Notice Number: NOT-TR-19-018
Key Dates
Release Date: March 6, 2019
NOT-TR-19-025
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
KEY DATES
Pre-proposals and proposals will be accepted and reviewed on a rolling basis. The dates in the table below are the last dates the pre-proposals and proposals will be accepted for that cycle. Pre-proposals and proposals submitted after those dates will be considered for the next cycle.
*Cycle I |
Cycle II |
Cycle III |
|
Pre-proposal |
March 18, 2019 |
July 18, 2019 |
November 18, 2019 |
Full proposal |
April 22, 2019 |
August 22, 2019 |
December 23, 2019 |
**Notification from NCATS |
June 1, 2019 |
October 1, 2019 |
February 1, 2020 |
*Proposals submitted within the first cycle will be considered for implementation on a rolling basis
**Notification whether the full proposal will enter into discussions with NCATS scientists to make a final determination of feasibility, alignment of goals, and project plan with milestones and go-no go decisions.
PURPOSE
NIH’s Helping to End Addiction Long-termSM (HEAL) Initiative seeks 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.
BACKGROUND
As part of the NIH HEAL initiative, the NCATS continues its efforts for developing drugs and human cell-based testing platforms for pain, addiction and overdose complements the target identification, animal model efficacy testing, and human clinical network expertise of other laboratories to enable the development of new experimental therapeutics through drug screening in human-based, physiologically relevant in vitro systems, high efficiency chemical synthesis of new compounds, and IND enabling studies. Given the limitations of current treatments and failures in the development efforts for new therapies, drugs that modulate novel targets and have different and better structure-activity profiles are needed.
The NCATS intramural research program, Division of Preclinical Innovation (DPI) can provide exceptional expertise and resources for efficient translation of promising therapeutic development projects that address questions relevant to pain, addiction and overdose. Depending on the nature of the proposed collaboration, expertise in more than one laboratory may be applied. Specifically, collaboration opportunities are available with or among the following NCATS laboratories/programs:
- Stem Cell Translation Laboratory
- 3-Dimensional Tissue Bioprinting Laboratory
- Pharmacological Probe Development Program
- Enabling Investigational New Drug (IND) Applications
DESCRIPTION
The NCATS DPI houses expertise in biomolecular screening, automated biology, stem cell biology, medicinal chemistry, cheminformatics, big data analysis, and preclinical drug development. The NCATS DPI has advanced equipment and resources not available to most laboratories, such as large compound libraries (e.g., diverse drug-like molecules, approved and investigational drugs, mechanism-based compounds, and natural products), quantitative high-throughput and high-content screening, robotic automation of cell culture workflows, multiscale assay development,3-D bioprinting, next-generation sequencing, and integrated platforms to profile gene and protein expression and measure functional endpoints in standard cultures and in single-cells. Additional information about the technical capabilities of the NCATS DPI can be found here: https://ncats.nih.gov/heal/intramural-capabilities.
Collaboration proposals that seek to leverage the following capabilities will be considered:
- Human cell-based screening platforms that include the potential for:
1) creation of sensory/pain neurons from multiple levels using human induced pluripotent stem cells;
2) biofabrication of 3D tissue-in-a-well as human cell-based models for the cellular and molecular processes involved in pain, addiction and overdose including tissue models of the blood brain barrier.
- Opportunities in the realm of developing small molecules directed to new targets include:
1) identification of drug leads through assay development, high-throughput screening and medicinal chemistry optimization;
2) identification of new chemical structures that modulate pain, addiction and overdose; and
3) development of IND-eligible investigational drugs for clinical testing.
The NCATS is particularly interested in collaborations that will:
- Lead to discovery of novel targets for pain, addiction, or overdose;
- Leverage our medicinal chemistry capabilities to optimize an already identified compound of interest.
Collaboration proposals that propose the following types of projects will not be considered:
- Proposals that do not align with the goals of the NCATS Preclinical HEAL program, Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose
- Proposals that are determined to require resources/capabilities that are not available in the NCATS laboratories
- The aims of the proposed work are not feasible or the collaborator’s institution does not have the resources needed to contribute to the project
- The translational science and public health impact on the opioid epidemic is not evident
The NCATS DPI uses a milestone-driven, multi-stakeholder team approach to drive project execution. The program commits significant in-kind resources to enable completion of a project and will continue to commit resources as long as the milestones are achieved and resources and expertise are available. In all cases, measurable parameters (deliverables, timelines) will be agreed upon and implemented as a metric for informed decision making. A project will be deemed successful when the team achieves the agreed-upon common goal(s). Collaborators must agree to work with NCATS to publicly disseminate relevant data, protocol steps and new compounds upon completion of the project.
SUBMISSION AND FUNDING INFORMATION
Proposal submission is a two-step process. Potential collaborators submit a 2-page pdf pre-proposal to the email address below to allow NCATS scientists to determine if the proposed project fits with the goals of the Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose program and the NCATS laboratories capabilities.
The NCATS DPI operational model is built on collaboration among components of NIH and external partners. Collaborators bring actionable existing data and disease knowledge to the collaboration, but lack either the expertise or resources to enable discovery. In-kind support will be provided by the NCATS laboratories/programs.
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
- Eligible Agencies of the Federal Government, including NIH intramural laboratories
FOREIGN INSTITUTIONS
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Prospective collaborators are encouraged to review the technical assistance slide deck available at https://ncats.nih.gov/heal/intramural-capabilities. Additional information about this collaboration opportunity will be available at: https://ncats.nih.gov/heal/funding.
Inquiries
Please direct all inquiries to:
Steven Pittenger, PhD
National Center for Advancing Translational Sciences
[email protected]
and Human Services (HHS)
