Corante

About this author
Zack Lynch is author of The Neuro Revolution: How Brain Science Is Changing Our World (St. Martin's Press, July 2009).
He is the founder and executive director of the Neurotechnology Industry Organization (NIO) and co-founder of NeuroInsights. He serves on the advisory boards of the McGovern Institute for Brain Research at MIT, the Center for Neuroeconomic Studies, Science Progress, and SocialText, a social software company. Please send newsworthy items or feedback - to Zack Lynch.
Follow me on Twitter at @neurorev
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September 26, 2010

Neuroscience Hearing on Capitol Hill Wednesday Sept 29, 2pm

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Posted by Zack Lynch

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Please join me this coming Wednesday on Capitol Hill when the Oversight and Government Reform Committee has scheduled a hearing on "The Future of Neuroscience Research and Development." The hearing will be held at 2:00 p.m. in room 2203 Rayburn House Office Building, and I urge you to attend.

NIO's conversations with Congressman Kennedy and others on the Hill were the impetus for this hearing. We identified a need for a congressional examination of the government's existing coordination among neuroscience research arms and pressed for congressional exploration. During our meetings on Capitol Hill we have continually emphasized the importance of increased coordination in government neuroscience research, strong government support for innovative neurotech ventures, as well as increased resources for the FDA to enable efficient reviews of neurotech products.

I'd like to thank Congressman Kennedy for taking seriously our call of oversight and exploration of this important area as well as all of our members for their efforts and support.

Congressman Kennedy wanted me to pass on this personal letter from him regarding the neuroscience hearing next Wednesday at 2PM. We hope you can come.

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July 2, 2010

Neurotech 2010: Translational Researchers Highlight Innovation

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Posted by Zack Lynch

NDF.pngWhile venture capitalists have been dialing back on potentially risky early stage investments, translational researchers have been marching ahead. Government funding is pushing new discoveries forward, but sometimes the best of these languish in academic labs where companies and more adventurous investors are less likely to discover them. This year the Neurotech Development Foundation (NDF), a new nonprofit founded to promote the advancement of translational neuroscience research, and several institutes at the NIH (including NINDS, NIMH, and NIA) teamed up to find and showcase the most promising work to Neurotech 2010 attendees in Boston on May 20, 2010. We've just posted the full article here which highlights the breakthrough translational work of the researchers selected for the session.

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April 29, 2010

Speakers for Neurotech 2010 - Boston, May 19-20

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Posted by Zack Lynch

350_conference-banner-2010-350.jpgWe've been heads down putting together an amazing conference this year. Visit the Neurotech 2010 conference website to see full schedule. Here are this year's speakers:

Andrew Firlik General Partner, Foundation Medical Partners; Stephen Knight, Managing Partner, Fidelity Biosciences; Art Pappas, Managing Partner, Pappas Ventures; Liam Ratcliffe, Venture Partner, New Leaf Venture Partners; Casey Lynch, Managing Director, NeuroInsights -- Ulf Ljungberg, CEO, NeuroNova; Brad Margus, President & CEO, Envoy Therapeutics; Will Rosellini, CEO, MicroTransponder Inc.; Jim Schoeneck, President & CEO, BrainCells, Inc., Ellen Baron, Partner, Oxford Bioscience Partners -- Mike Detke, Chief Medical Officer, MedAvante; Jamie Heywood Co-founder, Chairman, PatientsLikeMe; Remy Luthringer, CEO, Forenap Pharma; Suzan Onel Partner, K&L Gates; Joyce Cramer, President, Epilepsy Therapy Project -- Greg Stock, CEO, Signum Biosciences; Konrad Glund, CEO, Probiodrug; Michael Pierschbacher, CEO, American Life Science Pharmaceuticals; Shawn Lyndon. CEO, Orasi Medical; Dan O'Connell, Managing Partner, NeuroVentures Capital -- Chris Fibiger Chief Scientific Officer, Biovail; Marianne De Backer, VP Business Development, Johnson & Johnson; Guy Seabrook, Sr. Director, Neuroscience Global External Research & Development, Eli Lilly; Ravi Kiron,Managing Director, Adjuvant Global Advisors -- Christopher deCharms, CEO, Omneuron; Alex Doman, CEO, Advanced Brain Technologies, Tom Dusenberry, CEO, Dusenberry Entertainment; Revere Greist Founder, Waypoint Health Innovations; A.K. Pradeep, CEO, NeuroFocus, Roger Quy General Partner, Technology Partners -- Shafique Virani, Director CNS Business Development, Roche; Lothar Krinke, SVP, Research and Development, Medtronic; Leslie Coney; Sr. Director of Business Development, Biogen Idec; Doug Carlson Sr. Director, US Business Development, Lundbeck A/S; Christine de Los Reyes,Managing Partner, Biotech Partnering Solutions; Jim Broderick, President, SetPoint Medical; Ed Boyden, Assistant Professor, MIT Media Lab; Ben Matteo, CEO, Eos Neuroscience; Marcelo Lima, President and CEO, ImThera Medical, -- Derek Small, COO & Acting CEO, Naurex, Bob Linke, President & CEO, Embera NeuroTherapeutics; Andreas Neef, Fellow, Bernstein Focus Neurotechnology; Walter Greenleaf President & CEO, InWorld Solutions; Manuel Lopez-Figueroa, Vice President, Bay City Capital -- Amy Kruse Executive Director, Neuroscience Division, Total Immersion Software, Kaleb McDowell, Soldier Performance Division, Neuroscience Strategic Research Initiative, Cognition & Neuroergonomics - Collaborative Alliance Manager, Army Research Laboratory; Dylan Schmorrow, Office of the Secretary of Defense, Assistant Director, Human Systems, Roy Stripling, Head Human Performance Training & Education, Office of Naval Research, Chris Forsythe, Distinguished Member of Technical Staff, Sandia National Laboratories -- Ronald Burch CEO, Cerephex, Stephen Collins, President and CEO, NeuroTherapeutics Pharma; Bruce McCarthy,CEO, Afferent Pharmaceuticals; Linda Watkins, Founder, Xalud Therapeutics; Heath Lukatch, Partner, Novo Ventures Bruce Bean, Harvard; Gabriela Chiosis, Sloan Kettering Cancer Center; Miles Cunningham, McLean Hospital; Hagit Eldar-Finkelman, Tel Aviv University; Ana Lukic, Predictek; Mike Vitek, Cognosci, Junying Yuan, Harvard; Jill Heemskerk, Program Director, Office of Translational Research, NINDS/NIH

If you are in neurotech, you should probably be here. Register

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March 23, 2010

Giving the Brain a Voice: NIO Public Policy Tour in DC tomorrow

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Posted by Zack Lynch

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I've organized NIO's fourth annual Public Policy Tour of Washington, DC tomorrow with the help of the K&L Gates team. The one-day event will focus on high-level meetings on Capitol Hill. Meetings are scheduled with key congressmen and their staffers at their offices. We have over a dozen executives flying in who will introduce NIO and present our key proposals, including the National Neurotechnology Initiative (NNTI) and for Congressional hearings on the state of federal neuroscience research and development. Meetings set up with Lynch (D-MA), Space (D-OH), Kennedy (D-RI), Whitfield (R-KY), Schakowsky (D-IL), Sutton (D-OH), Jordan (R-OH),Rogers (R-MI), Tierney (D-MA), Pallone (D-NJ), Dingell (D-MI), Eshoo (D-CA), Capps (D-CA), Shadegg (R-AZ), Cummings (D-MD) and several more.

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December 10, 2009

New Neurotech Legislative Initiative in Early Development

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Posted by Zack Lynch

DC.jpgBlogging has taken a back seat to a whole bunch of legislative projects, meetings (attending and organizing), and membership recruitment efforts. Here is a bit of insight into a new piece of legislation we may be pushing forward with at NIO in the coming year.

Transferable Priority Review Vouchers for Severe and Neglected Brain Diseases: A priority review voucher is an incentive for companies to invest in new drugs and medical devices for severe and neglected diseases of the brain and nervous system. The legislation would authorize the FDA to award a transferable “priority review voucher” to the sponsor (manufacturer) of a newly approved drug, biologic or medical device that targets severe and neglected brain diseases. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs), 505(b)(2) applications, Premarket Approval applications (PMA) and Premaket Notification 510(k) applications. The voucher, which is transferable and can be sold, entitles the bearer to a priority review for another product.

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October 8, 2009

2010 Translational Neurotech Summit, Call For Speakers

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Posted by Zack Lynch

2010NDFSummit%20banner%20448.jpgThe Neurotech Development Foundation is organizing a Translational Neurotech Summit on May 18, 2010. This one day gathering of scientists, entrepreneurs, executives and investors will be held coordination with The 5th annual Neurotech Investing and Partnering Conference May 19-20, 2010. The goal of the summit is to facilitate the movement of promising neurotechnology (pharmaceuticals, biologics, cell-based therapeutics, devices and diagnostics) from universities, government labs and research institutes into the private sector.

CALL FOR SPEAKERS
Showcase your translational research project to potential investors and partners:
* Cutting edge research projects ready for investment or hand off to industry (preclinical or clinical)
* Pharmaceuticals, biologics, cell therapies, devices, and diagnostics
* Presenter abstracts accepted from October 1 through January 5, 2010
* Presenters notified by February 15 and coached on presentation, partnering, and start-up strategy
* Presentations selected based on quality of research, interest to industry, and fit with program
* Presentations will be 10 minutes plus Q&A with session panel

The summit will feature the top researchers from across translational neuroscience including Alzheimer's, addiction, ALS, anxiety, depressive disorders, epilepsy, migraine, mild cognitive impairment, Huntington's, multiple sclerosis, obesity, pain, Parkinson's, schizophrenia, age-related macular degeneration, sensory disorders, sleep disorders, and stroke. Download Fillable Presenter Submission Form

Steering Committee:
-Casey Lynch, Managing Director, NeuroInsights & President, Neurotech Development Foundation
-Frank Eeckman, MD, PhD Consultant, NeuroInsights
-Jill Heemskerk, PhD, Program Director, Office of Translational Research, NINDS/NIH
-Charles Jennings, PhD, Director of McGovern Institute Neurotechnology Program, MIT
-Zack Lynch, Executive Director, Neurotechnology Industry Organization
-Dan O'Connell, Managing Director, NeuroVentures Capital
-Gail Schechter, PhD, Director Center for Bioentrepreneurship at UCSF
-Paul Stypulkowski, PhD, Senior Director Research, Medtronic
-Guy Seabrook, PhD, Senior Director, Neuroscience Global External Research &
Development, Eli Lilly

The summit is hosted by the Neurotechnology Development Foundation, a 501(c)(3) nonprofit created to accelerate the development of treatments for the brain and nervous system by promoting translation of basic research.

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June 12, 2009

National Neurotech Initiative up on Capitol Hill

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Posted by Zack Lynch

Capitol%2B11-07.jpgWhile I spent Monday on a special working group at the National Institute of Neurological Disease and Stroke reimagining the Small Business Innovation Research Program in Rockville, Maryland, Tuesday was full of 10 separate meetings up on Capitol Hill lobbying for the National Neurotechnology Initiative. In the morning I met with the staff of Senators Burr, Greg, Bingaman, and Merkley in their offices while the afternoon was spent talking with Representatives Dingell, Markey, DeGette, Burgess, Sarbanes, and Space. Progress.

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March 30, 2009

National Neurotechnology Initiative in NYTimes today

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Posted by Zack Lynch

NYTimes.pngSlowly but surely, the word about the beneficial effects that the National Neurotechnology Initiative Act would have on our ability to accelerate the development of treatments for the brain and nervous system is slowly seeping into the national consciousness as evidenced by the today's Op-ed mention by Michael Paul Mason in his piece Keeping Our Head.

"THE death of the actress Natasha Richardson after a fall on a ski slope has further publicized an ugly truth that millions of Americans already know: Hardly anyone outside of an emergency room knows how to respond to brain trauma. There isn’t a standard response system that has been adequately promulgated in high school or college athletics, boxing rings or ski resorts. We’re fascinated by the inner workings of the brain and marvel at its mysteries, yet we aren’t very serious about protecting our most prized organ.

"The best hope for legislative reform comes from the National Neurotechnology Initiative Act, introduced last year, which calls for $200 million toward “science and technology that allows an individual to analyze, understand, treat and heal the brain and nervous system.”

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January 27, 2009

Neurotech Innovation and Job Stimulus Proposal

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Posted by Zack Lynch

innovcoalition.pngNIO is supporting an economic stimulus proposal to promote innovation and job creation by U.S. research-intensive emerging companies.The core of the proposal is a one time refund of net operating losses (NOLs) in lieu of other tax benefits to sustain critical R&D during the current financial downturn (details below).

NIO is helping build an "innovation coalition" of trade groups in support of the stimulus proposal that represent additional science and technology driven sectors of the economy which already includes the NanoBusiness Alliance, Biotechnology Industry Organization, Personal Space Flight Federation, Water Innovations Alliance. NIO is hosting meetings on Capitol Hill on February 10-11 in support of this proposal and the National Neurotechnology Initiative.

Details


Economic Stimulus Proposal to Promote Innovation and Job Creation by U.S. Research-Intensive Emerging Companies

One Time Refund of NOLs in Lieu of Other Tax Benefits to Sustain Critical R&D During Current Financial Downturn

Description: Allow companies to temporarily elect to receive a refund of their accumulated net operating losses (NOLs) at a discounted rate in lieu of claiming qualified research expenses, as defined by Code 41(b), for Tax Year 2008. The proposal would have the following features:

* Election to receive a refund of accrued NOLs at a discounted rate (i.e., 35% corporate tax minus a discount percentage).
* Refunds must be reinvested in investments that would qualify as U.S.-based research expenses under Code 41(b).
* Company would permanently forgo the opportunity to claim all NOLs involved in the computation of the refund.
* Applies only to loss companies in Tax Year 2008.
* Limited to small companies.
* Refund capped at a per company dollar amount.

Example: Assuming a discount percentage of 15%, a small neurotech/biotech/nanotech/cleantech company with $100M in accumulated NOLs could elect to claim a refund of $20M on their 2008 tax return ($100M x (35% - 15%) = $20M). The $20M refund could only be used to pay for U.S.-based research activities. The company would forgo the ability to carry forward the remaining $80M in NOLs for future tax years.

Rationale: Many of America's most promising companies in the areas of science and technology are struggling to raise the necessary research funding to survive the current economic slowdown and may disappear if economic conditions do not improve in the very near future. In order to save the high-paying, research-intensive jobs of America's innovation economy, Congress should allow companies to accelerate the utilization of their tax assets. Companies struggling to conduct capital-intensive R&D and meet payroll during the economic downturn will forgo a larger tax benefit in the future to claim a smaller tax benefit today. The proposal has minimum revenue impact since companies are only claiming accumulated NOLs at a substantial discount in return for forgoing the ability to claim remaining NOLs in future tax years.

As I mentioned recently in Forbes we need to act now to stem the loss of innovative neurotherapeutics. This proposal will greatly benefit emerging companies developing drugs, devices and diagnostics for the brain and nervous system who are currently struggling to raise the necessary research funding to survive the current economic downturn. Join us in Washington DC.

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January 7, 2009

2009 NIO Public Policy Tour in DC

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Posted by Zack Lynch

0-washington-dc_master.jpgNIO's third annual Public Policy Tour of Washington, DC will take place on Tuesday and Wednesday, February 10-11, 2009. The two-day event will include high-level meetings on Capitol Hill and with the Department of Veterans Affairs and National Institutes of Health. The NIO Public Policy Tour of Washington, DC commences Tuesday, February 10 on Capitol Hill. Meetings are scheduled with key Senators, Representatives of the House and their staffers at their offices. Participants will introduce NIO and present our key proposals, including the National Neurotechnology Initiative (NNTI). This will be followed by a meeting with representatives from the National Institutes of Health. Wednesday, February 11, will begin up on Capitol Hill and will finish with a mid-day meeting with key officials at the Department of Veterans Affairs. NIO members will get to introduce themselves and join in a free form discussion with officials about their individual company issues.

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May 30, 2008

Write Congress Today in Support of the National Neurotechnology Initiative Act

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Posted by Zack Lynch

NNTI%20graphic.pngWith the recent introduction of the National Neurotechnology Initiative (NNTI) Act in the House (H.R. 5989) and the Senate (S.2989) earlier this month, the time has come to ramp up a national grassroots campaign in support of the NNTI and I would like to ask for your help. It is imperative that we get a substantive amount of Congressional support as quickly as possible as we are targeting Congressional hearings prior to the August break.

Take action: We need to flood Congressional fax machines and mail boxes with individual letters of support from key constituents like you over the next four weeks. I urge you to visit NIO's Take Action webpage

Here you can download sample letters to customize and send. Full instructions appear on that webpage, as well as a link to help access your representatives' contact information and fax numbers.


Spread the word:
Because of limited resources and an aggressive legislative schedule, it is absolutely vital that we build a network of support for this bill. Please forward this appeal along with a personal note of support to your network of contacts and ask that they express their support to Congress and share with their networks as well. Please forward onto co-workers, board members, researchers, clinicians, nurses, patients, advocacy groups, friends, family, anyone with a stake in elevating therapies and cures for brain related illnesses.

We need your help - and ten minutes of your time - to secure Congressional support for newly introduced legislation designed to dramatically accelerate new treatments for brain and nervous system injuries and illnesses. This legislation stands to significantly improve the lives of more than 100 million Americans. Take 10 minutes to protect your future brain.

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May 12, 2008

National Neurotechnology Intiative Act Introduced in Both House and Senate

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Posted by Zack Lynch

NNTI%20HR%205989.pngI am extremely happy to share that the NNTI was introduced into the House and Senate last week! This is a major milestone for the industry and for those suffering from brain-related illnesses.

BIPARTISAN GROUP OF SENATORS AND REPRESENTATIVES INTRODUCE BILL TO BATTLE BRAIN-RELATED ILLNESS

National Neurotechnology Initiative Act seeks to accelerate development of new treatments for brain and nervous system ailments

SAN FRANCISCO & WASHINGTON, D.C., May 7, 2008 – A bipartisan team of prominent members of both houses of Congress introduced today the National Neurotechnology Initiative (NNTI) Act, a bill designed to foster new discoveries and accelerate the development of new and safer treatments for the one in three Americans living with a brain-related illness, injury or disease.

Championing the NNTI, Senators Pete V. Domenici (R-NM) and Patty Murray (D-WA) and Representatives Patrick J. Kennedy (D-RI 1st) and Ileana Ros-Lehtinen (R-FL 18th) have called upon Congress to reverse the growing economic burden generated by brain-related illness, which has reached $1.3 trillion per year in the U.S. due to healthcare costs and lost income.

"The sheer numbers speak for themselves: There are 100 million Americans suffering from a brain-related illness, with an enormous economic burden that continues to grow as the population ages," said Zack Lynch, Executive Director of the Neurotechnology Industry Organization. "For a modest investment, Congress has the opportunity to streamline research efforts, accelerate the development of new treatments, promote innovation by small businesses and have a meaningful impact on the lives of those suffering from devastating diseases and injuries.”

Designed to increase the speed at which discoveries reach the market, the NNTI employs targeted increases in funding to improve Federal research coordination and ease bottlenecks that inhibit the development of treatments for brain-related illnesses. The bill accomplishes these goals with less than 4 percent of the total Federal neuroscience research budget - $200 million – and reflects a more balanced disease-cost to research-dollars-expended ratio.

“With nearly one in three Americans suffering from some kind of neurological illness, disorder, or injury, I believe it is time we take a serious look at how we approach and fund research into neuroscience and neurotechnology,” Senator Domenici said. “Neuroscience dovetails nicely with the work I’ve long advocated for greater research on the brain and nervous system disease and disorders, particularly in relation to mental health. This new legislation, I believe, offers an excellent vehicle for us to make greater advances in this area.”

"While our ability to understand how the brain works grows each day, our ability to understand and repair brain illnesses remains limited," said Senator Murray. "For the millions of Americans that suffer from a brain-related illness, and the thousands of Americans coming home from Iraq and Afghanistan with Traumatic Brain Injury and PTSD, a new federal commitment to research and treatment can't wait. This bill will place a premium on sharing the information researchers gain everyday and will support ongoing but underfunded programs at NIH.”

“With so many Americans suffering from brain-related illnesses, it is crucial for us as a society to maximize our efforts and continue learning about the many facets of the brain, leading to a healthier life for all Americans,” said Congressman Patrick Kennedy.

“The time has arrived to offer a serious and comprehensive legislative approach to help the countless Americans struggling and living with brain and nervous system illnesses,” said Congresswoman Ros-Lehtinen. “To not act on this important issue is to relegate millions of our citizens to second class status and a lifetime of disabilities. This legislation would develop a comprehensive federal response to research and treatment for brain related diseases. I urge my colleagues to join us in this most noble endeavor.”

Download and Read NNTI Act (H.R. 5989 / S. 2989)

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March 19, 2008

NIO Public Policy Tour 2008 Recap

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Posted by Zack Lynch

I'm pleased to report that the Neurotechnology Industry Organization's second annual public policy tour in Washington DC last week was a resounding success. As this event demonstrates, NIO's influence and impact on commercial neuroscience continued to grow as we help connect the diverse spectrum of neurotechnology companies and advocates to policymakers.

US%20Capitol.jpgOn 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 those working to improve the lives of patients with brain and nervous system ailments. A full description of our meetings and listings of those we met with can be found here, and below I'll recount some of the highlights.

Capitol Hill

NIO representatives canvassed Capitol Hill in support of the National Neurotechnology Initiative (NNTI), NIO's flagship legislation created by NIO members. Elected representatives and their key staff members expressed substantial interest in the legislation and its promise to help ease bench-to-bedside bottlenecks, accelerating the development and commercialization of treatments and cures for brain-related illnesses.

In particular, Congressional representatives were interested to learn more about how the NNTI will:
· Increase coordination and efficiency of research among federal agencies
· Impact treatments important to the military, such as for TBI and PTSD
· Address aging illnesses whose economic burden threaten the economy
· Secure the U.S.'s position as the world's leader for this rapidly growing industry

During the afternoon Congressman Patrick Kennedy (D-RI), a champion for mental health, announced at a reception for NIO members that he plans to introduce the National Neurotechnology Initiative Act in the House of Representatives. Thanks to the superb advocacy work of our tour participants, we have already received indications that several co-sponsors plan to sign on in the very near future.

CMS and FDA

The next day many tour participants continued high-level meetings on Capitol Hill while others traveled to the offices of the Centers for Medicare & Medicaid Services (CMS) to introduce NIO and discuss ways for the industry to work with CMS to support our objectives.

Among other important topics of conversation, CMS solicited and NIO agreed to develop a horizon scanning project to identify brain and nervous system drugs, devices and diagnostics that will likely impact CMS reimbursement within the next 2-5 years. See here for additional topics of discussion and important contacts at the organization for NIO members.

Later the entire NIO policy tour group reconvened at the FDA where we met with officials from CDER, CBER and CDRH. Meeting highlights include an overview of the Critical Path Opportunity Program (including an in-depth discussion on CPO 38 - issues affecting epilepsy trials -- at the request of NIO member The Epilepsy Therapy Project); developing more effective working relationships with CDRH; and some of CBER's most pressing technological needs. See here for more in-depth information about the meetings and a full participant list from the FDA.

Next Steps

Following these meetings, there will be several more opportunities for NIO supporters to promote the NNTI within Congress (stay tuned for more on how you can specifically help) as well as form key working groups to strengthen our burgeoning alliances with the FDA and CMS.

I'd like to thank all of our participants and partners who worked so hard to make this event such a success. Without the commitment 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, this would never have been possible.

I look forward to working with each of you again - and those of you unable to attend this year - on NIO's third annual public policy tour of Washington DC in March 2009.

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January 28, 2008

NIO bets big in capital

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Posted by Zack Lynch

Zack%20Lynch%20Neurotech%20SF%20Business%20Times.jpgRon Leuty at The San Francisco Business Times interviewed me last week and the result was the following pithy article: Neuroscience organization bets big in capital: Industry group seeks $200M to research brain abnormalities

A young, San Francisco-based trade organization representing neuroscience companies has lined up companies nationally and heavy hitters in the nation's capital to lobby for a $200 million superfund to help bring products to market for brain and nervous system diseases ranging from Alzheimer's to insomnia.

The 17-month-old Neurotechnology Industry Organization is working with Kirkpatrick & Lockhart Preston Gates Ellis LLP -- the New York law firm also known as K&L Gates, as in William Gates Sr., the father of Microsoft Corp. co-founder Bill Gates -- to push its plan in Washington, D.C.

The NIO's five-part plan, dubbed a "Human Genome Project for the brain" by Executive Director Zack Lynch, would earmark:

* $80 million for the National Institutes of Health's "Blueprint for Neuroscience Research," developed by 16 institutes that offer grants for neuroscience issues ranging from depression and Parkinson's Disease to spinal cord research and traumatic brain injury;
* $75 million to the NIH's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs for neuroscience startups and research;
* $30 million to increase staffing and training at the U.S. Food and Drug Administration to reduce a regulatory bottleneck that has delayed approval of some therapies;
* $10 million a year for studying the societal implications -- including ethical and legal questions -- of advancing neurotechnologies; and
* $5 million annually for a national neurotechnology coordination office to aggregate what federal agencies as diverse as the NIH and the Department of Defense are doing in neurotech.

The plan would accelerate bringing neuroscience innovations to patient bedsides, Lynch said. Parts of the program, like SBIR and STTR, also would help create new companies in neurotech centers like the Bay Area, Lynch said.

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December 20, 2007

NIO Year in Review and Look Forward to 2008

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Posted by Zack Lynch

NIO%20logo.gif
There is no mistaking the progress: 2007 was an excellent year for the Neurotechnology Industry Organization! Our public policy agenda and public relations efforts made significant headway throughout the year and we look to build on this momentum in 2008.

Since our founding just sixteen months ago, over 60 organizations have joined our mission to accelerate the development of treatments for the brain and nervous system. As the only trade association representing companies involved in neuroscience (drugs, devices and diagnostics), brain research centers and patient advocacy groups, NIO is quickly becoming a powerful agent for change.

NIO's primary purpose is to increase awareness of neurotechnologies, reduce barriers to innovation, and support industry growth. With this in mind, I'd like to share with you some of our key activities from 2007, NIO's first full year in operation, and preview what's to come in 2008.

Read Full Review and Look Forward on NIO's website here. If you ever wonder why my blogging has slowed down it is because I'm spending nearly all my time on these projects.

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October 29, 2007

Careers in Neuroscience and Neurotech

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Posted by Zack Lynch

careers_in_neuroscience_lead_jpg.jpg
"The subject areas that qualify as neuroscience are as far-reaching and as interconnected as neurons themselves. Consequently, neuroscientists often work on questions that span several distinct subfields. Many neuroscience programs are interdepartmental and take on the structure of an institute rather than a department." Emma Hitt writes a good overview of careers in neuroscience for Science magazine this week in Careers in Neuroscience: From Protons to Poetry. My three cents was that a strong demand exists for people with regulatory and clinical trial management expertise related to neurological diseases and psychiatric illnesses. For jobs in the neurotech industry check out NIO's job board.

"Whatever path a student decides upon, neuroscience is replete with opportunities for graduate students and postdocs who have given thought to planning their career path. People who are just entering into this field will be the Nobel Prize winners of this next generation, says Insel. "This really is the place for the brightest and the best students to jump in because we know so little, and the opportunities are so great."

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October 4, 2007

Policy Focus: Neurotech Leaves the Nest but Waits for Policy Push

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Posted by Zack Lynch

splogo.gifI've recently joined the advisory board of a new publication called Science Progress which aims to influence US public policy by embracing the best of American scientific and political thought. On the website you can find several interesting articles including a piece by Vint Cerf who reflects forward on our nation’s incredible ability to respond swiftly to complex scientific challenges as well as an op-ed article that I wrote, BrainTech is Here: Neurotechnology Leaves the Nest but Waits for Policy Push, where I attempt to succinctly explain the reasons why we need a National Neurotechnology Initiative. Here is the beginning of the article, I recommend reading the rest on Science Progress.

There’s no mistaking the progress. Neurotechnology—the tools to treat and understand the brain and nervous system—holds the potential to transform nearly every aspect of our lives and revolutionize our conception of the human mind.

Imagine walking into a doctor’s office where an advanced brain scanning system can detect cellular-level changes that signal the onset of Alzheimer’s disease, years before any physical or mental symptoms manifest. You and your loved ones’ quality of life could then be extended by decades with a treatment plan personalized to your specific case. Today, brain imaging technologies such as this are only just 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 2 billion people worldwide that currently suffer from brain illnesses such as Alzheimer’s.

The annual national economic burden of brain-related disorders has reached over $1 trillion (see chart) and is growing alarmingly 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 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.

Investigation into the mechanisms and functions of the brain will lead to vastly improved understanding of brain disease and injuries, human cognition and behavior, and will give us an unprecedented ability to treat and heal those in need, as well as begin to reduce this growing burden on our economy. But all of this won’t happen on its own.... (read on)

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September 10, 2007

Briefing the U.S. Intelligence Community on Neurotech

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Posted by Zack Lynch

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Last month I was invited by the Defense Intelligence Agency to brief a special committee on the current and future state of neurotech in Washington DC at the National Academy of Sciences. The Committee on Military and Intelligence Methodology for Emergent Neurophysiological and Cognitive/Neural Science Research in the Next Two Decades is working on a study to identify the trends in brain research that may help the U.S. Intelligence Community anticipate the state of such research internationally in the year 2027.

I was one of about a dozen speakers brought in for this intense two day session. I started off by providing an extensive overview of NeuroInsights latest neurotech market and investment information. I then honed in on the transformative impact the passage of the National Neurotechnology Initiative (NNTI), a program I have been spearheading within NIO, the trade association I launched last year, could have on the global brain industry landscape. The NNTI is a newly proposed $200M/year Federal research and development program designed to coordinate strategic investment across multiple government agencies to accelerate the development of vitally important areas of the field.

In addition to making the case that the development of new drugs and devices for the brain and nervous system are critical to U.S. national defense and warfighter rehabilitation, I argued that huge quality of life improvements and economic payoffs will accrue to the countries that successfully nurture the emerging neurotechnology industry. Moreover, the NNTI will not only stimulate economic growth in the United States, but like other visionary Federal R&D initiatives like the Human Genome Project will spur greater public investment among all nations seeking a competitive voice in the fast growing global industry known as neurotech.

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August 28, 2007

Neurotech Job Board Launched by NIO

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Posted by Zack Lynch

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The Neurotechnology Industry Organization has launched a Neurotech Job Board dedicated to commercial neuroscience (drugs, devices and diagnostics). There are currently over 150 neurotech job listings from over 50 companies across 3 continents.

The Neurotech Job Board is open to all companies involved in neuroscience worldwide and is completely free to use. It the place where employees with industry experience and a neuroscience focus look for jobs like:

- Senior Director Research, Discovery Medicine - Neuroscience
- Neuromodulation Senior Scientist
- CNS Director of Clinical Operations
- Senior Neurological Regulatory Affairs Specialist
- CNS Biology Specialist
- Director, New Product Planning, CNS

Stay competitive and post your company's employment opportunities.Please alert your colleagues and your HR team to this new industry resource.

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 was founded in August 2006 and has attracted over fifty members in our first year.

Visit us at booth 4311 at the Society for Neuroscience conference in San Diego, November 4-7.

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August 7, 2007

NIO Redesigns Logo, Launches new Website

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Posted by Zack Lynch

I've been spending some time redesigning the website for the Neurotechnology Industry Organization including a new logo. Hope everyone enjoys it.

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August 2, 2007

NSF Goes Neurotech

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Posted by Zack Lynch

The National Science Foundation has established the Office of Emerging Frontiers in Research and Innovation (EFRI). The EFRI office is launching a new funding opportunity for interdisciplinary teams (engineers and neuroscientists) in the following area Cognitive Optimization and Prediction: From Neural Systems to Neurotechnology.

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July 9, 2007

New NIH Neurotech Funding Opportunities

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Posted by Zack Lynch

sbir_logo.gifLast week the NIH announced new Federal funding for neurotechnology R&D (SBIR PA-07-389) and (STTR PA-07-390). These funding opportunity announcements are expected to advance understanding of the nervous system, behavior or the diagnosis and treatment of nervous system diseases and disorders, through support of research, development, and enhancement of a wide range of neurotechnologies.

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July 3, 2007

A Blue Sky Vision for the Future of Neuroscience

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Posted by Zack Lynch

ninds.gifThe National Institute of Neurological Disorders and Stroke (NINDS) is in the process of developing a blue sky vision for neuroscience and neurology to help them develop their goals over the next fifteen years. This vision will serve as the foundation for subsequent planning activities. They are seeking your input. You may answer all of the questions, or you may respond to the subset that interest you the most. The deadline for response is August 31, 2007.

1: What advances should we expect in clinical care for neurological disorders over the next fifteen years, based on anticipated progress in biomedical research? What scientific advances will result in a quantum leap in the care of neurologic disorders, and what aspects of care are likely to remain unchanged?
2: Which major questions need to be answered in order to revolutionize how we understand the nervous system and prevent, diagnose, and treat nervous system disorders?
3: What new technical capabilities have the potential to revolutionize neuroscience research and clinical practice in the next fifteen years?
4: What will the neuroscience research landscape look like in fifteen years, and how can NINDS best contribute?
5. What, if any, infrastructural resources are needed to advance clinical or basic neuroscience research?
6. What ethical, legal, and social issues are likely to arise from advances in basic and clinical neuroscience over the next fifteen years, for which the NINDS should be prepared?

It is great to see NINDS taking such a proactive medium term view. Hopefully, you'll find time in your schedule to answer some these questions. I will.

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May 29, 2007

Bold Future of Neurotechnology in San Francisco Chronicle

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Posted by Zack Lynch

ZC%20SFChron%20pic.pngBernadette Tansey, staff business reporter at the San Francisco Chronicle, wrote an impressive article that appeared on the front page of today's business section about how I became involved in neurotech and what Casey and I are doing to help accelerate its development. Here is part of the article, but you should really read the whole piece. Brainstorming about the brain - Entrepreneur pioneers systems to allows to allow neuroscientists to share their discoveries:


"If you're Zack Lynch, you look for the next technology poised to take off like a rocket.

Lynch, 35, is betting that brain scientists will unleash the next waves of world-transforming discoveries. Since 2001, he has founded a flock of enterprises to track and accelerate the field of neurotechnology, which develops drugs and tools that influence the brain and nervous system. His ventures include conferences, neurotech investment analyses and a fledgling trade association.

The San Francisco entrepreneur began his career working for software companies after writing his UCLA master's thesis on the business transformations caused by the Internet. But he wanted to focus on a technology revolution that was just beginning. His wife and a brother were neurobiologists, and he got hooked on the field's possibilities.

Lynch saw the potential for rapid leaps in the understanding of the central nervous system with the rise of automated research tools such as biochips and brain imaging devices. That scientific progress, he said, could help tackle the psychiatric illnesses and nerve disorders that create an economic burden he estimates at roughly $1 trillion in the United States. Beyond disease treatments, Lynch could envision neurobiology breakthroughs that might improve memory and change emotion and communication.

"The societal implications are profound," he said.

But Lynch decided that neurotechnology businesses weren't coordinating with each other enough to advance their own interests in areas such as government research funding and private investment. No industry group represented the whole sweep of neurotech applications, which covers drugs, devices, diagnostic tests and software, he said. Like his father, Lynch started bringing competitors together to get them talking."

Seriously, read the whole article here. Kudos to Bernadette for her exceptional reporting.

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April 11, 2007

The End of Abuse - Recognizing Addiction as a Disease Act of 2007

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Posted by Zack Lynch

A bill is winding its way through Congress which seeks to remove the term "abuse" from the name of two NIH institutes. The goal is to attribute addiction as a disease and not as abuse. The two institutes would be renamed as follows:

1. National Institute on Drug Abuse (NIDA) would be renamed National Institute on Disease of Addiction (NIDA)
2. National Institute on Alcohol Abuse and Alcoholism would be renamed National Institute on Alcohol Disorders and Health (NIADH)

Senator Joe Biden's bill (S1011) has a Findings section which is very helpful in reframing the perspective about addictions:

S1011: SEC. 2. FINDINGS.

Congress makes the following findings:

(1) Addiction is a chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences. It is considered a brain disease because drugs change the brain's structure and manner in which it functions. These brain changes can be long lasting, and can lead to the harmful behaviors seen in people who abuse drugs. The disease of addiction affects both brain and behavior, and scientists have identified many of the biological and environmental factors that contribute to the development and progression of the disease.

(2) The pejorative term `abuse' used in connection with diseases of addiction has the adverse effect of increasing social stigma and personal shame, both of which are so often barriers to an individual's decision to seek treatment.

mediaheader1.jpg Senator Joe Biden's bill (S1011) was introduced on 3/28 with Kennedy and Enzi. It is a companion bill to Patrick Kennedy's (HR1348), which was introduced on March 3 with Rep. Sullivan (R-OK) as the co-sponsor. The name of S1011 is "Recognizing Addiction as a Disease Act of 2007" and HR1348 is `NIDA and NIAAA Name Redesignation Act'.

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April 2, 2007

Neurotech Execs Tap Political Leaders in Washington DC

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Posted by Zack Lynch

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Last Thursday, the Neurotechnology Industry Organization met with dozens of elected officials and policy makers in Washington DC 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.

During NIO’s Public Policy Tour, executives from some twenty neurotechnology companies and organizations met with political leaders including directors from the National Institutes of Health and the Food and Drug Administration to discuss the role their offices can play in improving fundamental brain-related research and bringing new treatments for nervous system illnesses more quickly to those in need.

Neurotechnology leaders taking part in NIO’s Public Policy Tour included 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 met with included Rep. Brian Baird, Rep. Joe Barton, Sen. Bob Bennett, Sen. Benjamin Cardin, Rep. Steve Chabot, Sen. Pete Domenici, Sen. Byron Dorgan, Rep. John Duncan, Sen. Mike Enzie, Sen. Dianne Feinstein, Rep. Bart Gordon, Rep. Jay Inslee, Sen. Edward Kennedy, Rep. Patrick Kennedy, Sen. John Kerry, Sen. Herb Kohl, Sen. Trent Lott, and Rep. Todd Tiahrt.

In short, NIO's first Public Policy Tour in Washington DC was an outstanding success with significant support emerging for the National Neurotechnology Initiative.

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March 21, 2007

The National NeuroTechnology Initiative (NNTI)

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Posted by Zack Lynch

NIOsmall.pngOn March 29th the Neurotechnology Industry Organization (NIO) is hosting our first neurotechnology public policy tour in Washington DC. Over twenty neurotech executives are flying in from across the country for morning meetings with more than a dozen Senators, Representatives of the House and their staffers, as well as, afternoon meetings with key teams at the FDA and NIH. At these meetings members will be discussing several ways that the Federal government could better support neurotech companies in their quest to develop next generation treatments for brain and nervous system illnesses. One of the programs we will be proposing is the development of a National NeuroTechnology Initiative (NNTI).

The National Neurotechnology Initiative (NNTI) seeks to establish a federal research and development program, based in a National Coordination Office (NCO), to direct interagency efforts in neurotechnology. The NNTI provides an opportunity for organized, strategic investment across federal agencies to accelerate development of vitally important areas of neurotechnology research and development. Four key program areas will be discussed including: the establishment of national research centers in neurotechnology; major research initiatives in neurotechnology; translational development of neurotechnology; and research in consideration of ethical, legal and social issues related to neurotechnology.

The national economic burden from brain and nervous system illnesses has reached over $500 billion a year and is growing alarmingly due to an aging population. Investigation into the mechanisms and functions of the brain will lead to vastly improved understanding of brain disease and injuries, human cognition and behavior, and will give us an unprecedented ability to treat and heal those in need.

A coordinated national effort is needed across Federal agencies to accelerate development of vitally important areas of neurotechnology. Like previous successful models of coordinated Federal investment initiatives including the Human Genome Project and the National Nanotechnology Initiative (NNI), we know that the NNTI would lead to a cascade of investment, discovery, applications, and benefits that can only be imagined today.

More to be revealed next Thursday.

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February 27, 2007

Two Billion Affected By All Brain-Related Illness

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Posted by Zack Lynch

NIO-Logo.jpgNIO sent out this press release in response to the WHO Report on Neurological Disorders in order to shed light on entire scope of the problem we face.

Neurotechnology Industry Organization: WHO Report Underscores, Underestimates Impact of Brain-Related Illness

Group calls on industry, political, investment leaders to address growing problem

SAN FRANCISCO, CA – February 27, 2007 – NIO, the Neurotechnology Industry Organization, today announced that a new World Health Organization (WHO) report which estimates that one billion people worldwide suffer from neurological disorders is just the tip of the iceberg when it comes to measuring the global impact of brain-related illness. According to NIO, when psychiatric illnesses including addiction, attention disorders, anxiety, depression, schizophrenia and sleep disorders are incorporated, the number of people affected by brain disorders reaches nearly two billion, almost 100 million in the U.S. alone. The group estimates the global economic burden at $1 trillion per year.

“We applaud the WHO’s efforts to shed light on the very real and serious problem of worldwide neurological disorders,” said NIO Executive Director Zack Lynch. “Despite the large and growing unmet markets, massive economic cost, and untold human suffering, there are few effective treatments that delay, prevent and cure chronic neurological and psychiatric diseases.”

According to NIO the 500 companies worldwide focused on diseases of the brain, face fundamentally different investment requirements, research and development challenges, and regulatory milestones than other life science organizations. Despite significant hurdles, the industry is working to accelerate the development of new treatments by leveraging converging technological breakthroughs across biotechnology, information technology, nanotechnology and neuroscience.

“As the global population ages, the burden of brain-related illness will continue to grow,” said Lynch. “The WHO report recommends a number of personal and political actions to help address this burden. NIO also calls upon the diverse neurotechnology companies across the medical device, diagnostic and drug development spectrum, as well as research institutions and advocacy organizations to work together and with legislators and regulators to accelerate investment, improve the clinical development process, and deliver effective treatments to individuals suffering worldwide.”

Download NIO release - Download file

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One Billion Affected by Neurological Disorders Says WHO

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Posted by Zack Lynch

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A report released today from the World Health Organization (WHO) shows that neurological disorders, ranging from epilepsy to Alzheimer disease, from stroke to headache, affect up to one billion people worldwide. Neurological disorders also include brain injuries, neuroinfections, multiple sclerosis and Parkinson disease. The report, Neurological disorders: Public health challenges, reveals that of the one billion people affected worldwide, 50 million suffer from epilepsy and 24 million from Alzheimer and other dementias. Neurological disorders affect people in all countries, irrespective of age, sex, education or income. The report recommends a series of simple but effective actions. It argues for greater commitment from decision makers, increased social and professional awareness, strategies that address stigma and discrimination, national capacity building and international collaboration.

NOTE: This report specifically excludes psychiatric illnesses (follow link: What are neurological disorders) which would boost this number by another billion. This means that brain-related illnesses impact nearly 2 Billion people worldwide. Based on this new data I estimate that the global economic burden of brain illnesses now exceeds $2 Trillion a year.

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December 5, 2006

Neurotechnosocioeconomics and the Global Burden of Brain Disease

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Posted by Zack Lynch

Neurotechnosocioeconomics is the study of the ways that neurotechnology has an impact on social and economic systems.

I'm currently talking with Chris Murray at the Harvard School of Public Health about researching and writing a report on the Global Economic Burden of Neurological Diseases and Psychiatric Illnesses. The report, which would be sponsored by the Neurotechnology Industry Organization, would seek to calculate the economic burden for specific illnesses including Alzheimer's disease, addiction, anxiety, attention disorders, depression, epilepsy, hearing loss, insomnia, chronic pain, Parkinson's, schizophrenia, stroke and a few other brain-related illnesses. The report would determine the total economic burden for both the US and world and would include future projections given a few different technological scenarios.

The goal of the report is to get credible data about the economic consequences of brain diseases so that NIO can use them in Congressional testimony to argue for increased funding of translational neurotechnology research, tax incentives for neurotech investment, and a host of other purposes in support of NIO's mission to accelerate the development of treatments and cures for brain diseases.

Only by "dollarizing" the impact of these illnesses will it become undeniably clear how profound a problem brain diseases represent to the world's economies, especially with our growing and aging populations. Clear, credible, and "dollarized" data will allow our legislators to make intelligent trade-offs when determining budget priorities.

A key question the report will need to answer is what do we mean by economic burden, and how do we calculate it? There are three components to this type of analysis:

1. Prevalence, disability, mortality and DALYs lost. This is the standard components of the global burden of disease. There are well established methodologies to undertake this.

2. Expenditure in health systems on interventions for neurological and psychiatric conditions. This information is much harder to find given present data and will likely require considerable data collation or collection efforts.

3. Lost economic output due to these conditions. The problem with these
calculations is that they are the results of either (1) times some constant (a little more complicated but you get the idea) or (2) require panel data. There is much more methodological debate about how to do this well relative to the other two.

It is here where neurotechnosocioeconomic analysis will come into play. Unlike other medical technologies that generally result in someone surviving or passing away (e.g. cancer, heart attack), many neurotechnologies (e.g. drugs for schizophrenia) improve the quality of life across a continuum of disability (e.g. some people will return to be high functioning members of society - no economic burden, while others improve sufficiently only to be less than totally disabled - high economic burden).

Thus, the economic impact of a neurotechnology is dependent upon the how advanced a particular treatment is for each disease. A cure could equate to a low long term economic burden (but perhaps a high short term cost depending on the price of the treatment), while a drug that improves the quality of life for six months (e.g. current treatments for Alzheimer's) would shave only a tiny amount of the economic burden - high economic cost. I think you get the point.

While I believe that we will obtain some very useable metrics about the near term economic burden (0-10 years) given some assumptions of neurotechnologies in the clinical pipeline, medium and long term estimates will need to be analyzed in a scenario framework with different technological assumptions.

So, what's this study going to cost?

Before I answer that, why don't we ask, "What is it worth?"

What if we could increase funding for brain related diseases by $1 billion over the next five years? What if we developed tax incentives that accelerated investment in small innovation neurotechnology companies resulting in an additional $1 billion dollars of venture investment flowing into private commercial neuroscience startups in the next five years?

For context on these numbers, according to NeuroInsights, annual government support for the neurosciences across all institutes at the NIH is around $5 billion while total venture investment in neurotech in 2005 rose to a little more $1.5 billion. In this light, it become clear that the billion dollar increases I am suggesting above are not of the realm of consideration, especially when annualized over five years.

With the economic burden of Alzheimer's disease alone in the United States surpassing $100 billion a year, the potential payoff of making the decision to increase funding and incentivize investment seems quite rational. Moreover, since my research estimates that the global economic burden far exceeds $1 trillion, I believe a convincing case can be made.

But none of this will happen unless we have "clear, credible, and dollarized" information available to legislators to help them make intelligent decisions. In short, we must dollarize in order to help us prioritize.

So, okay, what is this going to cost?

From Chris, "Finally, in terms of cost, if this were a new research study, the price tag would be in the 2 million range. If you want an analysis built on existing studies which will be much less satisfactory, the cost is clearly going to be much lower. It really will depend on what you want to use the study for."

All of this said, I am now in the process of raising $2 million for this study. It seems like a minor investment relative to the billions of dollars of additional investment in support of the development of treatments for brain-related illnesses. Please join me in this campaign.

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November 21, 2006

Recent Neurotech Regulatory and Financing News

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Posted by Zack Lynch

Here is some recent news relevant to the NIO community that FasterCures brought to my attention:

FDA looks at increasing access to experimental drugs
The FDA plans to create two proposals involving the use of experimental drugs for seriously ill patients with few treatment options, according to sources. One proposal will clarify, formalize and simplify how the drugs can be made available to patients while the other involves the price that can be charged for the drugs. The Wall Street Journal (subscription required) (11/9)

Nonprofit funding groups help in drug R&D
Companies increasingly are looking toward nonprofit funding organizations to help in the research and development of new drugs, collaborations referred to as product development partnerships. Nonprofits benefit, too. "We work with partners to ensure availability and affordability. The key is that the end products reach people," a nonprofit director said. The Scientist (free registration) (11/1)

Experts urge more taxpayer funding to support FDA
Witnesses at a Senate hearing said the FDA budget should include increased taxpayer funding, in addition to increased fees paid by the companies it regulates. The change would ease public concerns that the agency is compromised by its reliance on industry fees. The hearing focused on a bipartisan bill to strengthen the FDA's role in ensuring the safety of new drugs. The Washington Post/Associated Press (free registration) (11/16)

Problems abound in fund-raising for rare diseases
Richard K. Olney, an amyotrophic lateral sclerosis researcher, fund-raiser and patient has encountered roadblocks common to raising money for research into rare diseases. Tough economic times, less awareness and recognition, and competition from other charity causes -- including ones with a larger pool of patients or patients who live longer and can stay more active in the efforts -- can make it difficult to attract attention and funds to rare diseases. The Wall Street Journal (free content) (11/21)

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November 14, 2006

Top Ten Reasons For Personalized Medicine

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Posted by Zack Lynch

I just spent the past two days at a Personalized Medicine conference sponsored by Burrill and the Personalized Medicine Coalition. Among the many interesting sessions, dominated by diagnostic company CEOs, Ed Abrahams, the PMC's Executive Director gave a talk that covered the top 10 value propositions for supporting and promoting personalized medicine. Advocates of personalized medicine have stressed its potential to:

1) Detect disease at an earlier stage, when it is easier to treat effectively
2) Enable the selection of optimal therapy and reduce trial-and-error prescribing
3) Reduce adverse drug reactions
4) Increase patient compliance with therapy
5) Improve the selection of targets for drug discovery
6) Reduce the time, cost, and failure rate of clinical trials
7) Revive drugs that failed clinical trials or were withdrawn from the market
8) Avoid withdrawal of marketed drugs
9) Shift the emphasis in medicine from reaction to prevention
10) Reduce the overall cost of healthcare

Logo_PersMed_06.gifSeems like a list we could all agree would be great to have. To support his presentation, the PMC published a pithy primer on the topic of personalized medicine which I recommend. (Download report here). As an aside, from my conversations it looks interest in developing diagnostics for neurological diseases is on the rise, but still far behind the developments in oncology.

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October 13, 2006

Neurotechnology Industry Organization Launched to Advance Treatments for Brain and Nervous System Illnesses

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Posted by Zack Lynch

(This press release was sent over the wire this morning. Please share.)

Neurotechnology Industry Organization Launched to Advance Treatments for Brain and Nervous System Illnesses

New Global Trade Association to Advocate for the Brain Industry

SAN FRANCISCO, CA – (BUSINESS WIRE)– More than 20 leading pharmaceutical, medical device, and diagnostic companies, along with major academic brain research centers and patient advocacy groups, have joined together to form a new trade association called the Neurotechnology Industry Organization (NIO). Based in San Francisco, California, NIO is a non-profit group created to accelerate the development of treatments and cures for brain and nervous system diseases.

The $110 billion neurotechnology industry includes pharmaceuticals, biologics, cell-based therapeutics and medical devices, as well as diagnostic and surgical equipment for critical unmet needs including: Alzheimer's, addiction, anxiety, depression, epilepsy, hearing loss, insomnia, multiple sclerosis, obesity, pain, Parkinson's, schizophrenia, stroke and other brain-related illnesses.

“Despite the clear need and significant market opportunity, neurotechnology companies face a host of issues that stifle innovation, growth and rapid delivery of effective therapies. NIO will provide a collective voice for commercial neuroscience organizations to address these issues,” said Zack Lynch, Founder and Executive Director of the newly formed Neurotechnology Industry Organization. “We will kick off our first year with a global awareness campaign highlighting the industry’s progress and a public policy tour for members to interact with government officials.”

Over 1.5 billion people worldwide and nearly 100 million Americans suffer from a brain or nervous system illness. In addition to untold human suffering, the annual economic burden has reached over $1 trillion worldwide with $300 billion a year in the U.S alone. This burden is accelerating as the population ages and population increases. These factors are creating unprecedented demand for treatments that delay, prevent and cure chronic neurological and psychiatric diseases.

The 500 companies involved in commercial neuroscience face fundamentally different investment requirements, research and development challenges, and regulatory milestones than other life science and healthcare companies. NIO was created to help governments, patients, and the public understand the unique needs of the neurotech industry.

“We are delighted to be a founding member of NIO,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept, Inc. “We are pleased that this advocacy group has been formed to address the important issues of our industry.”

Founding member organizations span a broad spectrum of drug, device and diagnostic companies from across the world unified by common interests. They include: Acumen Pharmaceuticals (South San Francisco, CA), Amarin Corporation (London, England), Brain Resource Company (Sydney, Australia), Ceregene (San Diego, CA), Cyberkinetics Neurotechnology Systems Inc. (Boston, MA), NeuroPace (Mountain View, CA), NeuroNova AB (Stockholm, Sweden), Sound Pharmaceuticals (Seattle, WA), Targacept, Inc. (Winston-Salem, NC), and United Therapeutics (Silver Spring, MD); neuroscience research centers including: Allen Institute for Brain Science (Seattle, WA), Blanchette Rockefeller Neurosciences Institute (Morgantown, WV), McGovern Institute for Brain Research at MIT (Cambridge, MA), and the MIND Institute (Albuquerque, NM); patient advocacy groups and research foundations including: Alzheimer's Drug Discovery Foundation (New York, NY), Epilepsy Therapy Development Project (Reston, VA) and Neurotech Network (Tampa, FL); venture capital firms NeuroVentures (Charlottesville, VA) and Technology Partners (Palo Alto, CA); and strategic partner Preston Gates Ellis & Rouvelas Meeds LLP (Washington, DC).

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About the Neurotechnology Industry Organization

The Neurotechnology Industry Organization (NIO) is a non-profit trade association that represents a broad spectrum of companies involved in neurotechnology (drugs, devices and diagnostics), neuroscience research centers and brain disease advocacy groups across the United States and the world. NIO's mission is to accelerate cures for brain and nervous system diseases by promoting the neurotechnology industry's progress, advocating the industry's position to government officials, and providing business development services to its members. For more information on the Neurotechnology Industry Organization, please visit www.neurotechindustry.org

About the Neurotechnology Industry

The neurotechnology industry includes companies researching, developing, manufacturing and marketing pharmaceuticals, biologics, cell-based therapeutics and medical devices, as well as diagnostic and surgical equipment for the treatment of brain and nervous system illnesses including: Alzheimer's, addiction, anxiety, depression, epilepsy, hearing loss, insomnia, multiple sclerosis, obesity, pain, Parkinson's, schizophrenia, stroke and other brain-related illnesses. In 2005, neurotechnology companies generated over $110 billion in revenue, according to NeuroInsights.

Contact:
Zack Lynch - zack(at)neurotechindustry.org

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September 25, 2006

NIO Volunteers Needed for SFN Conference May 14-18

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Posted by Zack Lynch

Just do it.

If you plan on attending the Society for Neuroscience Conference in Atlanta May 14-18 and would like to contribute a few hours (3-4) at the Neurotechnology Industry Organization's exhibition booth, we'd greatly appreciate it.

As a new non-profit, we can offer you an exhibitor pass (if you don't already have a pass), a way to learn more about NIO (I'll give you a personal tutorial on NIO), and the opportunity to meet like-minded individuals interested in giving commercial neuroscience organizations a unified voice to help accelerate the cures for brain and nervous system diseases.

Exhibits are open from 9:30 a.m. to 5 p.m., Sunday through Wednesday (May 14-18). Pick a morning or afternoon on any day and then send me an email at zack (at) neurotechindustry.org. We'll make sure you are prepared. Please look at this as something that will be fun, interesting and relaxing. This offer is open to all individuals. Thanks for your support.

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August 24, 2006

Neurotechnology Industry Organization Introduced

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Posted by Zack Lynch

The Neurotechnology Industry Organization (NIO) is a new trade association representing a broad spectrum of neurotechnology companies (drugs, devices and diagnostics), brain research centers and brain-illness advocacy groups across the United States and the world.

NIO's mission is to accelerate cures for brain and nervous system diseases by:

- Promoting the neurotechnology industry's progress & contributions to quality of life
- Advocating the neurotech industry's position to regulators and elected officials
- Providing effective business development services to members

NIO's programs increase awareness of neurotechnologies, reduce barriers to investment and innovation and support intelligent long-term growth of the industry.

Why the Neurotechnology Industry Organization now?

nio%20png.pngNeurotechnology companies face fundamentally different investment requirements, research and development challenges, and regulatory milestones than other life science and healthcare companies. The Neurotechnology Industry Organization (NIO) was formed to help governments, patients, and companies understand the benefits of neurotech products and the unique needs of this industry.

Learn about the Founder's Circle membership opportunity.

Over 1.5 billion people worldwide and nearly 100 million Americans suffer from a brain or nervous system illness. In addition to untold human suffering, the annual economic burden has reached over $1 trillion dollars worldwide with $300 billion a year in the U.S alone. This burden is accelerating as the population ages and population increases. These factors are creating unprecedented demand for treatments that delay, prevent and cure chronic neurological and psychiatric diseases.

The neurotechnology industry includes companies researching, developing, manufacturing and marketing pharmaceuticals, biologics and medical devices, as well as diagnostic and surgical equipment for the treatment of neurological and psychiatric illnesses including: Alzheimer's, addiction, anxiety, depression, epilepsy, hearing loss, insomnia, multiple sclerosis, obesity, pain, Parkinson's, schizophrenia, stroke and more. Together these diseases represent more than 30% of the total burden of disease in established market economies.

Converging technological breakthroughs across a wide variety of industries including biotechnology, information technology and nanotechnology are now making it possible to develop radically new treatments for unmet medical needs.

Despite the clear human need and significant global market opportunity, neurotechnology companies face a host of issues that stifle innovation, growth and the rapid delivery of more effective therapies. NIO was formed to provide commercial neuroscience organizations a collective voice to address these issues.

Please visit the Neurotechnology Industry Organization website for more information. NIO is currently accepting members to the visionary Founder's Circle and will be formally launching the organization later this fall at the Society for Neuroscience conference. Contact me through NIO if you are interested in membership.

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