NIO Programs

The neurotechnology industry faces different investment requirements, research and development challenges, and regulatory milestones that other life science and healthcare sectors. The Neurotechnology Industry Organization (NIO) was formed to help governments, patients, and the public understand the benefits of neurotech products and the unique needs of this industry.

NIO's programs have the following goals:

• Advocate the neurotechnology industry’s position to regulators and elected officials
• Inform national and international media about industry’s progress and contributions to quality of life
• Provide business development services to members
  

NIO achieves these goals through three programs:

Industry Promotion

NIO works to educate the public, media and elected officials about the benefits of neurotechnology. NIO promotes neurotechnology as critical to national healthcare saving, national competitiveness, quality of life and human potential.

Public Policy

NIO provides a unified policy voice in Washington, D.C. NIO aggressively advocates in the halls of Congress and White House for important member issues such as favorable changes in the tax code for neurotech research and development. NIO develops position papers, analyzes legislation, and provides expert testimony to political leaders and regulators on neurotech issues. NIO works closely with existing trade associations to avoid duplication of efforts and leverage their activities.

Business Development

NIO supports the industry by providing business development services to members across a wide variety of activities, including start up marketing support; inclusion in the neurotech industry business directory; and participation in an annual public policy tour in Washington D.C.

NIO Steering Committees

NIO exists to serve the needs of the commercial neuroscience community.

Under the NIO umbrella, NIO members are encouraged to form steering committees to address issues that promote industry growth and accelerate the research, development and delivery of drugs, devices and diagnostics for the brain and nervous system.

The role of a steering committee is to develop a consensus opinion across a community of interest relative to a specific issue.  Once a consensus opinion is reached, NIO can approach the particular federal agency in question in order to begin a dialogue to clarify ways to obtain improved guidance, remove technical roadblocks, reduce regulatory uncertainty and/or improve productivity.

A steering committee consists of NIO members and non-members who together constitute a broad spectrum of interests with respect to an issue such that they can credibly speak for the community on such a matter, including the perspectives of researchers, clinicians, companies, patient advocates and research foundations.

Forming a NIO Steering Committee

1. Develop 1-2 paragraphs on an issue to be addressed and a list of potential organizations that could be interested in working on this issue.
2. Contact Zack Lynch at NIO (415)341-0193 and let him know you are interested in developing a steering committee and set up a call to discuss.
3. NIO's regulatory counsel at K&L Gates will review previous regulations and guidance on the issue to determine validity/ plausibility.
4. Develop more detailed 1-2 page overview of the issue to be addressed. NIO's regulatory counsel will help in this process.
5. NIO will use this document to begin outreach to potentially interested organizations.
6. Surveys and conference calls will be used to clarify issue and to develop a consensus opinion. In some cases in person meetings may be necessary.
7. Participation in the steering group requires that individuals be able to at least make regular conference calls to push the issue forward.
8. Steering committee members may be required to pay additional steering committee dues to NIO
9. Once consensus is reached, NIO will approach the agency in question to begin dialogue.
10. NIO will work with steering committees to set up robust agency meetings as well as provide guidance and organize follow-up meetings.

Emerging NIO Steering Committees

Epilepsy Steering Group: This group is seeking to develop a consensus on epilepsy trial designs that would facilitate and speed development under Critical Path Opportunity 38 (Development of Trial Protocols for Specific Therapeutic Areas). For example, potential labeling and approval based on success in what are now considered secondary endpoints (including patient reported outcomes) and the consideration of seizure severity reduction as a primary endpoint in future trials.

Neurodiagnostics EEG Steering Group:  This group is seeking guidance from the FDA on the development of gold standards for evaluation of EEG data, algorithms, and electrode placement.

Potential NIO Steering Committees

Neuromodulation Industry Roadmap: This potential public private working group would develop a 20 year framework that can serve to develop strategic plans for and investments in this technology and business.  In the roadmap, the industry will identify barriers and appropriate near-term, mid-term and long-term actions to address these barriers.  The industry will attempt to prioritize these actions and identify priorities for R&D efforts. The roadmap is intended to help guide government and corporate policy towards the overall goal of making the neuromodulation sector a significant contributor to global public health.

CMS Horizon Scanning Project:  CMS is keenly interested in keeping up to date on emerging novel therapeutic approaches. At the conclusion of our 2008 meeting with CMS during the public policy tour, NIO received CMS’ blessing to develop a horizon scanning project for drugs, devices and diagnostics for the brain and nervous system that are likely to impact CMS in the next 2-5 years.

Combination products: The area of combination products in neurology and psychiatry is an area rife with regulatory complexity.  This potential working group would scan emerging issues and work together to overcome potential barriers.