2018 Application Guidelines

OVERVIEW

The IFOPA offers the ACT (Accelerating Cures and Treatments) for FOP grant program to help enable the development of safe and transformative therapies for fibrodysplasia ossificans progressive (FOP). The research grant program provides, through a competitive application process, funding to scientists conducting research on FOP.

The program awards research grants for a minimum of $25,000 and a maximum of $100,000 for one year. Approximately $100,000 is available for funding in 2018, allowing for either multiple grants of less than $100,000 or a single grant for the full amount. Researchers may receive a second year of funding based on their progress and milestones achieved in the first year and the availability of continued funding.

Research grants should focus on the discovery and advancement of therapeutic approaches to FOP, including:

• Potential new therapies that either provide a novel approach to treating FOP or have convincing animal data to warrant further research;
• Combination treatments that may provide better efficacy, allow for more persistent treatment, or to allow treatment for the pediatric population;
• Repurposed drugs that already have a known safety profile and could be a treatment option;
• Preclinical research that investigates a drug’s effectiveness post-resection of heterotopic bone;
• Research that further elucidates the mechanisms for FOP muscle and regeneration as well as tendon and ligament repair.

Proposals involving meaningful collaboration among investigators with complementary capabilities are encouraged. Awards can be split among the investigators’ institutions as needed. Grant funds cannot be used for indirect or overhead costs.

CONFIDENTIALITY

The submission of proposals and the identity of applicants is sensitive information that is treated by the IFOPA and the Scientific Advisory Board as confidential. Winning applications will be announced publicly, but other applications will remain confidential.

SCIENTIFIC ADVISORY BOARD

Proposals are evaluated by a Scientific Advisory Board that is free of conflict of interest and has relevant and appropriate expertise to evaluate proposals. The recommendations of the Scientific Advisory Board are subject to final review and approval by the IFOPA Research Committee, which then makes a final funding recommendation to the IFOPA Board of Directors. All members of the review groups are bound by terms of confidentiality.

The Scientific Advisory Board is comprised of five researchers who have scientific expertise related to FOP. The areas of scientific expertise of the committee are varied to ensure different perspectives are represented. Additional reviewers may be recruited on an ad hoc basis to ensure appropriate expertise is available. Click here to review the current scientific advisors.

Proposal Evaluation Process

All grant applications are blinded with respect to investigator and institution identity for review by the Scientific Advisory Board. The Scientific Advisory Board then rates proposals according to the defined criteria for evaluation and assesses the overall likelihood for the project to make a significant advancement towards for FOP. Once proposals have been fully evaluated on all metrics except for investigator capabilities, the identity of the applicants is unblinded to allow for discussion of investigator and institutional capabilities. The Scientific Advisory Board then develops a recommendation to the IFOPA for funding recipients and amounts.

The IFOPA Research Committee is convened to review the recommendations of the Scientific Advisory Board and to develop a proposal for approval by the IFOPA Board of Directors.

Applications that are scored favorably but not funded during the initial awards cycle may be funded as additional money becomes available.

The Scientific Advisory Board does not provide a written evaluation back to the applicants.

Criteria for Proposal Evaluation

Funding decisions are based on the scientific merit of the project, including its potential for therapeutic translation, the capabilities of the investigator and research team, and the likelihood that the project will be completed successfully within the proposed timeframe. Proposals are rated according to each of the following specific criteria:

Medical Impact: Projects should fit the goal of the program, which is to advance new therapeutic approaches to FOP. Projects that have a disposition toward approaches likely to have near-term clinical or translational relevance will be scored higher.

Scientific rationale for the proposed study and its impact for patients: Proposed projects should have a clearly articulated scientific rationale. Applicants should provide all essential preclinical and/or clinical rationale and indicate how a particular project is critical for moving an idea or potential therapy towards a treatment for patients.

Innovation: Applicants should justify how proposed efforts will lead ultimately to novel therapeutic strategies or significant improvements on existing therapies. Use of novel methods that can increase chances for successful completion of a project or provide more direct and definitive data are particularly encouraged.

Overall experimental design and objectives: Applicants should carefully describe each proposed study, keeping the following issues in mind:

• Each study hypothesis and/or objective should be clearly articulated and proposed methods should be appropriate and sufficient to achieve these goals.
• Details of key measures, statistical analysis plans (including use of appropriate power analyses) and ‘success criteria' for making decisions regarding next experimental steps should be described.
• Use of particular research tools (e.g., animal models) should be justified, and applicability to FOP disease in humans should be articulated.
• For studies involving living human subjects, evidence for adequate protection and safety monitoring should be included.
• Studies proposed as ancillary efforts to a larger project should be justified and results clearly relevant for making decisions about the parent project. Sufficient details of the parent project should be included to allow an evaluation of the ancillary study's rationale.
• Potential problem areas and alternative strategies should be outlined.

Investigator/Environment: The investigative team should be appropriately trained and well-suited to carry out the proposed work. The environment within which work will be performed should have sufficient access to resources to ensure successful completion of the project. Provisions for adequate data management, monitoring and analysis (e.g., biostatistical support) should be indicated.

Sharing Plan: Applicants should provide details on how data and/or research tools (e.g., clinical datasets, research reagents and models) will be made available to the public for future research purposes.

Budget: The proposed budget should be reasonable and justified for the research proposed. Details of personnel (including non-paid collaborators), study reagents, supplies and all other costs should be indicated and justified. Costs should be allocated to coincide with key project milestones and not simply averaged over the entire project period. As noted above, grant funds cannot be used for indirect or overhead costs.

Project Timeline: Timelines for completing each study should be clearly defined and include relevant milestones. Project goals must be achievable within the award period.

IFOPA Research Portfolio: Overlap with other IFOPA investments are considered before making any final funding decisions.

Proposal Content

Submitted proposals should include the following information, according to the page limits noted:

• Executive Summary: Major goals, objectives and expected impact of research; rationale for the project (1 page)
• Detailed Research Plan: Design of research; process for collecting and analyzing data; potential risks and their management; outline of research steps, timeline, and milestones (up to 3 pages)
• Detailed Budget: Projected costs of the project, to be linked to the research plans and milestones
• Curriculum Vitae: The qualifications of the Principal Investigator and key personnel. Please include the curriculum vitae in NIH bio-sketch format.
• Facility description: An outline of the facility or laboratory in which research will take place with a listing of existing equipment applicable to project (1 page or less)
• Other sources of financial and collaborative support: This should include support already applied for (even if in process) and/or received (1 page or less)

Proposal Submission

Grant applications are due by July 6, 2018 and may be submitted to the IFOPA by email to [email protected] in one completed PDF file.

Contact

Please direct any questions to:

Adam Sherman
Director, Research Development & Partnerships
Phone: (407) 365-4194
Email: [email protected]