domingo, 15 de abril de 2018

Statement on public-private partnerships as part of the NIH HEAL Initiative | National Institutes of Health (NIH)

Statement on public-private partnerships as part of the NIH HEAL Initiative | National Institutes of Health (NIH)

National Institutes of Health (NIH) - Turning Discovery into Health

Statement on public-private partnerships as part of the NIH HEAL Initiative

NIH recently launched the Helping to End Addiction Long-term (HEAL) Initiative, a trans-agency effort to speed scientific solutions to stem the national opioid crisis. While the HEAL Initiative will be advanced through NIH-funded research, there are some areas that could be accelerated through public-private partnerships.  I want to express my gratitude to the members of the Advisory Committee to the Director (ACD) Working Group, who were charged to provide advice on the appropriate ethical boundaries for engaging with and accepting resources from biopharmaceutical companies, some of which manufacture opioids, as we consider ways to accelerate scientific solutions to end the opioid crisis. Their thoughtful report on this complex issue was presented to and approved by the ACD last week and provides clear guidance. I fully embrace their recommendation that NIH should vigorously address the national opioid crisis with government funds and decline cash contributions through partnerships from the private sector.
It is clear, however, that the opioid crisis is beyond the scope of any one organization or sector. NIH and biopharmaceutical companies bring unique skills and assets to bear on this crisis.  NIH will use the ACD guidance as we continue our discussions with biopharmaceutical organizations to advance focused medication development for addiction and pain.  This engagement may include agreements for sharing clinical and preclinical data, as well as promising but currently dormant compounds that have proven safe in humans and may succeed in treating pain or addiction with additional research.   We will also need to identify biomarkers to help us understand and predict which therapies will be effective in which patients. As part of the HEAL Initiative, NIH plans to launch a clinical trials network that will allow multiple new and repurposed compounds for the treatment of pain to be tested simultaneously for effectiveness. We believe that the combination of testing compounds that have already received large investments and passed safety testing against biomarkers of effectiveness within a flexible clinical trials network will significantly accelerate the development of effective therapies. We agree with and appreciate the ACD’s guidance to verify donated assets and tailor the governance structures for each initiative that may be pursued through public-private partnerships to ensure appropriate oversight and guidance. Any partnerships that NIH does establish with biopharmaceutical organizations as part of the HEAL Initiative will be done with the utmost transparency.
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

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