title: Commercialization of cellular immunotherapies for cancer.
abstract: Successful commercialization of a cell therapy requires more than proving safety and efficacy to the regulators. The inherent complexity of cellular products delivers particular manufacturing, logistical and reimbursement hurdles that threaten commercial viability for any therapy with a less than spectacular clinical profile that truly changes the standard of care. This is particularly acute for autologous cell therapies where patients receive bespoke treatments manufactured from a sample of their own cells and where economies of scale, which play an important role in containing the production costs for small molecule and antibody therapeutics, are highly limited. Nevertheless, the promise of 'game-changing' efficacy, as exemplified by very high levels of complete responses in refractory haematological malignancies, has attracted capital investments on a vast scale, and the attendant pace of technology development provides promising indicators for future clinical and commercial success.
authors.affiliation: Alacrita LLP, 2 Royal College Steet, London NW1 0NH, UK awalker@alacrita.com.
authors.forename: Anthony
authors.initials: A
authors.lastname: Walker
authors.affiliation: Alacrita LLC, Cambridge Innovation Center, Kendall Square, Cambridge MA 02142, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Johnson
mesh_terms: D003132:Commerce / Q000458:organization & administration*; D016527:Drug Costs; D004345:Drug Industry / Q000458:organization & administration*; D006801:Humans; D007167:Immunotherapy; D009369:Neoplasms / Q000628:therapy*; D012051:Reimbursement Mechanisms
keywords: CAR-T; cellular therapy; immunotherapy; oncology; solid tumours