Perspectives: Neurotechnology Leaves the Nest, Awaiting a Policy Push

Zack Lynch is Executive Director, Neurotechnology Industry Organization (NIO). The Neurotechnology Industry Organization (NIO) is the trade association representing companies involved in commercial neuroscience (drugs, devices and diagnostics), brain research centers, and advocacy groups across the world. NIO is based in San Francisco with offices in Washington DC. www.neurotechindustry.org

Why Neurotechnology Needs a Policy Push

By Zach Lynch

Emerging tools to treat the brain and the nervous system have the potential to transform nearly every aspect of our lives. There’s no mistaking the progress. Neurotechnology — the tools to treat and understand the brain and nervous system — will also revolutionize our concept of the human mind. It is now time for public policy to catch up to the science.

Quality of life

Imagine walking into a doctor’s office where an advanced brain scanning system can detect cellular-level changes that signal the onset of epilepsy, before any symptoms begin. The quality of life for you and your loved ones might be extended by decades with a treatment plan personalized to your specific case. Today, similar brain imaging technologies are beginning to illuminate the causes of brain-related illnesses. But a wide chasm must still be crossed if we are to develop effective treatments for the nearly 100 million Americans and two billion people worldwide that currently suffer from brain illnesses such as epilepsy.

The annual national economic burden of brain-related disorders has reached over $1 trillion (see chart) and is growing at an alarming rate due to an aging population. While research into the brain and brain-related illnesses is moving forward more rapidly than any other science today, our understanding of how the brain works still has many gaps and our ability to repair brain damage remains limited. Critical unmet medical needs exist in almost every area of brain and nervous system disorders, including: Alzheimer's disease, addiction, anxiety, autism, depression, epilepsy, multiple sclerosis, obesity, Parkinson's disease, pain, sensory disorders, spinal cord injury, stroke, schizophrenia, sleep disorders, and traumatic brain injury.

The Annual US Economic Burden of Brain-Related Illnesses has reached over $1 trillion (click image for larger chart)

Investigation into the mechanisms and functions of the brain will lead to vastly improved understanding of brain disease and injuries, human cognition and behavior. Additionally such research will give us an unprecedented ability to treat and heal those in need and begin to reduce this growing burden on our economy. But how will this happen?

Cost and complexity

Emerging neurotech companies developing drugs, medical devices or diagnostics for the brain and nervous system face more difficult investment requirements, research and development challenges, and regulatory milestones than other healthcare sectors. This additional complexity results in higher costs and longer time to market for many neurotech treatments. For example, to bring a neuropharmaceutical treatment to market costs nearly $100 million more and takes two years longer than it takes to market the average drug.

Some companies can get private funding to bring low-risk drugs to market. However few risk-averse private investors will fund research into potentially more powerful treatments that leverage novel approaches such as gene therapy for Alzheimer’s disease or neurostimulation for mental illnesses. Today, the potential for innovative treatments has never been higher — but brain researchers and neurotech entrepreneurs require additional support if they are to bring their ideas out of the labs and into patients’ lives.

The need for a national initiative

A targeted, coordinated national effort is needed to support the development of neurotechnology across the board. It is vitally important that public infrastructure be developed to ensure that today’s neurotechnology discoveries quickly become tools to improve the human condition. Government must become a partner with the private sector to encourage the translation of brain research into treatments.

In an effort to improve national coordination and accelerate neurotech innovation, the Neurotechnology Industry Organization is spearheading the National Neurotechnology Initiative (NNTI). The NNTI calls for establishing a National Neurotechnology Coordinating Office within the Department of Health and Human Services to help agencies plan joint and complementary research strategies and to serve as the unified voice of federal neurotechnology efforts. The new initiative also seeks to create an advisory panel of experts from industry, academic institutions, and non-profit organizations to inform the new Office on issues including research and development priorities, technology transfer, commercial applications, and ethical, legal, and social issues.

The NNTI legislation, which is currently being evaluated by healthcare policymakers on Capitol Hill, includes $200 million in new Federal funding for the first fiscal year. This funding would flow to the National Institutes of Health, the Food and Drug Administration (FDA) and several other agencies to kick-start new research, prepare the regulatory ground for consideration of new neurotechnology tools, and examine the ethical, legal and social implications of this new field.

Under our proposal, the National Institutes of Health would receive funds to coordinate research and move that research out of government labs and into young innovative companies developing the next generation of neurotech treatments. The FDA would be able to hire neuroscience-related staff and develop workshops to create more robust neurotech standards to ensure the increased timeliness and safety of the neurotechnology review process.

Like previous successful models of coordinated federal investment initiatives, including the Human Genome Project and the National Nanotechnology Initiative, the NNTI will lead to a cascade of investment, discovery, applications, and benefits that can only be imagined today. At the same time, a federal research effort can help ensure the responsible development of neurotechnology by establishing ethical guidelines and policy for research, development, and applications.

The role of Congress and global expansion

With a coordinated federal investment, a Congressional bill can ensure that the United States remains at the forefront of the race to uncover the workings of the mind. Huge economic payoffs will accrue to new and emerging centers of neurotechnology excellence around our nation, among them the San Francisco Bay area, Boston, San Diego, Seattle, and Greater New York. The growth of strong neurotech regions will have long-lasting implications for employment, infrastructure development and regional competitiveness.

Today the United States leads the world in neurotechnology R&D and commercialization, but the United Kingdom, China, Sweden, Japan and Germany are all developing their own centers of neurotechnology excellence. The global expansion of knowledge in this new scientific arena is good for the United States and good for humanity. Yet it is critical that the progressive traditions of American science and technology, especially our longstanding focus on the legal and ethical implications of new scientific discoveries, carry special weight as this new science matures.

Neurotechnology applications have the potential to transform highly specialized areas of medicine, computing, and defense, and will also affect the everyday lives of Americans. How this plays out, and the benefits or consequences of these new tools, will depend on the U.S. government taking a leadership role in neurotechnology R&D. As Congress weighs our legislative proposals, we invite the broader scientific community to examine our proposal and support this important cross-disciplinary initiative.

Edited by Steven C. Schachter, MD

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