Bringing regenerative medicines to the clinic: The future for regulation and reimbursement

Tania Bubela, Christopher McCabe, Peter Archibald, Harold Atkins, Steven Bradshaw, Panos Kefalas, Michelle Mujoomdar, Claire Packer, James Piret, Mike Raxworthy, Marta Soares, Sowmya Viswanathan

Research output: Contribution to journalReview articlepeer-review

40 Citations (Scopus)


Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.

Original languageEnglish
Pages (from-to)897-911
Number of pages15
JournalRegenerative Medicine
Issue number7
Publication statusPublished - Oct 2015
Externally publishedYes


  • access with evidence development
  • adaptive licensing
  • advanced-therapy medicinal products
  • cost-effectiveness modeling
  • horizon scanning
  • patent landscaping
  • regenerative medicine
  • regulation
  • reimbursement
  • value of information


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