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Apr 5, 2013

BRAIN Initiative Sparks Food for Thought

  • The brain activity map initiative announced by President Barack Obama should yield valuable insights into the supercomputer in our heads. But it also raises issues of research coordination, privacy, and funding that investigators need to address for the project to succeed, according to a lawyer specializing in health industry issues.

    A working group at NIH has been charged with addressing these and other issues as it develops a multiyear plan with goals, timeframes, and estimated costs for the initiative, called Brain Research through Advancing Innovative Neurotechnologies (BRAIN). Cornelia (Cori) Bargmann of The Rockefeller University and William Newsome of Stanford University are co-chairs of the working group.

    Priority one for the group should be coordination among institutions to prevent duplication of research efforts, Stephen W. Bernstein, a partner in the Boston office of law firm McDermott Will & Emery, told GEN yesterday.

    “The biggest conceptual issue, and the way to make this go, is to architect a way for unrelated institutions to collaborate in the research,” said Bernstein, who heads the firm’s Health Industry Advisory Practice Group. “Will there be some kind of central institutional review board that can manage all the studies, or are each of the research institutions going to have to look at their own IRB? How is that going to work? That’s a threshold issue, and every institution has its own way of looking at that. That’s got to get resolved.”

    Another priority, Bernstein said, should be defining a role for disease foundations, which in recent years have filled the drug-development gap between academia and industry by uniting their researchers, funding their studies, and, sometimes, conducting their own research.

    “NIH needs to develop the roadmap for how people participate so that things can be done efficiently, but not get too doctrinal about it because I think that will slow things down,” Bernstein said.

    Among participation issues: How patients are enrolled in studies, how data from medical records can be used and stored (identified or de-identified?), and how institutions handle blood or tissue collection, since many patients will be unable to give consent due to age or infirmity.

    BRAIN initiative institutions will need to build answers to those questions into their clinical processes, while a framework for surrogate consent will be needed, and consent between institutions will need to be broad enough to cover expanded collaborations involving additional partners, Bernstein added.

    Joining NIH in the initiative will be the National Science Foundation and the Defense Advanced Research Projects Agency. Obama will include $100 million to launch BRAIN in his proposed budget for fiscal year 2014.

    According to NIH’s RePORT database, the agency expects to spend $3.87 billion on brain disorder research in FY2013. As GEN recently reported, the BRAIN initiative is projected to cost more than $3 billion—$300 million a year over 10 years. Washington spent $2.7 billion in 1991 dollars (about $4.6 billion today) on the Human Genome Project.

    Obama has sought to justify the expense by arguing dollars—Washington says the genome project returned $140 per dollar spent—and disease-fighting potential: “We’re still unable to cure diseases like Alzheimer’s or autism, or fully reverse the effects of a stroke.”

    During FY2013, NIH expects to spend $316 million on stroke research, $170 million on autism, and $449 million on Alzheimer’s—for which Obama’s administration launched a “National Plan” last year to prevent and effectively treat the disease by 2025.

    “There is this enormous mystery waiting to be unlocked,” Obama said April 2. “The BRAIN Initiative will change that by giving scientists the tools they need to get a dynamic picture of the brain in action and better understand how we think and how we learn and how we remember. And that knowledge could be—will be—transformative.

    Bernstein said federal funds spent for BRAIN will spark additional spending by biopharmas, private institutions, disease groups, foundations, and others engaged in venture philanthropy.

    “That will create some very nice collaborations among all those parties. The challenge is, how will they all work together to reach the result?” Bernstein added.


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