Synopsis: The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives. SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov. This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals. The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. For purposes of the SBIR program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; AND, (4) has, including its affiliates, no more than 500 employees. Note: This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. See 13 C.F.R. § 121.702. THE FOLLOWING RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN THIS SBIR CONTRACT SOLICITATION ARPA-H 01 - Inexpensive plant-based manufacturing of viruses - The purpose of this topic is to create competitive and inexpensive production processes for viral vectors. There is an unmet need for affordable and scalable production of viral vectors to fuel viral vector drug candidate pipelines and to support vector standardization and the vector standard supply. ARPA-H 02 - LymphoLab ProDiscover Kit - The purpose of this topic is to develop in-vitro lymphatic assays that are affordable, and modular, offering the ability of this tool kit to be implemented in any lab environment across the USA and beyond. Proposals will be asked to consider incorporating various key aspects of the lymphatic microenvironment, such as relevant extracellular matrix (ECM) components, lumen formation, various lymphatic and immune cells, physiological flow rates and biomechanics, and imaging. ARPA-H 03 - Continuous Monitoring of Vascular health using Smart Biomimetic Implantables - The purpose of this topic is to support the development of a medical device prototype that aims to create a smart implantable stent or vascular graft that will both structurally correct for a vessel blockage and become a cardiovascular (CV) health monitoring tool with each biomarker (hemodynamics, troponin) normalized to the specific user’s baseline(s) and accurately measure biomarkers throughout the lifespan of the patient. The stent will be powered by and transmit data to a health app wirelessly, and continuously monitor CV biomarkers including vessel occlusion, flow, arterial pressure, and troponin levels. ARPA-H 04 - Personalized medicine platform for predicting response to immunotherapy - There is a pressing need for clinical platforms/approaches capable of guiding clinicians in selecting the most appropriate immunotherapeutic strategy for each patient prior to the patient undergoing initial treatment. The goal of this topic is to catalyze innovative developments in personalized medicine that address the complexities of immunotherapy response prediction in a clinically employable manner. ARPA-H 05 - Saving Baby Hearts: Fully Autonomous Neonatal Echocardiography for the Diagnosis of Critical Congenital Heart Disease - The purpose of this topic is to develop the first-in-class fully autonomous, simple-to-use, low-cost, universally accessible complete echocardiography device for neonates at risk of cyanotic (fatal) congenital heart disease. ARPA-H 06 - Improving Identity and Access Management with Clinical Context - The overall purpose of this topic area is to create novel IAM systems for healthcare that prevent data exposure and reduce potential breach blast radius by enabling unifies control execution in a federated environment, streamline access authorization, leverage artificial intelligence to detect risks, and reduce the cost burden of IAM in hospital system.
