‘De-risking’ the moonshots at ARPA-H

The ideas and innovators shaping health care

Jun 28, 2023 View in browser   By Erin Schumaker, Ben Leonard, Carmen Paun and Evan Peng FORWARD THINKING Jenkins sees multiple pathways to medical breakthroughs. | Adam Lee/ARPA-H The fledgling Advanced Research Projects Agency for Health is about to pick up the pace. The new agency charged with funding high-risk, high-reward research unveiled its first program, NITRO, or Novel Innovations for Tissue Regeneration in Osteoarthritis, last month. It’s now seeking innovative plans from scientists to develop a breakthrough therapy that would allow the body to repair its own joints. Research proposals are due next month. It's the first of what's expected to become a steady clip of such announcements from ARPA-H, according to Amy Jenkins, who directs the agency’s Health Science Futures Office, one its four focus areas. The others are scalable solutions, proactive health and resilient systems. Jenkins, who joined ARPA-H this year after working at the agency on which it’s modeled — the Defense Advanced Research Projects Agency — talked with Erin about her goals. This interview has been edited for length and clarity. What should people know about ARPA-H’s Health Science Futures Office?  We’re trying to think about what foundational scientific breakthroughs, technological breakthroughs, we need to make in order to change health outcomes for the future. How can I envision these foundational advances? Any examples?   I think of them on three scales. I think of it at the molecular scale — new ways of delivering drugs. I also think of a cellular or tissue scale — new ways of imaging the heart, new ways of imaging the brain — that are cheaper or faster. Then I think on the scale of the order of the body, so new surgical tools, new ways of doing surgery. Is there anything people get wrong about ARPA-H that we can clear up?  People thought we were going to focus on just one disease, or a couple of diseases: cancer, Alzheimer’s, diabetes. The offices are actually formatted around the types of technologies and the types of innovations that may come out of them. A lot of people, when they first looked at our focus areas, were taken aback — they were expecting, you know, the cancer office. Now that people understand — we’ll have an office building foundations and fundamental science and technology breakthroughs, we’ll have an office that’s developing solutions that allow us to scale that could be applied to any disease state — I think that people are excited about that. It allows you to make massive impacts against a variety of disease states all at once. We are disease agnostic. Can NITRO tell us anything about future ARPA-H programs? One thing that’s really important that we do at ARPA-H is de-risking. We need to have at least a fundamental reason to believe an idea is possible — it may be very difficult or unlikely — but we want that fundamental understanding that it is possible. Then we want to de-risk by taking multiple approaches. Maybe there's four different paths to get to the solution. I think NITRO was a great example of that. If you read the NITRO announcement, we said you could potentially use cellular engineering; you could use biologics. Maybe we take four or five different approaches to try to de-risk what the future holds. Things that are very inventive are more achievable when we take multiple shots at getting to that final goal. What's coming down the pipeline? What can we anticipate in the near future?  We are going to have program managers who are releasing NITRO-type solicitations very frequently. I would anticipate 20 or more of those types of announcements in the next calendar year. We also anticipate having close to 80 program managers eventually and them starting new programs about once every one and a half years.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     WELCOME TO FUTURE PULSE Audi Field, Washington, D.C. | Ben Leonard This is where we explore the ideas and innovators shaping health care. Obesity may increase your risk of health problems, but it can be good for your loan application in Uganda, where loan officers who didn’t have much information about a potential borrower’s creditworthiness rated people who were obese much higher than thinner ones, considering it a sign of wealth. Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, host Megan Messerly talks with Carmen about her reporting on how the abortion debate in Congress threatens to jeopardize the reauthorization of the AIDS relief program PEPFAR. Listen to today’s Pulse Check podcast THE REGULATORS HHS is threatening to come down hard on health tech firms that hoard patient data. | John Shinkle/POLITICO $1,000,000 The potential fine for health tech firms that violate HHS information-blocking rules. Health IT developers, health information exchanges and networks that hoard patient data could face big penalties, according to a new rule the Health and Human Services Department finalized yesterday. Why it matters: Congress wants health firms with control of patient records to share them when patients ask and has directed HHS to ban so-called information-blocking in a 2016 law, the 21st Century Cures Act. Patients’ records are protected by HIPAA, the federal health privacy law. But patients sometimes want their records shared if, for example, they want to see a new provider. When electronic records are shared seamlessly, it’s easier for patients to shop around and receive care from specialists. It also helps avert medical errors. Leniency denied: HHS will use its discretion, targeting the most egregious violators. It also rejected industry requests to substitute education or corrective action plans for fines. Companies that acknowledge violations will be eligible for reduced penalties. The agency will also have an appeals process. What’s next? The rules go into effect 60 days after being published in the Federal Register. The new rules don’t apply to health care providers, but HHS has targeted September to release a proposed rule for provider penalties. WORLD VIEW The Gates Foundation is betting big on a new tuberculosis shot. | AP The Bill & Melinda Gates Foundation and the U.K.-based research charity Wellcome will spend $550 million to conduct a Phase III clinical trial for a tuberculosis vaccine that the funders hope will be the first new approved shot in a century. The Gates Foundation will contribute $400 million and Wellcome $150 million to the late-stage research of the M72 vaccine candidate. Why it matters: A vaccine that’s 50 percent effective at preventing pulmonary tuberculosis could prevent up to 8.5 million deaths, avert the need for 42 million courses of antibiotic treatment and save another $41.5 billion in TB-related costs, mostly in the world’s poorest countries, according to the World Health Organization. More than 10 million people fell ill with TB and 1.6 million died in 2021, according to WHO estimates. The M72 vaccine, among 16 shots in the pipeline, has been in development for the last 20 years, the Gates Foundation said. In a Phase IIb trial, it showed approximately 50 percent efficacy in reducing pulmonary TB in adults with latent tuberculosis infection, “an unprecedented result in decades of TB vaccine research,” the foundation said. What’s next? The Bill & Melinda Gates Medical Research Institute, a nonprofit organization and subsidiary of the Gates Foundation, will lead the Phase III trial, which will enroll 26,000 people at more than 50 sites in Africa and Southeast Asia.   SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     WASHINGTON WATCH Sen. Rick Scott thinks Customs and Border Protection can do more to fight fentanyl smuggling. | Gregory Bull/AP Photo Senate-passed legislation to combat the synthetic opioid at the root of America’s overdose crisis is now awaiting House consideration. The bills are: — The TRANQ Research Act tasks the Commerce Department’s National Institute of Standards and Technology to study xylazine, the horse tranquilizer known as tranq that dealers are mixing with fentaynl to deadly effect. — The END Fentanyl Act requires the Customs and Border Protection division of the Homeland Security Department to reexamine its procedures for detecting drugs and to ensure it is using best practices at all ports of entry. The House has already passed the Tranq Research Act, by Rep. Mike Collins, R-Ga., but the Senate tweaked the language last week before passing it so the House will need to vote again before the measure goes to President Joe Biden. On the customs measure, Sen. Rick Scott, R-Fla., has teamed with Rep. Michael Guest, R-Miss., who has introduced a companion House bill that’s still pending.   Follow us on Twitter Ben Leonard @_BenLeonard_ Ruth Reader @RuthReader Carmen Paun @carmenpaun Erin Schumaker @erinlschumaker   Follow us

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