Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization. (April 2016)

• Record Type: Journal Article
• Authors: Hassan, Sally; Huang, Hsini; Warren, Kim; Mahdavi, Behzad; Smith, David; Jong, Simcha; Farid, Suzanne S
• Is Part Of: Regenerative medicine. Volume 11:Number 3(2016)
• Page Start: 287
• Page End: 305
• Publication Date: 2016-04
• Subjects: allogeneic cell therapy manufacture -- cost of goods -- drug development costs and cash flow -- process change; Cellular therapy -- Periodicals; Stem cells -- Transplantation -- Periodicals; Degeneration (Pathology) -- Treatment -- Periodicals; Regeneration (Biology) -- Periodicals; 611.018
• DOI: 10.2217/rme-2015-0034
• Languages: English
• ISSNs: 1746-0751

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.