2025-2026 Stanford CTS Pilot Grants

Stanford CTS Pilot Program Overview

The Stanford Clinical & Translational Science (CTS) Pilot Program supports early-stage projects that advance the science of translation, emphasizing collaborative, transdisciplinary work and generalizable translational outcomes. The program provides pilot funding, mentorship, and innovation training to accelerate the translation of discoveries into better health outcomes.

Areas of Interest include: 

• The Science of Translation: Projects that develop or validate new approaches to improve the efficiency, effectiveness, or generalizability of the translational process.
• Health Policy in Translational Research: Investigations into policies or regulatory frameworks that influence translational success across multiple healthcare contexts
• Research Rigor & Reproducibility: Projects that will adhere to the Rigor and Reproducibility guidelines based on the four elements of rigor described by the NIH (https://grants.nih.gov/policy/reproducibility/index.htm).

Eligible projects may include:

• Platform technologies that enable products with applications across multiple clinical specialties.  This can also include methods for increasing effectiveness of existing products, streamlining regulatory approval, scaling production, or adapting for diverse healthcare settings.
• Novel diagnostic tools that increase understanding of a disease and its mechanisms, and enable new therapeutic approaches for validation across multiple diseases, interoperability with existing systems, or frameworks for accelerating clinical adoption.
• Methods for streamlining prototype and product development, reducing fabrication and validation time and cost, and facilitating transition to manufacturing
• Studies on policies, incentives, and process improvements that help de-risk innovation and make regulatory pathways more efficient and predictable.

Awards will be managed by the following Stanford programs:

• SPARK Translational Research Program is a novel drug and diagnostics discovery program that helps train academics in translational research and translational science. We teach an innovative, cost-effective way to overcome the hurdles associated with translating academic discoveries and speed the development of drugs and diagnostics that address real clinical needs.
• Stanford Mussallem Center for Biodesign educates trainees in biomedical technology innovation and health policy through fellowships, courses, mentoring, and funding opportunities. Biodesign HealthTech pilot projects should develop generalizable insights into the translational process rather than focusing solely on product development. 

Amount and Period of Funding:

The maximum funding amount is $50,000 for 10 months and must be completed in that timeframe. Funds must be applied to specific tasks that increase the probability of translational success in accordance with Spectrum and NIH-NCATS funding guidelines. Unexpended funds will be forfeited.

Important dates:

• CTS Pilot Request for Applications released: March 2025
• Application Deadline: Tuesday, April 15, 2025 at 11:59 PM PT
• Award Announcements: July 2025
• NCATS Prior Approval Process & Budget: July - August 15, 2025
• Award Distributed: Mid-August 2025
• Funding Timeframe: September 1, 2025 - June 30, 2026 (extension not allowed)
   

Institutional representatives:

Not applicable. Because this is an internal Stanford funding opportunity, you do not have to submit your applications through your RPM in RMG or your CGO in OSR for their approval. 
 

Selection and Award Process

Proposals will be evaluated by independent faculty and external reviewers based on selection criteria and scoring systems. Reviewers will prioritize applications that present bold, innovative approaches with significant potential for translational impact.

Awardees will receive preliminary notification of selection. Final awards will be granted only after all requirements are met. Teams that fail to meet requirements on time may forfeit their award to runner-up teams.

Requirements including, but not limited to:

• Final budgets received from departmental finance;
• NIH biosketches;
• IRB approval, or determination that human subjects are not involved;
• CITI training (Group 7) completed by project investigators and their research staff;
• IACUC approval for animal studies;
• NCATS prior approval for projects involving human subjects or living vertebrate animals.
   

Evaluation Criteria

The research must relate directly to applications in healthcare, and the objectives of the project should include an outcome that will benefit patients. Evaluation of proposals will be on the basis of innovation and scientific merit, potential healthcare impact, and feasibility, as well as Translational Science Principles of generalizability, efficiency, and/or speed. Priority will be given to projects that emphasize additional Translational Science principles.
 

NCATS Process for Prior Approval Requests for Human Subjects Research and Vertebrate Animal Research

Projects involving human subjects or vertebrate animals require NCATS prior approval before awards can be issued and funds released. This process ensures compliance with ethical and safety standards.

Timeline & Process

• Approval takes a minimum of 30 days, and funding cannot be disbursed until approval is secured.
• Spectrum staff will assist awardees in compiling and submitting required documents to NCATS.
• Refer to the CTS Pilot – NCATS Prior Approval Checklist for the list of required documents.
• Refer to the following NCATS links for Prior Approval submission instructions for research involving:
  • Human Subjects
  • Vertebrate Animals

For answers to common questions, please see the NCATS’ FAQ page.
 

Application Instructions

Application Process

• Submit applications through Stanford Seed Funding.
• We strongly encourage applicants to share proposal ideas with the program contacts prior to submission:
  • SPARK Program Manager, Gretchen Ehrenkaufer, gehrenk@stanford.edu
  • Biodesign Translational Program Manager, Linda Lucian, llucian@stanford.edu
     

Applications should follow the guidelines below:

Format

• Page specifications
  • 8.5 x 11” page size
  • At least 0.5” margins on all sides
  • At least 10-point font size
• Save your documents as PDFs (or Excel for the budget, Word for the budget justification) and upload them to the Seed Funding application form.
   

Cover Sheet (1-page limit, upload as a single PDF)

• Title of proposal
• Two hypotheses: Research hypothesis and Translational hypothesis addressing at least one Translational Science Principles below.
  • Produce Generalizable Solutions for Common and Persistent Challenges
  • Enhance the Efficiency and Speed of Translational Research
• PI name, title, department, and email
• Co-PI or Co-Investigator names, titles, departments, and emails (if applicable)
• Amount of funding requested
• IRB or APLAC eProtocol number and submission status (eProtocol does not need to be submitted or approved but needs to be initiated).
  • Pilots are required to submit a new eProtocol and must reference the NIH UM1 Grant # UM1TR004930 and SPO # 329368 under the funding section. The project title must also match the title on the IRB or IACUC Approval Letter.
  • Approvals for animals and human subjects should be addressed ahead of the grant-funding period, including the protocol number or the letter of exemption. Approvals are strictly required for funding dispersal and are generally not a valid rationale for no-cost extension requests.
  • For more information on IRB or APLAC protocol submission, please visit http://humansubjects.stanford.edu or https://researchcompliance.stanford.edu/panels/aplac. 
     

Proposal Narrative (4-page limit, upload as a single PDF)

Please address the following:

• Research Question(s) and Specific Aims
• Describe the unmet need, impacted population, and gaps in current approaches (Impact, population need, current options)
• Background / Significance: Summarize the current state of the field and limitations of existing approaches. Explain how the project could improve efficacy, speed, or generalizability (Impact)
• Preliminary Data and Feasibility (if applicable): Provide preliminary data or explain how feasibility and risks will be assessed.
• Approach / Methods (key measures, outcomes, and analytic plan): Outline the study design and methods, ensuring methodological rigor. Highlight contributions from interdisciplinary collaborators (team science)
• Originality / Innovation: explain how the project is novel or advances beyond current approaches (novelty).
• Potential Implications / Contribution of Work: Describe how the project will generate generalizable insights in translational science (impact, generalizability)
• Research Timeline and Milestones (Quarterly benchmarks): Provide a timeline with milestones linked to outcomes (feasibility, scope, budget)
• Translational Plan for Follow-On Work: Outline the path from pilot to future studies or follow-on funding. (sustainability, impact)
• References may be included (not included in page limit)
   

Budget (not part of 4-page limit; upload as an Excel file)

• Separate budget into distinct sections:
  • non-IRB/non-IACUC related costs
  • IRB related costs
  • IACUC related costs
    • Animal purchases are considered technical supplies and Stanford Veterinary Services Center (SVSC) animal care indirect costs (IDC) will apply to animal care. Please identify the animal (i.e. mice, rabbits, monkeys) and cost of purchases, separate the cost of live animals from the cost of animal care, and include the SVSC animal care IDC in the budget (see special rates here).
• Allowable expenditures include: investigator’s salary, research personnel salaries, travel (if project-related), and project supplies.
  • Salaries are capped at the 2023 NIH salary cap of $212,100.
  • Include the cost per unit and # of units, or hourly rate and # of hours for consultants/service agreements, if applicable.
• Unallowable expenditures include: subawards, capital equipment costing more than $5,000, intellectual property services, and food
   

Budget Justification (not part of 4-page limit; upload as a Word file)

• Use provided justification template here.
• Your budget justification should provide an explanation of factors used to determine costs on each budget line item in your proposal.
• Reminder: Separate budget into distinct sections:
  • non-IRB/non-IACUC related costs
  • IRB related costs
  • IACUC related costs
    • Animal purchases are considered technical supplies and Stanford Veterinary Services Center (SVSC) animal care indirect costs (IDC) will apply to animal care. Please identify the animal (i.e. mice, rabbits, monkeys) and cost of purchases, separate the cost of live animals from the cost of animal care, and include the SVSC animal care IDC in the budget (see special rates here).
       

Key Personnel Bios (1-paragraph maximum for each key personnel; uploaded as a single PDF)

• Required for the PI, Co-PI(s), Co-I(s), and other senior/key personnel.
• Senior/key personnel are defined as all individuals who contribute in a substantive, meaningful way to the scientific development or execution of the project.
• Do not submit NIH biosketches.
   

CE PI Waivers (if applicable; uploaded as a single PDF)

• Required for Clinical Educator (CE) faculty serving as lead PI on the pilot project.
• Reminder: CEs with PI waivers do not have the authority to be the primary mentor of graduate students. They can be a primary mentor of MD postdoctoral trainees engaged in clinical trials, clinical database reviews or other forms of clinical research that directly and primarily focuses on patients in the Standard Medicine healthcare system.
   

Notes:

• Figures and tables included within the body of the proposal will count towards the 4-page limit.
• Do not include appendices to the proposal.
• Applications that do not comply with the requirements will not be considered for review.
• Funding will not be dispersed without clearance of any applicable APLAC, IRB or IRB exemption requirements, including NCATS prior approval.
• If the research does not involve animals or human subjects, award recipients must provide confirmation.
   

Definitions:

Translational Science Principles: The NCATS Translational Science Principles characterize effective translational science approaches. The Principles were generated by an NCATS committee with expertise across the translational spectrum, and in science, operations and administration.

• Prioritize Initiatives That Address Unmet Needs: Focus on pursuing scientific goals that address unmet scientific, patient or population health needs.
• Produce Generalizable Solutions for Common and Persistent Challenges: Develop innovations that address persistent challenges to advancing translational progress that are found across multiple research initiatives or projects, or span research on multiple diseases or conditions.
• Emphasize Creativity and Innovation: Leverage creativity and innovation in research design, conduct, and facilitating factors, with the goal of increasing the impact of the research.
• Leverage Cross-Disciplinary Team Science: Engage team members with expertise across disciplines, fields, and professions to produce research that advances translation along the translational research continuum.
• Enhance the Efficiency and Speed of Translational Research: Implement evidence-informed practices and scientific and operational innovations to accelerate the pace of translational research.
• Utilize Boundary-Crossing Partnerships: Leverage collaborations across agencies and sectors and engage patients and communities in research to advance translational progress.
• Use Bold and Rigorous Research Approaches: Develop ambitious research questions and address them with rigorous and robust methods toward generating reproducible findings that contribute to advancing translation.
   

Questions: 

For questions regarding the scope of the proposal, criteria for awards or the review process, contact:

• SPARK Program Manager, Gretchen Ehrenkaufer, gehrenk@stanford.edu
• Biodesign Translational Program Manager, Linda Lucian, llucian@stanford.edu

For questions regarding the application process and requirements, please contact K12/Pilots Program Manager, Ellen Orasa, eorasa@stanford.edu.
 

Grant Acknowledgment:

The Stanford CTS Pilot Program is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UM1TR004921. See NCATS Strategic Plan 2025-2030 for further information (https://ncats.nih.gov/about/ncats-overview/strategic-plan).