Thank you for taking the time to consider joining the Neurotechnology Industry Organization (NIO), the first and only trade group that lobbies on behalf of neuroscience-focused companies, brain research institutes, and patient advocacy groups across the spectrum of neurological disease, psychiatric illnesses and nervous system injuries. We are disease agnostic, and inclusive of all therapeutic platforms: drugs, devices, cell-based therapeutics and diagnostics. Our founding thesis is that lifting the burden of brain disease is a unique challenge that can only be met by fostering a dedicated translational and commercial neuroscience ecosystem.
NIO is working on programs that could translate into millions of dollars for your company’s bottom-line and billions of dollars for commercial neuroscience. Your membership is critical to get our legislative initiatives organized and passed.
We must act now to instigate changes that will stimulate neuroscience innovation. With a widening of the “valley of death,” continuing regulatory uncertainty and the growing cost of CNS clinical trials, only NIO is targeted enough to drive specific change that will positively impact organizations involved in commercial neuroscience while being broad enough to garner a wide base of support to push through substantial change. NIO has momentum on our side with over 100 organizations joining us.
If your organization is involved in neuroscience, we ask you to join NIO today to enable us to drive forward on these important initiatives. NIO is spearheading creative and effective legislation focused on accelerating innovation, increasing funding and speeding regulatory approval.
- Neurodegenerative Drug Incentive Initiative Act: A legislative proposal for creating a market exclusivity extension for disease-modifying therapies targeting neurodegenerative diseases which is based on historical precedent of the Orphan Drug Act. Disease modifying therapies take years and hundreds of millions of dollars more to develop than the typical drugs. Many disease modifying drugs currently in development, will have less than 5 years of exclusivity, if and when, they reach the market. This short period of market exclusivity means that many investors and developers are abandoning investment in disease modifying approaches. A guaranteed market-exclusivity period of 10 years would encourage the development of promising treatments that will otherwise not be developed. Learn more.
- NIO/FDA private/public working group: An initiative to work collaboratively with the FDA, in particular under the CDRH Innovation Initiative, to improve the efficiency of the evaluation process for neuroscience products and to increase communication and clarity during the regulatory process.
- Transferable Priority Review Vouchers for Severe and Neglected Brain Diseases: A priority review voucher is an incentive for companies to invest in new drugs and medical devices for severe and neglected diseases of the brain and nervous system. The legislation would authorize the FDA to award a transferable “priority review voucher” to the sponsor (manufacturer) of a newly approved drug, biologic or medical device that targets severe and neglected brain diseases.
- Neurotechnology Defense Initiative: NIO is currently in the early stages of drafting legislation to spur industry involvement with brain-related issues critical to national security. These include the signature injuries of modern warfare - PTSD, traumatic brain injury, tinnitus, and limb loss - as well as new neurotechnologies to improve war-fighting and soldier resilience. This act creates an Office of Neurotechnology within the Department of Defense to direct and centralize neuroscience R&D and provides significant new funding for translational neurotechnology programs.
NIO does more than lobby the Federal government on your behalf. We are in constant dialog with all relevant government agencies about every aspect of our ecosystem. Recent efforts include engagement with FDA around the need to develop and sustain the necessary new expertise needed to evaluate the safety and efficacy of new CNS products. NIO is also working with FDA to define the appropriate public-private partnership for academia and industry to provide input to, and collaborate on, the FDA’s newly announced Regulatory Science agenda as it relates to the brain and nervous system.
NIO is actively participating in a working group aimed at transforming the SBIR program at the National Institute of Neurological Disorders and Stroke (NINDS) from static grant processes to a proactive portfolio management approach. Viewed from this perspective, the NINDS SBIR program is a $240M neuroscience specific fund renewed every seven years. Among our recommendations: Set up a management structure similar to an early stage investment firm; Hire a group of full-time, managers to manage grants, projects and proactive outreach; Allocate more money to jump start innovation, and expedite peer review; Create a new pathway for entities limited by 51% ownership requirement; Develop a diverse advisory board from academia, industry, government, and the investment community to help this important program succeed
Each March, NIO hosts our annual public policy tour in Washington DC that is open to all NIO member executives. For one day we come together up on Capitol Hill to lobby Representatives and Senators on behalf of commercial neuroscience. Meet with your lawmakers and let them know about how your work in commercial neuroscience impacts the lives of their constituents and all Americans. We set up the meetings, and NIO members fly in to help support legislation allocating new funding for neurotechnology and keep our ecosystem top of mind for the legislators with oversight over it.
Each May, NIO hosts its annual Neurotech Investing and Partnering Conference. Organized by NIO in coordination with NeuroInsights, this market defining conference features keynotes on the state of the neurotechnology industry, cutting edge company presentations, and panel discussions on a comprehensive selection of topics of critical interest to commercial neuroscience. The location of this event alternates between Boston and San Francisco and attracts 200-300 of the top neurotechnology deal-makers from pharma and the medical device industry, venture investors, emerging neuroscience-focused companies, as well as experts from government and academic medicine. Acknowledging the global opportunity that is being defined by the rapid pace of neurotechnology commercialization, in September of 2011, NeuroInsights and NIO hosted the inaugural European investing and partnering conference in Helsinki, Finland.
As a member of NIO you will enjoy the following benefits:
• Influence in the industry’s overall development agenda
• Additional access to key opinion leaders in Congress, regulatory agencies, and the media
• Participation in working groups and stakeholder meetings
• Expanded networking at neurotech investing and partnering events throughout the year
• Participation in neuroscience education initiatives and public awareness campaigns
• Industry leadership through participation in driving innovative legislation
In our first five years, over 100 organizations have joined NIO in order to accelerate treatments and cures for brain and nervous system illnesses. I hope that you will consider joining us in support of our mission to “give the brain a voice.” Please visit our membership page and give Zack Lynch or John Reppas a call to discuss membership (415-341-0193).
Frequently Asked Questions (FAQ)
Meet the NIO team and advisors