Key Dates

Related Announcements

NOT GM 19-054 NOTICE OF INFORMATION: NIGMS Priorities for Sepsis Research

PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) Clinical Trial Not Allowed

PA-19-271 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) Clinical Trial Required

PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) Clinical Trial Not Allowed

PA-19-273 PHS 2019-020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) Clinical Trial Required

PAR-19-333 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Not Allowed

PAR-19-334 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The purpose of this Notice is to inform the SBIR/STTR community that the National Institute of General Medical Sciences (NIGMS) is interested in receiving early stage research and development projects through the NIH SBIR/STTR program to create commercializable tools or technologies for sepsis research, detection, or therapy.

Background

Despite decades of intensive study, sepsis remains a poorly understood condition with limited diagnostic tools and few specific treatments. A working group of the National Advisory General Medical Sciences (NAGMS) Council was convened to advise NIGMS on how to optimize its research grant support of preclinical and clinical sepsis studies to most effectively provide fundamental knowledge of human sepsis and to enable translation of this knowledge into improved diagnostic tools and therapies.

Based on the recommendations of the NAGMS Council Sepsis Working Group and consistent with its mission, NIGMS intends to continue its support of fundamental discovery science (basic and clinical) relevant to understanding the biological mechanisms and clinical heterogeneity that underlie the pathogenesis and resolution of sepsis in humans. NIGMS will use the NIH SBIR/STTR program to accelerate translation of fundamental and mechanistic knowledge into early stage clinical research and development projects and products. NIGMS will also coordinate with other NIH institutes and government agencies to enable efficient clinical testing of new diagnostics and treatments for sepsis.

Research Objectives

NIGMS is interested in accelerating development of rapid diagnostics and improved therapeutics for sepsis detection and treatment. NIGMS encourages investigators to use the NIH SBIR/STTR program to develop novel tools and technologies for sepsis research, detection, and treatment. NIGMS strongly encourages technological innovation that is based on mechanistic work using samples and data from critically ill patients rather than on data obtained from animal models.

Specific topics of research interest include, but are not limited to the following:

• Diagnostic tools for pre-hospital and emergency department settings
• Predictive clinical algorithms, electronic health record tools, and point-of-care diagnostics particularly those that will enable bedside use of molecular/-omic information
• Clinical decision support, including use of artificial intelligence and machine learning approaches, to develop tools for early recognition and endotyping of sepsis, assessment of treatment responses and patient deterioration, and long-term prognosis prediction in various care settings
• Biosensors and intelligent array systems to facilitate molecular phenotyping of sepsis patients
• Non-invasive technologies for patient phenotyping/subtyping/stratification
• Microfluidic technologies for use in sepsis research, diagnosis, and/or treatment
• Technologies that combine various types of data (analytical, clinical, molecular, -omic) for diagnosis and/or phenotyping of sepsis patients
• Biomarker panels to enable rapid diagnosis and/or optimization of treatment
• Alternatives to or improved animal models for testing of sepsis therapeutics
• Proof of concept evaluation of endotype-guided host-based therapies

Application and Submission Information

This Notice applies to due dates on or after September 5, 2020 and continues through September 12, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissuances of these announcement through the expiration date of this Notice.

• PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) Clinical Trial Not Allowed
• PA-19-271 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) Clinical Trial Required
• PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) Clinical Trial Not Allowed
• PA-19-273 PHS 2019-020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) Clinical Trial Required
• PAR-19-333 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Not Allowed
• PAR-19-334 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-GM-20-028 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Inquiries

Sailaja Koduri, Ph.D.

National Institute of General Medical Sciences

Division of Pharmacology, Physiology and Biological Chemistry

Email: [email protected]