Applied Clinical Trials

June 7, 2016

By Bruce Bloom, JD, DDS

There are over 7,000 “unsolved” diseases for which patients have no universally successful treatment. There are also thousands of generic drugs that can be repurposed to help these patients. Built on knowledge from scientific discoveries, anecdotal evidence, and/or bioinformatics, generic drug repurposing research can often lead to quick and affordable development of “new” medical solutions. Once a generic drug repurposing opportunity has been identified, a key issue is whether the clinical trial validation should focus on supporting a path to commercialization or to physician off-label use. The direction of focus depends on the entity supporting the clinical trial development.

Development entities that support generic drug repurposing clinical trials are either commercial or philanthropic. When thinking about outcomes, commercial entities (pharma, biotech, financial investors) typically focus on financial and shareholder value, while philanthropic entities (patient advocacy groups, foundations, individual philanthropists, government) primarily focus on patient impact.

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