......Advancing the Brain Industry Together

2007 NIO Public Policy Tour Summary (read press release)

On March 29, 2007, the Neurotechnology Industry Organization met with dozens of elected officials and policy makers in Washington to discuss the opportunities and obstacles facing companies and organizations working to improve the lives of those with brain and nervous system illnesses.

A key topic of discussion with elected Senators and Representatives was the group’s National Neurotechnology Initiative (NNTI), a proposed Federal research and development program designed to coordinate balanced and focused strategic investment across multiple agencies to accelerate development of vitally important areas of the field. We made significant progress on all three policy objectives with exceptionally strong meetings on Capitol Hill as well as with the NIH and FDA. The NIO Public Policy Tour was an outstanding success.

Neurotechnology Companies Participants:

Accera, Inc, Acumen Pharmaceuticals, Adlyfe, Afferent Corporation, Boston Life Sciences, Brain Resource Company, Concentric Medical, Cyberkinetics Neurotechnology Systems, Medical Device Network of Australia, NeuroScience Associates, Neurotech Network, NeuroVentures Capital, Posit Science, RemeGenix, Sound Pharmaceuticals, StemCells, Inc., Targacept, and The MIND Institute.

Elected Officials NIO members met with included:

Elected officials met with included Sen. John Kerry (D-MA), Sen. Benjamin Cardin (D-MD), Sen. Dianne Feinstein (D-CA), Sen. Herb Kohl (D-WI), Sen. Edward Kennedy (D-MA), Sen. Pete Domenici (R-NM), Sen. Byron Dorgan (D-ND), Sen. Mike Enzi (R-WY), Sen. Trent Lott (R-MI), Rep. Brian Baird (D-WA), Rep. Bart Gordon (D-TN), Rep. Jay Inslee (D-WA), Rep. Patrick Kennedy (D-RI), and Rep. Todd Tiahrt (R-KS), Rep. Joe Barton (R-TX), Sen. Bob Bennett (R-UT), Rep. Steve Chabot (R-OH), Rep. John Duncan (R-TN). The level of interest among members about sponsoring NNTI legislation was both surprising and exciting.

NIH Meeting

Discussions at the NIH included an overview of the NNTI; a review of the NIH Blueprint for Neuroscience Research and Bioengineering Consortium (BECON); and a conversation about restoration of SBIR grant eligibility for neurotech companies with minority ownership by individuals.

NIH participants:

Heather Rieff, National Institute of Neurological Disorders and Stroke (NINDS)

Joe Pancrazio, National Institute of Neurological Disorders and Stroke (NINDS)

Laurie Arrants, National Institute of Neurological Disorders and Stroke (NINDS)

Jill Heemskerk, National Institute of Neurological Disorders and Stroke (NINDS)

Stephanie Fertig, National Institute of Neurological Disorders and Stroke (NINDS)

Marcelle Morrison-Bogorad, National Institute on Ageing (NIA)

William Heetderks, National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Amy Swain, National Center for Research Resources (NCRR) National Institute on Drug Abuse (NIDA)

Michael Huerta, National Institute of Mental Health (NIMH)

JoAnne Goodnight, Office of the NIH Director

JP Kim, Office of the NIH Director

Tina Bordonaro, Office of the NIH Director

FDA Meeting

Discussions at the FDA revolved developing guiding principles to improve product development and approval processes, with focus on emerging neurotechnology product areas that currently lack generally established objective end points and clinical trial models. Participants also interacted in a free form discussion with FDA officials about their individual company issues.

Attendees

Dr. Janet Woodcock, Deputy FDA Commissioner and Chief Medical Officer

Dr. Wendy R. Sanhai, Senior Scientific Advisor, Office of the Commissioner

Dr. Shirley Murphy, Director of Translational Sciences (CDER)

Dr. Robert Temple, Director of Medical Policy, Center for Drug Evaluation and Research (CDER)

Dr. Marilyn Lightfoote, Director of Biologics at Office of Science and Engineering Laboratories (CDRH)

Dr. Robert Powell, Senior Officer, Office of Clinical Pharmacology & Biopharmaceutics (CDER)

Dr. Ellen Maher, Center for Biologics Evaluation and Research (CBER)

Dr. Don Fink, Center for Biologics Evaluation and Research (CBER)

Dr. Mitch Mathis, Deputy Director, Psychiatry Products Division (CDER)