November 6, 2015 – The Cooley’s Anemia Foundation is accepting applications for medical research grants and fellowships in areas related to thalassemia. The awards are in 3 categories: Support for Ongoing Clinical Research in Thalassemia; Clinical Trials in Thalassemia Cell and Gene Therapy; and Research Fellowships.
Details are as follows:
SUPPORT FOR ONGOING CLINICAL RESEARCH IN THALASSEMIA
The Cooley’s Anemia Foundation invites national and international applicants to apply for grants to support ongoing clinical research projects in thalassemia.
The goal of this initiative is to support investigators from all disciplines and backgrounds (MD, RN, PhD, MPH, MSW or other disciplines) with their ongoing clinical projects to address one or more of the following areas impacting patients with thalassemia, including but not limited to: cardiac issues and iron overload; fertility, pregnancy and family planning; quality of life, psychosocial impact and/or burden of disease.
The stipends will be $40,000 annually with possibility of one-year renewal upon submission of a renewal application. Approval will be based upon determination of satisfactory progress and availability of funds. Funds may be used for either salary or non-salary purposes, but the administrative cost is limited to 10% of the total amount granted.
This level of funding would be appropriate for support of innovative small-scale pilot studies, observational trials, or ancillary support for ongoing interventional studies (for example, support of a trainee joining an existing trial, or new biological endpoint analyses for an existing trial). In the case of ancillary studies, investigators should clearly document the support for the parent trial in their “other support” declarations.
Junior and senior faculty are eligible; fellows and trainees are not eligible. Investigators must interact directly with patients or patient-related data. Basic research, when included in this “Ongoing Clinical Research” program, must be related to a direct clinical focus of the grant application.
Assurance must be given that adequate facilities exist and will continue to be available to conduct the research project and that the project has been reviewed and approved by the appropriate committee or governing body on human research. The research may not be conducted at a for-profit laboratory.
Letters of Intent & application:
Interested individuals are invited to submit a letter of intent by January 15, 2016, which includes the name of primary applicant, affiliation, and focus of proposal (not to exceed one paragraph). The completed application is due February 1, 2016. Both the letter of intent and the application should be emailed in PDF format to: firstname.lastname@example.org.
CLINICAL TRIALS IN THALASSEMIA CELL AND GENE THERAPY GRANT AWARD
The Cooley’s Anemia Foundation invites national and international applicants to apply for grants to facilitate clinical trials in Cell and Gene Therapy to advance a cure for thalassemia. Both phase I (safety) and phase II (efficacy) trials are eligible for support.
Funding and candidate eligibility:
Applicants should state explicitly the status of their proposed trials; for example, whether the trial has been approved by the Recombinant DNA Advisory Committee (RAC), or Food and Drug Administration (or equivalent processes at non-US sites), or whether review meetings at regulatory agencies have been scheduled.
Studies proposed for this RFA must be accompanied by a realistic timeline of progress to human trials. The Foundation recognizes that this timeline can be long. While the funds may be used toward any aspect of launching a human gene therapy trial, the Foundation will request careful documentation of other support of the investigator(s) and the project, and a thorough justification of the allocation of costs to various support mechanisms. This will best enable reviewers to assess feasibility of the proposed project. Examples of expenses allowed will include:
- Clinical-grade vector production and quality control
- Research subject assessments
- Late-preclinical studies and ex vivo studies on research subjects required for safety and efficacy assessments (including, but not limited to, evaluation of vector genome integration events, studies of transduction efficiency, studies of globin production by transduced hematopoietic stem cells from subjects)
- Patient care costs directly related to the study
- Research assistant or research nursing support.
Assurance must be given that adequate clinical and other facilities (including, where applicable, laboratory and vector production facilities) exist and are available to conduct the research project and, in case of investigations involving human subjects, a full human subject protection plan should be included as an appendix.
Total funding of up to $60,000 per year will be available (including indirect costs of 8%). With satisfactory evidence of progress and availability of funding grants may be renewed for a second year. Excluded from funding in this grant are lodging and other personal costs for research subjects to come to a treatment center.
Support for investigator effort may not exceed 10% of the current NIH salary cap.
Animal studies, if any, must be directly relevant to the specific proposed clinical trial.
The research may not be conducted at a for-profit laboratory.
The completed application is due February 1, 2016. A PDF format of the application should be emailed to: email@example.com.
The Cooley’s Anemia Foundation invites national and international clinical and basic science investigators (postdoctoral or junior faculty) to apply for its prestigious fellowship program. Applications should be focused on the understanding or treatment of thalassemia or a complication that is related to thalassemia. The areas of interest include, but are not limited to, studies of globin gene regulation, globin gene transfer and expression, fetal hemoglobin production, hematopoietic stem cell research, bone marrow transplantation, iron chelation and iron overload, endocrine and cardiac disorders in thalassemia, and transfusion therapy and its complications.
Postdoctoral applicants must have adequate preceptorship and guidance by an experienced investigator. The sponsor of a postdoctoral fellow should be an investigator with adequate experience and at an institution with adequate research facilities. The application is expected to be the original work of the candidate but should reflect the close advice of the interested and involved sponsor. Postdoctoral applicants must have an M.D., Ph.D., or equivalent degree, and cannot hold a faculty position.
Junior faculty applicants must have an M.D., Ph.D., or equivalent degree, and must have completed less than five years at the assistant professor level at the time the applications are due. Junior faculty members do not require sponsors.
Fellowships are awarded to the medical institutions where the research is to be undertaken; thus, each application must be approved by and administered through the appropriate administrative representative at the institution. Assurance must be given that adequate laboratory facilities exist and are available to conduct the research project and, in case of investigations involving human subjects, that the project has been reviewed and approved by the appropriate committee or governing body on human research. The research may not be conducted at a for-profit laboratory.
Preference will be given to applicants who have not yet achieved R-01 funding from the NIH.
Awards are for a one-year period, beginning July 1, 2016 and running through June 30, 2017 and are renewable for a second year upon application and consideration of progress made in the first year and the research plan for the second year. Continuation of fellowships for year two will also be contingent upon the availability of funds.
Interested individuals are invited to complete and return applications and letters of reference no later than Monday, February 1, 2016. Notification will be given to applicants by June 30, 2016.
For further information, please contact:
Cooley’s Anemia Foundation
330 Seventh Avenue #200
New York, NY 10001
800 522 7222