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Overview - 2012 Funding Opportunities/Submitting a Proposal

The development of new therapies for pediatric cancers with the poorest outcomes is essential to improving survivorship. Solving Kids’ Cancer focuses on expanding the menu of therapeutic options to positively impact children in treatment today as well as those diagnosed in the future through clinical studies of novel agents.

In the next two years, more pediatric cancer genomes will be decoded with additional pathways and targets identified. Numerous candidate agents and delivery mechanisms that potentially target these biological discoveries will need to be studied in children to confirm their biologic relevance. The Therapeutic Development Initiative(TDI) is Solving Kids’ Cancer’s strategic program to support the investigation of novel treatments through clinical studies to answer important research questions as quickly, effectively, and economically as possible.

The TDI utilizes a pre-proposal format called a Clinical Idea of Intent for all submissions that is used to evaluate your proposal’s fit with the stated aims and review criteria of the TDI. All submitted Clinical Ideas of Intent will be reviewed through a triage process and those proposals meeting the aims of the program will be requested to submit further proposal details. Proposals can be submitted open-ended throughout the year, keeping in-mind that proposals received earlier have a greater chance of support based on the programming budget.

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MAY 1, 2012 RFP OPPORTUNITY - Call for Idea of Intent proposals for ACT FAST initiative. DUE JUNE 15, 2012

ACT FAST (Adoptive Cell Therapy For Adolescent/pediatric Solid Tumors) is a new initiative by SKC to prioritize collaboration and expediency in creating clinical trials in this emerging area of immunotherapy.

Starting May 1, 2012, we invite submission of ideas of clinical trials that incorporate Adoptive Cell Therapy strategies to address the need to treat, control and prevent the recurrence of cancer for children with high-risk pediatric solid tumors and deliver near-term benefits to these patients through clinical investigation by a multi-institutional, collaborative and synergistic team of expert investigators.

Detailed information and instructions are here. Applicant information sheet for completion is here. DUE DATE for all submissions is JUNE 15, 2012.

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SUBMITTING A CLINICAL IDEA OF INTENT TO THE TDI - Aims & Guidelines

Mandatory Aims

  1. The TDI supports clinical testing of promising therapies that may significantly and fundamentally improve treatment for children with pediatric cancer. While SKC values pre-clinical research, only clinical studies are supported via the TDI program. Final pre-clinical work that is requisite to the submission of a protocol may be considered in certain circumstances.

  2. The clinical study must focus on neuroblastoma, pediatric CNS tumors and/or sarcomas

Prioritized Guidelines
  • Novel investigational agents– first-in-children or first in specific cancer type
  • Ability for study protocol to be submitted for IRB review within 6-months of proposal approval
  • Study designed to answer hypothesis quickly:
    • Phase Ø, Proof-of-Concept, or small Phase I study design (read more)
    • Enrollment anticipated to be completed within two years of IRB approval
  • Pre-clinical data: While TDI proposals must be clinical in nature, there has to be sufficient pre-clinical support (multiple cell line data, xenograft data and patient-derived cell line/animal data with promising tumor response) to recommend an initial study in children. Any pre-clinical work must be completed within 6-months of the proposal submission
  • Study will include determination of potential efficacy of promising disease-modifying therapy
  • Study proposes biology component that will advance disease understanding beyond drug dosing
TDI Funding Philosophy

Ideal proposals will be those that focus on novel and potentially high-impact therapeutic approaches through well designed clinical studies for neuroblastoma, pediatric CNS tumors &/or sarcomas. Novel clinical research proposals may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other uniquely creative qualities. Research that is an incremental advance upon published data/results from current/past clinical research efforts is not considered innovative and will not be considered for funding under this award mechanism. The TDI will prioritize studies with the greatest potential to slow or halt disease progression beyond current standards of care.

The primary evaluation criteria for any proposed trial will be a clear and justified rationale based on demonstrated promise in pre-clinical tests or, demonstrated clinical efficacy in other disease indications that would justify testing in pediatric cancer. If such data are unpublished, the applicant is responsible for providing all relevant data supporting the particular rationale for the therapeutic approach. Although different therapeutic development programs may exist at different clinical testing phases, SKC feels its impact can best be felt by focusing on studies that utilize a smaller number of patients and where it can be demonstrated that a target is "druggable" to determine if a clinical program is worthy of moving forward in a larger scale consortium or cooperative group multi-center clinical setting.

EXAMPLES OF PREVIOUSLY FUNDED PROJECTS

Proposal Format, Submission timelines, Review, Approval, Award Amounts & Duration

PROPOSAL FORMAT

The Clinical Idea of Intent is a streamlined pre-proposal form submitted online through the TDI Portal that summarizes the novel hypothesis/clinical study being proposed. This allows a quick and efficient process for both submitting and reviewing initial proposals as well as communicating back to the applicant. more information

SUBMISSION TIMELINES

The TDI accepts Clinical Idea of Intent proposals throughout the year open-ended. These will be considered by TDI scientific advisors as they are submitted. Although there are no submission deadlines, it is recommended to apply as early as possible to have the greatest opportunity for support based on the appropriated programming budget. SKC employs an expedited, abbreviated granting mechanism to accelerate discoveries and ultimately translate findings to childhood cancer patients more quickly

REVIEW

The TDI reviews proposals on a rolling basis. Initial review will occur within 30-days of submission. Formal communication will be initiated within 5-weeks of submission. If appropriate, the TDI will invite more detailed proposals or seek further discussions to identify potential funding collaboration. This may include a discussion of needs assessment.

APPROVAL

Approvals of all TDI Proposals are made by the TDI Scientific Advisory Board and the Solving Kids’ Cancer Board of Directors. Requesting additional proposal information after triage review of a Clinical Idea of Intent does not constitute a funding approval. After approval, a Project Grant Agreement will be created and agreed upon by the Investigator and the Charity. SKC strives to make approvals within 3-months of the proposal submission.

AWARD AMOUNTS

Clinical Project Grant Awards are provided in a range from $25,000 to $300,000 depending on the nature of the proposed project. No institutional overhead or indirect funding will be provided under the terms of the grant.

AWARD DURATION

The TDI program funds Clinical Project Grants up to two years for promising therapeutic approaches with potential to significantly improve the treatment of pediatric cancer

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Additional Information

Eligibility

  • SKC welcomes applications from researchers within or outside the United States. Prior work in cancer research is not a prerequisite for applying
  • Research fellows applying for funding must identify a full-time institution faculty member with whom they are affiliated. Research fellows whose project is ultimately approved and funded will be expected to complete the proposed project
  • Companies interested in support for clinical efforts in pediatrics are welcome to apply.

Applicable to All Proposals for Funding

  • Application and required documents must be in English
  • No institutional overhead or indirect funding will be provided under the terms of the grant
  • All submissions are considered confidential and are available to the Scientific Advisory Board, the Board of Directors, and the staff of SKC only

Qualifications and Conditions

  • All awards will be payable to grant recipients to administer for the purposes of the submitted grant only
  • Personnel costs may not exceed 15-20% of the budget. Exceptions may be made for proposals documenting a need for more.

Any questions related to the 2012 proposal submission process should be addressed by email to:grants@solvingkidscancer.org