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Commercialization of Investigational Cell Therapy Products

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Abstract

Over the last several decades, cellular therapies have emerged as novel forms of treatment with potential to benefit patients who currently have limited to no treatment options. Cell therapies have been developed for a wide variety of maladies, including heart disease, neurodegenerative diseases, immunodeficiencies, as well as hematologic and solid cancers. However, due to their substantial complexity compared to small molecules or other biologic drugs, developing and commercializing cell therapies remains difficult. Some commonly identified challenges include maintaining stable funding through lengthy developmental timelines, rigorous regulatory hurdles, scalability and manufacturing concerns, distribution, and unclear reimbursement processes. However, limited commercial successes have not dampened enthusiasm or expectations for the field. Here, we describe examples of cellular therapy products that have been successfully commercialized, as well as the components necessary to achieve commercialization.

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Disclosures

HEH is a co-founder with equity in Allovir and Marker Therapeutics, has served on Advisory Boards for Gilead, Tessa Therapeutics, Novartis, PACT Pharma, and Kiadis, and received research funding from Tessa Therapeutics and Kuur Therapeutics. LCH serves on an Advisory Board for Incyte. AA has no disclosures.

Grant Support

The authors are supported by NIH NCI SPORE in Lymphoma 5P50CA126752, SU2C/AACR 604817 Meg Vosburg T cell Lymphoma Dream Team, and a CPRIT fellowship to AA (RP160283). Stand Up To Cancer is a program of the Entertainment Industry Foundation administered by the American Association for Cancer Research. We also appreciate the support of the shared resources of the Dan L Duncan Comprehensive Cancer Center (P30 CA125123).

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  1. M. D. Anderson Cancer Center, Houston, TX, USA

    Aimaz Afrough

  2. Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital and Texas Children’s Hospital, Houston, TX, USA

    Helen E. Heslop & LaQuisa C. Hill

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  1. Aimaz Afrough
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  3. LaQuisa C. Hill
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Correspondence to LaQuisa C. Hill .

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  1. Texas Children’s Cancer Center, Center for Cell and Gene Therapy, Houston, TX, USA

    Adrian P. Gee

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Afrough, A., Heslop, H.E., Hill, L.C. (2022). Commercialization of Investigational Cell Therapy Products. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_9

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