- About ABC
- COVID-19 and the Brain
- Contact Us
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 central nervous system (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 of patients living with CNS disorders.
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 in leveraging these tools to bring products to market. 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 potential solutions.
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.
More About the Problem
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
Articles Articulating the Problem
Volume 20, Number 5 – September/October 2018
Analysis & Insight into Critical Drug Development Issues
Neuron. 2014 Nov 5;84(3):554-63. doi: 10.1016/j.neuron.2014.10.027. Epub 2014 Nov 5.
Clin Pharmacol Ther. 2010 Mar;87(3):272-7. doi: 10.1038/clpt.2009.295. Epub 2010 Feb 3.
Neuron. 2013 Oct 30;80(3):561-7. doi: 10.1016/j.neuron.2013.09.041.
Science 30 Jul 2010:
Imperial College, London, United Kingdom
Int J Neuropsychopharmacol. 2013 Aug;16(7):1687-93. doi: 10.1017/S1461145713000345. Epub 2013 May 7.
American Neurological Association
Neuroscience Investment: Challenges & Outlook. Presentation at the annual Biotechnology Industry Organization meeting.
Munro, J. (2018).
Biostatistics, kxx069. Heem Wong, C., Wei Saih, K., & Lo, A.W. (2018)