Request for Applications Dr. William E. Paul Distinguished Innovator Awards in Lupus and Autoimmunity. $1 Million Grants

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Request for Applications Dr. William E. Paul Distinguished Innovator Awards in Lupus and Autoimmunity Release Date: November 15, 2018 Letter of Intent Due Date: March 15, 2019 Earliest Start Date: November 2019 Background $1 Million Grants The Lupus Research Alliance (LRA) is the world s leading private funder of lupus research. The organization s mission is to improve treatments for lupus while advancing towards a cure through the support for research. At present, therapy for lupus is empiric and involves a variety of mostly non-specific anti-inflammatory and immunosuppressive agents. While these treatments are frequently beneficial, many patients do not respond adequately and suffer significant side effects including organ damage. Importantly, many unanswered questions regarding the pathogenesis of lupus remain and new conceptual and therapeutic approaches are urgently needed. To address these critical knowledge gaps and to markedly advance lupus research, the Lupus Research Alliance established the Distinguished Innovator Award (DIA). This grant mechanism is intended to attract exceptionally creative scientists from all relevant scientific disciplines and to provide them with a robust and sustained support to explore bold and paradigm shifting ideas that could lead to ground-breaking discoveries in lupus research. Investigators working in areas outside of lupus are strongly encouraged to apply. This is a highly competitive award. Only one or two applications per year will be selected for funding. Following the initial 2-page Letter of Intent (LOI) stage of the application process, five to six investigators will be invited to submit full applications in order to maximize their efforts. Program Goals The Distinguished Innovator Awards provide outstanding scientists with substantial support for up to four years to conduct novel research into the fundamental causes of systemic lupus erythematosus that can provide new directions towards a cure. The Lupus Research Alliance welcomes novel, hypothesis- or discovery-driven proposals in human and/or animal-model based lupus research. The research proposal must aim to uncover the fundamental causes of lupus and present a compelling vision of how the discovery would lay the groundwork for a cure, prevention, or highly effective therapy. Applications will be judged primarily on the novelty, potential and quality of the research proposal, and the strengths and track record of the investigator. Emphasis will be on the rationale for the hypothesis rather than the amount of preliminary data. Continuations of long-term research projects will not be considered. Successful applicants will be outstanding

investigators who have demonstrated creativity and productivity in their field of research. We encourage applications from investigators in diverse disciplines including, but not limited to, immunology, genetics, molecular-, cell- and systems biology. Eligibility Applicants must hold a faculty position, at the assistant professor level or above, at an academic institution. The Lupus Research Alliance does not impose geographic restriction on its applicants and researchers working outside of the US are also encouraged to apply. Application Guidelines Applications must be submitted electronically, via proposalcentral by 11:59pm ET on the stated deadline. Paper applications are not accepted. A two-stage application process will be employed. A 2-page Letter of Intent (LOI) will be used to judge the significance, novelty and alignment of the proposed project concept with the DIA funding mechanism. Only applicants whose LOIs have successfully passed this first review stage will be invited to submit full applications. I. Letter of Intent A Letter of Intent is required and must be submitted electronically, via proposalcentral, by 11:59pm ET on the stated deadline. It should contain the following information: (Items 1-4 should not exceed 2 pages. Figures, tables and legends are included within the page limit. However, citations are not counted towards the page limit.) 1. Brief background: Provide a succinct contextual framework for the proposed project. This section may be particularly valuable to applicants new to lupus and applying knowledge from other scientific areas that need to be introduced to bear on lupus. 2. Overall objective and preliminary Specific Aims: State the overall objective and outline the preliminary specific aims. 3. Project plan: Describe the significance, innovation, and approach for the proposed project. 4. Resource assessment: Assess your ability to carry out this project and outline resources you may need to accomplish it, such as access to proprietary reagents or technologies and key collaborators. If the applicant s primary scientific expertise is outside of lupus, please describe how you intend to apply your unique knowledge to address a critical issue in the pathogenesis and/or treatment of lupus. 5. Biosketch: A standard NIH-style Biosketch for all key personnel working on the project. This should include a description of other financial support available to the applicant(s) for his/her research endeavors. Applicants who are not based in the United States may submit a copy of their curriculum vitae. Restriction on Number of Applications Only one LOI will be accepted per principal investigator in a grant cycle. II. Full Application Full applications may be submitted only by applicants whose LOIs has been approved and who have been invited by the Lupus Research Alliance to advance to the next stage of the review process. Applications should contain the below information and should be submitted via 2

proposalcentral (please log into this site for detailed description). The full application site will only be accessible to applicants with approved LOIs. 1. Lay Abstract: Summary of the proposed research and how it will accelerate the development of new treatments for lupus. This must be written in lay language geared to a twelfth-grade reading level and suitable for use in publications (not to exceed 3,000 characters). Please do not submit a scientific abstract in this section. 2. Scientific Abstract: A technical abstract of the research plan that includes the application s long-term objectives and specific aims. Investigators should highlight the relevance of the work to lupus. The abstract should not exceed 3,000 characters. 3. Research Plan: A 10-page research plan (items a-e) should include a description of the following: a. Specific Aims b. Significance: Describe the scientific rationale for the project. Explain the relevance of the proposed work to the fundamental causes of lupus. Explain how the work will lead to a cure, prevention, or highly effective therapy for lupus. c. Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms in lupus. d. Preliminary data e. Experimental design and methods: Describe the overall strategy, methodology, and analyses to be used to accomplish the stated specific aims. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Discuss anticipated outcomes, potential problems and alternative strategies. f. Milestones: List the expected status of the project at various time points for the duration of the grant. The list of milestones should reflect the specific aims of the proposal. A suggested format is a table, listing, by priority, the aims, along with their expected dates of completion and measures. These milestones will be used to evaluate progress and to facilitate communication between the principal investigators and the Lupus Research Alliance. g. Literature citations should be listed and are not included in the page limit for the Research Plan. 4. Biosketch: Provide a standard NIH-style biosketch for all key personnel working on the project. This should include a description of other financial support available to the applicant(s) for his/her research endeavors. Applicants who are not based in the United States may submit a copy of their curriculum vitae. 5. Detailed Budget and Summary: A budget for the project prepared in U.S. dollars. The budget should be for up to four years and should not exceed $250,000 per year. 6. Budget Justification: A detailed justification for the budgetary requests must be provided. The information in this section should be divided into two sections. The first section should include the following line items: personnel, consultant costs (if any), supplies and equipment. The second section should list all other line items including but not limited to: travel to the annual LRA investigators meeting, consortium/contractual costs and other expenses. Funds cannot be used to pay for tuition or education expenses. Each section should not exceed 2,000 characters. Any additional information should be included as an appendix to the application. 7. Other support: Indicate all current and pending grant applications, their specific aims, amounts and extent of overlap, if any. If overlap exists, a statement regarding intended disposition of funds in the event of dual granting is required, signed by an official of the 3

applicant s institution. Ordinarily, this would constitute return of funds to all but one granting agency. However, under certain circumstances, monies granted could be appropriately apportioned. 8. Facilities & Equipment Description: Provide a short description of the facilities and equipment available to support the project. 9. Assurances: Appropriate institutional assurances regarding the use of human subjects and animals, as applicable, must be provided. 10. Consent Forms: If relevant, copies or drafts of all informed consent forms, to be distributed to participants for signature in this study (or their legal guardians), should be provided. 11. Consultant/Co-Investigator/Collaborator Letters: Optional, only submit if relevant to the application. 12. Signed Cover Page: The signed cover page, which reflects the applicant s agreement to abide by the rules governing grant awards from the Lupus Research Alliance, should be uploaded electronically. Instructions are available on the proposalcentral website. Review Criteria The scientific review committee will consider each of the following criteria in assigning the application s overall score, weighting them as appropriate for each application. Novelty of the proposed research: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Scientific merit of the research proposal: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Relevance of the project to the fundamental causes of lupus Potential of project to lead to lupus cure, prevention or a highly effective therapy Investigator: Does the investigator have a demonstrated track record of innovation, of shifting scientific paradigms and breaking open new areas of research? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Terms of Award The Distinguished Innovator Award grants will be supported for up to US $250,000 per year for up to four years. Funds may be used for any appropriate research costs and up to 10% of the total annual budget (US $25,000) may be allocated to salary of the principal investigator. Indirect costs should not exceed 10% of the total budget (excluding equipment), and must be included within the $250,000 annual budget cap. Progress reports are required at the end of each year and are reviewed by Lupus Research Alliance staff and scientific advisors. Ultimately, funding decisions will be made by the Lupus Research Alliance Board of Directors. Forming partnerships with the grant recipients is one of the cornerstones of the Lupus Research Alliance s funding philosophy. Towards this end, awardees are required to attend the Lupus 4

Research Alliance annual scientific conference and share the concepts and progress of their research. Travel funds, provided by the grant award, should be used to attend this meeting. The Lupus Research Alliance is committed to the publication and dissemination of all information and materials developed using the organization s resources. All recipients of LRA awards must agree to this principle, and must take steps to facilitate availability of data and materials. Review Process Grant applications are reviewed by the Lupus Research Alliance s Distinguished Innovator Awards Review Committee, which makes recommendations to the Board of Directors. The Lupus Research Alliance reserves the right to consult qualified third parties as necessary. Review Feedback For applicants invited to submit full proposals, a summary statement, containing the reviewers critiques and a synopsis of the review discussions, will be provided within three months of the review date. Applications not recommended to advance to the full proposal stage will not receive written critiques. The Lupus Research Alliance does not provide scores or applications rankings to applicants. Key Dates RFA Release: November 15, 2018 Earliest Submission: November 15, 2018 Letter of Intent Due: March 15, 2019 Letter of Intent Decision: May 1, 2019 Full Application* Due: June 26, 2019 Scientific and Board Reviews: August September 2019 Response to Applicants^: October 1, 2019 Earliest Anticipated Start: November 1, 2019 *By invitation only with an approved LOI ^For full applications only Inquiries Scientific: Teodora Staeva, PhD Research Director Lupus Research Alliance tstaeva@lupusresearch.org +1-646-884-6090 Administrative: Diomaris Gonzalez Director, Grant Programs Lupus Research Alliance dgonzalez@lupusresearch.org +1-646-884-6056 proposalcentral: For help with the electronic grant application process, please contact the help desk of proposalcentral pcsupport@altum.com +1-800-875-2562, extension 227 5