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Quality management and outcome evaluation of cellular immunotherapy of cancer
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Abstract:
Among the various available cancer treatment modalities, anti-tumor immune escape is attracting tremendous attention worldwide and has become one of the fast-developing research fields, especially when the anti-prostate cancer vaccine was approved by the FDA and the monocloan antibodies, which targeted PD-1 and CTLA-4, were successfully launched into market. Since 2010, tremendous research progress has been made on cellular immunotherapy of cancer in China. Nevertheless, practically cellular immunotherapy of cancer is facing several challenging issues. Including: 1) how to choose the proper treatment modality and time duration; 2) how to manage the quality control; 3) how to evaluate the treatment outcome; and 4) how to obtain stronger empirical evidence to support the benefits of the treatment. With regard to quality management and outcome evaluation, there exist similarities and differences between cellular immunotherapy and traditional biological and chemical drugs for cancers. Similar to the quality control of biological and chemical treatments of cancer, the quality management of cellular immunotherapy of cancer involves such aspects as the structure of the clinic or center, personnel training and testing program. In contrast, the outcome evaluation of cellular immunotherapy of cancer cannot simply follow the traditional method for biological and chemical cancer therapies. This paper aims to review the recent development in the quality management and outcome evaluation of cellular immunotherapy of cancer, hoping to bring these issues to the attention of peers in China.
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Project Supported:
Project supported by the Natinoal High Technology Reseach and Development Program (863 program) of China, and the Key New Drug Greation and Manufacturing Program of China （No. 2011ZX09102-001）
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