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Thursday, November 21 • 9:55am - 10:15am
Enabling New Medicines: Sampling and Consent Management to Support Complex Biomarker Research in CAR T Cell Clinical Trials

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This talk will review complexity of CAR T cell clinical trials, with focus on the biomarker and exploratory research that is inherent to such trials and sampling required to support such research.  In the context of allogeneic CAR T trials, there is interest in understanding patient, tumor and T cell donor attributes that are associated with efficacy or safety.  Thus sampling and research plans are quite complex.  In trials with complex biomarker endpoints, the ability to achieve a globally acceptable informed consent is a challenge, and one that must be addressed so as to preserve the ability to generate robust data across the entire trial population.  The ICH E18 Guidance was developed in part to harmonize guidance and expectations on the conduct of genomic research within clinical trials.   Some elements of this Guidance will be discussed.

avatar for Rebecca Blanchard, Ph.D.

Rebecca Blanchard, Ph.D.

Vice President, Translational Pharmacology, CRISPR Therapeutics, Cambridge, MA
Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research and development across multiple therapeutic areas.  She is currently Vice President of Translational Pharmacology at CRISPR Therapeutics where she is responsible for Safety Toxicology... Read More →


Rose Gonzales

Director, Pfizer

Thursday November 21, 2019 9:55am - 10:15am EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

Attendees (1)