Strategic Plan for Fiscal Years 2024 - 2026 The Advanced Research Projects Agency for Health (ARPA-H) was established in March 2022 to improve health outcomes for everyone. By supporting the development of high-impact solutions to society’s most challenging health problems, ARPA-H aims to create the next generation of lifesaving treatments and cures to improve the health and well-being of all Americans. ARPA-H will operate at the forefront of scientific advancement, catalyzing groundbreaking innovation and nurturing high-risk, high-reward programs with the potential to transform the health ecosystem. This FY24 - FY26 ARPA-H Strategic Plan sets the Agency's inaugural goals as follows:Through implementation of this strategy, ARPA-H will address the most urgent challenges in the health ecosystem, including issues such as the escalating rates of chronic diseases, inequitable access to high-quality health care, vulnerabilities in data security and privacy, prevention and treatment strategies for cancer, novel interventions for neurodegenerative diseases, strategies to improve the mental health and substance use disorder crises, the continued need for pandemic preparedness, and the rise of antimicrobial resistance, among others.Advanced Research Projects Agency for HealthARPAH_c01d2e64-b408-11ef-88ba-f5791d83ea00Renee Wegrzyn, Ph.D.Director, Advanced Research Projects Agency for HealthCongressThis document outlines ARPA-H's Strategic Plan for the fiscal years 2024 to 2026. As required by the Consolidated Appropriations Act of 2023, every three years a new Strategic Plan will be formulated and transmitted to the Senate Committee on Health, Education, Labor, and Pensions, the Senate Committee on Appropriations, the House of Representatives Committee on Energy and Commerce, and the House of Representatives Committee on AppropriationsSenate Committee on Health, Education, Labor, and PensionsSenate Committee on AppropriationsHouse of Representatives Committee on Energy and CommerceHouse of Representatives Committee on AppropriationsThe most urgent challenges in the health ecosystem are addressed_c01d3058-b408-11ef-88ba-f5791d83ea00To accelerate better health outcomes for everyone_c01d3274-b408-11ef-88ba-f5791d83ea00PrinciplesGuiding Principles ~ These principles help direct the agency’s actions, decisions, and behavior. They shape ARPA-H culture, inform policies and practices, and guide employees in achieving the mission and objectives... ^^ By adhering to these core principles, ARPA-H commits to being a dynamic and forward-thinking agency that actively drives innovation, accelerates research breakthroughs, and positions itself as a pivotal player in advancing health-related technologies and solutions.EquityARPA-H is committed to advancing equity within the agency and throughout its technical portfolio, including with respect to race, ethnicity, gender/gender identity, sexual orientation, disability, geography, employment and insurance status, and socioeconomic status. The ARPA-H workforce represents diverse backgrounds and perspectives, which is essential to fostering a creative, inclusive culture and developing policies, practices, and programs that sustain an ongoing focus on equity. ARPA-H programs are required to establish plans to address potential misuse and disparities in health outcomes, affordability, and accessibility prior to launch. The programs push boundaries to ensure that their advancements benefit everyone, especially those who have historically been underrepresented in biomedical research and development efforts.AccessibilityAccessibility and Affordability ~ Through program design, contract structures, activation of a nationwide health innovation network, early patient and community engagement, and a focus on transition pathways, ARPA-H will prioritize making solutions accessible and affordable to those in need.AffordabilityClarityClear Pathways to Success ~ ARPA-H de-risks solutions so they may transition successfully to advanced developers and downstream funders following ARPA-H investment. Every ARPA-H effort considers possible transition pathways at inception. Transition pathways may include, but are not limited to, a health care system or provider network that will deploy the licensed technology through their care network; a venture capital-backed emerging company with demonstrated commitment to the technology’s domain area; an additional government agency that will adopt the solution; or an established company or non-profit with existing infrastructure for development, sales, and distribution.FocusProblem Focused ~ The ARPA-H model is centered around solving specific, high-risk, high-reward problems with technical and programmatic rigor over finite amounts of time. This problem-focused approach aims to address critical challenges in the health sector, emphasizing precision and effectiveness.AgilityAgility and Adaptability ~ ARPA-H emphasizes iterative development and rapid prototyping to allow for quick adaptation and refinement of projects based on real-world results and feedback from patients and caregivers -- ARPA-H's primary customers. ARPA-H also has flexible awards processes to pivot and adjust project funding based on emerging trends, breakthroughs, and evolving needs.AdaptabilityManagementProgram Manager-Driven ~ In the ARPA-H framework, Program Managers (PMs) are integral drivers of innovation. These term-limited health ecosystem visionaries bring together creativity, determination, and proven expertise. They work with unique urgency, efficiency, and speed, adopting a bottom-up approach to tackle some of the most complex issues in health care today.CollaborationCross-Disciplinary Collaboration ~ ARPA-H promotes collaboration across diverse technical fields and market sectors. By encouraging experts from varied domains to work together, ARPA-H fosters a creative exchange of ideas that can lead to innovative solutions, including from non-traditional sources.Cross-DisciplinarityAccountabilityARPA-H places a strong emphasis on measurable outcomes and milestones. Projects are closely monitored, and funding is tied to achieving specific goals, ensuring that taxpayer investment leads to tangible results.TechnologiesExpand Technical Possibilities for the Future of Health_c01d32ba-b408-11ef-88ba-f5791d83ea001ARPA-H strategically invests in foundational technologies that are poised to revolutionize the future of health. Current development of platform technologies to address human diseases faces challenges in integrating diverse disciplines, such as biology, engineering, and data science, to create comprehensive solutions. ^^ ARPA-H will focus on removing obstacles that inhibit innovation and explore new ideas and methods to accelerate progress. These ideas and methods will transcend specific disease boundaries, catalyze breakthroughs across a wide spectrum of health challenges, and address critical hurdles to ensure scalability, interoperability, and regulatory compliance across multidisciplinary platforms. ResearchCatalyze research toward platform technologies_c01d32f6-b408-11ef-88ba-f5791d83ea001.1Develop new tools and technologies for detection, manufacturing, and drug development, and envision new and "programmable" drug modalities.ToolsAccelerate development of novel tools to enable a new future of health care_c01d335a-b408-11ef-88ba-f5791d83ea001.2Establish novel methods for targeted drug delivery, new disease-agnostic drug paradigms, cell and gene-based therapies, innovations in organ transplantation, and agile technologies designed to facilitate the discovery, characterization, and production of preventatives and therapeutics.ParadigmsLead creation of entirely new paradigms_c01d3396-b408-11ef-88ba-f5791d83ea001.3Develop technologies that can easily reconfigure to treat multiple diseases, accelerate the ability to discover new therapies, and reduce off-target effects of existing therapies.EcosystemForge a Resilient Health Ecosystem to Ensure Optimal Well-Being for All_c01d33d2-b408-11ef-88ba-f5791d83ea002ARPA-H will address systemic challenges across the health landscape by investing in cutting-edge technologies that address long-standing gaps in the quality, efficacy, and availability of care. Aspects of today’s health systems remain fragile due to systemic challenges, which include rising health care costs, inadequate health care coverage for significant populations, outdated infrastructure, and health disparities among different demographic groups. Acute challenges, such as hospital closures, supply chain disruptions, staffing shortages, cyberattacks, public health crises, and the emergence of new diseases, exacerbate existing fragilities, making it more difficult to maintain high standards of care. These challenges are compounded by the fact that systems remain fragmented, hindering the ability to gain comprehensive insights, make informed decisions, develop tailored interventions, and share critical health information between stakeholders. ^^ ARPA-H will drive innovations that enhance the adaptability, reliability, and interoperability of the health ecosystem. These innovations will foster flexibility and enable adaptation to system stressors so that people and systems remain well-positioned to deliver high-quality care and improve health outcomes.InnovationEmpower patients, providers, and communities through transformational innovation_c01d3418-b408-11ef-88ba-f5791d83ea002.1PatientsProvidersCommunitiesDevelop user-centric digital health tools, platforms, technologies, and intervention models that actively manage prevention, diagnosis, treatment, and care across the health continuum. Such advances will enable personalized care, real-time monitoring, evidence-based approaches, and informed decision-making. Ultimately, high-quality care depends on the combination of people and technology working seamlessly together to enhance human performance, communication, and care for the whole person.InterconnectionFoster an interconnected health ecosystem_c01d345e-b408-11ef-88ba-f5791d83ea002.2Create novel capabilities to advance the integration of health-related systems, from the individual to population scale. These innovations will streamline coordination across clinical care, operations, public health, research, and community health. Efforts in this area will strengthen the connectivity, interoperability, and operational efficiency of health infrastructure to facilitate safe, secure, and seamless exchange of information among health care providers, patients, researchers, and stakeholders.Stability, Adaptability & RobustnessEnhance stability, adaptability, and robustness across the health ecosystem_c01d349a-b408-11ef-88ba-f5791d83ea002.3Innovate agile and sustainable approaches to anticipate, mitigate, and adapt to evolving health challenges. Efforts will explore new paradigms to minimize disruptions caused by supply chain shortages, emerging pathogens, or catastrophic events. Such approaches will leverage artificial intelligence (AI), decentralized models, predictive analytics, and adaptive technologies to broaden the availability of high-quality care, reduce pressure and vulnerabilities on the health ecosystem, and enhance emergency response.CareDrive Scalable Solutions to Improve Health Care Access and Affordability_c01d34ea-b408-11ef-88ba-f5791d83ea003ARPA-H will leverage an interdisciplinary approach and collaborative networks to create programs that address challenges of geography, distribution, manufacturing, data and information, thereby improving health care access and affordability. In the United States, many communities and remote areas lack access to timely and quality health care, which leads to disparities in health outcomes for those populations. Bottlenecks during the manufacturing processes of products and health technologies also lead to delays and limited availability, preventing effective distribution of health care solutions to areas of need, especially in emergencies. ^^ ARPA-H will improve the scalability and affordability of health care solutions, bridge gaps in underserved areas, and extend remote access to expertise by developing location-specific interventions, telemedicine solutions, and mobile health clinics. Through its focus on rapid innovation and local partnerships, as well as flexible distribution networks and streamlined manufacturing processes, ARPA-H will accelerate the availability of critical health care technologies and makes them more affordable for everyone.AffordabilityEnhance affordability through scalable technologies and interventions_c01d3530-b408-11ef-88ba-f5791d83ea003.1Prioritize research and development efforts aimed at creating scalable health care technologies and interventions that reduce cost. These efforts include investing in innovative approaches to improve affordability, such as drugrepurposing, telemedicine, point-of-care diagnostics, and modular health care infrastructure, that can be rapidly deployed and adapted to various geographic, economic, and manufacturing contexts.NetworksEstablish collaborative distribution networks_c01d3576-b408-11ef-88ba-f5791d83ea003.2Partner with local communities, health care providers, and technology companies to establish collaborative distribution networks that address challenges related to geography, affordability, manufacturing, and economies of scale, ensuring equitable, quick, and efficient "last mile" delivery of health care solutions.BiomanufacturingLead the biomanufacturing revolution_c01d35c6-b408-11ef-88ba-f5791d83ea003.3BiomanufacturersScientistsIndustriesDrive innovation at the intersection of biology and technology to redefine the landscape of biomanufacturing, empowering scientists and industries to rapidly translate cutting-edge research into life-changing products, secure the health supply chain, and accelerate the pace of scientific discovery.CapacityBuild Proactive Health Capacity to Keep People from Becoming Patients_c01d3616-b408-11ef-88ba-f5791d83ea004ARPA-H will raise public awareness, foster a culture of proactive health management, and implement innovative strategies that empower individuals to take charge of their wellness to mitigate the development of health issues. Currently, health care systems focus almost exclusively on treating illnesses and managing existing conditions, so advances are needed to generalize from a sick care system to a well care system that keeps people healthy for longer. Disparate factors affect health outcomes, including health care access, education, economic resources, community support services, and living environments. Efforts to keep individuals from becoming patients are currently hindered by limited public awareness about preventive health practices, inadequate incentives for health care providers, and a lack of comprehensive, personalized approaches to assess risk early. There is a critical need for a paradigm shift from a reactive model centered on treating illnesses to a proactive one that prioritizes preventive measures and furthers holistic health promotion strategies. ^^ ARPA-H will invest in new preventative programs that can detect and characterize disease risk, promote treatments and behaviors that anticipate threats to American’s health -- whether those threats are viral, bacterial, chemical, physical, or psychological -- and help bridge the gap in health disparitiesPrevention & WellnessPromote prevention and wellness_c01d3666-b408-11ef-88ba-f5791d83ea004.1Lead initiatives to enhance public awareness and education on preventive health practices. By leveraging innovative communication channels, digital platforms, and community engagement, ARPA-H aims to disseminate accurate and accessible information about healthy lifestyles, risk factors, and early detection, thereby empowering individuals to make informed decisions about their health and reducing the likelihood of preventable health issues.CollaborationFoster interdisciplinary collaboration for holistic health_c01d36c0-b408-11ef-88ba-f5791d83ea004.2Facilitate collaboration among health care providers, researchers, technologists, and community stakeholders to develop comprehensive and personalized approaches to proactive health management. By integrating data-driven insights, genomic insights, wearable technologies, and behavioral science, ARPA-H aims to create a holistic framework for early risk assessment and tailored interventions.IncentivesIncentivize health care transformation toward prevention_c01d3710-b408-11ef-88ba-f5791d83ea004.3Reshape U.S. health care incentives to prioritize preventive measures and proactive health practices. By partnering with policymakers, payers, and health care institutions, ARPA-H aims to develop innovative reimbursement models, financial incentives, and regulatory frameworks that reward health care providers for promoting and practicing preventive care.InnovationFoster Data-Driven Innovation Across the Health Ecosystem_c01d3760-b408-11ef-88ba-f5791d83ea005ARPA-H will establish and maintain a data ecosystem to accelerate and leverage health care and life science research for real world impact, expedite ARPA-H program formulation, and track how ARPA-H investments affect long term health outcomes. Presently, researchers invest substantial time in procuring, cleansing, and preparing data. Additionally, the exponential growth of medical data, from electronic health records (EHR) to wearable devices, compounded with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other privacy requirements, poses challenges in managing and extracting meaningful insights from available data. The complex interplay of factors influencing health outcomes, including genetics, lifestyle, and environmental factors, necessitates a holistic approach that only advanced data analytics can provide. ^^ ARPA-H aims to develop data-driven architecture that will leverage integrated data and sophisticated analytical tools, including the transformative potential of machine learning (ML) and recent advancements in generative AI, to seamlessly acquire data from diverse sources like ARPA-H programs, EHR, diagnostic records, images, Internet of Things (IoT) data, genetics and other omics data, and health care and life science research data from labs. ARPA-H aims to provide tools to identify data quality issues, perform automatic remediation, and facilitate data sharing while ensuring security and privacy. These capabilities, if successful, will generate new avenues of exploration in diagnostics, therapeutics, personalized medicine, disease modeling, and data analytics, ultimately leading to improved health outcomes and a more efficient and responsive health care system. ^^ ARPA-H recognizes that disadvantaged communities are often under-represented in research, which will be exacerbated if artificial intelligence models are trained only on readily available data. ARPA-H will seek to develop data technologies that encourage underrepresented groups to participate in research, including technologies that build trust in data and enable visibility into how participation in research benefits their specific communities. Within the organization, ARPA-H will enable a data-driven culture where IT infrastructure, applications, data management, cybersecurity, and IT governance foster collaboration with partners, drive effective decisionmaking, inform resource allocation, and enable comprehensive strategies to strengthen ARPA-H’s security posture, safeguard research assets, and ensure compliance with data privacy standards.Data SharingEstablish collaborative data sharing capabilities_c01d3878-b408-11ef-88ba-f5791d83ea005.1Develop and implement standardized data sharing protocols and platforms to eliminate data silos, foster collaboration, and ensure that relevant and comprehensive data is accessible for research, analysis, and innovation across the entire health ecosystem, including with international partners.RepresentationIdentify opportunities to expand representation of underrepresented groups in research data_c01d38d2-b408-11ef-88ba-f5791d83ea005.2Underrepresented GroupsDrive empowered participation in research and data sharing by groups traditionally underrepresented in research to increase availability of data representing the diversity of the American people -- and, thus, more representative health solutions.AIHarness generative AI for resource-optimized health technology R&D_c01d392c-b408-11ef-88ba-f5791d83ea005.3Leverage the capabilities of generative AI to develop a sophisticated decision support system. This system will inform allocation of resources, prioritization of research initiatives, and decisions about investment choices within health technology R&D to ensure alignment with the most promising opportunities.TransitionIncrease the Probability of Successful Transition_c01d3990-b408-11ef-88ba-f5791d83ea006ARPA-H-funded biomedical and health research breakthroughs and innovation will only be successful if they get to the American people. In practice this means transitioning programs and capabilities out of the agency and into the policies, products, and services that reach all Americans. ^^ ARPA-H will coordinate efforts to minimize duplication and facilitate new coalitions to successfully transition high-risk/high-reward initiatives, programs, and capabilities for downstream adoption. Through growing ARPA-H's nationwide network and presence across all 50 states, supporting PM and performer engagement with potential partners and funders, providing guidance on business and regulatory processes, and offering many other transition-focused services, ARPA-H will demonstrate the pathways to successful translation at each stage of the research program lifecycle. In doing so, the agency will de-risk its investments and ensure that research products can be sustained without additional ARPA-H funding. NetworkEstablish and build a health innovation network to ensure ARPA-H capabilities reach all Americans_c01d39f4-b408-11ef-88ba-f5791d83ea006.1ARPA-H will continue to operate under a hub and spoke model to form a network of people, institutions, and capabilities placed within relevant geographies and with diverse populations across the spectrum of health-related social needs and support systems that impact health outcomes. With the stakeholder engagement hub dedicated to developing partnerships, the customer experience hub featuring human-centered approaches to product and service design, and the investor catalyst hub helping to bring ideas to market, ARPA-H continues to be engaged across the entire United States.Insights & PartnershipsConnect stakeholder insights and partnerships_c01d3a4e-b408-11ef-88ba-f5791d83ea006.2ARPA-H will continue to develop partnerships across federal and community networks to connect Program Managers to investors, entrepreneurs, partners, customers, technical experts, and other Federal agencies throughout the program lifecycle. These connections ensure that efforts are not redundant and increase performers’ abilities to significantly advance the state of the art.SolutionsSupport performer teams to bring the most compelling solutions to bear_c01d3b02-b408-11ef-88ba-f5791d83ea006.3Performer TeamsARPA-H is invested in the long-term success of performers and provides services such as resources to bridge gaps between prototypes and products, business and entrepreneurship coaching education, and regulatory support to accelerate performer progress.OrganizationBuild a World-Class Organization_c01d3b70-b408-11ef-88ba-f5791d83ea007ARPA-H is committed to building and maintaining alignment of its people, resources, strategy, governance, and technology. Through an adaptive human capital strategy, strong stewardship of resources, effective planning practices, and an information technology strategy rooted in technological innovation, ARPA-H will support the development of high-impact solutions to the nation’s most challenging health problems.TalentRecruit, retain, and develop leading talent across the ARPA-H enterprise_c01d3bca-b408-11ef-88ba-f5791d83ea007.1ARPA-H will sustain a workforce of talented operational staff and program managers that demonstrate diversity of lived experience, geography, and scientific, technical, and management expertise from government, industry, academia, and think tanks, among others. Through building a bold, expert workforce, cultivating an administratively and scientifically nimble culture, and providing modernized, flexible workspace, ARPA-H will ensure that federal employees and contractors represent broad populations across the biomedical and health landscape and possess the skills, competencies, and tools required to achieve the agency’s mission.FinancesMaintain strong stewardship of financial resources_c01d3c6a-b408-11ef-88ba-f5791d83ea007.2ARPA-H is committed to effective financial stewardship and risk management to ensure prudent use of resources. Through robust financial management practices, ARPA-H will focus on transparency and accountability to maintain program integrity, effective internal controls, and public trust.Strategy, Planning & ExecutionPromote effective strategy, planning, and execution practices_c01d3cd8-b408-11ef-88ba-f5791d83ea007.3ARPA-H is invested in agile and iterative strategy and planning to prioritize efforts, monitor progress, and facilitate agency responsiveness to emerging opportunities and threats, as well as promoting effective governance, data- and evidence-driven processes, and a culture of accountability that enables strategic decisionmaking across the agency.2023-10-012026-09-302024-12-06https://arpa-h.gov/sites/default/files/2024-01/FY24-26_ARPA-H_Strategic_Plan_011724_508_v1.pdfOwenAmburOwen.Ambur@verizon.net