Business models, Reimbursement and COGS Subcommittee
Charter
To define economic aspects of manufacturing and distributing clinical cell products, and the factors that influence reimbursement and use of cell therapy products in routine clinical practice.
Objectives
- Construct a roadmap for early stage cell therapy initiatives – technology transfer, early stage capital or partnering, and development milestones
- Focus on issues related to development of products (Safety and Feasibility) and later stage commercialization of products (Proof of Concept, Pivotal Approval trials)
- Focus on efforts to produce economically feasible, and industrially scalable products
- Define commercialization parameters and establish an educational network in concert with other ISCT groups
Priorities
- Construct web access and discussion forum for overview of reimbursement decisions and policy with a global perspective
- Explore issues related to cost of cell therapy treatment vs. current standard of care:
- Liaise with Therapeutic Area subcommittee and workshops
- Create a directory of global contract manufacturing service providers
- Conduct case study analysis of Cell Therapy Business Models
- Patient designated –e.g. Dendreon
- Universal donor – adherent stem cells
- Regenerative medicine (emerging stem cells) and tissue engineering
- Personalized medicine – iPS and pluripotency
Key Benchmarks 2011
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Expand membership of sub-committee to include consultants in Reimbursement space, financial analysts and venture firms |
March |
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Issue preliminary perspective in Cytotherapy Editorial on Cell Therapy Reimbursement |
June |
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Launch informational document on current policy for reimbursement determination in Europe, NA, and Asia |
June, |
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Launch first of a global workshop series on Cell Therapy Business Models and Reimbursement |
September |
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Issue Manufacturing Guidance Document for COGS: Prototype autologous vs allogeneic manufacturing options with staged cost considerations |
December |
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Web based data base for service providers |
December |
