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Improving Public Health through “Accelerating Clinical Innovation”

Summary: 
HHS and FasterCures are working to accelerate innovation by growing our understanding of the speed and efficiency of the innovation system.

Edison’s famous quote that genius is 99% perspiration and 1% inspiration isn’t just true for light bulbs. It’s also true for the world of healthcare. At HHS we aren’t just trying to replicate Edison’s systematic approach to invention, but also figure out how the system of bio-medical innovation, both incremental and disruptive works. We can then find out how the federal government’s healthcare initiatives, of which we are the standard, can be reformed and refocused to advance innovation in healthcare, with the ultimate goal of improving the health and wellbeing of the American people.

American patients, and indeed patients around the world know their health is improved and their lives saved by medical technologies, from the tried-and-true to cutting edge therapies. But by the time new technologies reach patients, many years and many billions of dollars have been spent on the innovation journey from the first concept through scientific development, clinical testing, regulatory review, insurance coverage determination and reimbursement decisions, and finally incorporation into clinical care. Much of this expense in time and money is necessary, but a lot of it isn’t. Indeed, all too often, treatments are mired in a system that is isolated, entrenched, bureaucratic and too slow for patients.

In 2017, HHS embarked on a mission to “reimagine” how the department works and to identify opportunities for improving how we fulfill our public health mission. The people of the Accelerate Clinical Innovation (ACI) initiative, a component of this “ReImagine HHS” effort, are working on ways to move new health technologies more efficiently from early ideas to widespread patient access, while maintaining critical standards for public health and product safety. ACI has taken an approach that, in order to accelerate innovation, we must first understand the speed and efficiency of the innovation ecosystem. Therefore, ACI has embarked on a mission to develop valid, empirical evidence on the status and progress of the biomedical innovation ecosystem. Then, with a system of measurement in place, government can more readily identify promising reforms in the government’s own innovation policy and processes and the likely impact.

The ACI initiative and FasterCures – a part of the Milken Institute - had independently been developing biomedical ecosystem metrics. Now we will be working together to draw on the strengths of both organizations seeking meaningful and lasting change for the benefit of patients. We each knew that stakeholders involved with the innovation journey, including individuals from sectors as disparate as patients, physicians, scientists, manufacturers, insurers, regulators, and investors, each have a goal, but each also bring different perspectives and equities.

The first task of ACI was to better understand the “Innovators’ Path” through journey mapping exercises, relying on the stakeholders’ perspectives. We learned that incremental innovation in medicine follows a well-described path and result in worthy and important achievements over time. However, disruptive innovation that fundamentally changes care, is a more complex system that is difficult to navigate, especially for seasoned professionals within large organizations with ample resources. And because each disruptive innovation is different, it experiences different challenges in science, process, market evaluation, and many other aspects of development and delivery.

The FasterCures-HHS partnership has engaged experts to identify common principles and begin the development of metrics and an evaluation model. These metrics will assess the overall performance of the system, including government performance, in achieving public health benefit for patients. The model builds on the foundation of existing measures, and will also include measures of innovation activity, including the actions and incentives of philanthropists, product sponsors, and other funders. Overall system performance in areas of transparency, patient-centeredness and collaboration are also being examined. Historically, moving innovation forward has focused on reform to federal polices, but the government, although being the largest single actor, can only influence certain aspects of the innovation ecosystem; it is therefore critical to analyze the rules of all major types of stakeholders when developing an overall view of the innovation ecosystem. Our shared goal is to develop a set of replicable metrics which can be used to benchmark the biomedical innovation ecosystem, identify opportunities for change, and measure the impact of implementing it.

We will also identify areas where innovation efforts should be focused. ACI and FasterCures are working to develop an analytical landscape model to identify priorities for innovation investment based on 1) the expected public health impact of improvements to treatment; 2) the current cost of treatment to the healthcare system, and 3) whether current innovation in this treatment area appears unusually slow. These criteria were partly inspired by the Administration’s Advancing American Kidney Health initiative and the existing public-private partnership accelerator, KidneyX. The partnership has engaged leading experts in epidemiology, economics, finance, and business intelligence to develop the landscape model. By building repeatable methods into the model, the calculations on priorities can also be compared over time to assess the impact of focused efforts and make course corrections as necessary.

Improving public health by accelerating biomedical innovation is a tremendous but, we believe, achievable goal. It will require commitment, strong partnership and robust and continuing engagement from all parts of the biomedical innovation ecosystem. Because of the broad range of this effort, and the reach into so many areas, it is vital that openness and continuing transparency be the hallmarks of the development efforts and assessment of measures. HHS and FasterCures are engaging through public workshops, discussions, and publication during the process of constructing measures. To this end, HHS already hosted a public hearing on this topic on June 20, 2019, and FasterCures has held a series of workshops, most recently on July 23, 2019. Going forward, FasterCures will convene additional workshops and sessions including at the upcoming Milken Institute’s Future of Health Summit, October 28-30.

This is not a project to develop a single invention, but the reform of a system of innovation that should make it easier for all future innovators in our field. It is innovation about innovation itself. We at HHS look forward to working with this sector in the future on both the specific, incremental, and disruptive innovative inventions, and also helping give rise to a better and better-informed platform for future innovations.

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