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Enabling Next Generation Sequencing Within Global Clinical Trials
Session Chair(s)
Sabah Malek
Director, Regulatory Affairs, Oncology Business Group
Eisai Inc., United States
As targeted therapies are being increasingly developed by pharmaceutical companies, there is a keen interest in identifying and stratifying patients by genetic alterations. Next generation sequencing can provide this and the ability to potentially screen high volumes of patients to be matched to trials. However, the use of next generation sequencing within these clinical trials provides its own set of challenges, including actionability of genomic information, use of local testing, utilization within clinical trials, and regulatory hurdles. All of these considerations covered within the session can influence a program’s clinical strategy and design.
Learning Objective : Recognize the paradigm shift which clinical trials are undergoing through the availability of characterizing cancers by molecular diagnostics; Discuss the various clinical trial design options and challenges which will help generate data to support simultaneous global market authorizations for both medicinal and potential diagnostic products.
Speaker(s)
Enabling Next Generation Sequencing within Global Clinical Trials: Clinical and Regulatory Concerns
Sabah Malek
Eisai Inc., United States
Director, Regulatory Affairs, Oncology Business Group
Impact of Local Testing in a Targeted Therapy Setting with Companion Diagnostic Development
Douglas Robinson, PhD
Novartis Institutes for BioMedical Research (NIBR) , United States
Global Head, Biomarkers and Diagnostics Biometrics
FDA Perspective
Jennifer S. Dickey, PhD
FDA, United States
Regulatory Reviewer, Office of InVitro Diagnostics and Radiological Health, CDRH
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