Deadline: 31-Oct-24
Apply now for the Osteosarcoma Institute’s Grant Program.
Types of Grants
- Clinical Trials
- Scope
- The primary objective of proposed Phase I/II or Phase II clinical trials in relapsed/refractory osteosarcoma should be to improve event free survival (EFS) at 4 months beyond historical rates known to be in the range of 12% for patients with unresectable disease. The proposed trial may be carried out in a single institution, a clinical trial consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct clinical trials. Please provide specific timetables for protocol development, regulatory approvals, industry agreements, IRB approvals, activation, accrual, and reporting. They will consider the applicant’s history of efficiently entering agreements, opening trials, and meeting accrual expectations for trials of relapsed osteosarcoma patients, with the expectation that results will be available within three years of trial initiation. Other desirable characteristics for proposals include:
- Answering an important question
- Strong preclinical rationale
- Rigorous trial design and correlative endpoints to allow for productive failure.
- Budget reasonableness (per patient and total)
- Leverage from concurrent financial support of the trial (e.g., direct institutional support, industry and/or philanthropic support, securing drug, etc.)
- The primary objective of proposed Phase I/II or Phase II clinical trials in relapsed/refractory osteosarcoma should be to improve event free survival (EFS) at 4 months beyond historical rates known to be in the range of 12% for patients with unresectable disease. The proposed trial may be carried out in a single institution, a clinical trial consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct clinical trials. Please provide specific timetables for protocol development, regulatory approvals, industry agreements, IRB approvals, activation, accrual, and reporting. They will consider the applicant’s history of efficiently entering agreements, opening trials, and meeting accrual expectations for trials of relapsed osteosarcoma patients, with the expectation that results will be available within three years of trial initiation. Other desirable characteristics for proposals include:
- Scope
- Correlative Science
- Scope of Proposal
- Correlative studies should seek to generate data from clinical trials aimed at improving event free survival of recurrent and metastatic osteosarcoma patients. The highest priorities for correlative science proposals are to create the opportunity, should the associated clinical trial fail, to understand the reasons for that failure and allow for productive iteration of the approach; and
- to identify specific predictors of response. Nonetheless, proposals may include hypothesis testing and/or exploratory, hypothesis generating elements, but all proposals should include/prioritize the following:
- The generation of new biology data associated with a clinical trial that will improve the understanding of osteosarcoma metastasis and/or accelerate the launch of future clinical or translational osteosarcoma studies.
- Power analyses demonstrating the number of samples from patients needed to answer each correlative question proposed to be answered, and the rationale for asserting that the required samples will be obtained.
- Preliminary data demonstrating technical ability to apply desired technology for biological analysis to relevant osteosarcoma biospecimens.
- Scope of Proposal
- Preclinical/Translational
- Scope of Proposal
- A translational imperative for the OSI is to cultivate and support a research agenda that will identify biological dependencies in the disease that can be targeted in patients. This research agenda will ideally include the use of novel laboratory approaches and bioinformatic tools applied to osteosarcoma cells, a diversity of in vivo models across species and human patient samples. Furthermore, they are particularly interested in the study of dependencies that may impact a variety of potential phenotypes associated with the disease, including metastatic proclivity, DDR in the context of a structurally complex genome, identifying novel disease targets using surfaceome approaches, targeting mechanisms of resistance to first generation T cell checkpoint blockade in osteosarcoma, and other immunotherapeutic opportunities. While they value projects designed to enable new clinical studies, they also realize and value foundational research studies that will identify the desired biological dependencies/targets.
- Scope of Proposal
- High-Risk/High-Impact
- Scope of Proposal
- Grantmaking involves balancing the potential impact of a successful research project with the risk of experimental failure. Traditionally, risk mitigation is accomplished during the research proposal review process in several ways, including heavily weighing preliminary data. While the historical balance point has proven broadly effective and successful, the stubborn lack of progress in osteosarcoma suggests that alternatives should be considered. Thus, the aim of this grant program is to place less emphasis on preliminary data in order to encourage projects exploring bold innovations that may fall within any stage of the drug development path, and that seek to deliver curative outcomes to patients with osteosarcoma. Proposals will be most valued based on their innovation and sound scientific hypothesis, and the likelihood that the approach will address a true dependency in osteosarcoma.
- The desired criteria for this high-risk/high-impact osteosarcoma drug development research are:
- Bold ideas that will generate evidence of success or failure within 12 months.
- A new research direction rather than a continuation of ongoing funded research.
- While preliminary data are not required, the applicant must demonstrate feasibility of a persuasive research plan.
- Rigorous, quarterly interactive grant progress reviews to be used to guide ongoing direction and distribution of research support.
- A successful high-risk/high-impact grant proposal should have one or more of the following characteristics:
- A proposal that, upon successful conclusion of the project, may mature into a successful submission for a traditional OSI grant or launch a translational development plan with investigators, institutions, or commercial biopharma companies.
- An existing relationship that makes the development of a therapeutic asset in biopharma feasible.
- Scope of Proposal
Funding Information
- Clinical Trials
- Up to $800,000 total over two to three years (inclusive of indirect costs not to exceed 10% of the requested project budget).
- Correlative Science
- From $200,000 – $500,000 total over two years (inclusive of indirect costs not to exceed 10% of the requested project budget).
- Preclinical/Translational
- Up to $500,000 total for two years (inclusive of indirect costs not to exceed 10% of the requested project budget).
- High-Risk/High-Impact
- From $25,000 – $125,000 total over one year (inclusive of indirect costs not to exceed 10% of the requested project budget).
Eligibility Criteria
- Funds must be granted to nonprofit/charitable institutions or organizations.
- Grantee organization does not need to be based in the United States.
- Applicants must have an MD, PhD, MD/PhD, or equivalent and be appointed as faculty (or equivalent) at an academic institution.
- Applicants need not be United States citizens.
- Applicants must have a track record of publication and funding productivity that demonstrates the project can be accomplished by the investigators.
- Applicant must propose a new research direction, not a continuation of ongoing funded research.
- All established researchers requesting funds should show how their project is a departure from ongoing funded work. New projects may be an extension of other work but cannot overlap any funded studies unless the applicant clearly demonstrates that new funding will not duplicate existing support.
- Applicants selected for funding will permit the OSI to publicize the grant for fundraising purposes, including, but not limited to a five-minute video discussing the research project, photos of lab, and photos of children participating in clinical trials, where applicable.
For more information, visit Osteosarcoma Institute.