Leukemia & Lymphoma Society: The Quest For Cures
The Leukemia & Lymphoma Society (LLS) is proud to announce The Quest For Cures (QFC), a new series of Request for Proposals (RFPs) to identify and develop safer, more effective treatment paradigms for patients with hematological malignancies. LLS has formed a partnership with Celgene to create the first of such RFPs that will build the foundation of this new LLS initiative. This initiative will identify and fund priority research areas, with support from biotech and pharmaceutical partners in order to address significant unmet medical needs. The near-term goal of this program is to advance the scientific and medical understanding of the various hematological malignances.
LLS is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services to patients and their families.
Celgene is a global biopharmaceutical company committed to improving the lives of patients' worldwide by delivering innovative and life-changing drugs for our patients. With more than 300 clinical trials, Celgene has focused on delivering novel therapies for patients with incurable hematological malignancies, including multiple myeloma, myeylodysplastic syndromes, chronic lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), and myelofibrosis.
Description of The Awards:
The "Quest For CURES" research topics are aimed to gain a better understanding of the underlying causes leading to failure of current treatments and to identify novel therapeutic targets and ultimately new treatments. LLS and Celgene RFP topics available for funding with this initial RFP are the following:
Novel approaches for measuring and monitoring clonal heterogeneity in the clinical setting at both the genomic and epigenetic levels and assessing its contribution to response or resistance to therapy. Proposal topics of interest under this general area include but are not limited to the following:
a. Studies to define the proportions of genetically unique clones that have relevant mutations that can potentially drive resistance, either directly or by contributing to epigenetic plasticity.
b. Models in which to study the impact of targeting epigenetic modifying enzymes or other molecular targets on the development and evolution of clonal heterogeneity.
New molecular stratification mechanisms to identify key subsets of patients with B cell malignancies; application of these tools should be tractable to prospectively identify patients predicted to have poor outcomes with current standard therapies, aiming to direct these patients to novel therapeutic interventions that specifically address the identified cause(s) of treatment failure. Proposal topics of interest under this general area include but are not limited to the following:
a. Clinically tractable approaches to prospectively identify previously untreated DLBCL patients who are unlikely to achieve complete remission or who will have remission duration of less than a year following R-CHOP therapy. The approach should have potential for substantially greater sensitivity and specificity than the IPI or IHC based cell of origin methods and should additionally point to novel therapeutic targets.
Enhancing the understanding of the role of the microenvironment in initiation and maintenance of hematologic malignancies with emphasis on the mechanisms by which the elements of the microenvironment contribute to chemoresistance. Proposal topics of interest under this general area include but are not limited to the following:
a. Development of in vitro, 3-dimensional co-culture systems using primary and/or immortalized cell lines that recapitulate cell:cell interactions in the lymph node or bone marrow microenvironment. Proposals should describe how the superiority of these systems over currently available models would be demonstrated in terms of predicting sensitivity or resistance of leukemia or lymphoma cells to treatment.
b. Novel methods for utilizing clinical specimens to study the contributions of the lymph node and/or bone marrow microenvironments to response or resistance.
This RFP represents a new LLS research grant paradigm; QFC projects should, if successful, have a measurable impact on the diagnosis or treatment of patients with hematologic malignancies over the next 5 to 10 years. Proposals must include specific timelines, milestones and deliverables that researchers believe are achievable with their proposed funding. The range of funding available is from $200,000 to $400,000 annually, for research to be completed in a period of 2 years.
Additional funding, for projects that have demonstrated exceptional progress in the initial 2 years may be available; subject to review by LLS and its company partners. Additional funding is not guaranteed for any of the projects, but is contingent on the achievement of the project goals. The LLS Research Department staff will work with researchers to monitor progress and provide insight and expertise to each project. Both Celgene and LLS are committed to supporting early stage, foundational research as well as new therapy development. Researchers and institutions should note that Celgene would consider each project, as a project the company would potentially like to further develop as a potential therapeutic or diagnostic for patients.
Special Considerations for Grantees and Their Institutions:
In addition to LLS's standard terms and conditions for academic grant awards, QFC also includes the following requirements. In partnership with Celgene and their funding, academic institutions and researchers will have to agree to provide Celgene with first rights to negotiate for intellectual property deriving from or reduced to practice during each project. Should Celgene choose to negotiate for rights to IP, Celgene shall have an exclusive period for this negotiation. If an agreement is not reached the Institution and researcher may not enter into an agreement with terms any less favorable than what was last offered by Celgene for a certain period of time. Please inquire with LLS for disclosure of those time periods. Also, if after said period of time, the Institution has not entered into another agreement, Celgene shall have the right to elect to enter into another exclusive dealing period. During the period of the grant and the Periods when Celgene exercises its rights the institution is prevented from disclosing intellectual property rights outside normal activity or enter into negotiations with a third party. These specified periods for negotiation will be spelled out in the contract and available for review during the application process. Each applicant to the QFC is required to have his or her institution certify agreement with the IP terms and Celgene Rights at the time of application submission. For questions regarding this policy, please contact Allison Formal VP, Research Business Development at allison.formal@lls.org or at 914-282-2753.
WHO CAN APPLY
General Eligibility Criteria:
Citizenship and Degree - Applicants (principal investigator) must hold an M.D., Ph.D., or equivalent degree, and work in domestic or foreign non-profit organizations, such as universities, colleges, hospitals or other academic laboratories. Applications may involve multiple institutions however, the applicant (principal investigator) should have an independent research or academic position and his/her academic institution will be responsible for signing off on all terms of the QFC grant agreement. The applicant need not be a U.S. citizen, and there are no restrictions on applicant age, race, gender or creed. Applications from non-academic facilities and the National Institute of Health are not eligible. An applicant may only submit one application per RFP cycle in the QFC.
Leadership and Staffing - The application will require one principal investigator who is responsible for the preparation and submission of the proposal including budget, the conduct of the research programs and adherence with all stipulations made by LLS in this document, the Quest For Cures Guidelines and Instructions, the special terms outlined by LLS and Celgene, and in the grant contract if funded. Modifications to leadership and staffing are subject to the Relocation or Transfer and Interruption, Abandonment or Leave of Absence section of LLS's Policies & Procedures document.
APPLICATION PROCESS AND DEADLINES
The applicant and Sponsoring Institution must register independently with the proposal CENTRAL site in order for applicant to apply (see Instructions / General / Using proposal CENTRAL). Timelines and deadlines for the application process are shown below.
LETTERS OF INTENT (LOI) - Each applicant must submit an LOI by June 3, 2013 at 3:00 PM, ET via proposal CENTRAL website. LOIs will include a brief abstract describing the overall proposal, specific aims and projected milestones. LOIs will be reviewed for responsiveness to the RFP topics and approved/rejected by LLS shortly after the time of submission. Once the LOI has been approved, the Full Application will be available to the applicant on proposal CENTRAL for submission by July 15th, 2013.
FULL APPLICATION - Full applications will only be accepted via proposal CENTRAL. The submission deadlines will be strictly enforced. Please note that all times are Eastern Standard Time (EST). If any date falls on a weekend or a U.S. holiday, the deadline becomes the following business day.
There will be two review and funding cycles. The timeline for this initial cycle (Cycle 1) is detailed below. Applicants that do not receive funding during the first review cycle are ONLY eligible to re-apply with the same/similar proposal for the second review cycle by invitation. All applicants are welcome to submit entirely new proposals.
To apply please visit proposalCENTRAL by visiting the following url: https://proposalcentral.altum.com/
Review Cycle 1
Call for Proposals February 2013
Letter of Intent Deadline June 3, 2013, 3:00, PM, ET
Full Application Deadline July 15, 2013, 3:00, PM ET
Scientific Peer Review Committee September 2013
Notification of Awards October 2013
Anticipated Funding Start Date December 2013
The topics for the second review cycle have not yet been determined. The application process for the second review cycle will begin in the summer 2013. There will be a separate announcement containing the topics and application deadlines for Cycle 2.
REVIEW PROCESS OF FULL APPLICATIONS
Full Applications will be reviewed after the July 15th submission deadline (Cycle 1) by a diverse peer review panel. Once ranked, the priority score and funding recommendations from the peer review panel will be presented to the Joint Steering Committee (LLS Research Staff and Celgene Representatives) for final determination of awardees.
Any applicant (PI) selected for funding will be notified within 45 days of the funding decision. Funding decisions are relayed by email only and are not available by telephone. All priority scores are confidential and are only available to LLS's Joint Steering Committee, LLS's Mission Oversight Committee, and administrative personnel only. Written critiques of the application are not formally provided to an applicant.
REVIEW CRITERIA
An application will be judged on the following criteria:
The probability of a significant advancement in the scientific and medical understanding of the hematological malignances
The conceptual basis upon which the proposal rests
A specific timeline with clearly articulated milestones and deliverables
The novelty of the concept
The feasibility of the research strategy
Thoughtful and clear presentation
The overall plan for bringing the research findings to clinical application
Experience, background, and qualifications of investigators
Adequacy of resources and environment (facilities, patient population, data management, and data analysis)
Adequacy of provisions for protection of human subjects if applicable
For additional questions regarding LLS research programs, eligibility and application processes, please contact Sammy Hattar, Director of Research Administration: Sammy.Hattar@lls.org or (914) 821-8290.
