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1) Introduction to ARPA-H (from https://www.nih.gov/arpa-h)

President Biden proposed the creation of the Advanced Research Projects Agency for Health (ARPA-H) to improve the U.S. government’s ability to speed biomedical and health research. Public Law 117-103 was enacted on March 15, 2022, authorizing the establishment of ARPA-H within the U.S. Department of Health and Human Services.

Recent advances in biomedical and health sciences—from immunotherapy to treat cancer, to the highly effective COVID-19 vaccines—demonstrate the strengths and successes of the U.S. biomedical enterprise. Such advances present an opportunity to revolutionize how to prevent, treat, and even cure a range of diseases including cancer, infectious diseases, Alzheimer’s disease, and many others that together affect a significant number of Americans.

ARPA-H will support transformative high-risk, high-reward research to drive biomedical and health breakthroughs—ranging from molecular to societal—that would provide transformative solutions for all patients.

2) Establishment of the Advanced Research Projects Agency for Health (5.24.22)

This notice announces the establishment of the Advanced Research Projects Agency for Health (or ARPA-H) within the National Institutes of Health (NIH). This reorganization was approved by the Secretary of Health and Human Services and takes effect May 24, 2022. . . .

Advanced Research Projects Agency for Health: (1) Provides leadership for high-risk, high-reward biomedical and health research to speed application and implementation of health breakthroughs equitably. (2) Creates, supports, and manages programs to catalyze the development of transformative, evidenced-based, use-driven capabilities, platforms, and technologies in a range of biomedical and health research areas. (3) Facilitates partnerships and collaboration among government, academia, industry, and other sectors to accelerate the translation of innovation into meaningful and measurable benefits for the nation. (4) Converts use-driven research into tangible, sustainable solutions for patients. . . .

Strategic Resources Office: (1) Advises the ARPA-H Director and staff on all phases of ARPA-H-wide administration and management. (2) Provides leadership and direction to all aspects of ARPA-H management. (3) Oversees the management of functions in the areas of personnel management, management policy, management assessment, and logistics management, IT support, safety, space and facility management, property, support services, and security operations. (4) Coordinates with and serves as a liaison to the relevant NIH offices to provide a high-level of service to ARPA-H staff.

Treatment Innovation Office: (1) Furthers development of novel and innovative therapeutics or other interventions to manage, treat, or cure diseases and conditions. (2) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to disease or condition management therapies. (3) Responds to requests for information on highly technical matters and matters of public policy related to therapeutics and treatment interventions.

Health Equity, Dissemination, and Implementation Office: (1) Advances programs that concentrate on promoting health equity, access to care, and ethical aspects of science and technology development. (2) Undertakes projects and initiatives to address and lessen health disparities and inequities in biomedical and health research within the United States and abroad. (3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to health equity, inclusion, recruitment, enrollment, and retention, access to care, and ethical aspects of science and technology development, as well dissemination and implementation of those research advances into real-world settings and clinical practice. (4) Responds to requests for information on highly technical matters and matters of scientific and public policy related to health equity, inclusion, recruitment, enrollment, and retention, access to care, and ethical aspects of science and technology development, as well dissemination and implementation of those research advances into real-world settings and clinical practice.

Health Data Office: (1) Focuses on thoughtful approaches to revolutionizing how scientific and health data and information technology are collected, organized, integrated, and used. (2) Develops strategies to assemble interdisciplinary teams to fuse mathematical approaches and biomedical research creating massive datasets that are carefully annotated, made widely available, allow for integration across programs, and are sensitive to issues of subject consent, personal privacy, and unintended biases that are crucial for addressing the most significant biomedical problems faced by society. (3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to health data and information technology. (4) Responds to requests for information on highly technical matters and matters of scientific and public policy related to health data and information technology.

Health Promotion and Disease Detection Office: (1) Advances approaches, interventions, and technologies that further the overall health and wellness of Americans and prevent diseases. (2) Promotes innovation in tools, technologies, processes, or other approaches that enhance early detection of diseases. (3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to health promotion and disease detection. (4) Responds to requests for information on highly technical matters and matters of public policy related to health promotion and disease detection.

Health Resources and Policies Office: (1) Advances progress in confronting challenges to the overall ecosystem of biomedical and health research, whether they be processes, policies, or models, to enable acceleration of advances. (2) Applies scientific and engineering principles to solve challenges that delay the delivery of technologies, interventions, or other approaches to the patient. (3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to health resources and policy. (4) Responds to requests for information on highly technical matters and matters of scientific and public policy related to health resources and policy.

Systems Technology Office: (1) Focuses on those systems that impact health—from physiologic systems (e.g., immune) to the healthcare system and everything in between. (2) Speeds progress in the integration of systems, including and especially technological approaches to doing so. (3) Advises the ARPA-H Director on matters concerning ARPA-H-sponsored research activities related to health systems technology. (4) Responds to requests for information on highly technical matters and matters of scientific and public policy related to health systems technology.

Equity and Inclusion Office: (1) Coordinates, facilitates, and supports programs to ensure equity, diversity, and inclusion in all aspects of ARPA-H's work. (2) Provides strategic and programmatic leadership for ARPA-H's efforts to reduce health disparities and foster health equity in biomedical research. (3) Evaluates ARPA-H's progress towards achieving greater diversity and health equity in biomedical and health research. (4) Promotes ARPA-H efforts to build a diverse cohort of collaborators, staff, performers, and others.

Strategic Planning, Evaluation, and Analytics Office: (1) Oversees ARPA-H-wide planning, evaluation, and analysis/analytic activities. (2) Advises ARPA-H leadership and staff on all aspects of strategic planning, reporting, and operational effectiveness for ARPA-H activities. (3) Provides leadership and guidance to ARPA-H's business community in the development and oversight of a strategic administrative management plan, goals, organizational effectiveness and business analytics. (4) Oversees the development of analytic and evaluation strategies to drive greater efficiency and effectiveness in administrative and programmatic operations.

Innovation and Entrepreneurship Office: (1) Inspires innovation and creativity throughout ARPA-H, including stimulating the culture of innovation, ideation, and dynamic thinking and leveraging design research and design thinking. (2) Promotes practical strategies to provide resources for programs and projects to incorporate and implement transition principles to inform innovation in overall ARPA-H commercialization strategies. (3) Serves as the ARPA-H focal point for the management of all Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program activities, and implementation of pertinent legislation, rules and regulations and associated matters related to the SBIR/STTR Program. (4) Proposes and implements innovative strategies to promote the commercialization of innovative high impact technologies including research tools, medical devices, and therapeutics throughout the program development and management lifecycle. (5) Assesses the commercial potential of ARPA-H technology priorities and provides guidance on how best to structure programs, projects, and goals for successful transition.

FR notice: https://www.federalregister.gov/d/2022-11519

3) HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director (news release 5.25.22)

Health and Human Services Secretary Xavier Becerra today announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health and the appointment of Adam H. Russell, D.Phil., as acting deputy director. Currently, Dr. Russell is the Chief Scientist at University of Maryland's Applied Research Laboratory for Intelligence and Security (ARLIS). He spent more than a decade as a Program Manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA). Dr. Russell will begin his new role in June.

With broad technical and management experience across several disciplines, ranging from cognitive neuroscience and physiology to cultural psychology and social anthropology, Dr. Russell will guide the early stages of building the administrative structure of the agency and oversee the hiring of initial operational staff to ensure the agency is stood up as effectively and efficiently as possible. President Biden will appoint an ARPA-H Director who will be responsible for administration and operation of ARPA-H and will report to the HHS Secretary.

"We are ecstatic that Dr. Adam Russell has accepted the challenge to help launch ARPA-H, President Biden's bold, new endeavor to support ambitious and potentially transformational health research in this country," said Secretary Becerra. "ARPA-H will have a singular purpose: to drive breakthroughs in health, including the prevention, detection and treatment of diseases such as cancer, Alzheimer's and diabetes." . . .

https://www.hhs.gov/about/news/2022/05/25/hhs-secretary-becerra-establishes-arpa-h-within-nih-names-adam-h-russell-phil-acting-deputy-director.html  

4) OSTP ARPA-H webpage https://www.whitehouse.gov/ostp/advanced-research-projects-agency-for-health-arpa-h/

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