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Cytotherapy. 2020 Mar 18. pii: S1465-3249(20)30034-7. doi: 10.1016/j.jcyt.2020.01.014. [Epub ahead of print]

Accelerating the development of innovative cellular therapy products for the treatment of cancer.

Author information

1
Friends of Cancer Research, Washington, DC, USA. Electronic address: mstewart@focr.org.
2
Lyell Immunopharma, San Francisco, California, USA.
3
Parker Institute for Cancer Immunotherapy, San Francisco, California, USA.
4
University of Pennsylvania, Philadelphia, Pennsylvania, USA.
5
Legend Biotech, Piscataway, New Jersey, USA.
6
Juno Therapeutics, A Bristol-Myers Squibb Company, Seattle, Washington.
7
Arsenal Biosciences, South San Francisco, California, USA.
8
Novartis Pharmaceuticals, Rockville, Maryland, USA.
9
PACT Pharma, South San Francisco, California, USA.
10
Genentech, A Member of the Roche Group, Washington, DC, USA.
11
Friends of Cancer Research, Washington, DC, USA.
12
Parker Institute for Cancer Immunotherapy, San Francisco, California, USA; University of California San Francisco, San Francisco, California, USA.

Abstract

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.

KEYWORDS:

cell therapy; clinical development; manufacturing; regulatory policy; t-cell–based therapies

PMID:
32199724
DOI:
10.1016/j.jcyt.2020.01.014
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Conflict of interest statement

Declaration of Competing Interest Jeff Bluestone is employed by Sonoma BioTherapeutics, a Treg cell therapy company, and reports grants and personal fees from Juno, non-financial support from Becton Dickenson, and has several issued and pending patents. Lisa Butterfield received consulting honoraria from Calidi Biotherapeutics, SapVax, NextCure, Replimmune, Western Oncolytics, Torque Therapeutics and Phyxis Oncology and has stock options in Calidi Biotherapeutics, NextCure and Phyxis Oncology. Ramy Ibrahim is an observer on the board of directors for Lyell Immunopharma and serves on the Scientific Advisory Board for Bit Bio. Michael Kalos is an employee of Arsenal Biosciences and has stock in Arsenal Biosciences and Johnson and Johnson. Anne Keane is employed by Lyell Immunopharma. Chin Koerner is employed by Novartis. Ann Lee is employed by Juno Therapeutics, A Bristol Myers Squibb Company. Bruce Levine is on the Scientific Advisory Board for Avectas, Brammer Bio, Incysus, CRC Oncology/Cure Genetics, Vycellix and Ori Biotech, received consultancy fees from Brammer Bio, Incysus and CRC Oncology/Cure Genetics, has patents and royalties with and received research funding from Novartis Pharmaceuticals Corporation and holds equity ownership in and received research funding from Tmunity Therapeutics. Ingrid Markovic is employed by Genentech. Tim Moore is employed by PACT Pharma. Chris Ramsborg is employed by Juno Therapeutics, A Bristol Myers Squibb Company. Bruce Thompson is an employee of Lyell Immunopharma. Yuan Xu is employed by Legend Biotech and currently owns equity in Merck.

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