Proposal to Collaborate Instructions

Overview

This is not a grant application — if successful, funds will not be transferred to your institution to support your project. Rather, this is an application to collaborate with and gain access to the scientific capabilities, expertise and resources of the NCATS Division of Pre-Clinical Innovation (DPI), with the goal of developing novel testing platforms or developing promising probes of therapeutic candidates for pain, addiction or overdose indications. If successful, you will partner with DPI staff in developing a collaborative project plan. DPI will provide translational and drug development expertise and operations, and the applicant investigator collaborator(s) will provide starting points for the project and biological/disease expertise.

General Information

Pre-proposals and proposals will be accepted and reviewed on a rolling basis. The dates in the table below are the last dates when the pre-proposals and proposals will be accepted for the cycle under which they are listed. 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 of whether the full proposal will enter into discussions with NCATS scientists for a final determination of feasibility, alignment of goals, and collaboration plan with milestones and go/no-go decisions.

  • Pre-proposals are requested to maximize efficiency of effort from collaborators and NCATS, ensuring candidate projects are within the scope of the NIH HEAL (Helping End Addiction Long-termSM) Initiative and the capacities of the NCATS DPI. Successful pre-proposal applicants will be asked to submit a full proposal.
  • Pre-proposals can be submitted at any time to NCATSDPIHEALCollab@nih.gov.
  • No full proposals will be accepted if they were not invited in response to a pre-proposal.
  • Applicants whose full proposals are accepted will enter into discussions with NCATS scientists to explore possible implementation and make a final determination of whether to develop a collaboration plan. Factors that will be considered in this decision include feasibility, alignment of goals, potential milestones and go/no-go decisions. Only after a collaboration plan is agreed to by both partners will the project officially begin.
  • Organizations eligible to submit collaboration proposals include:
    • 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
  • Submission requirements:
    • Potential collaborators are advised to submit only one proposal per submission cycle.
    • Resubmissions are allowed only if substantially improved.

Pre-Proposal Submission Process

  • Pre-proposals are limited to two pages, 11-point Calibri font; material beyond the two-page limit will not be considered.
  • Pre-proposals must be submitted by email to NCATSDPIHEALcollab@nih.gov.
  • Pre-proposals must use the following structure:
    • Proposal title
    • Name, affiliation and expertise of lead collaborator
    • Primary component of the Human Cell-Based Screening (HCBS) program being applied to (choose one):
      • iPSC-Derived Cell-Based Model Development
      • Development of 3-Dimensional Biofabricated Tissue Models
      • Pharmacological Probe Development
      • Pre-Clinical Drug Development
    • Current state/starting point for proposed collaboration
    • Goal/desired deliverable from proposed collaboration
    • Novelty of approach/desired deliverable. If similar models, probes or drugs currently exist or are in development, explain why your approach is different and better.
    • Statement of how success on the proposed project would impact the opioid crisis and advance the goals of the HCBS initiative
    • NOTE: Any intellectual property (IP) generated before initiation of the NCATS collaboration will be retained by the investigator/institution as background IP. The potential for development of new IP will depend on the stage at which the project enters into collaboration with NCATS. However, all collaborators should anticipate that there may be joint IP development with NCATS employees. Inventorship of any new, multi-party IP created from this collaboration will be determined according to U.S. patent law and governed under an agreement that will be executed at the outset of the formal research partnership, such as a Cooperative Research and Development Agreement (CRADA) or a Research Collaboration Agreement (RCA). Applicants are encouraged to review the templates for CRADAs and RCAs and talk with their respective technology transfer office prior to submitting a collaboration proposal, to ensure that they will have the freedom to enter into an agreement with NCATS. The templates can be found at /alliances/forms. Questions regarding these NCATS agreement templates can be sent to the NCATS Office of Strategic Alliances via email at NCATSPartnerships@mail.nih.gov.

Full Proposal Submission Process

Potential collaborators will use the following process to submit a full proposal.

  • Full proposals are limited to seven pages, 11-point Calibri font, inclusive of data tables and figures. The proposal should incorporate information from the two-page pre-proposal.
  • Full proposals must be submitted to the e-mail address provided with the notification to submit.
  • Full proposals must use the following structure:
    • Proposal title
    • Name, affiliation and expertise of the lead collaborator and other key personnel
    • Primary component of the HCBS program being applied to (choose one):
      • iPSC-Derived Cell-Based Model Development
      • Development of 3-Dimensional Biofabricated Tissue Models
      • Pharmacological Probe Development
      • Pre-Clinical Drug Development
    • Current support for the project and resources available
      • Description of any unique resources (models, reagents, etc.) you will bring to the collaboration
    • Detailed description of the starting point and desired deliverable from the proposed collaboration, including accomplishments to date, prototypes and current roadblocks to reaching the deliverable
    • Detail on the novelty of the approach/desired deliverable, including prior art. If similar models, probes or drugs currently exist or are in development, explain why your approach is different and better.
    • Proposer’s conception of best scientific approach to reaching deliverable
      • Proposed milestones, assignment of responsibilities — NCATS vs. potential collaborator — and proposed timeline (note: Collaborations that can be completed within 2-3 years are anticipated.)
      • Proposed go/no-go decision points
      • Next steps if the project is successful
    • Indication of how the desired deliverable would impact the opioid crisis and advance the goals of the NIH HEAL Initiative
  • Supplemental Information
    • Support Letters (not to exceed one page each) should be a commitment of support, not merely an endorsement
      • From additional collaborators who will be contributing to the project
      • From the collaborators’ institution(s)
    • Description of IP (not to exceed four pages): To ensure freedom to operate on the proposed project, a clear description of the relevant patent space and status of IP is required (where relevant). This includes a list of any patents issued or pending with respect to either the agent to be developed or any non-commercially available technology or material required for the proposed project. Should a project require the use of non-commercially available technology or equipment that is patented by a third party, the collaborator should be prepared to explain how these materials will be accessed for this proposed collaboration. The following information is REQUIRED for the full proposal. If any of the following are not applicable to the project, state that explicitly (e.g., “There is no IP filed for the technology to be used for this project.”).
      • Details of any existing IP at the collaborating institution that will be used in the project
        • Patents and patent applications
        • Significant know-how
        • Details of any third-party obligations regarding the relevant IP
    • Reference List
      • No more than 15 references relating directly to the proposal
    • Key Papers
      • PDFs of no more than two key papers to ensure all readers have access to critical data that may be cited
    • Biosketches for All Key Personnel
      • Each biosketch should be no more than three pages and include the qualifications of key personnel, how they will contribute to the collaboration, verification of their ability to commit the time anticipated to complete the proposed work, and track record of collaboration.
    • Protection of Human Subjects (if applicable)

Input from Technical Experts

Projects will be evaluated by ad-hoc technical experts with the necessary technical and subject matter expertise. Input from technical experts is a privileged communication with the NIH and may involve trade secrets, as well as commercial and financial information that is considered business confidential information.

  • Areas for Input: Technical experts will not provide a score but rather will provide input on the strengths and weaknesses of the proposal, using the questions below to structure their review. Because this is a proposal for collaboration, the collaboration plan and much of the scientific approach will be determined after the project is selected. The technical review should focus on the research that has been done to date on the project, the areas proposed for collaboration, and the impact on the opioid crisis if the goals/end point of the collaboration are achieved, as well as the potential for the project to progress after the collaboration has ended. In general, collaborations that can be completed in 2 to 3 years are anticipated.
    • Technical Review Criteria
      • Scientific merits of the proposed collaboration
        • Is the premise of the project strong?
        • If the goals are accomplished, how will the opioid crisis be affected?
        • Will the work shift paradigms?
        • Is the work novel?
        • If human material is being used, is the description of human subjects protection consistent with NIH policies?
        • Are potential pitfalls/issues described?
      • Investigator(s)
        • Do the collaborators have the appropriate training and experience to advance the project once the collaboration has come to a close?
        • What is the record of accomplishment and collaboration?
      • Environment
        • If collaborators are proposed to conduct parts of the project themselves, do they have the necessary resources to accomplish their aims?
        • Is there evidence of institutional support?
      • Feasibility of completing goals
        • Will the milestones serve as strategic and objective benchmarks of progress?
        • Are the milestones realistic?
      • Synergy with HCBS goals
      • Translational sciences and public health impact
    • Experts will also note:
      • Specific strengths of the project
      • Specific weaknesses/recommendations for project improvement
  • Decisions about which projects to explore with the potential collaborator for possible implementation will be made by the Scientific Director and NCATS Director, based on the input of the technical experts, portfolio balance and availability of NCATS resources.
  • Decision Notification
    • The program manager will send the prospective collaborator a letter informing him/her whether the project has been accepted for consideration.

Next: Collaboration Notification