Clinical Development and New Product Introduction Subcommittee
Charter
To serve as a network hub for connecting industry, regulatory agencies, therapeutic societies and translational centers to advance emerging cellular therapies.
Objectives
- To track the status of advancing stem cell therapies and identify roadblocks and solutions to further commercialization
- To organize workshops and forums in emerging cell based therapies in order to inform industry and capital investors towards accurate risk analysis in commercial trials
- To expose global regulatory agencies to open debate around standardized pre-clinical models and safety assessment in specific disease areas
- To work with ISCT committees and membership to provide physicians with sufficient characterization and potency information to distinguish similar stem cell types relative to patient safety and benefit
Priorities
- To create relationships with ISCT stem cell and therapeutic area committees to prototype workshop and key opinion leader forums
- To work with the ISCT Industry Community to prioritize commercialization objectives, and to hold forums in two global areas within first year of activity
- To engage therapeutic society members to join ISCT, the Commercialization Committee and new Therapeutic Area Committees for the purpose of organizing KOL workshops and forums
- To identify new relationships with regenerative medicine companies and institutional stem cell centers.
Key Benchmarks 2011
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Stage therapeutic area Webinar, Focus Group and Workshops: |
September |
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Benchmark and reach publication expectations from workshops including publication in Cytotherapy |
September to March 2012 |
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Integrate Industry Community perspectives and prioritize 2011, 2012 themes |
July |
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Initiate Webinar Series on product, process platforms in Australia, Asia |
June |
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Solve for integration of Regulatory Agencies, utilizing ISCT LRAs and public forums; Bring discussion topics from Therapeutic workshops into public meetings with global Regulatory agencies |
September |
