Notice Number: NOT-HL-19-678

Key Dates
Release Date: March 14, 2019
Expiration Date: July 17, 2020

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform potential applicants to the National Heart, Lung and Blood Institute (NHLBI) of an area of special interest in exploring bold, new bioengineering approaches or concepts, including computationally-efficient methods, that are important to a substantive heart, lung, blood or sleep area, and in supporting the early phases of these innovative bioengineering projects which are, in turn, expected to transition into research to translate them into practice, technologies, or commercial products.

Background

The NHLBI bioengineering community has transformed medicine by creating the artificial heart, pacemakers and implantable cardioverter defibrillators, ventricular assist devices, stents, human tissue chip devices and cell/gene/combination product therapies. These examples demonstrate that bioengineering is a synergistic approach that crosses not only all technology-related areas of NHLBI, but also all of our disease-specific domains. Further, bioengineering is unique because unlike most areas of scientific focus such as heart disease, it demands collaboration across disciplines, which is a necessary component of advancingneeded technologies. The bioengineering community’s ability to achieve alternative and more effective therapies is an urgent need for NHLBI. It is envisioned that this targeted NOSI will serve as an opportunity to spur truly novel ideas, address scientific gaps, and to programmatically balance bioengineering projects across the NHLBI.

Cardiovascular, lung, blood, and sleep conditions are chronic and expensive ailments, which are compounded by an aging population. NHLBI’s ability to support alternative and more effective therapies for impacted patients is an urgent need. Innovative bioengineering ideas have both a strong history in providing new therapies and great potential for many more. This initiative is designed to support bioengineering teams to work on the next great novel ideas to do just that. One example is related to the current limitations of stem cell technologies for reparative medicine which have yet to reach their full potentials. While improved understanding of cells, tissue properties, and specialized biomaterials has enabled diverse, trans-disciplinary teams to create innovative approaches for the treatment of disorders within the NHLBI's mission, gaps remain in our understanding and, ultimately, full clinical application of stem cell technologies for reparative medicine. Novel breakthroughs are needed to fill these gaps, such as in the areas of computationally-efficient methods and models to link gene and protein dynamics to cellular phenotype outcomes and microenvironments using nanoscale material approaches.

Research Objectives

This Notice of Special Interest (NOSI) invites research applications that propose short-term, exploratory bioengineering studies. The exploratory nature of the R21 mechanism is meant to foster discovery- and design-driven bioengineering research ideas that are important across the Institute and that are critical for future hypothesis-generating projects. It is noteworthy that this program emphasizes development rather thanefficacy of first-generation prototypes. The NHLBI is interested in the development of highly innovative or blue sky ideas for diagnostics, therapeutics, surgical technologies, computational modeling tools, smart biomaterials for self-adjusting implants, and nanotechnologies, as applied to the mission areas of the Institute.

Long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications proposing to conduct clinical trials are not appropriate for this NOSI. Applicants who already have first-generation prototypes, new processes of proven feasibility, or applications proposing to validate highly innovative strategies for creating new animal models are not responsive to this announcement, but should consider applying for support under the NHLBI Catalyze Program, which plans to release funding announcements in FY2019 and FY2020. Overviews of the Catalyze program initiatives can be found at: https://www.nhlbi.nih.gov/events/2018/national-heart-lung-and-blood-advisory-council-june-2018-meeting-summary.

Topics identified as high priority for further research include, but are not limited to, the following:

• 3D imaging methods, including new molecular probes, for in vivo real-time monitoring, and techniques for metabolic imaging of disease progression
• Image processing tools and methodology for big data, precision medicine, systems biology and omics, especially for guiding interventions and patient screening
• Cardiovascular, lung and blood repair and regeneration
• Artificial lungs as a bridge to transplant or for treatment of lung failure
• Platforms for clinical decision support, electronic health records, and mobile health monitoring devices
• Additive solutions and cell/tissue/organ processing and preservation technologies
• Storage bags and/or new processes to enhance blood cell function and survival after storage and transfusion
• Design principles that affect organ-specific transplantation biology and regenerative medicine
• Tools/algorithms for objective evaluation of sleep/circadian health and disorders
• Tools, methods and technologies that facilitate therapeutic advances and behavioral changes to address problems in energy balance, weight control and obesity
• Tools to better understand biological host sex differences
• Artificial oxygen (O2) carrier to substitute for banked blood in settings where stored blood is unavailable or undesirable
• Mathematical modeling and computational simulation techniques to understand mechanisms of heart, lung, blood and sleep systems, including gene, protein, and metabolic regulatory networks
• Tissue micro-oxygenation systems
• Nanotechnologies that significantly improve diagnostic and medical devices

Application and Submission Information:

Applications in response to this Notice must be submitted through NIH Parent Announcement PA-19-053: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

All instructions for the Parent Announcement must be followed.

Submissions must indicate that they are in response to NOT-HL-19-678 in Field 4.b on the SF 424 form.

Inquiries

Please direct all inquiries to:

Narasimhan Danthi, Ph.D.
Division of Cardiovascular Sciences
Telephone: 301-435-5170
Email: [email protected]

Martha S. Lundberg, Ph.D.
Division of Cardiovascular Sciences
Telephone: 301-435-0513
Email: [email protected]

Albert Lee, Ph.D.
Division of Cardiovascular Sciences
Telephone: 301-435-0513
Email: [email protected]

Marishka K. Brown, Ph.D.
Division of Lung Diseases
Telephone: 301-435-0199
Email: [email protected]

Qing Sara Lin, Ph.D.
Division of Lung Diseases
Telephone: 301-435-0222
Email: [email protected]

Margaret Ochocinska, Ph.D.
Division of Blood Diseases and Resources
Telephone: 301-827-8285
Email: [email protected]

Ronald Warren, Ph.D.
Division of Blood Diseases and Resources
Telephone: 301-827-8288
Email: [email protected]