title: Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  The framework can facilitate early decision-making during process development.
authors.affiliation: Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Gordon Street, London, WC1H 0AH, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Hassan
authors.affiliation: Graduate Institute of Public Affairs & Department of Political Science, National Taiwan University, No. 1, Sec. 4, Roosevelt Road, Taipei, 10617 Taiwan.
authors.forename: Hsini
authors.initials: H
authors.lastname: Huang
authors.affiliation: Cell Processing Technologies, Lonza Walkersville, Inc., 8830 Biggs Ford Road, Walkersville, MD 21793-0127, USA.
authors.forename: Kim
authors.initials: K
authors.lastname: Warren
authors.affiliation: Cell Processing Technologies, Lonza Walkersville, Inc., 8830 Biggs Ford Road, Walkersville, MD 21793-0127, USA.
authors.forename: Behzad
authors.initials: B
authors.lastname: Mahdavi
authors.affiliation: Cell Processing Technologies, Lonza Walkersville, Inc., 8830 Biggs Ford Road, Walkersville, MD 21793-0127, USA.
authors.forename: David
authors.initials: D
authors.lastname: Smith
authors.affiliation: Department of Management Science & Innovation, University College London, Gower St, London, WC1E 6BT, UK.
authors.forename: Simcha
authors.initials: S
authors.lastname: Jong
authors.affiliation: Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Gordon Street, London, WC1H 0AH, UK.
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Farid
mesh_terms: D064591:Allografts; D064987:Cell- and Tissue-Based Therapy / Q000191:economics*; D003365:Costs and Cost Analysis; D004353:Drug Evaluation, Preclinical / Q000191:economics*; D006801:Humans; D018803:Models, Economic; D033581:Stem Cell Transplantation / Q000191:economics*; D013234:Stem Cells
keywords: allogeneic cell therapy manufacture; drug development costs and cash flow; process change