ABCI2 Background

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

January 20-21, 2015 Workshop Agenda

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

Tufts Center for the Study of Drug Development IMPACT Report

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.

Medicines for the mind: policy-based "pull" incentives for creating breakthrough CNS drugs.

Choi DW1Armitage R2Brady LS3Coetzee T4Fisher W5Hyman S6Pande A7Paul S8Potter W3Roin B9Sherer T10.

 

Clin Pharmacol Ther. 2010 Mar;87(3):272-7. doi: 10.1038/clpt.2009.295. Epub 2010 Feb 3.

Trends in risks associated with new drug development: success rates for investigational drugs.

DiMasi JA1Feldman LSeckler AWilson A.

 

Neuron. 2013 Oct 30;80(3):561-7. doi: 10.1016/j.neuron.2013.09.041.

Twenty-five years of progress: the view from NIMH and NINDS.

Insel TR1Landis SC.

 

Is Pharma Running Out of Brainy Ideas?

Greg Miller

Science  30 Jul 2010:
Vol. 329, Issue 5991, pp. 502-504

 

The full cost and burden of disorders of the brain in Europe exposed for the first time

David J. Nutt

Imperial College, London, United Kingdom

 

Int J Neuropsychopharmacol. 2013 Aug;16(7):1687-93. doi: 10.1017/S1461145713000345. Epub 2013 May 7.

The current development of CNS drug research.

Wegener G1Rujescu D.

 

The Burden of Neurological Disease in the United States: A Summary Report and Call to Action (2017).

American Neurological Association

 

Neuroscience Investment: Challenges & Outlook.  Presentation at the annual Biotechnology Industry Organization meeting.

Munro, J. (2018). 

 

Estimation of clinical trial success rates and related parameters.

Biostatistics, kxx069. Heem Wong, C., Wei Saih, K., & Lo, A.W. (2018)

American Brain Coalition

P.O. Box 1549 | Maple Grove, MN 55311 | Phone: (763) 557-2913