Dear Members,

NIO's influence and impact on commercial neuroscience continued to grow last week during our 2nd public policy tour in Washington DC. During this incredibly successful event our participants -- from a diverse spectrum of neurotechnology companies and advocates -- provided U.S. policymakers with a personal connection to the promise of the industry.

On March 12 and 13, NIO members met with over fifty elected representatives on Capitol Hill and over thirty officials at the FDA and CMS to discuss the opportunities and obstacles facing companies and organizations working to improve the lives of those with brain and nervous system illnesses.

I would like to offer special thanks to the neurotechnology leaders and partners who participated in NIO's Public Policy tour from Accera, Adlyfe, Advanced Neuromodulation Systems, Alseres Pharmaceuticals, BiotechPartnering Solutions, Boston Scientific, Brain Aneurysm Foundation, Cogmed America, Cognitive Drug Research, CorTechs Labs, Cyberkinetics Neurotechnology Systems, Epilepsy Study Consortium, Feinstein Kean Healthcare, International Neuromodulation Society, Kappametrics, K&L Gates, KidsDx, Medtronic, NeuroInsights, NeuroNexus Technologies, NeuroScience Associates, Neurotech Development Foundation, Neurotech Network, Neurotech Reports, North American Neuromodulation Society, Pfizer, PhotoThera, Posit Science, and Sound Pharmaceuticals.

These remarkable organizations helped push neurotechnology front and center in Washington, and made great strides in lobbying for the National Neurotechnology Initiative (NNTI), NIO’s flagship legislation which was created by the organization’s members. There is great momentum right now for the NNTI and I will be following up with each of you with more information on how you can personally help make this bill a priority and signed into law in a timely manner.

Capitol Hill Meetings

Nearly forty NIO participants canvassed Capitol Hill in support of the National Neurotechnology Initiative legislation meeting with over forty key Senators, Representatives of the House and their staffers at their offices. Members were greeted with substantial interest and enthusiasm for the legislation. Overall, we are seeing tremendous support the $200 million bill aimed at accelerating treatments and cures for brain-related illnesses.

Elected officials were particularly interested in learning about exciting new treatments and diagnostics in development by member companies and wanted to know more about how the bill would (1) increase coordination and efficiency of research among federal agencies (2) promote development of treatments for disorders important to the military like traumatic brain injury and post traumatic stress disorder, (3) promote development of treatments for chronic illness of aging which will increase the burden on our healthcare economy in the coming years and (4) secure the United States’ position as the world’s leading nexus for this rapidly growing industry.

In the late afternoon, NIO members gathered at the National Press Club to hear Congressman Patrick Kennedy (D-RI) announce that he will introduce the National Neurotechnology Initiative Act. This was a seminal moment in the evolution of the legislation that NIO is spearheading. Thanks to the superb advocacy work of tour participants we have already received confirmation that there will be several additional co-sponsors announced in the near future.

Participants met with the following Senators, Representatives of the House and their staffers at their Capitol Hill offices: Sen. Cantwell (D-WA), Sen. Cardin (D-MD), Sen. Clinton (D-NY), Sen. Coburn (R-OK), Sen. Durbin (D-IL), Sen. Hutchison (R-TX), Sen. Isakson (R-GA), Sen. Landrieu (D-LA), Sen. Murkowski (R-AK), Sen. Murray (D-WA), Sen. Smith (R-OR), Sen. Stevens (R-AK), Sen. Whitehouse (D-RI), Rep. Baird (D-WA), Rep. Blackburn (R-TN), Rep. Boucher (D-VA), Rep. Burgess (R-TX), Rep. Camp (D-MI), Rep. Campbell (R-CA), Rep. Dicks (D-WA), Rep. Dingell (D-MI), Rep. Duncan (R-TN), Rep. Engel (D-NY), Rep. Eshoo (D- CA), Rep. Gingrey (R-GA), Rep. Hooley (D-OR), Rep. Inslee (D-WA), Rep. Kanjorski (D-PA), Rep. Kennedy (D-RI), Rep. Linder (R-GA), Rep. McDermott (D-WA), Rep. McGovern (D-MA), Rep. McIntyre(D-NC), Rep. McMorris Rodgers (R-WA), Rep. Miller (R-MI), Rep. Tim Murphy (R-PA), Rep. Pelosi (D-CA), Rep. Rogers (R-MI), Rep. Ros-Lehtinen (R-FL), Rep. Stupak (D-MI), Rep. Taylor (D-MS), Rep. Van Hollen (D-MD), Rep. Visclosky (D-IN), Rep. Wilson (R-NM).

Additionally a delegation met with Deputy Secretary Troy’s staff in the Department of Health and Human Services, which oversees the NIH, FDA and CMS among other agencies. They were extremely interested in hearing NIO’s feedback about interaction with these agencies and understanding where improvements could be made in efficiency, communication or budget allocation.

There is an exceptional high level of interest among members of Congress and their staffs about the NNTI legislation. Once the bill is introduced we will continue to extend our requests for support for the legislation through meetings, special hearings and letters of support from member companies and other stakeholders.

CMS Meeting

Many participants returned to the Hill Thursday morning for a series of high level meetings, while a group of 10 participants travelled to the Baltimore offices of the Centers for Medicare & Medicaid Services (CMS) to introduce NIO and to discuss ways that we could work effectively with CMS to support our industry's objectives.

CMS welcomed us into a full room with over fifteen experts from across the organization. During the meeting we discussed how the Center for Innovation and Technology operates, as well as CMS' intention to introduce a broader parallel review process (which will be discussed in an upcoming public forum) and their dislike of industry fast-track proposals. Additionally, CMS expressed a disinclination to approve reimbursement for a broader indication if biomarkers had been used to select clinical trial participants. The agency also indicated it would take a harder line against what it considered superfluous and unnecessary testing.

CMS is keenly interested in keeping up to date on emerging novel therapeutic approaches. At the conclusion of our meeting, 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. We will be following up with CMS to develop an internal working group to usher forward this opportunity.

In a follow up communication, CMS asked me to relate to NIO’s members that the agency routinely meets with companies to discuss study design issues from the perspective of how national and local coverage determinations are made. Depending upon the phase of clinical development, their colleagues in the Center for Medicare Management may be invited to participate if you would also like to discuss coding and payment for new technologies; alternatively, you are welcome to meet with them separately. To key contacts provided for your use include: Louis Jacques, MD, Director, Division of Items and Services, 410-786-4521, Louis.jacques@cms.hhs.gov; Marcel Salive, MD MPH, Director, Division of Medical and Surgical Services, 410-786-0297, Marcel.salive@cms.hhs.gov. In addition they provided me with a link to the CMS clinical trial policy whose goal is to encourage and facilitate participation of Medicare beneficiaries in high quality research studies relevant to their health.

CMS Attendees included: Dr. Jeff Rich, CMM Director; Liz Richter, CMM Deputy Director, Amy Bassano, Acting Director, Hospital and Ambulatory Policy Group (HAPG), CMM, Marc Harstein, Acting Deputy Director, HAPG/CMM; Dr. Barry Straub, Director, Office of Clinical Standards & Quality (OCSQ); Dr. Steve Phurrough, Group Director, Coverage & Analysis Group (CAG)/OCSQ; Tamara Syrek Jensen, CAG/OCSQ; Laurence Wilson, Director, Chronic Care Policy Group (CCPG)/CMM; Carol Blackford, Acting Deputy Director, CCPG/CMM; Jane Thorpe, Office of Policy; Arthur Melzter, OCSQ; Stuart Caplan, OCQ; Jean Stiller, OCSQ; Susan Miller, OCSQ; Leslye Fitterman, OCSQ; Louis Jacques, OCSQ

FDA Meeting

Thursday afternoon all tour participants met up at the Rockville offices of the FDA to meet with fifteen officials spanning CDER, CBER, and CDRH (see list below). Melissa Robb from the Commissioner’s office kicked off the meting with a brief overview of the Critical Path Opportunity Program. After our members introduced themselves, we put forth the request made by the Epilepsy Therapy Project, a NIO member, to establish a channel for open communication with the FDA regarding some key issues affecting epilepsy trials. These fall under Critical Path Opportunity 38. The agency agreed to a follow up conversation in which we will discuss organizing a joint scientific meeting focused on alternative trial designs for epilepsy drugs. Finally, the agency expressed interest in working with the industry on neuroimaging biomarkers

We also solicited feedback from the CDRH and CBER officials on how to most appropriately and effectively work with their groups on how to bring about positive change. CDRH representatives including Mark Melkerson explained the process that they recently went through to develop cartilage guidance, which was a good example because it involved several centers within the agency and required a broad consensus.

CBER's Celia Witten was particularly interested in working with the industry on developing tools for tracking the movement of cells in humans. Faced with assessing the safety of novel stem cell treatments, the agency would like to be able to track implanted cells to determine if they remain where they are implanted or move throughout the body. CBER agreed to send NIO a “wishlist” of supporting technologies that the agency would like to see developed in the coming years, in support of clinical trials.

Melissa Robb indicated that she would be our contact going forward for more specific proposals. Members are encouraged to find areas of common interest where a specific proposal for a working group can be developed. We can then submit these proposals, and Melissa will coordinate the appropriate personnel and scheduling at the FDA. While CDER’s Division of Neurology, in particular, indicated a lack of resources to participate in working groups and discussions, we hope that our efforts to bring the division funding through the NNTI legislation and discussions with HHS will help to overcome this barrier. FDA welcomed NIO’s support in this matter.

FDA Attendees

Russell G. Katz, M.D. (Rusty Katz); Director; Division of Neurology Products; Office of Drug Evaluation I; Office of New Drugs; CDER

Joseph P. Hanig, Ph.D.; Deputy Director; Division of Applied Pharmacology Research; Office of Testing and Research; Office of Pharmaceutical Science; CDER

Mark N. Melkerson, M.S.; Director; Division of General, Restorative and Neurological Devices; Office of Device Evaluation; CDRH

Steve I. Gutman, M.D.; Director; Office of In Vitro Diagnostic Device Evaluation and Safety; CDRH

Joel Myklebust, P.E., Ph.D.; Director; Division of Physics; Office of Science and Engineering Laboratories; CDRH

Peter D. Rumm, M.D.; Deputy Director, General Surgical Branch, Plastic and Reconstructive Surgery Branch and Restorative Branch; Division of General, Restorative and Neurological Devices; Office of Device Evaluation; CDRH

Kristen A. Bowsher, Ph.D.; Electrical Engineer; Restorative Devices Branch; Division of General, Restorative and Neurological Devices; Office of Device Evaluation; CDRH

Celia Witten, M.D., Ph.D.; Director; Office of Cellular, Tissue and Gene Therapies; CBER

Donald W. Fink (Don Fink); Biologist; Cell Therapies Branch; Division of Cellular and Gene Therapies; Office of Cellular, Tissue and Gene Therapies; CBER

Thomas P. Finn (Tom Finn); Microbiologist; Cell Therapies Branch; Division of Cellular and Gene Therapies; Office of Cellular, Tissue and Gene Therapies; CBER

Dr. Ellen Maher; Medical Officer; Cell Therapies Branch; Division of Cellular and Gene Therapies; Office of Cellular, Tissue and Gene Therapies; CBER

David B. Banks; Public Health Specialist; Office of Special Health Issues; Office of External Relations; Office of the Commissioner

Carlos L. Pena; Senior Science Policy Analyst; Office of Science and Health Coordination; Office of the Commissioner

Rachel E. Behrman; Supervisory Medical Officer; Office of the Commissioner

Melissa A. Robb; Senior Program Management; Office of the Commissioner

Once again, thank you to all who took the time out of their busy schedules to join NIO in giving the brain a voice in Washington. I look forward to providing regular updates on the initiatives that were discussed with our legislators and agency partners. I look forward to working with you on making next year’s tour even better.

Sincerely,