NIO 2007 Year in Review, 2008 Look Forward
December 18, 2007
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.
2007
2007 Public Policy Tour: On
March 29, twenty NIO executives came to Washington DC to participate in
our first public policy tour. We met with dozens of elected officials
and policy makers to discuss the opportunities and obstacles facing
neurotech companies. A key topic of discussion at our meetings on
Capitol Hill, the FDA and NIH was the National Neurotechnology
Initiative. Overall, the NIO Public Policy Tour was an outstanding
success and members found candid discussions with FDA officials
particularly rewarding. Read 2007 NIO public policy tour recap.
National Neurotechnology Initiative (NNTI):
A major focus of NIO's policy efforts for 2007, the NNTI is a
$200M/year Federal research and development initiative aimed at
supporting innovation, accelerating translational neuroscience and
improving the efficiency of the FDA review process for neuroscience
drugs, devices and diagnostics. More: Overview of NNTI.
Crafted legislation
- Members of NIO's Public Policy committee came together in the first
half of the year to draft a proposed National Neurotechnology
Initiative Act. Over the course of several months, numerous NIO members
shared their priorities for neurotech research policy and made
substantial contributions to the final draft bill.
Spearheading introduction
- NIO members have joined me on six separate trips to Capitol Hill
throughout the year to garner an ever-growing cadre of support for the
NNTI legislation. These exceptional meetings were organized and
supported by NIO's public policy team at K&L Gates. During these
visits, we have spoken with the offices of over forty Senators and
members of Congress. Nearly everyone has voiced support for the
legislation and several Senators have expressed interest in becoming
champions for the bill. Read Op-ed in support of NNTI.
NIO/FDA private-public working group:
After meeting with Dr. Janet Woodcock, Deputy FDA Commissioner and
other key staffers relevant to commercial neuroscience, members of our
FDA policy committee built a consensus agenda whose goal is to get the
FDA to improve the efficiency of the evaluation process for
neuroscience products and to increase communication and clarity during
the regulatory process. After vetting our strategy with a host of FDA
consultants, we have recently decided the best way to achieve our
objectives is to leverage the FDA's own Critical Path Initiative. We
are in the process of choosing a specific initiative, which will yield
meetings with the agency in 2008.
Public Relations:
NIO actively outreaches to national media outlets to encourage coverage
of neurotech, which will foster greater investor, policymaker, and
consumer interest. Over the past year, NIO and its members have been
highlighted in over 25 articles appearing in San Francisco Chronicle,
BioWorld, Science magazine, Journal of Life Sciences, Reuters among
many others.
In August we launched a redesigned website. In October we launched a Neurotech Job Board. In November we unveiled the top ten trends in neuroscience which we expect will drive industry growth in years to come. More: Read NIO in the News.
Events: In addition to our public policy tour in DC in March, NIO was involved in a number of highly visible events throughout the year.
- We
hosted our first annual meeting on May 18 in San Francisco where NIO
members shared their ideas for member growth, policy issues and
financing.
- On
September 25, NIO hosted a neurotech media tour in New York City in
conjunction with the launch of the Nasdaq NeuroInsights Neurotech
Index. Five neurotech CEO's joined me at meetings with the Wall Street
Journal, Forbes and Scientific American Mind to discuss their recent
success.
- On
November 3-7, NIO had an exhibition booth at the annual Society for
Neuroscience conference in San Diego. We also hosted a successful
partnering social on the evening of November 4, which was attended by
over 50 neurotech executives.
Also
on behalf of the organization, I spoke at a host of biotech and
neuroscience meetings across the US and abroad throughout the year
including the annual Anti-Epileptic Drug conference in Florida,
Committee on Military and Intelligence Methodology in the Next Two
Decades in Washington DC, the Neurotech Reports conference in Newport
Beach and the European Neuroscience and Society Network conference in
London in late November. These types of visibility opportunities will
gain increasing importance as NIO works to spread the word about
neurotech far and wide.
Amicus Brief: NIO
also advocates for our members on intellectual property issues. In
particular, we believe that certainty in the patent system is critical
to encourage investment in neurotech R&D. On December 13, NIO filed
an amicus brief in support of the patent owners in a pending patent law
case before the Federal Circuit Court of Appeals in Washington, DC.
Our amicus brief in this case supports reversal of a recent district
court decision that questions a quarter century of settled law and
leaves patent owners subject to challenges for simply following the
rules laid out by the PTO.
Membership:
NIO's membership more than doubled in 2007 with nearly 40 new
companies, academic brain research centers and patient advocacy groups
joining together to "give the brain a voice." NIO's growth is a
testament to the fact that there is tremendous common ground among
industry participants and that by working together we can increase
awareness of neurotechnologies, reduce barriers to innovation, and
support industry growth. More: View brief descriptions of all NIO members.
2008
Looking
forward, 2008 promises to bring another year of exciting growth and
continued momentum. We have plans in place to not only build on all of
our existing programs but add a few more as well. Here is an overview
of what you can expect in the coming year:
National Neurotechnology Initiative 2008: Our
K&L Gates lobbying team is squarely focused on getting the NNTI
bill introduced early in 2008. After introduction, Congressional
hearings will be held on the legislation. The NNTI will be the primary
focus of our meetings on Capitol Hill during the 2008 public policy
tour in March. It is important to note that several forces are
converging which might accelerate the passage of this bill, even as
Congress struggles to pass other legislation.
Here's how you can help:
- Attend the NIO public policy tour in March
- Attend the Congressional hearings whenever possible
- Contact
your local representatives in support of the legislation, and galvanize
your various partners, vendors and investors to do the same (we will
supply general text)
- Agree
to byline an editorial piece for submission to your local news paper,
urging Congress to pass the NNTI. Feinstein Kean Healthcare and NIO
will supply the text and contact the editors, we just need the weight
of your signatures to promote publication.
Neurotechnology Development Foundation: To
help further promote neurotechnology development we are in the process
of creating a new 501(c)(3) non-profit entity whose objective will be
to stimulate neurotech investment and promote treatment development.
The NDF will be able to apply for grants that NIO is not eligible for.
The NDF is currently working on a $2M grant for 2009 that will enable
it to place individuals who have expertise in the translational
development of neurotechnologies in matching programs with neurotech
companies. This Neurotechnology Fellowship Program
(NFP) will fund fellows to provide up to six months of training and
advice regarding general start-up issues, strategic business
development, grant and venture financing, preclinical drug development,
clinical trial planning, and insurance reimbursement. The NFP will be
an additional focus of our meetings on Capitol Hill during the 2008
public policy tour in March.
Bay Area Neurotech Media Roundtable, San Francisco (January 22):
NIO is hosting a special two-hour Bay Area neurotech CEO roundtable
with the editors of the Pink Sheet Daily. As you're probably aware, The
Pink Sheet is a well-read and respected news service devoted to the
pharmaceutical industry. As NIO grows we will be hosting more of these
media roundtables in more regions.
2008 Public Policy Tour, Washington DC (March 12-13):
On March 12th, we will canvass Capitol Hill and meet with leading
Senators and members of Congress in support of neurotechnology. We will
target Congressional hearings if the NNTI legislation has been
introduced. On Thursday morning we plan to head to the FDA to meet with
FDA Commissioner Andrew von Eschenbach and staff from key offices
across the agency relevant for neuroscience to discuss NIO's critical
path initiative project as well as share in a free form discussion
individual company issues. Still in planning, is a meeting with CMS
that will revolve around reimbursement for neurodevices. In order to
make our voice heard, it is critical that we have as many members on
the Hill, from as many Congressional districts as possible.
NIO/YouTube Brain Awareness Week global competition (March 16):
NIO is teaming up with the Society for Neuroscience and the Dana
Alliance for Brain Initiatives to sponsor a competition for Brain
Awareness week (March 10-16). K-12 students will post 30-60 second
videos on YouTube based on the theme "Brain Power." Posted videos can
take the shape of a poem, cartoon, a short movie, parody, song, drama,
or experiment as long as it is relevant to the theme. Last year nearly
1 million people across 2,000 partner organizations in 69 countries
participated in Brain Awareness week.
CIMIT/NIO Epilepsy Innovation Summit (May 7):
NIO has teamed up with the Center for Integration of Medicine and
Innovative Technology (CIMIT) to host a one-day working group summit
focused on next generation treatments for Epilepsy. CIMIT is a
non-profit consortium of Boston area teaching hospitals, engineering
schools and research laboratories where clinicians, engineers, industry
leaders, scientists and the military, work in interdisciplinary teams
to generate promising, leading-edge translational technologies for
healthcare.
Neurotech Industry Investing & Partnering Conference, Boston (May 8 & 9): NIO
is co-hosting this premier partnering and investing conference for the
neurotechnology industry including pharmaceuticals, medical devices and
diagnostics. The conference is a global forum where investors,
executives, entrepreneurs, scientists and others involved in the
development of new treatments and diagnostics for the brain and nervous
system come together to shape the future of their organization and the
industry.
NIO Annual Meeting, Boston, MA (May 9): To
correspond with the Neurotech Industry Investing & Partnering
Conference, NIO members will come together to discuss issue critical to
the success of the industry and their organization. An organized
networking lunch will provide time for members to get to know each.
Updates on current programs and future plans will also be discussed.
Membership 2008:
NIO membership must continue to grow rapidly in order to achieve the
critical mass necessary to support our current and future programs. The
more you can help put me in contact with the right person, the more
time I will have to build on our strategic programs. Once we reach 100
members, NIO should have the resources necessary to build a team,
enabling us to be even more responsive to your needs.
Get Involved: NIO
is a member-driven organization. Members can be involved on the FDA
Policy committee, the CMS Reimbursement committee, Public Policy
committee or the membership committee.
"Giving the Brain a Voice"
Today,
nearly 2 billion people worldwide and nearly 100 million American's
suffer from a brain or nervous system illness. Brain-related illness
generates more healthcare costs and lost income than any other
therapeutic area: $2.0 trillion annually worldwide, $1.1 trillion
annually in the US. This economic burden is accelerating as the
population ages and expands, creating unprecedented demand for
treatments that delay, prevent and cure chronic brain-related illness.
Despite
the clear human need and significant global market opportunity,
neurotechnology companies face unique investment requirements, research
and development challenges, and regulatory milestones which can require
more time and money to develop and deliver new treatments than in other
life science and healthcare sectors.
NIO was formed in August of
2006 to provide commercial neuroscience organizations a collective
voice to address these issues and to help patients, the public,
investors and government officials understand the benefits of
neurotechnology products and the unique needs of this industry.
With continued growth we are well on our way to making an important difference. Join NIO today!
Sincerely,
Zack Lynch
Executive Director
Neurotechnology Industry Organization
The
Neurotechnology Industry Organization (NIO) is a non-profit trade
association representing companies involved in neuroscience - drugs,
devices and diagnostics, brain research centers, and advocacy groups
across the world. More information: www.neurotechindustry.org
NIO Members Since Founding August 2006
Corporate --
Acadia Pharmaceuticals, Accera, Acorda Therapeutics, Acumen
Pharmaceuticals, Adlyfe, Alseres Pharmaceuticals, Amarin, BrainCells,
Inc., Brain Resource Company, Ceregene, Cogmed, Cognitive Drug
Research, CoMentis, Cortechs Labs, CNS Response, Cyberkinetics
Neurotechnology Systems, CyberLearning Technology, EEG Spectrum
International, Ellman Innovations, EnVivo Pharmaceuticals, Innovative
Neurotechnologies, Medivation, Neurologix, NeuroNova, NeuroPace,
NeuroProtect, NeuroScience Associates, Northstar Neuroscience,
RemeGenix, Sound Pharmaceuticals, StemCells, Inc., Targacept, United
Therapeutics, Xenoport, Xytis -- Brain research centers
-- Allen Institute for Brain Science, Blanchette Rockefeller
Neurosciences Institute, CIMIT Neurotechnology program, McGovern
Institute for Brain Research at MIT, Mind Research Network, Van der
Veer Institute for Brain Research -- Patient advocacy groups and research foundations
-- Accelerate Brain Cancer Cure, ALS Hope Foundation, Alzheimer's Drug
Discovery Foundation, Brain Aneurysm Foundation, Epilepsy Therapy
Development Project, International Neuroscience Network Foundation,
NAMI, NARSAD, Neurotech Network, Myelin Repair Foundation, Parkinson's
Research Foundation -- Venture capital firms -- Brain Trust Accelerator Fund, NeuroVentures, Technology Partners -- Strategic Partners --
American Society for Experimental Neurotherapeutics, BiotechPartnering
Solutions, Buchanan Ingersoll & Rooney, Feinstein Kean Healthcare,
K&L Gates, NeuroInsights, NeuroInvestment, Neurotech Reports, Nixon
Peabody, The Potomac Institute's Center for Neurotech Studies View brief descriptions of all NIO members.
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