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Cancer immunotherapy-regulatory challenges for clinical studies
5th International Conference and Exhibition on Cell and Gene Therapy
May 19-21, 2016 San Antonio, USA
Bridget Heelan
Parexel International, UK
Posters & Accepted Abstracts: J Stem Cell Res Ther
Abstract:
Some of the challenges relating to proof of concept, immune monitoring, patient section and clinical endpoints when developing therapeutic cancer vaccines will be discussed. While the expected main mechanism of action of cancer immunotherapy differs from standard chemotherapies, the need to show a clinically relevant benefit remains the ultimate goal of treatment. When one of the mechanisms of action can be shown, this aids in biomarker identification, proof of concept studies and dose finding. Some of the challenges in interpreting results from immune monitoring will be highlighted. The need for adequate proof of concept studies prior to initiating phase 3 trials will be discussed.
Biography :
Email: bheelan@doctors.org.uk