification

John Wagner, M.D., Ph.D., Senior Vice President & Head, Clinical & Translational Sciences, Takeda Pharmaceuticals

Talk Title to be Announced

Carolyn Compton, M.D., Ph.D., Professor, Life Sciences, Arizona State University

Challenges of Validating Biomarkers for Clinical Trial Use

Iman Jilani, Ph.D., Director, Oncology Clinical Assay Group, Early Development, Translational and Immuno-Oncology, Global Oncology, Pfizer