Accelerating the development of innovative cellular therapy products for the treatment of cancer
| Autor: | Mark Stewart, Laura Lasiter, Timothy Moore, Ann Lee, Chris Ramsborg, Jeff Allen, Jeffrey A. Bluestone, Ellen V. Sigal, Bruce L. Levine, Ramy Ibrahim, Chin Koerner, Yuan Xu, Bruce Thompson, Michael Kalos, Lisa H. Butterfield, Anne Keane, Ingrid Markovic |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Parents Cancer Research medicine.medical_specialty medicine.medical_treatment Immunology Cell- and Tissue-Based Therapy Immunotherapy Adoptive Cell therapy 03 medical and health sciences 0302 clinical medicine Cancer immunotherapy Neoplasms medicine Immunology and Allergy Humans Intensive care medicine Child Genetics (clinical) Transplantation business.industry United States Food and Drug Administration Therapies Investigational Cancer Cell Biology medicine.disease Expert group Combined Modality Therapy Chimeric antigen receptor United States 030104 developmental biology Clinical research Oncology Drug development 030220 oncology & carcinogenesis New product development Patient Safety business |
| Zdroj: | Cytotherapy. 22(5) |
| ISSN: | 1477-2566 |
| Popis: | The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US Food and Drug Administration and other agencies worldwide for two types of hematologic cancers. To facilitate the development of these therapies for patients with life-threatening cancers with limited or no therapeutic options, science- and risk-based approaches will be critical to mitigating and balancing any potential risk associated with either early clinical research or more flexible manufacturing paradigms. Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy convened an expert group of stakeholders to develop specific strategies and proposals for regulatory opportunities to accelerate the development of cell therapies as promising new therapeutics. This meeting took place in Washington, DC on May 17, 2019. As academia and industry expand research efforts and cellular product development pipelines, this report summarizes opportunities to accelerate entry into the clinic for exploratory studies and optimization of cell products through manufacturing improvements for these promising new therapies. |
| Databáze: | OpenAIRE |
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