How a new federal agency for scientific breakthroughs can succeed
While it may not yet be on the tip of everyone’s tongue, a potentially game-changing new federal medical research agency called the Advanced Research Projects...
While it may not yet be on the tip of everyone’s tongue, a potentially game-changing new federal medical research agency called the Advanced Research Projects Agency for Health (ARPA-H) is gearing up to power breakthroughs in biomedical and health research. With a can-do model that will fund ambitious projects such as those seeking cures for cancer and Alzheimer’s, the agency will promote three-year partnerships between academic researchers and industry leaders to tackle some of the toughest challenges.
The agency’s approach is based on the storied Defense Advanced Research Projects Agency (DARPA), known for its role in developing the internet, stealth technologies and advancing vaccine technology that helped speed the development of COVID-19 vaccines.
But as laudable as ARPA-H’s goals are, there are bear traps to avoid if the agency is to succeed. As dean of a major medical research institution along with a perspective of having worked inside the National Institutes of Health, here’s what I see as the biggest hurdles the nascent agency will need to clear.
First, the agency needs to avoid the tendency, often difficult among government agencies, to reinvent the wheel. ARPA-H envisions project managers tasked with identifying a difficult health challenge and then finding the best academic and industry researchers to solve the problem. So far, so good. But the truth is, many of the most pressing questions are already front-of-mind at the NIH and other leading research centers.
ARPA-H must start its search by looking to these powerhouses for the projects that will meet the agency’s remit and benefit most from its support to get innovative products to market faster. Similarly, by keeping channels open with major academic medical centers such as Duke, ARPA-H will have access to scientific and technology experts when assembling its teams.
A close connection between ARPA-H and NIH will have another benefit — one that was highlighted both during the race to find HIV therapies and more recently COVID vaccines — it will further promote collaboration between NIH’s laboratory-based expertise and institutions and industry with clinical trial capacity and know-how. Put simply, this kind of team science is how real-world solutions are developed. Steady and dependable funding for both is critical and necessary.
Second, the agency must plan for bureaucratic practicalities now. If ARPA-H’s goal is research that results in clinical applications such as a new diagnostic test or drug, eventually it means getting the Food and Drug Administration’s approval. To avoid delays, ARPA-H needs to involve the FDA early to streamline the path to approval. This will be particularly important in incentivizing commercial partners who will see approval as imperative to success and eventual insurance coverage. And when it comes to the private sector, ARPA-H should cut red tape now and accelerate industry participation by hashing out the sharing of intellectual property and institutional credit.
Third, ARPA-H must think big. One of the most important lessons-learned from the pandemic was the need for a national data-sharing infrastructure. Medical centers caring for a deluge of COVID patients were technically hampered and unable to effectively share information, set up research models, or enroll patients in early trials. ARPA-H should prioritize projects that will build this infrastructure. It is not only essential before we face a future health crisis, but also in allowing the rapid testing and reporting of new therapies.
Fourth is crucial for the long-term success of the agency and public policy tied to science. ARPA-H must do its part to regain the public’s trust in science – having been significantly damaged in the wake of the pandemic. This means clearly communicating its mission to the public in ways that are both accessible and meaningful to people.
The great news is that ARPA-H is pointed in the right direction. All it needs to do is assemble the best and brightest, create the path and get out of the way.
Dr. Mary Klotman is executive vice president for health affairs at Duke University, as well as dean of Duke University School of Medicine, and chief academic officer for Duke Health.
How a new federal agency for scientific breakthroughs can succeed
While it may not yet be on the tip of everyone’s tongue, a potentially game-changing new federal medical research agency called the Advanced Research Projects...
While it may not yet be on the tip of everyone’s tongue, a potentially game-changing new federal medical research agency called the Advanced Research Projects Agency for Health (ARPA-H) is gearing up to power breakthroughs in biomedical and health research. With a can-do model that will fund ambitious projects such as those seeking cures for cancer and Alzheimer’s, the agency will promote three-year partnerships between academic researchers and industry leaders to tackle some of the toughest challenges.
The agency’s approach is based on the storied Defense Advanced Research Projects Agency (DARPA), known for its role in developing the internet, stealth technologies and advancing vaccine technology that helped speed the development of COVID-19 vaccines.
But as laudable as ARPA-H’s goals are, there are bear traps to avoid if the agency is to succeed. As dean of a major medical research institution along with a perspective of having worked inside the National Institutes of Health, here’s what I see as the biggest hurdles the nascent agency will need to clear.
First, the agency needs to avoid the tendency, often difficult among government agencies, to reinvent the wheel. ARPA-H envisions project managers tasked with identifying a difficult health challenge and then finding the best academic and industry researchers to solve the problem. So far, so good. But the truth is, many of the most pressing questions are already front-of-mind at the NIH and other leading research centers.
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ARPA-H must start its search by looking to these powerhouses for the projects that will meet the agency’s remit and benefit most from its support to get innovative products to market faster. Similarly, by keeping channels open with major academic medical centers such as Duke, ARPA-H will have access to scientific and technology experts when assembling its teams.
A close connection between ARPA-H and NIH will have another benefit — one that was highlighted both during the race to find HIV therapies and more recently COVID vaccines — it will further promote collaboration between NIH’s laboratory-based expertise and institutions and industry with clinical trial capacity and know-how. Put simply, this kind of team science is how real-world solutions are developed. Steady and dependable funding for both is critical and necessary.
Second, the agency must plan for bureaucratic practicalities now. If ARPA-H’s goal is research that results in clinical applications such as a new diagnostic test or drug, eventually it means getting the Food and Drug Administration’s approval. To avoid delays, ARPA-H needs to involve the FDA early to streamline the path to approval. This will be particularly important in incentivizing commercial partners who will see approval as imperative to success and eventual insurance coverage. And when it comes to the private sector, ARPA-H should cut red tape now and accelerate industry participation by hashing out the sharing of intellectual property and institutional credit.
Third, ARPA-H must think big. One of the most important lessons-learned from the pandemic was the need for a national data-sharing infrastructure. Medical centers caring for a deluge of COVID patients were technically hampered and unable to effectively share information, set up research models, or enroll patients in early trials. ARPA-H should prioritize projects that will build this infrastructure. It is not only essential before we face a future health crisis, but also in allowing the rapid testing and reporting of new therapies.
Fourth is crucial for the long-term success of the agency and public policy tied to science. ARPA-H must do its part to regain the public’s trust in science – having been significantly damaged in the wake of the pandemic. This means clearly communicating its mission to the public in ways that are both accessible and meaningful to people.
The great news is that ARPA-H is pointed in the right direction. All it needs to do is assemble the best and brightest, create the path and get out of the way.
Dr. Mary Klotman is executive vice president for health affairs at Duke University, as well as dean of Duke University School of Medicine, and chief academic officer for Duke Health.
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