2014–2015 Sanford Stem Cell Clinical Center Project Fund

Our goal is to provide administrative and other relevant support to help with the execution of creative development of clinical trials of novel stem cell related therapies for a range of human disorders. The work should be done at UC San Diego in Sanford Stem Cell Clinical Center at UC San Diego Health, except where this is technically unfeasible or undesirable. In general, we will not support preclinical work with the possible exception, based on strong merit, of support needed to finish up IND-enabling studies. The Sanford Center offers funding for direct costs specifically related to the project. No overhead costs can be paid.
 
Strong, fundable projects are in the Late Product Development/Translation stage and include plans to get to Phase I/II clinical trials in two years, July 2015-July 2017. Early-Stage applicants (or Feasibility stage applicants) must provide a strongly persuasive argument for the unique scientific merit or provide the bulk of funding on their end. The Sanford Center will consider funding projects that

     a)   Perform definitive IND-enabling studies (Late Product Development).
     b)   Perform FDA requested studies to lift clinical hold of an IND.
     c)   Rare exceptions, based on strong merit, to overcome hurdles and increase the project’s chance for further funding from other sources (Late, and possibly Early Product Development).
 
Fundable projects will have already identified the correct regulatory path - device, biologic (gene therapy, cell, etc.) or drug, have met early regulatory requirements, have a strategy for meeting all regulatory requirements. Strong projects will have in place appropriate Good Documentation Practices and are in transition to Good Manufacturing Practice. Fundable projects have a strong financial partner. 
 
Fundable projects have

1. Proposed mechanism of action (i.e., relevant therapeutic activity or intended biological effect).

2. Pilot proof of concept studies (to establish the feasibility and rationale for use of your investigational product in the targeted patient population).

3. Evidence that the project IND could be submitted to FDA in two years.

 

Eligibility

Only pre-applications that were invited to submit full proposals by the Project Identification Committee in February 2015 are eligible to seek funding.
 

Application

1. Please download the following application materials and follow the instructions to prepare your full proposal.

2. Please send complete application materials to Jennifer Braswell, PhD and CC Cynthia Kuan.

Deadline

May 1, 2015  

Contact information for programmatic inquiries

Vickie L. Sheckler
Project Manager
Sanford Stem Cell Clinical Center
UC San Diego
Email: vsheckler@ucsd.edu

For application & budgetary inquiries

Cynthia Kuan
Fiscal Specialist
Sanford Stem Cell Clinical Center
UC San Diego
Email: c1kuan@ucsd.edu