2012 CHCT opportunity for Harvard investigators to conduct translational research pertaining to cellular therapies

January 9, 2012

The prime mandate of the Center for Human Cell Therapy (CHCT) is to provide resources to investigators to facilitate bench-to-bedside development of novel cellular therapies for the treatment of human diseases (www.chct.org). CHCT is part of the Production Assistance in Cellular Therapies (PACT) program of the National Heart Lung and Blood Disease Institute (NHLBI). For more information on the PACT program please visit www.pactgroup.net.

Successful clinical cell therapies require the translation of laboratory-based techniques into standard operating procedures that follow regulatory guidelines, and ensure safety and potency of the product. The CHCT is committed to foster the development of preclinical research and clinical trials by providing the necessary translational services to interested investigators. The result of a successful translational phase is: 1) a robust and validated cell manufacturing process, 2) specific characterization and quality control assays, and 3) pre-clinical data needed for FDA submission of Investigational New Drug (IND) applications.

The CHCT is soliciting applications from investigators who have developed cellular therapies in model systems and want to evaluate these therapies in well-designed rigorous clinical trials. CHCT will consider supporting activities that will bring proof of concept discoveries into the translational development stage. Selected candidates will partner with CHCT and receive translational services from CHCT. Investigators who partner with CHCT do not receive direct funds from CHCT to support their research efforts, rather, CHCT provides investigators with valuable translational research services which are sponsored by the NHLBI PACT program.  CHCT applications are open to any faculty member of the Harvard community.

Applications will be reviewed on a rolling basis.

Questions about applications or other aspects of the CHCT should be addressed to:
Leslie E. Silberstein, MD
Director, Center for Human Cell Therapy
Children's Hospital Boston
Phone: 617-919-2390
E-mail: info@chct.org

Review Process
Applications will be reviewed on a rolling basis. CHCT will make final decisions and invite
selected applications to submit a full PACT application based on the criteria below.

Letter of Intent
We encourage prospective applicants to submit a letter of intent, which should include:
* Descriptive title of proposed research
* Contact information for principle investigator
* Names of other key personnel
* Participating institutions

A letter of intent is not required, is not binding, and will not enter into the review of the
subsequent application. Letters of intent should be sent by email to Leslie Silberstein, M.D. at the address listed above.

Format of Application (maximum 5 pages, excluding cover letter and biosketch)
Applications should include:
* Cover letter stating names, affiliations, and contact information for the principle
* Biographical sketch
* Summary of proposed research including abstract, background, rationale, specific aims,
experimental design
* Summary of relevant animal studies including proof of concept data
* Summary of product development including conceptual framework, design, analysis for a research study
* Summary of cell product potential and proposed clinical use
* Summary budget including justification; budget should not include personnel or
institutional costs
* Supporting materials if needed

Submission and any inquiries pertaining to this application:
Please send an electronic copy (by e-mail toinfo@chct.org)

Click here for a copy of the RFP to share with your colleagues.

See also: 2012, Announcement