Frequently Asked Questions (FAQs) for Establishing Collaborations with SCTL (NOT-RM-17-030)

At this time, the Stem Cell Translation Laboratory (SCTL) at The National Center for Advancing Translational Sciences (NCATS), part of the NIH Common Fund Regenerative Medicine Program (RMP), is seeking new collaborations to help achieve common goals in iPSC biology in a faster and more coordinated fashion. Interested investigators may propose to collaborate with SCTL on projects to bring induced pluripotent stem cell (iPSC) technology closer to clinical application, drug discovery, and regenerative medicine. 

1. What are some major research goals for the NCATS’ SCTL? 

• Working in a multidisciplinary collaborative team approach, NCATS’ SCTL scientists aim to: Establish detailed quality control (QC) standards to define pluripotency and differentiated cell types.
• Develop methods to assess molecular and cellular variations/signatures in cellular phenotypes derived from iPSCs
• Develop standardized methods to produce mature cells from iPSCs meeting QC and reproducibility standards.
• Discover, validate and disseminate small molecule reagents to replace expensive recombinant proteins, xenogenic material and undefined media components in cell differentiation protocols.

2. There is a notice in the NIH Guide that announced the opportunity to collaborate with the SCTL. Is the collaboration considered a funding opportunity? Will the SCTL provide funding to selected collaborators? 

This is not a grant application, and no external funding is available. Rather, it is an opportunity to collaborate with NCATS scientists and have access to the expertise and resources of SCTL.

3. What is the process to establish a collaboration project with SCTL?

Prospective collaborators are encouraged to contact SCTL for additional details about preparing a proposal: https://ncats.nih.gov/stemcell/work/proposal. Proposals will be assessed for scientific merit, technical feasibility, fit with available resources and alignment with SCTL programmatic goals.

4. When should potential collaborators submit a proposal? 

Interested investigators may submit proposals to collaborate with SCTL throughout the year. Proposals will be accepted on July 1, November 1, and March 1. Peer-review of submitted proposals will be held in August, December, and April of each year.

5. What is the review process for submitted proposals?

NCATS’ SCTL expects collaborative projects to have an emphasis on overcoming technological hurdles impeding the transition of iPSC research from “bench” to “bedside” (e.g., significant protocol improvement). NCATS staff will assess proposals for scope and availability of internal SCTL resources. SCTL staff then seek feedback on select proposals from stem cell experts to measure enthusiasm for the proposed science, competitiveness within the research area, and feasibility of success. Finally, there will be a second level of review to ensure programmatic fit with SCTL goals.

The review process will solicit feedback in the following areas:

• Strength of current data package
• Feasibility to complete goals
• Translational impact relative to current standard
• Likelihood of external adoption and broad impact

Details of the NIH and external expert deliberations are kept confidential by the SCTL program, though investigators will receive written communication regarding the proposal’s final outcome. All materials submitted to SCTL via proposalCENTRAL are considered confidential.

Following the scientific assessment, SCTL staff will evaluate select proposals further through due diligence and face-to-face meetings with potential collaborators, during which SCTL staff may request additional supporting data. Portfolio balance and availability of resources also will impact final decisions.

6. Will SCTL establish an agreement with collaborators?

Research projects are governed by formal NIH collaborative agreements. When a collaborative agreement is agreed to and signed by all parties, the collaborative project will start. More information about the available standard model agreements may be found on the NCATS website.

7. How will SCTL implement collaborative projects?

A. Project Team: Once a collaborative agreement has been executed, a project team will be formed. In consultation with the collaborating investigator, the project team will develop and define the following elements:

• Project Plan
• Timeline
• Milestones and Deliverables
• Go/No-Go Decision Points

B. Project Plan: The Project Plan will be approved by SCTL leadership. Any changes to the Project Plan will need to be approved by SCTL leadership. Go/no-go decisions will be made by the project team based on the Project Plan. In coordination with governance team members, SCTL leadership makes the final decision regarding changes to project scope or termination.

C. Project Termination: Upon failure to meet timelines, milestones, and/or deliverables or with the recommendation of the governance team, SCTL will terminate a project. Whenever possible, collaborating investigators will be provided guidance on how to move the project forward.