Scalable Solutions Office: Office-Wide Innovative Solutions Opening for Advanced Research Projects Agency for Health

This ISO seeks solution summaries and proposals for projects that fall within the general scope of the ARPA-H Scalable Solutions mission office. SSO expands what is technically possible by developing approaches that will leverage an interdisciplinary approach and collaborative networks to 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 SSO seeks solutions to 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. Solutions should focus on rapid innovation and the use of partnerships, as well as flexible distribution networks and streamlined manufacturing processes. The following SSO interest areas categorize the ground-breaking solutions we seek to support:

Scalable Technologies and Interventions:

• Approaches to improve affordability and equitable access to health care that are adaptable to various geographic, demographic, economic contexts and can be rapidly deployed at scale (e.g., drug-repurposing*, telemedicine, point-of-care diagnostics, and modular health care infrastructure).

• Tailored solutions for the pediatric population that provide parity in access to treatments and other health care interventions with the adult population and adapt to the pediatric patient’s changing physiology and developmental status over the course of years.

• Transformational approaches to reduce or eliminate health disparities, including tools and models for product design and care delivery that scale novel approaches in human factors and human-centered design to respond to full diversity of patients.

• Tools to enable the scaling of provider and institutional capabilities (e.g., school nurses and schools, walk-in clinics, homesteading care) to address unmet health care access needs and expand availability of critical services.

• Foundational capabilities to accelerate diagnoses and reduce the cost of treatments for rare diseases wherever patients are, without the need for specialized facilities or healthcare expertise.

* Solution summaries and proposals that focus on testing drugs for effectiveness for other disease states or use cases, are unlikely to be funded unless including additional R&D, or providing gains in cost reduction, accessibility, and/or equity.

Collaborative Distribution Networks:

• Methods for standardization, automation, and democratization of complex procedures 5 including, but not limited to, histopathology, rare disease diagnosis and treatment, and surgical interventions to ensure access and delivery to populations diverse in demographics, geographies, and resources at scale.

• Approaches to enhance delivery of effective healthcare solutions in rural or low resource settings, including but not limited to "last mile delivery”, at-home monitoring, imaging, drug delivery, telehealth augmentation, and support for remote medical procedures with limited need for specialized training.

• Technologies to enable the deployment of critical healthcare resources rapidly, equitably, and securely at scale to the point of need in permissive and non-permissive (i.e., damaged infrastructure, cyber-denied) environments during a public health crisis or natural disaster.

• Solutions to scale education and training of critical healthcare resources for health care providers and patients to ensure information integrity to prevent negative impacts to resource use/uptake.

• Innovative information technology, data and analytic products and technologies to enable ordering, inventory management, situational awareness, allocation planning and demand forecasting of critical healthcare resources during a public health crisis or natural disaster.

Biomanufacturing Innovations*:

• Innovative manufacturing technologies and approaches that reduce cost, shorten the timeline for production, advance domestic competitiveness and reduce supply chain risk of biologics, cellular and gene therapies, pharmaceuticals, medical devices and personal protective equipment.

• New approaches to support predictable, programable biological production of conventional and novel materials reliability at scale in a cost-effective sustainable manner.

• Novel solutions to reduce the reliance on specialized handling and cold chain management of pharmaceuticals and biologics.

• Scalable innovations to advance and strengthen biomanufacturing supply chain and resolve bottlenecks including:

o Advances in production of active pharmaceutical ingredients, process consumables, and other critical materials (i.e., enzymes, cell lines, etc);

o Novel biomanufacturing-related data products, technologies or models to integrate into supply chain situational awareness systems;

o Alternative materials and new manufacturing capabilities for personal protective equipment; and

o Improvement of capabilities sustainably re-shore manufacturing and utilize a broad array of readily accessible and cost-efficient feedstocks as part of strengthening the local and national industry base.

• Analytics and novel sensor systems to precisely manage bioproduction, real-time release assays, and predictive capabilities to inform tuning of biological chassis for efficient and effective scale-up of manufacturing to industrial scale.

*ARPA-H is not interested in approaches that merely increase capacity reservation.

Other high-quality submissions that propose revolutionary technologies that meet the goals of SSO will be considered even if they do not address the topics listed above.

Proposals are expected to use innovative approaches to enable revolutionary advances in medicine and healthcare, and the science and technology underlying these areas. While approaches that are disease agnostic are encouraged, ARPA-H welcomes proposals that bring radically new insights to address specific diseases including, but not limited to, cancer, diabetes, neurological diseases, pediatric and maternal/fetal health, infectious diseases, and cardiovascular disease.

Specifically excluded are proposals that represent an evolutionary or incremental advance in the current state of the art or technology that has reached the clinical trial stage. An example of this type of proposal might include the request to fund clinical trials of an otherwise developed product. Additionally, proposals directed towards policy changes, traditional education and training, or center coordination, formation, or development, and construction of physical infrastructure are outside the scope of the ARPA-H mission.