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Call for Innovative Research Projects in Advanced Therapies for Dravet Syndrome

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1. Introduction

Dravet Syndrome Foundation Spain (FSD) was created with the primary goal of removing the barriers that prevent research on Dravet syndrome from advancing, as well as encouraging the search for effective treatments that can mitigate or even cure the disease.

In this context, there is currently a need to support innovative research projects aimed at finding new treatments and improving the quality of life for those living with Dravet syndrome.

Therefore, FSD places a high priority on funding research that has a clear path to genetic understanding, clinical application and/or therapeutic development.

2. Call timeline

The FSD Scientific Committee will oversee the research grant program and provide funding recommendations to FSD Board of Trustees.

Deadlines of this call (hours in CET):

– Research Grant Announcement: November 3, 2020

– Deadline for receipt of letters of intent: Midnight December 6, 2020

– Invitation to apply: December 28, 2020

– Deadline for receipt of applications: Midnight March 7, 2021

– Announcement of the awarded Project(s): April 12, 2021

– Maximum project start date: before September 1, 2021

– Maximum project completion date: before August 31, 2023

FSD will grant up to a maximum of 120’000 euros in total, which will be applied to finance one or more projects with a maximum duration of 2 years.

Being a non-profit organization that depends on donations and fundraising from families, FSD is not able to cover overheads and any indirect cost of the project such as rents for labs, offices and facilities, library services or general administration. On the contrary, direct costs such as salaries directly attributed to the project, laboratory equipment, consumables, publications or travel expenses for project dissemination purposes can be covered by this grant.

3. Research Project

A. Significance

Top priority will be given to basic, preclinical and clinical research aimed at advanced and innovative therapies to mitigate or eliminate symptoms caused by Dravet syndrome. Eligible areas of study in this Call for Proposals include, but are not limited to, viral vector gene therapy, non-viral vector gene therapy and synthetic biology (e.g., development of small molecules which alter RNA splicing or protein conformation).

Specifically, this Call for Proposals focuses on innovative exploratory projects that are not currently funded by other entities due to their preliminary nature or because they study aspects of the disease not yet covered by other researchers. It could be that the results originating from these investigations will lay the foundation for future proposals to larger funding agencies.

However, applying the same criteria of scientific quality and innovation, this Call for Proposals may allow co-funding of projects currently funded by other agencies provided that they do not overlap with activities/objectives already covered, i.e. FSD’s funds will support essential and additional objectives.

In any case, the added value and impact on the understanding of the disease or the development of treatments for Dravet syndrome must be clearly established.

Proposals must have clear objectives that are achievable within a maximum two-year project period: a well-defined and achievable project timeline which includes milestones and contingency plans must be presented. A clear strategy should also be presented to ensure subsequent funding in case this is necessary.

In the case of projects in basic research, the application must state the viability of the project for a future transfer to the clinic.

If necessary, access to relevant and well characterized patient populations or adequate collections of biomaterials should be demonstrated.

B. Information to be included in the Letter of Intent

A Letter of Intent must be submitted to FSD. This letter will be in digital format and sent electronically through the online form available at this web page.

The letter will include the following sections, all written in English:

– Title of the project

– Details of the Principal Investigator

– Summary

– Objectives

– General Methods

– General Timeline

– General Budget

– Expected Results

– If applicable, feasibility of the project for future transfer to clinical research

– Complete contact information and contact person for all correspondence

C. Evaluation

An evaluation process, consisting of three steps, will be conducted:

First: The Letters of Intent received will be evaluated by the FSD Scientific Committee following the criteria of scientific quality, relevance and the potential to generate significant knowledge consistent with the objectives of the Call.

Ideas for projects selected in this first phase will receive a letter from FSD by which applicants will be invited to submit their full projects. Applicants will be notified of the result of this first evaluation step by email. No further written comments will be provided to applicants at this stage.

Second: The Scientific Committee will evaluate the full projects based on the following criteria: scientific quality, appropriateness and suitability of approaches, logic of the plan and experimental methods, probability of success and long-term sustainability of the research program.

Eligible projects, selected by the FSD Scientific Committee based on the criteria mentioned above, will enter the third and final evaluation step.

Third: The Scientific Committee will choose, among the fundable proposals, those that best fit the scope and objectives of the call.

All applicants will receive a written explanatory statement at the end of the evaluation process. The evaluators are subject to strict confidentiality regarding the matters of which they become aware during the review process.

D. Eligibility

To be eligible for this call, applicants must be scientifically independent and affiliated with a public or private research entity; Early career researchers, i.e., senior postdoctoral fellows, research associates, and assistant professors are eligible for this call provided that their affiliation with the host institution is assured throughout the funding period. The host entities must sign a formal statement in such case.

International applicants, whatever their ethnic origin, religion, age, gender and ability are called to apply to this program.

Collaborative projects involving more than one research group at the national or international level will be positively evaluated. Only one application per research group will be accepted. Exceptionally, in the case of collaborative projects, the same research group may submit more than one project as long as the collaborating groups are different in each project.

Entities, centres, research teams and principal investigators who have received funding, directly or indirectly, from FSD in the past must have fulfilled any and all contractual obligations to FSD, including but not limited to interim or final financial and project reports, to be eligible for this call for proposals.

FSD reserves the right to declare this call null and void if the quality of the proposals is considered insufficient or not suitable. FSD also reserves the right, at its discretion and without prior notice, to change, modify, add, or remove the portions of this call that it deems appropriate at any time.

E. Agreement of the host entity

Once the research project has been accepted, the applicant’s host entity must sign a letter of agreement that must be printed on paper and stamped with the official letterhead of the host entity. The scanned copy of this letter, in pdf format, must be sent to FSD via email to research@dravetfoundation.eu no later than fifteen (15) days after project approval.

F. Project follow-up

The successful applicants must provide an interim scientific report at a time to be defined according to the characteristics of the selected project, and a final report at the end of the funding period, both including financial details as proof of the use of the awarded funds. In addition, FSD kindly requests that award recipients diligently report any delays, changes or unexpected results. It is anticipated that FSD may invite or request award recipients to present their progress at the FSD Annual Family Meeting and/or the FSD Annual Scientific Conference.

G. Grant Agreement

Once the project is awarded, FSD will prepare a Grant Agreement. This agreement, written in Spanish or English, must be signed by the grant holders and their entities as well as by FSD, highlighting, among others, the following conditions:

– The start date of the project must not be later than September 1, 2021.

– Interim and final scientific and financial reports will be presented by the funded group to FSD. These reports will determine the continuity of funding by FSD.

– No indirect costs will be covered with this grant.

– The intellectual property and the income distribution derived from the discoveries made from the awarded project will be subject to post-award negotiations between FSD and the Entity of the awardee.

4. Contact details at FSD for further information

Research Team – Dravet Syndrome Foundation Spain
research@dravetfoundation.eu

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