Objective
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Background Rationale
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Description of Project
Dark Horse Consulting, with support from Breakthrough T1D, will provide expert consultative support to a therapeutic company developing a cell replacement therapy consisting of manufactured insulin-producing cells within an immunomodulatory scaffold that could restore glucose control without the need for lifelong immunosuppression.
Anticipated Outcome
Dark Horse Consulting Group will develop a final written report deliverable which will prioritize identified gaps using a two-factor scoring system, provide rationale, and recommended CMC and nonclinical strategies to mitigate high risk gaps with the objective to streamline the companies development path.
Relevance to T1D
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