|Nearly one-third of the U.S. population is affected by at least one of more than 1,000 diseases that affect the brain and nervous system. The nine most common brain diseases cost Americans an estimated $789 billion per year, a figure that is projected to increase sharply as the elderly population doubles from 2011 to 2050.
Neurological and psychiatric conditions can only be better treated when new discoveries and advancements are translated into life-changing interventions. However, private investment in neuroscience R&D continues to decline. For example:
•A recent study found that the number of central nervous system (CNS) program portfolios at large pharmaceutical companies decreased from 267 to 129 over 5 years (2009 to 2014).
•Venture funding for novel drug R&D decreased by 56 percent for psychiatry and 39 percent for neurology in two 5-year periods (2004–2008 versus. 2009–2013), compared to a less than 5 percent decline for oncology.
•Clinical trials plus Food and Drug Administration (FDA) review time for new treatments for central nervous system (CNS) disorders take an average of 32.1 months longer than non-CNS drugs.
•Furthermore, the etiology of brain-related disorders is inherently difficult.
In 2015, the National Academy of Medicine (NAM) took on this serious issue of declining investment in developing new treatments for neurological and psychiatric diseases. The NAM Committees that led the effort recommended that an organization such as the American Brain Coalition (ABC) work to identify and advocate for policy solutions that would incentivize companies to recommit to neuroscience R&D.
ABC is uniquely positioned to do this work, representing more than 100 organizations consisting of patient organizations, professional neuroscience societies, academic institutions, and neuroscience-interested industry. ABC members can credibly speak to the need, access thought leaders in this area, and provide a powerful voice to the patients calling for new and better treatments for neurological and psychiatric conditions.
•Utilize data and research to raise awareness among stakeholders and decision-makers about the crucial necessity to reverse the decline in private investment in brain research.
•Advocate for the legislative, regulatory and other policy changes that will reduce the barriers to R&D for neurological and psychiatric conditions, and provide incentives for increased investment in these areas.
The ABC Innovation Initiative (ABCI2) Task Force has agreed on the importance of involving the FDA. Dr. Scott Gottlieb, FDA Commissioner, released a set of guidance documents for industry — each of which addresses a specific problem concerning neuroscience research and development. We have drafted a response to the guidance documents, and are now working to arrange a meeting with him and relevant colleagues to discuss our response and to introduce the ABC Innovation Initiative.
Financial Incentives to Support Unmet Medical Needs for Nervous Systems Disorders
The Institute of Medicine (IOM) 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.
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
ABC Innovation Initiative Overview
The ABC has established the Innovation Initiative (“ABCI2”), a collaborative program to stimulate private investment in brain-related research, and strengthen the entire research and development system for expedited translation of neuroscience research into life changing therapies and cures. This ABC premier advocacy effort is comprised of key stakeholders within the brain community, including patient advocacy groups, organizations representing health professionals, and pharmaceutical research and manufacturers, collaborating to advance policy positions, legislation and regulations that will strengthen the incentives of for-profit entities to invest in neuroscience research – positively impacting brain disorders.