A clinical development paradigm for cancer vaccines and related biologics.

  title={A clinical development paradigm for cancer vaccines and related biologics.},
  author={A. M. Hoos and Giorgio Parmiani and Kristen M. Hege and Mario Sznol and Hans Loibner and A. M. M. Eggermont and Walter J. Urba and Brent A. Blumenstein and Natalie Sacks and Ulrich Keilholz and Geoffrey M. Nichol},
  journal={Journal of immunotherapy},
  volume={30 1},
Therapeutic cancer vaccines are a heterogeneous group of complex biologics with distinctly different clinical characteristics than cytotoxic agents. The current clinical development paradigm used for oncology drug development is based on criteria developed for cytotoxic agents. More flexible and focused developmental guidelines are needed to address the unique characteristics of therapeutic cancer vaccines. Over the course of 1 year, the Cancer Vaccine Clinical Trial Working Group, representing… CONTINUE READING


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