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Designing a Biomarker Program for your Cell Therapy

Monday, 21 April 2014 at 09:15

Add to Calendar ▼2014-04-21 09:15:002014-04-21 10:15:00Europe/LondonDesigning a Biomarker Program for your Cell TherapyClinical Translation of Stem Cells 2014 in Palm Springs, California, USAPalm Springs, California, USASELECTBIOenquiries@selectbiosciences.com

Biomarker programs can support many decision in product development and cell therapy is no exception.  This presentation describes the preclinical and early development biomarker program designed to monitor disease activity and response to treatment for an ocular cell therapy.  The biomarker program is designed to support approvable primary functional endpoints, surrogate, and exploratory biomarkers.  Although cell therapies can create a new set of challenges, they are being developed in whitespaces allowing for new, distinctive, and quantitative biomarkers.  Finally, integrated biomarker strategies can enhance our understanding of disease processes and support clinical development of novel cell therapies.