Growth-based innovation key to solve disease

[Margaret Anderson, Kimberly Myers, Nina Gonzalez, 5-23-2023, "Unlocking the potential of biomedical innovation: The crucial role the government and partnerships play in accelerating progress," Deloitte Insights, ] WL

Government can support the biomedical and health ecosystem by providing frameworks, resources, and last-mile infrastructure to help foster disruptive innovation. It was an extraordinary achievement. In less than one year, the biomedical ecosystem helped bring to life an mRNA vaccine with the power to stave off severe disease and death during the worst pandemic since 1918.1 Of course, this wasn’t really a miracle. It was just one example of what government and partners can do when challenged to develop disruptive innovations. Government has been a disruptive force for innovation across many sectors, from Defense Advanced Research Projects Agency (DARPA) laying the foundation for the internet in the 1960s, to the role of the National Institutes of Health’s (NIH) and US Department of Energy in the Human Genome Project, which mapped the full genome for the first time in 2003 with an international consortium of thousands of researchers, to the U.S. President’s Emergency Plan for AIDS Relief initiative that has saved more than 25 million lives from HIV/AIDS across the globe.2 There seems to be increased interest in having government invest in federal health infrastructure for innovation. Of note, two federal health agencies have been tasked with advancing later stage research: the National Center for Advancing Translational Science (NCATS), an agency that supports programs in translational research and works to accelerate the development process, and the Advanced Research Projects Agency for Health (ARPA-H) formed in 2022.3 With increasing investment and interest in government as a catalyst of disruptive innovation, opportunities abound for government to help solve some of the health sector’s biggest challenges today. Accelerated innovation during the COVID-19 pandemic provided an exemplary model for how government can work with partners to advance care and treatment for all diseases—a focus on impacted patients and communities, real-time information flow, collective prioritization of targets, regulatory input along the way, and a dissemination plan for the discovery. The scale and speed of COVID-19 therapeutics development represents a fundamental shift in how government could catalyze innovation. It’s critical that we reflect and set a course to solidify these practices, lest we lose the lessons learned and momentum for faster innovation and faster treatments and cures. In this study, we investigate how government can leverage lessons from COVID-19 collaborative innovation to accelerate biomedical innovation. Methodology We conducted a literature review and interviews with 15 leaders in government, biopharma, nonprofits, academia, and philanthropy to assess lessons learned from COVID-19 response, key drivers of innovation, partnership challenges and opportunities, the role of government in discovery and development, and ways in which the momentum of accelerated biomedical innovation can be sustained. Setting the stage: The biomedical ecosystem The biomedical research ecosystem is composed of multiple stakeholders, all with an array of participants and contingencies for their existence and success. These stakeholders include sponsoring organizations (e.g., venture capital and startups), federal agencies, pharmaceutical companies, academic entities, philanthropic entities (e.g., NGOs), and patients and communities. The past decade has seen several forward-leaning efforts that harness the power of these various entities, from the passage of the 21st Century Cures Act by Congress in 2016,4 to the articulation of a Cancer Moonshot by President Obama overseen by then Vice President Biden,5 which continues under now President Biden, to a recent addition to the innovation roster—the creation of a new agency, ARPA-H.6 With increasing funding for novel, Moonshot-like research, government may be poised to be a key player in driving disruptive ecosystemwide solutions. Three ways government and their partners can accelerate disruptive biomedical innovation Government can work with partners to leverage the full continuum of relationships, prioritize patients and communities in the innovation pipeline, and support funding and collaboration infrastructure for last-mile innovations (figure 1). Share image Or copy link 1. Leverage the full continuum of collaboration to help foster innovation Even before the COVID-19 pandemic, partnerships that encouraged sharing of important assets, expertise, and knowledge, while aiming to reduce administrative red tape, were seemingly gaining ground. A number of federal agencies have been actively working to foster innovation through such partnerships. Examples include: the National Cancer Institute (NCI) Formulary, the NIH Pragmatic Trials Collaboratory, and several National Center for Advancing Translational Sciences (NCATS) programs (see the sidebar, “Prepandemic partnerships for innovation”). Prepandemic partnerships for innovation During the COVID-19 pandemic, unprecedented collaborations were the bedrock of breakthrough innovation. It is important to “codify these lessons learned so as not to squander the many things the system discovered, and we need to see what was people-specific versus process-specific,” said one interviewee.12 One such collaboration was the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) coordinated by the Foundation for the NIH (FNIH) and launched in April 2020 in the early days of the pandemic. ACTIV’s mission was to develop a research strategy for prioritizing and speeding development of the most-promising COVID-19 vaccines and therapeutics. It brought together multiple federal agencies, pharmaceutical companies, and representatives from academia, international agencies, and philanthropic entities. ACTIV coordinated multiple clinical trials and reviewed many therapeutic compounds as well as shared its work through several scientific papers and presentations. Its spearheading role in the Countermeasures Acceleration Group (formerly known as Operation Warp Speed) can become a model for collaboration in the future of biomedical science.13 The incentives and mandates for collaboration outlined in the program led to vaccines being produced in record time and has been one of the most successful public-private partnerships in recent times.14 “The pandemic accelerated things at a pace we wouldn’t have seen if we did it the traditional way.”15 - Interviewee At the height of the pandemic, the entire ecosystem was focused on COVID-19 research and development, resulting in few competing priorities. Among the things that made the COVID-19 collaboration unique was the intensity of it: For example, 30–40 meetings a week at one point for one specific workstream.16 These sorts of partnerships are undeniably more demanding, and work best when partners have the resources and shared agenda that enable moving quickly. Though everyone under the tent had different perspectives, goals, and incentives, the end result was valuable for all partners: therapeutics and vaccines developed in record time. When optimized, partnerships can save costs and time. “Partnerships put a structure around innovation,” said one interviewee, “and that is key.”17 Partnering for innovation can take myriad forms along the continuum of collaboration—from loose project-based collaboration with defined end dates, to alliances whose partnerships are ongoing and entail shared risks, responsibilities, and rewards, as well as many forms in between.