Putting a price tag on novel autologous cellular therapies

Mohamed Abou-El-Enein, Gerhard Bauer, Nicholas Medcalf, Hans Dieter Volk, Petra Reinke

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

Cell therapies, especially autologous therapies, pose significant challenges to researchers who wish to move from small, probably academic, methods of manufacture to full commercial scale. There is a dearth of reliable information about the costs of operation, and this makes it difficult to predict with confidence the investment needed to translate the innovations to the clinic, other than as small-scale, clinician-led prescriptions. Here, we provide an example of the results of a cost model that takes into account the fixed and variable costs of manufacture of one such therapy. We also highlight the different factors that influence the product final pricing strategy. Our findings illustrate the need for cooperative and collective action by the research community in pre-competitive research to generate the operational models that are much needed to increase confidence in process development for these advanced products.

Original languageEnglish (US)
JournalCytotherapy
DOIs
StateAccepted/In press - Mar 14 2016

Keywords

  • Adoptive T-cell therapy
  • Commercialization
  • Cost of goods
  • Good manufacturing practice
  • Immunotherapy
  • Market adoption
  • Price
  • Regulation
  • Reimbursement
  • Scale-up

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy
  • Oncology
  • Genetics(clinical)
  • Transplantation
  • Cancer Research
  • Cell Biology

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  • Cite this

    Abou-El-Enein, M., Bauer, G., Medcalf, N., Volk, H. D., & Reinke, P. (Accepted/In press). Putting a price tag on novel autologous cellular therapies. Cytotherapy. https://doi.org/10.1016/j.jcyt.2016.05.005