MAPPING THE B.R.A.I.N.

Will the BRAIN Initiative be another Human Genome Project, or another Solyndra?

On April 2nd, 2013, U.S. President Barack Obama unveiled the “BRAIN” Initiative, which is short for Brain Research through Advancing Innovative Neurotechnologies. 

The initiative will launch with approximately $100 million in the President’s Fiscal Year 2014 budget allocated to brain research – to accelerate the development and application of new technologies that will enable researchers to produce a clearer and more dynamic picture of the brain and how the mind works. It will also look to show how individual brain cells and complex neural circuits interact at the speed of thought.  These technologies will explore how the brain records, processes, uses, stores, and retrieves vast quantities of information and shed light on the complex links between brain function and behavior.

This builds on the momentum set forth by the agenda set by the President’s State of the Union address, a call for significant investments in research and development to fuel innovation, and expand our understanding of the human brain and uncover new ways to treat, prevent and cure brain disorders such as Alzheimer’s, schizophrenia, autism, epilepsy, and traumatic brain injuries.

Despite optimism surrounding a strong pledge to funding innovation in our space, the commitment will raise significant questions; most importantly, about how the funds will be spent and how will it drive economic activity. Is this a drop in the bucket that will ultimately lead to a drive in the bioscience industry? Will this initiative complement the efforts of scientific understanding, much the same as the Human Genome Project did when it started nearly 25 years ago in 1989? How will bureaucracy and science co-exist, to avoid the pitfalls of the sluggish Human Genome Project?

The Money Trail

The BRAIN Initiative may be known as the spiritual successor to the Human Genome Project, not only for its desire to understand a mysterious place known to medical science, but for taking its cues from the initial success of the HGP.

The project is certainly as massive – mapping 100 trillion connections made by 85 billion neurons make up the human brain represents a gargantuan task, much in the same way the challenge of mapping the 20,000-25,000 individual genes that made up the bulk of the Human Genome Project.   But the comparison runs deeper – both in economics and scope.

Despite the general conclusion that the HGP did not move as quickly as the scientific community had hoped for, President Obama reminded us that every $1 invested in the Human Genome Project returned $140 to the economy.

Where does the money come from?

The BRAIN initiative in actuality will allocate $110 million to ‘start-ups,’ pledged from various government agencies: the National Institutes of Health ($40 million); the National Science Foundation ($20 million); and the Defense Advanced Research Projects Agency, DARPA ($50 million).

In addition private groups will match a significant portion of funds. The four major research partners for the BRAIN Initiative are: the Allen Institute for Brain Science ($60 million); the Howard Hughes Medical Institute ($30 million); the Salk Institute ($28 million); and the Kavli Foundation ($4 million), for a total of $232 million total for Fiscal Year 2014.

Yet, over the past 3 years biotech has operated under the threat of losing significant federal funding over the entire sector. In 2011 and 2012, we saw several DoD-supported studies frozen for lack of funds.

So how real are these pledges? The National Institutes of Health, for example, is taking a $1.6 billion dollar hit due to current sequestration cuts; whether or not the pace of funding pledged will be maintained with the next administration is unknown.

The U.S. Admits What the Rest of the World Has Said for Quite Some Time

Still, the good news for the industry: in addition to the United States’ pledge, many international hotbeds of innovation have joined in the cause.

The numbers put up from the U.S. coincide with the efforts from the (Switzerland-based) European Union Human Brain Project. The European Commission has deemed the Human Brain Project as a “Flagship Project,” and has earmarked $1.3 billion over 10 years towards research that will utilize supercomputers to simulate a neural network and to investigate how and which genes are expressed by neural activity.

China’s Brainetome Project, supported by the Ministry of Science and Technology of China, the National Nature Science Foundation of China and the Chinese Academy of Sciences, and in operation since 2004, has received some €80 million Euros in funding, focusing especially on diffusion Magnetic Resonance Imaging (dMRI), along with developments utilized from Cuba based on neurotechnology (as part of a project that has lasted about a decade).

The Cuban project combines a stratified active screening program for brain disorders at the population level by utilizing databases, analysis tools, and theoretical models to craft tools and treatments for early diagnosis and management.  Starting nearly a decade ago, this project has enjoyed success in accelerating the progress of neuroimaging and neuroinformatics technology, which opens promising paths to understanding what role each region of the brain plays in mental activity, along with the role of genetic and environmental variables in brain formation and activity, critical areas that the BRAIN Initiative will also seek to address. (this comes from comments by Dr. Pedro Valdés Sosa, Deputy Director for the Cuban Neurosciences Center.

A Re-Commitment to Incubating Innovation

The most tangible commercial opportunity is lowering the cost and effectiveness of brain treatments, the same way that the Human Genome Project brought down the cost of genetic mapping.

So, is there a chance that the BRAIN Initiative will make an immediate impact upon the market?

“The BRAIN Initiative sends a signal that this is an area that we need to be invested in, because if we don’t we’re going to pay for it one way or another,” said Gerald E. Commissiong, CEO of Amarantus Bioscience (AMBS) in an interview with OneMedPlace. Amarantus is currently undergoing preclinical testing for its headlining MANF therapy, designed to address Alzheimer’s, Parkinson’s and Traumatic Brain Injuries.

Commissiong went on to describe his view of the role that the initial infusion of funding will take, saying “More likely than not this will be more of a catalyst than in and of itself an important investment.”

His view may also be tempered by the fact that Amarantus’s MANF therapy was once developed at the NIH, and Amarantus’ CSO ran a division of the NIH. Amarantus may be an interesting case study in spinning out successful technologies into the private sector.

Political Agenda, or Re-Commitment to Innovation?

Traditional funding for early stage companies (grants, angel and venture) is drying up, and there exists a funding gap for emerging growth companies. Earlier in the process, grants to independent researchers are off significantly. Many people are having a tough time keeping their labs afloat, and the resulting attrition is affecting employment and growth on the private side. The United States is seeing more innovation (and state support) beyond its borders, and for the first time may lose its position as the world leader in medical advancement.

This Legislative Branch certainly hasn’t helped, as evidenced by the Affordable Care Act of 2010, specifically a $30 billion annual tax on medical devices.

According to an Op-Ed piece in the Wall Street Journal by Gregory Sorensen, CEO of Siemens Healthcare North America and former professor of Radiology at Harvard Medical School, since the tax went into effect on January 1st, 2013 manufacturers have already paid an estimated $450 million in new taxes, redirecting funds that could otherwise be used for innovation and other endeavors.

Sorensen also quoted figures put out by two libertarian free market think tanks, claiming the health law’s medical-device tax will reduce American medical research and development by an estimated $2 billion a year, and cost some 146,000 American jobs.

These underlying factors become all the more important as the decision of where to allocate BRAIN funds becomes real. When the debate begins as to whom is the main beneficiary of these efforts will be, will we discover a covert political agenda to prop up employment figures and “sector growth”, or a true commitment to furthering the science through commitment to the ‘best’ companies?

Before we look too jaded, it is important to note federal funding tends to align with companies indeed possessing top-notch valuations as well as groundbreaking applications in orphan or underserved market (such as Amarantus’ connection with the NIH), and companies such as CytoSorbents (CYSO) or ExThera Medical’s work in the sepsis arena with DARPA – previously covered by OneMedPlace. We simply want to make sure the BRAIN Initiative follows in this trend.

Still, the funding structures have indeed changed, and it would be logical to guess that the development structures (especially in light of the recently passed JOBS Act) would change. Hence, it should be anticipated that regulatory and commercialization paths would change as well to foster the information done at the R&D level.

Reactions & Criticisms: How do We Judge Success?

Dr. Sorensen is not the only one who sees the government tripping under its own feet in trying to help our sector.  Many are worried that this is just another handout to bigger companies to display growth at the shallowest of levels. In actuality, these funds should be and claim to be intended for researchers and PH.D candidates.

Moreover, many are worried that the funding for these initiatives will be cut. It is difficult to justify such a staunch commitment to brain research when significant dollars fueling virus, immune disorder, cancer, and regenerative medicine are scarcer with each passing month.

David Hovda Ph.D, Director of the Brain Research Center at UCLA, has expressed misgivings at the fact that the BRAIN Initiative, despite its lofty goals, really does not have a major, tangible endpoint.  When combined with the lack of information and details about the project, Hovda added, with significant brain research done without a substantial public commitment from the government, what or who is all this really for?

Still, there exists a healthy number of supporters. Society for Neuroscience (SFN) President Larry Swanson, a neurobiologist at the University of Southern California in Los Angeles, wrote on behalf of the SFN executive committee, calling the BRAIN Initiative “tremendously positive” for neuroscience.

Swanson has cautioned that critics should not rush to judgment, noting that  “It is my continuing hope that we all reserve judgment on the merits of the broader project until we first learn more about what it will prioritize and fund, and that is going to take some time.”

A main question in the medical community remains: to what extent will funds be allocated to innovation, vs. for patient care and efficiency?

Alvaro Fernandez, the CEO of SharpBrains.com, a leading independent market research and think tank tracking health and productivity applications of neuroscience, cautioned in a presupposition in “Venture Beat” in April, 2013 that the Initiative should focus as much on research and goals as it does on encouraging the development of cost-efficient diagnostic tools, and programs distributed over the Internet/Cloud.  Fernandez argued that these developments  can generate valuable data to expand the understanding of cognitive functioning, which, coupled with the Big Data analysis of the U.S./E.U./China, can yield amazing insights that have immediate applications.

At the core, the BRAIN Initiative must commit to building commercial applications and fostering the relationship between the private and public sector, and it must do so with the same fervency as it certainly will in fueling politically-charged talking-points related to employment and “remaining competitive.”

The Human Genome Project’s biggest win was the facilitation of incubating early-stage and publicly funded technology for spin out into the private sector. The result is a massive paradigm shift in how we approach treatment – away from normative medicine, and toward personalized medicine.

The BRAIN Initiative has a chance to be as scientifically relevant, and consequently to become a catalyst in true industry growth.

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