Regenerative medicine value systems: navigating the uncertainties

Lead Participant: Biolatris Limited

Abstract

Delivery of tools to navigate the regen med uncertainties.
VALUE has delivered tools for developers, manufactures and funders to understand regulatory requirements, supply chain logistics and reimbursement decision processes. It has also developed innovative models for investment and manufacturing.
Progress of the regenerative medicine industry is currently hindered by a series of uncertainties. The VALUE consortium is a microcosm of the sector and over the past two years has gained an in-depth understanding of, and developed solutions to, many of the market barriers. These relate to uncertainties regarding the regulatory requirements, how regenerative medicines are adopted by the NHS and Bupa, the need for adequate levels of funding and the need to understand the impact of the costs associated with manufacturing and product supply.
The VALUE Consortium has delivered the following tools and models:
• PAS83 – legislation and guidance for developers
• PAS84 – glossary of terms
• PAS94 – Characterization of human cells for clinical applications
• Navigation tools that aid the teaching and explanation of concepts and issues to the developers
• Bupa has developed and adopted a clinical decision process for regenerative medicines that is also available for adoption by all medical insurers
• Publication of a new ‘How To Why To Guides’ to increase awareness of the NHS adoption pathway for cell therapies
• Recognition of the potential value of regenerative medicines on an additional major industry sector and the potential to raise new finance based on an innovative investment and business model
• A computational model that predicts the cost, associate-risks and bottlenecks inherent in the CBMP development process. This facilitates the ‘’make or buy” decision for developers
• A tool/algorithm to clarify supply chain requirements for all types of cell therapies
• NHSBT has been able to develop a CMO business strategy to optimally serve the national and international regenerative medicine industry
Quote
• “Bringing together key opinion leaders from across the regenerative medicine value chain has been invaluable to understand the issues and constraints and so enable solutions to be developed within a real context” Cathy Prescott Biolatris
• “Having the first ATMP approval makes market adoption challenging. The outputs from VALUE will empower other players in the RM industry to make it too” James Blann TiGenix

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