Notice of Intent to Publish a Funding Opportunity Announcement to Support Biofabricated 3D Tissue Models of Nociception, Opioid Use Disorder and Overdose for Drug Screening (UH2/UH3 Clinical Trial Not Allowed)

Notice Number: NOT-TR-19-006

Key Dates

Release Date: October 18, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 01, 2018
First Estimated Application Due Date: February 28, 2019
Earliest Estimated Award Date: September 30, 2019
Earliest Estimated Start Date: September 30, 2019

Related Announcements
None

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS), as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative, intends to publish a Funding Opportunity Announcement (FOA) to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  

https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative

The FOA will utilize the UH2/UH3 activity code and is expected to be published in December 2018 with an application due date in February 2019.

The FOA will invite applications to develop and implement the use of 3D biofabricated tissue models in novel drug screening platforms, and advance pre-clinical discovery and development of non-addictive treatments for nociception, opioid use disorder (OUD) and/or overdose. In particular, during the UH2 phase this FOA supports the application of 3D biofabrication technologies to develop novel multicellular tissue constructs for drug screening by using physiologically-relevant human cells representing sensory/pain neurons, brain regions, and other tissues involved in nociception, addiction and/or overdose, including tissue models of the blood-brain barrier (BBB). The goal of the UH3 phase is to develop a screening platform and identify compounds that modulate the relevant phenotypes for pain, opioid use disorder and/or overdose. 

This FOA is looking for collaborations that can leverage both the NCATS 3D Bioprinting Laboratory’s biofabrication and screening capabilities ( https://ncats.nih.gov/bioprinting ) with the pain expertise and cell resources of the extramural research community.

This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals, consider the requirements that are integral to this initiative, and establish appropriate collaborations.

Research Initiative Details

For this FOA, the focus is to develop 3D tissue models for drug discovery and development of new pain, addiction and overdose therapeutics.  Extramural investigators will collaborate with the NCATS 3D Bioprinting Laboratory to biofabricate 3D functional tissues using physiologically-relevant human cells in a multi-well plate format together with relevant, HTS-compatible detection endpoints.  Extramural research community will provide expertise in developing specific disease models and disease-relevant assays in low-throughput format. NCATS 3D Bioprinting Laboratory will provide expertise in integrating 3D biofabrication technologies with phenotypic assay models that are compatible with high-throughput screening capabilities at the 3D Bioprinting Laboratory. NCATS 3D Bioprinting Laboratory will work towards the adaptation of the 3D tissue models and endpoint assays to a drug screening platform and implementation of screens. The ultimate goal is to identify compounds that modulate the relevant phenotypes for pain, opioid use disorder and/or overdose. The libraries screened will include compounds with annotated target and mechanism of action and approved drugs for drug repurposing screening (https://ncats.nih.gov/preclinical/core/compound).  NCATS will provide compounds to extramural investigator(s) for validation studies.

Applicants are expected to document the formation of partnerships with NCATS 3D Bioprinting Laboratory, as well as establish additional collaborations that would provide expertise necessary to successfully complete the project.

All normal and pathologically-relevant, as well as any reporter iPS cell lines required for the project must be established and validated by extramural investigator(s) prior to submission.  For primary cells, extramural investigators will have to demonstrate availability of the cells in large quantities for subsequent utilization in drug screening platforms. 

Matching Requirement:

As part of the HEAL Initiative, this FOA is subject to certain requirements for for-profit applicant organizations. Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Funding Information

Estimated Total Funding $1,500,000 for fiscal year 2019. Future year amounts will depend on annual appropriations.
Expected Number of Awards NCATS intends to fund an estimate of 2-3 awards .
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.350

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Applications are not being solicited at this time. 

 

Inquiries

Please direct all inquiries to:

Dobrila D. Rudnicki, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
301-594-2080
dobrila.rudnicki@mail.nih.gov


Danilo A. Tagle, Ph.D
Associate Director for Special Initiatives, Office of the Director, (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov

Margaret Sutherland, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5680
Email: sutherlandm@ninds.nih.gov



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