2 Year (2013 15) CLL/SLL Research Initiative CLL/SLL Collaborative Grant Guidelines & General Instructions for Application KEY DATES: Application Release Date: December 12, 2012 Application Deadline: February 19, 2013 Peer Review Process: February April 2013 Earliest Applicant Notification: May/ June 2013 Earliest Project Start Date: September 2013 The Lymphoma Research Foundation uses an electronic grants submission process. All interested grant applicants must submit their applications online through proposalcentral https://proposalcentral.altum.com SUMMARY: The Lymphoma Research Foundation (LRF) CLL/SLL Consortium seeks proposals for high quality research studies in chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL). Applications to this initiative must include the study of primary CLL/SLL patient samples to assure relevance to the human disease. In addition, applicants are required to explicitly delineate how the proposed research will incorporate collaborative interactions between/among investigators in different disciplines (e.g. pathology & medical oncology, basic science research & clinical investigators) and/or different institutions. AMOUNT OF GRANT: Applications may be for a time frame of up to 2 years duration for a budget of no more than $125,000 per year ($250K in total over 2 years). LRF allows 25 percent overhead, smaller overhead amounts are preferred. RESEARCH OBJECTIVES: Correlative project applications are welcome. Applicants are encouraged to design proposals that will complement existing LRF funded clinical projects or ongoing/recently completed 1 clinical trials within the NCI Cancer Cooperative Groups or investigator initiated clinical trials. Possible projects include correlative studies to ongoing trials, utilization of patient samples for specialized analyses, and Phase I or II clinical trials of novel therapeutic approaches. The proposed study should: Investigate the pathogenesis, epidemiology, diagnosis or therapy of CLL/SLL. Priority areas identified for funding include: 1 Recently completed clinical trials, for instance, a case where accrual has been completed but where outcome data are maturing. 1
Genomic/genetic analysis of CLL/SLL. What are the critical pathways involved in lymphomagenesis and what are the molecular predictors of tumor behavior? What biologic features of CLL/SLL and which biomarkers are predictive of outcome of CLL/SLL? Host Tumor Interactions in CLL/SLL. How does the immune system modulate CLL/SLL? Does the tumor microenvironment influence resistance of CLL/SLL to therapies? Transformation of CLL/SLL. What are the molecular events involved in transformation and what signaling pathways are impacted? How can transformation be delayed or prevented? Heterogeneity of CLL/SLL Behavior. What are the molecular, biologic, immunologic and microenvironmental factors determining the variability in clinical behavior of CLL/SLL? Drug Resistance. What are the molecular, biologic, immunologic and micro environmental factors determining resistance to rituximab and other key anti lymphoma agents? Development of Cell Lines and Animal Models of untransformed CLL/SLL. There are currently no good cell lines or mouse models of untransformed CLL/SLL to facilitate research progress in this field. Enhancement of Accrual of CLL/SLL patients to clinical trials. Despite a plethora of attractive agents for clinical trials, progress is slow due to the low accrual rate of patients to clinical trials in the USA. Convincing strategies with measurable endpoints documenting improvement in CLL/SLL trial accrual will be considered for funding. Novel therapies. Projects focused on new therapeutics should explore and elucidate the mechanisms of action. Monoclonal B cell lymphocytosis (MBL) in CLL/SLL families MBL is now recognized as the precursor state to CLL/SLL. What biologic factors contribute to, or are associated with, MBL developing into CLL/SLL? ELIGIBILITY: All principal investigators holding an academic faculty appointment, at non profit organizations, or public or private institutions such as universities, colleges, hospitals, and laboratories, may apply for the LRF CLL/SLL Research Initiative CLL/SLL Collaborative Grant. Eligible investigators must have a title of assistant, associate, or full professor or its equivalent. More junior investigators should apply for other LRF awards (Career Development Awards or Fellowship Awards). For profit entities are not eligible to apply for LRF funds. APPLICATION PROCESS: All interested applicants must submit their applications online through proposalcentral (https://proposalcentral.altum.com) by 11:59PM (EST) on Tuesday, February 19, 2013. NOTE: Applications will not be accepted after the deadline. To avoid being rushed at deadline time, applicants are encouraged to register and complete a professional profile at proposalcentral now. Applicants should make sure their grants and contracts office has registered their institution and signing officials with proposalcentral. In addition, please carefully review not only the remainder of this RFP but also the Checklist for Applicants, Section #2 on the ProposalCENTRAL electronic application form. A proposalcentral helpline is available for questions from applicants during normal business hours (8:30 a.m. 6:00 p.m.), Monday Friday, EST. Phone: 1 800 875 2562 (toll free) E mail: pcsupport@altum.com 2
PROPOSAL FORMAT: When applicants log into the Proposal Central website, the system contains 17 sections. The following table includes brief instructions for each section. SECTION INSTRUCTIONS 1. Title Page Applicants must type the name of their application here. 2. Download Templates: Checklist for Applicants Applicants should read this document before completing the application process. This document does not need to be submitted, but used as a tool to help in preparing your submission. LRF Waiver The LRF waiver must be signed by the applicant and the authorized official of the sponsoring institution. Original signatures in ink are required and hard copies must be submitted to LRF. Biosketch ( Applicant) Biosketch (Key Personnel) Research Plan Appendix To be completed by the applicant and limited to 2 pages. Applicants should use the template supplied and upload as a PDF. To be completed for each member of the key project team and limited to 2 pages per individual. Applicants should use the template supplied and upload as a PDF. Applicants must complete a research plan under the following headings, as per the template provided. Do not exceed 10 pages (using a minimum of type face 11pt). 1. Scientific Abstract 2. Lay abstract 3. Background 4. Research plan 5. Specific aims to be accomplished within the duration of the requested award 6. Quantitative milestones for both the middle and end of the project period This document explains the appendices that can be included in your application. All appendices should be uploaded as one document. This section allows applicants to give other users access to their grant application. 3. Enable Other Users to Access this Proposal 4. Applicant/PI An applicant s previously completed professional profile can be viewed and amended here. 5. Institution & Institutional An applicant s previously completed institutional details can be Contacts viewed and amended here. 6. Key Personnel Information on Key Personnel on the project can be added here. 3
7. Letters of Reference This section is designed to collect the contact information for three individuals providing confidential letters of recommendation. 8. Abstract(s) and Areas of Study Similar to the Research Plan, applicants are required to describe their project in both non technical and technical language. Applicants are also required to select areas of study appropriate to the proposed project and the categories that apply. 9. Budget Period Detail Applicants must complete in line with the proposed project budget. 10. Budget Summary This area does not need to be completed as it is a summary of the information populated from the previous section. 11. Other Research Support Applicants should complete for all current and pending research support. 12. Organization Assurances Applicants should complete in relation to human subjects, vertebrate animals, recombinant DNA and assurance questions. 13. Proposal Attachments Applicants should upload their attachments here (as downloaded from Section Two). Each of these must be converted into a PDF format. 14. Reviewer Exclusions Applicants may list other investigators to exclude from review of their proposal. 15. Validate To check for any documents missing that are required as part of the submission process, applicants can click on the validate button. 16. Signature Pages This document must be completed and a hard copy printed for submission to LRF. 17. Submit To submit your Proposal, please click the 'Submit' button below. PLEASE NOTE: Following the submission of applications on the Proposal Central system, only hard copies of the LRF Waiver and Signature Page document are required. These should be sent to LRF offices at: The Lymphoma Research Foundation Research Grants 115 Broadway Suite 1301 New York, NY 10006 REVIEW AND SELECTION PROCESS: Applications will be reviewed by the LRF Scientific Advisory Board who will make recommendations on applications to the LRF Board of Directors. The LRF Board of Directors will make final funding decisions based on available funds and program priorities. 4
The goals of LRF supported research are to advance the understanding of the biological systems underlying CLL/SLL and improve treatment of the disease. Reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The Scientific Advisory Board will then consider each of these criteria in assigning the application s final ranking: 1. Applicant qualifications and research experience; 2. Innovation of proposed research strategy and objectives; 3. Quality and impact of previous work in CLL/SLL and lymphoma in general; 4. Potential translational/clinical application to advancing treatment of CLL/SLL patients; 5. Reviewers estimation of likely success and impact of the project; 6. Responsiveness of application to the priority research areas listed above. 7. Evidence of cross discipline and/or cross institutional collaboration. 8. Resources, such as facilities and patient study group, available to support the project; 9. Financial resources available from other sources and overlap with possible LRF funding. The application does not need to be strong in all categories to be judged as likely to have major scientific impact and thus be worthy of a high ranking. Ranking will be assigned based on the overall merit of the proposal. However, please note that applications that do not address one of the priority areas or do not show evidence of collaboration will be disqualified. Additional review considerations: 1. Feasibility of research studies, patient accrual (if applicable), and other methodological considerations. 2. Budget: the reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 3. Adequacy of proposed statistical analysis. 4. If the study is related to a large project, discuss the degree to which it will contribute to the outcome of this larger project. LRF CONTACTS: Kathy Brown Director of Research kbrown@lymphoma.org, Telephone: 212 349 2910 Eileen O Malley Research Projects Coordinator eomalley@lymphoma.org, Telephone: 646 465 9115 5