Center for Pediatric Cellular Therapies: Clinical Trial Launch Grants

The Center for Pediatric Cellular Therapies (CPCT) is accepting Late Stage Preclinical/IND Enabling Research and Clinical Trial Launch Grant applications. Applications are due July 1, 2020 by 6:00 PM.

CPCT's mission is to operate at the forefront of novel cell-based therapeutics to develop new paradigms for the treatment of human diseases. The center fosters multidisciplinary scientific collaboration towards the development of novel cellular therapies and facilitates the rapid translation of new discoveries into clinical trials through provision of targeted infrastructure and expertise to meet these objectives. This includes supporting investigators through all stages of the Investigational New Drug (IND) application.

Two types of competitive grants are available:

  • Planning Grant
    • Late stage preclinical studies are acceptable
    • Emphasis on IND-enabling studies
    • An eventual IND submission to the FDA is an expected main outcome
    • Expected timeline of 6-12 months
    • Budget should be commensurate with project need, expected to be $40,000-$60,000
    • Expect to be able to transition to implementation grant if milestones are met
  • Implementation Grant
    • To implement the studies for moving novel cellular therapies to clinical use
    • Expected timeline of 2-3 years
    • Budget should be commensurate with project need, expected to be ~$200,000 total

PLEASE NOTE: Previous Planning Grant awardees may apply for a non-competitive Implementation Grant upon submission of their IND.

Project Period: October 1, 2020 - September 30, 2021

Eligibility

  • The principal investigator (PI) must have a faculty appointment in the Emory Department of Pediatrics. Primary, secondary, and adjunct appointments meet this criterion.
  • Staff scientists and fellows may not apply as sole PI; however, they may apply as co-PI on multi-PI applications. Fellows and staff scientists cannot be sole PI because the ultimate goal of these grants is to lead to a clinical trial, and fellows and staff scientists cannot be the PI on a clinical trial.

Applicants should write a two page a letter that includes:

  • Project title
  • PI and key personnel, indicating who is/will be the IND sponsor
  • Summary of project and methods (include hypotheses, aims/objectives)
  • Timeline of milestones (Note: Planning grant applicants should include a timeline for transition to an implementation grant. Milestones for the implementation grant will be requested at the transition.)
  • Simple budget and budget justification

All applications must be submitted electronically through the online application portal:

1) What are unallowable expenses?

  • Computers and general electronics, including smartphones and tablets
  • Software
  • Equipment
  • Service contracts
  • Food
  • Please note these additional budget restrictions:
    • The maximum amount that may be applied toward PI salary plus fringe is 25% of the total budget.
    • A maximum of $1,500 may be applied to travel, including registration fees, airfare, hotels and printing.
    • Indirect costs should not be included.

2) What happens to funds not spent by the project end date?

  • All funds not spent by the project end date are retained by the sponsor.

3) What happens if I cannot complete my project by the project end date?

  • All awardees may request one 12-month no cost extension (NCE) of the project period. Strong justification is required, and the request must be submitted in the grants management portal at least 60 days prior to the original project end date.

The first cycle of CPCT launch grants was held in 2019 and awards were made for the following projects:

Autologous Virus-Specific Cytotoxic T-cell Therapy in Solid Organ Transplant Recipients 
Inci Yildirim, MD, PhD, MSc, Assistant Professor, Emory University Department of Pediatrics

IND-enabling Pre-clinical Validation of iPSC-RBC Transfusions for Patients with Sickle Cell Disease (SCD)
John D. Roback, MD, PhD, Professor, Emory University Department of Pathology and Laboratory Medicine
Sean Stowell, MD PhD, Assistant Professor, Emory University Department of Pathology and Laboratory Medicine
Jiusheng Deng, PhD, Instructor, Emory University Department of Pathology and Laboratory Medicine

Program Questions
Ed Horwitz, MD, PhD, Co-Director, Center for Pediatric Cellular Therapies
Trent Spencer, PhD, Co-Director, Center for Pediatric Cellular Therapies

General Application Questions
Jianing Li, PhD, Program Manager

Budget Related Questions
Please contact the financial analyst for your division: