BARDA's Division of Research, Innovation, and Ventures (DRIVe) opened a new area of interest (AOI) under the EZ Broad Agency Announcement (EZ-BAA) solicitation, in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, for the development of advanced microphysiological systems (MPS) that can replicate components of vital human tissues and immune system functions and monitor their interactions. MPS, also called tissue chips, are 3D biophysical platforms comprised of cellular constructs that mimic the structure and function of vital human tissues and organs, such as the lungs, liver, and heart.
Accurately modeling human systems in vitro to test treatment effectiveness is a key step to accelerating the pace of drug discovery and development. However, predicting and testing the effects of therapeutics during early clinical studies is difficult, costly, time-consuming, and can fail to anticipate side effects in people. To safely and quickly evaluate a drug’s effectiveness and toxicity, researchers could utilize MPS in the early stages of studies. MPS may serve as a predictive tool in the drug development process, aid the screening of signaling molecules and drug targets, and help develop precision medicine-based therapies.
Experts at BARDA expect that the use of advanced MPS will create new opportunities for understanding mechanisms of health and disease, and enable more efficient assessment of promising potential biomedical interventions. Recent rapid advances in this field now make the prospect of MPS commercialization and broad usability more realistic. Key challenges remain, however, including difficulty of manufacturing, integration and use of medically-relevant sensors, and the combination of multiple tissues anchored by the immune system to model the human body’s response.
Under this EZ-BAA AOI, BARDA is seeking applicants with product ideas that focus on enhancing existing, fully-mature MPS that incorporate a human immune system component. These 3D platforms should include in-line sensors for continuous tissue monitoring, and utilize materials suitable for automated manufacturing and assembly of the platforms. Full proposals may be submitted until June 30, 2021. For more details, check out the Special Instructions 013, AOI #7 (PDF - 205KB) of the EZ-BAA (BAA-20-100-SOL-0002).
The EZ-BAA was created to provide a streamlined process through which BARDA's Division of Research, Innovation, and Ventures (DRIVe) can review and accept applications for development funding of transformative products and technologies to protect Americans from health security threats. The application process is both business-friendly and easy to follow.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st-century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 59 BARDA-supported products have achieved regulatory approval, licensure, or clearance. BARDA DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation's health security.
NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit https://ncats.nih.gov.