The SWOG ITSC Pilot Awards 2014 Announcement

Transcription

1 The SWOG ITSC Pilot Awards 2014 Announcement OVERVIEW SWOG formed an alliance with two premiere basic science research institutions - Cold Spring Harbor Laboratory (CSHL) and The Jackson Laboratory (JAX) to promote the integration of ground-breaking basic research into clinical trials. SWOG is part of a National Cancer Institute-supported National Clinical Trials Network (NCTN), with a mission to improve the practice of cancer medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors, primarily through design and conduct of clinical trials. Cold Spring Harbor Laboratory is an independent nonprofit research institution committed to exploring the molecular basis of human cancer through a focused, multidisciplinary approach, and using this knowledge to improve the diagnosis and treatment of all major forms of cancer. The Jackson Laboratory is an independent, nonprofit organization, focused on mammalian genetics research, which applies its strengths in genomics, preclinical modeling, and computational analytics to address the molecular pathways that drive cancer initiation, progression and resistance to therapy. Both CSHL and JAX are NCI-designated Cancer Centers. Working together, SWOG, CSHL, and JAX received seed grant funding from the NCI in 2014 to support an Integrated Translational Science Center (ITSC) with the goal of facilitating incorporation of translational science into Network Group clinical trials. The SWOG ITSC program is under the leadership of three co-principal Investigators: Dr. David Tuveson (CSHL Professor and Cancer Center Deputy Director), Dr. Edison Liu (JAX President, CEO and Cancer Center Director) and Dr. Laurence Baker (University of Michigan Professor, and Chair-Emeritus of SWOG). The mission of the ITSC is to bridge the gap between the laboratory and the clinic by elucidating the key clinical problems and challenges in oncology that can be addressed in the laboratory, discovering new diagnostic and therapeutic approaches that can be integrated into clinical trials, and providing a conduit for clinical trial results to be re-interpreted in the laboratory, identify basic research programs with potential clinical value and match them with clinical trials. The SWOG ITSC Pilot Awards are a funding program with the goal of catalyzing research collaborations between practicing oncologists and basic scientists to identify new therapeutic and diagnostic strategies and formulate scientifically-based clinical trials to rapidly evaluate such approaches for clinical benefit. These awards will support projects coming from a CSHL or JAX scientist who proposes a true partnership with a SWOG investigator. The CSHL or JAX scientist will serve as the lead PI of these pilots, with a SWOG investigator as co-pi. Collaborations with SWOG young investigators are strongly encouraged. Our first priority is to identify clinical pilot projects that will incorporate genomic and other novel translational technologies into planned, in progress or recently completed SWOG clinical trials. In addition, exploratory pilot projects either directly associated or not with a clinical trial - will also be funded with the aspiration that these could lead to projects integrated into clinical trials in future years. Clinical Pilots ($100,000 per year for two years) are those that incorporate translational science, (including expertise from molecular biology, genomic interrogation technologies, in vivo or in vitro animal models, pharmacology, as well as other modalities/disciplines) into SWOG/NCTN trials of novel and innovative therapies/approaches and advanced imaging for cancer patients, especially the incorporation of new, integral and integrated, molecular and imaging biomarkers.

2 Exploratory Pilots ($50,000-$100,000 for one year) are proof of concept studies that validate preclinical findings or models in a translational setting. Pilots in this class may be aimed at identifying new mechanisms of resistance in human cancers, test the feasibility of further development of biomarkers through small pilots in parallel with clinical trials, support targeted in vivo proof of efficacy studies for new therapeutic modalities, or validate new platforms for drug testing. These pilots should show a clear path to near-term incorporation into a clinical trial, but need not be associated with an existing SWOG trial initially. Support for these awards will be provided by The Hope Foundation, with matching funds from CSHL or JAX, depending on the home institution of the awardees. In the case where there are collaborations between an investigator and both CSHL and JAX, funding will be allocated according to percent effort of each basic science institute. The number of awards and duration of program is contingent upon available funding at The Hope Foundation, CSHL, and JAX. The available level of funding should support four to eight pilot projects per year. OBJECTIVES The ITSC Program is intended to foster novel scientific ideas, agents, targets, and technologies that have the potential to substantially advance the practice of clinical cancer research within SWOG and the NCTN. For example, a project may seek to identify new bio-markers for detection or evaluation of drug efficacy, develop new technologies for monitoring therapeutic response, identify resistance mechanisms, carry out co-clinical trials in animal models, exploit genomic data for computational prediction of resistance, or evaluate therapeutic combinations in silico or in animal models to optimize initial potency and avoid resistance. The application must provide a well-defined plan for achieving the goals of the pilot. In addition, each proposal must clearly describe the overarching clinical need or application that the pilot will address. KEY DATES Letter of Intent: August 29, 2014 Request for full applications for selected projects: September 5, 2014 Full application due October 1, 2014 Award Announcements: SWOG Group Meeting Oct 22-25, 2014 Award Period: January 1, December 31, 2015 ELIGIBLE APPLICANTS Any CSHL, JAX and SWOG investigator is encouraged to proposed pilot studies for this program. All studies will be a joint program between a lead PI from CSHL or JAX, partnering with a SWOG-based clinician as a Co-PI. Each site (JAX, CSHL, SWOG) is encouraged to send multiple proposals for the annual RFAs. Individual applicants may submit more than one application, provided that each application is scientifically distinct. Awardees will be expected to present their work at one or more semiannual SWOG group meetings and to adhere to Group policies and procedures as applicable to the project.

3 Though funding is awarded for Investigator-initiated projects, funding will be awarded directly to an institution. APPLICATION REQUIREMENTS A letter of intent is due August 29, These LOI will be reviewed by the ITSC Executive Committee, and pilots will be selected for submission of a full application. Projects will be prioritized based on (1) significance (i.e. potential for transforming impact on the understanding, diagnosis, prevention, or treatment of human cancer); (2) scientific merit; (3) clear ability to integrate with clinical trials; (4) technological or conceptual innovation; and (5) demonstration of synergistic relationship between scientists at CSHL or JAX and clinicians in SWOG or other NCTN partners. The LOI should be no more than two pages, follow the format specifications below, and include: 1. Name and institution of JAX/CSHL investigator 2. Name and institution of SWOG clinical investigator 3. Specific aims, including a statement of the clinical need or application that the pilot will address. 4. One paragraph description of the overall goals and approach of the pilot 5. Indicate whether this is a clinical or exploratory pilot, with rough estimate of budget. The full ITSC application for selected pilots is due October 1, 2014: 1. Cover Letter that introduces project, PIs and their relationship to SWOG 2. Abstract, limited to 250 words 3. PHS398 Mandatory Forms ( a. Face Page b. Summary/Relevance/Key Personnel (form page 2) c. Budget for Entire Proposed Period d. Budget Justification (1 page) e. Biographical Sketch for Key Personnel (4 pages, similar to NIH) f. Other Support 4. Specific Aims page, including a brief background, underlying hypothesis, aims and significance (1 page). 5. Research Plan (PHS398 format, 3-page limit inclusive of tables, graphs) FORMAT SPECIFICATIONS Font: Use an Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color, and a font size no smaller than 11 points. A symbol font may be used to insert Greek letters or special characters. A smaller font size may be used for figures, graphs, diagrams, charts, tables, figure legends, and footnotes, but this type must follow the font typeface requirement and be readily legible. Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch. Print must be clear and legible. Paper Size and Page Margins: Use standard paper size (8 ½" x 11") Use at least one-half inch margins (top, bottom, left, and right) for all pages. SUBMISSION

4 Letters of intent and full applications should be sent as a single searchable PDF file with the subject line SWOG/ITSC Pilot Project - [PI last name]. Letters of Intent should be sent to Denise Roberts at robertsd@cshl.edu. Full applications should be sent to the following, depending on the home institution of the JAX or CSHL PI: JAX: grants@jax.org/ CSHL: itsc@cshl.edu BUDGET LIMITATIONS Clinical pilots will be funded at the level of $100,000 (direct costs) per year for two years. PI salaries should be calculated using the NIH salary cap. A maximum of 5% effort each for the CSHL/JAX PI and the clinical PI may be requested. Exploratory pilots will be funded at the level of $50,000-$100,000 (direct costs) for one year. PI salaries should be calculated using the NIH salary cap. A maximum of 5% effort each for the CSHL/JAX PI and the clinical PI may be requested. Funds in this award may be used to conduct assays studies/analyses associated with clinical trials and/or to conduct pilot clinical studies for biospecimen acquisition to obtain preliminary data. Funds may not be used to support a therapeutic intervention trial requiring patient enrollment. SCORING CRITERIA Awards will be issued through a competitive, peer-review process that includes representatives from SWOG, Cold Spring Harbor Laboratory, and The Jackson Laboratory, as well as additional external reviewers, as deemed necessary. All applicants will receive an Overall Impact Score and brief written critique. The scoring criteria and definitions of the Translational Research Award coincide with the current NIH peer review process, with range of scores from 1 (best) to 9 (worst). The 5 core NIH criteria will be used, with additional criteria gauging feasibility and pertinence to the goals of the ITSC. Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. A score will also be provided for feasibility. - Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services or preventative interventions that drive this field? - Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? Do the investigators have complementary and integrated expertise?

5 - Innovation. Does the proposal have the potential to advance the field? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement or new of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? - Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? - Feasibility and pertinence. Is the project feasible and can it be concluded within the projected timeframe? Is there a clear potential for this project to integrate with late-phase clinical trials? Does the project demonstrate a synergistic relationship between scientists at CSHL or JAX and clinicians in SWOG or other NCTN partners? PAYMENT: Payment will be remitted as described in the executed Award Notice from The SWOG ITSC. Certain contingencies for release of funds may exist, including provision of Just In Time data, confirmation of SWOG samples/bank inventory, IRB approval, or updated Other Support forms, as applicable. Since the funding for pilots comes from several different sources, the funds will be administered differently based on restrictions in distribution. For funds from The Hope Foundation portion of the award, indirect costs are limited to a rate of 25%. Funds provided by The Jackson Laboratory must be used within The Jackson Laboratory, and funds provided by Cold Spring Harbor Laboratory must be used within Cold Spring Harbor Laboratory. PROGRESS REPORTS: Awardees will be required to provide a 2-page progress and financial report nine months after the initiation of funding (Sept 1, 2015). They will be expected to present their results, when requested, either at one of the semiannual SWOG meetings or at one of the Translational Workshops held at CSHL or JAX. Please note: In compliance with the Physician Payments Sunshine Act, components of this program (travel, meals, educational materials) may require reports of payment or transfer of value provided to all US licensed physicians. The Hope Foundation will alert grantees should regulations mandate reporting. INQUIRIES: All inquiries related to this may be directed to: Barbara Tennent (JAX), Barbara.tennent@jax.org, (207) Denise Roberts (CSHL), robertsd@cshl.edu, (516)