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Three years ago, the National Academy of Medicine (then the Institute of Medicine) Forum on Neuroscience and Nervous System Disorders, in collaboration with the IOM Forum on Drug Discovery, Development, and Translation, convened a workshop on January 20–21, 2015, to explore policy changes that might increase private sector investment in research and development (R&D) innovation that fills unmet medical needs for CNS disorders. Workshop participants strategized about how to incentivize companies to fortify their CNS drug development programs, shrinking obstacles that currently deter ventures. Representatives from academia, government agencies, patient groups, and industry gathered to share information and viewpoints, and to brainstorm about budget-neutral policy changes that could help widen the pipeline toward drugs that address unmet needs for CNS disorders.
National Academy of Sciences Financial Incentives to Encourage Development of Therapies That Address Unmet Medical Needs for Nervous System Disorders: Workshop Summary – published July 6, 2015
Excerpts from the Workshop Summary
After the workshop, conversations about streamlining the clinical development and review of therapies continued as part of the development and passage of the 21st Century Cures Act. As a result, FDA was armed with much needed tools to modernize their processes. Yet, we find that the neuroscience sector remains at a disadvantage and there has been little movement for policy changes that would specifically incentivize the development of therapies that address unmet needs for people with neurological or psychiatric conditions.
The ABC has made a considerable effort to educate our community on the need to continue these conversations, and through the American Brain Coalition Innovation Initiative (ABCI2), has convened experts to discuss the challenges and identify policy areas of interest in detail.
The ABCI2 Task Force, the body designed to develop the action plan for carrying out the ABCI2’s mission was appointed in the spring of 2017 and has had a number of meetings, both in-person and via conference call, to outline a plan for how to best move the Initiative forward.