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Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization

Hassan, S; Huang, H; Warren, K; Mahdavi, B; Smith, D; Jong, S; Farid, SS; (2016) Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization. Regenerative Medicine , 11 (3) pp. 287-305. 10.2217/rme-2015-0034. Green open access

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Abstract

AIMS: Some allogeneic cell therapies requiring a high dose of cells for large indication groups demand a change in cell expansion technology, from planar units to microcarriers in single-use bioreactors for the market phase. The aim was to model the optimal timing for making this change. MATERIALS & METHODS: A development lifecycle cash flow framework was created to examine the implications of process changes to microcarrier cultures at different stages of a cell therapy's lifecycle. RESULTS: The analysis performed under assumptions used in the framework predicted that making this switch earlier in development is optimal from a total expected out-of-pocket cost perspective. From a risk-adjusted net present value view, switching at Phase I is economically competitive but a post-approval switch can offer the highest risk-adjusted net present value as the cost of switching is offset by initial market penetration with planar technologies. CONCLUSION: The framework can facilitate early decision-making during process development.

Type: Article
Title: Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.2217/rme-2015-0034
Publisher version: http://dx.doi.org/10.2217/rme-2015-0034
Language: English
Additional information: Copyright © 2016 Future Medicine Ltd.
Keywords: allogeneic cell therapy manufacture, drug development costs and cash flow, process change
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > UCL School of Management
URI: http://discovery.ucl.ac.uk/id/eprint/1486184
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