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Personalized Medicine Approaches During Early-Phase Clinical Research
Session Chair(s)
David J Pepperl, PhD
Senior Consultant and Nonclinical Group Leader
Biologics Consulting, United States
Recent advances in molecular screening, gene sequencing and microarray technology have not only accelerated the identification of novel biomarkers, but are also rapidly revolutionizing the field of personalized medicine, particularly in the oncology arena. As an example, next-generation sequencing is routinely used in early-phase clinical research for the detection of genetic mutations that are associated with disease. Using these novel methodologies, potentially significant mutations and biomarkers can be distinguished from those that are less likely to be significant at an early stage of development. Specifically, this session will discuss some of the novel approaches currently being used to identify and qualify novel biomarkers for tumor targeting and efficacy. Case examples highlighting the clinical use of novel biomarkers will also be presented. Finally, a number of the regulatory concerns and challenges in leveraging novel biomarker technology for early clinical development will also be discussed.
Learning Objective : Identify cutting-edge methods for shifting through genomic data to identify mutations that have the most potential for clinical significance; Describe some real-word applications of biomarker technology in early clinical development; Discuss the regulatory implications of utilizing biomarkers in drug development.
Speaker(s)
From PDX to the Clinic: A Biomarker Story
Pavan Kumar, PhD
H3 Biomedicine, Inc., United States
Director of Biomarkers and Companion Diagnostics
Regulatory Considerations for Companion Diagnostic Development
Sabah Malek
Eisai Inc., United States
Director, Regulatory Affairs, Oncology Business Group
Biomarkers as an Integral Part of Modern Drug Discovery and Development
Jannik N. Andersen
Xios Therapeutics, United States
Vice President, Head of Research
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