Washington Editor

WASHINGTON - Representatives of a newly formed trade association recently made the rounds here, meeting with congressional members, FDA officials and staff at the National Institutes of Health as part of a public policy tour to outline its members' collective agenda.

Called the Neurotechnology Industry Organization, or NIO, it has attracted brain and nervous system disease-focused drugmakers, device companies and diagnostic firms, as well as venture capitalists, researchers and patient advocates to a single, technology-inclusive mission: accelerating treatments and cures. Principally, they spoke with policy-makers about their proposal for a federal research and development program to coordinate investment across multiple government agencies to push product development, the National Neurotechnology Initiative (NNTI).

"Fundamentally, what we're trying to do is give the brain a voice," said NIO founder and executive director Zack Lynch, noting the "vast interest and need out there" for new neurotech products. He told BioWorld Today that about 100 million Americans suffer from a brain or nervous system illness, costing the nation's economy about $1.1 trillion per year, and those burdens are climbing as the population simultaneously grows and gets older. Obviously, such problems are even larger on a worldwide basis.

"It's not uncommon," said Lynch, who is based in San Francisco. More than a dozen congressional members have become "very receptive" to the NNTI, he added, so legislation to get it up and running is being drafted.

To build the program, which is projected to cost about $200 million annually, Lynch has proposed four primary components: establishing national neurotech research centers to promote interdisciplinary study through collaboration in neuroscience, cognitive science, behavioral psychology, molecular biology, computer science, robotics and other fields; funding neurotech's translational development through existing federal funding programs for small businesses and developing tax credits for neurotech investors; promoting major research initiatives with challenge grants targeted at basic science and applications; and exploring research into associated ethical, legal and social issues.

Such a coordinated effort would oversee neurotech activity within the NIH, the Department of Defense, the Department of Energy, the National Science Foundation, the Department of Veterans Affairs and other agencies, "to put them in touch with each other," Lynch said. There are precedents to NIO's plan, with the Human Genome Project and the National Nanotechnology Initiative examples of successful, coordinated federal investment efforts.

The group's discussion at the NIH, which included government researchers focused on neurological disorders, stroke, aging, imaging, mental health and drug abuse, centered on developing the NNTI in the context of the NIH's "Blueprint For Neuroscience Research" and its "Bioengineering Consortium," two programs that Lynch said "play well" with NIO's plan.

During the meeting with the FDA, high-ranking officials from the agency's drugs, biologics and device divisions engaged in a feedback session with NIO members who posed basic and detailed questions on regulatory hurdles. The discussion also explored forming a public-private working group on emerging indications for neurotech products.

Lynch, whose idea to develop the trade association stemmed from his work running a neurotech-focused market research firm called NeuroInsights, believes the NNTI would bring down barriers to those in the space, namely by attracting more public and private money to speed the development of new treatments and cures. "Diseases of the brain [represent] a fragmented field," he said, calling it "critically important" to develop a unified front for spreading a singular message. Going forward for NIO, the group must maintain momentum by building a diversified membership base of large and small companies, Lynch said.

Later this week, NIO is hosting a neurotech partnering and investing conference outside San Francisco. The event will open with the unveiling of this year's Neurotech Industry Report, which includes market data and trends.

The sector includes about 500 companies worldwide, Lynch said, which generate in excess of $100 billion in global revenue.

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