CCTS Call for Drug Discovery and Development Applications for Funding of Transformational Team Science

CCTS Call for Drug Discovery and Development Applications for Funding of Transformational Team Science
Linda Dwoskin, PhD, Director
Jon Thorson, PhD, Co-Director

The UK Center for Clinical and Translational Science (CCTS) is now accepting applications for Funding to Develop Team Science in Drug Discovery and Development. The purpose of this funding mechanism is three-fold: i) to provide a new opportunity and resources to support innovative, collaborative research in drug discovery and development relevant to health challenges and disparities faced by the nation; ii) to specifically build the teams and obtain the preliminary data necessary to compete for large extramural programmatic initiatives such as those funded via NIH Program Project/Center grant (P or U series) mechanisms; and iii) to stimulate integration of the Drug Discovery and Development core resource (the UK Center for Pharmaceutical Research and Innovation) with programmatic initiatives focused upon drug discovery and development at UK. Program project/center grants are large, multi-project efforts that generally include a minimum of three research projects led by established investigators and at least one core built around a common synergistic theme wherein interrelationships between component projects are expected to result in a greater contribution to the program goals than if each project were pursued separately. Up to $125,000 in total direct funding may be requested for a 12-month project.

Applications will be accepted and reviewed according to the following schedule:

REQUIREMENTS FOR APPLICANTS: Eligibility is limited to full-time regular, special and clinical title faculty as well as full time research faculty of the University of Kentucky and affiliated institutions. Investigators in training including residents, post-doctoral fellows, and clinical fellows are not eligible to serve as PIs but may be co-investigators. Note: As competition for Program Project/Center grants (P and U series) mechanisms is extremely high, program/project PIs should be established investigators.

LETTER OF INTENT: All prospective applicants (PIs and co-PIs) must first submit a Letter of Intent (LOI) and biosketch to Charolette Garland (257-5265, cawgarland@uky.edu) by November 1, 2013. The Letter of Intent (three page maximum) should put forth a brief executive summary of the overall program/center, specific proposed projects within the program (3-5 projects), proposed cores (at least one), proposed internal/external consultants or collaborators, and potential external partners where applicable. The LOI should clearly articulate the significance, innovation, synergy, and project aims for the proposed pilot project. The Letter of Intent also should provide a justification for how the proposed work will advance the team’s research towards gaining external funding and specifically note potential targeted program announcements and/or discussions with program officers that will support an extramural funding application to be submitted by or before January 2015. If applicable, the specific external funding announcement/opportunity should be cited. The Therapeutic Advisory Panel will review the letters of intent by November 15, 2013, and will invite a subset of the applicants to submit a full application. The body of the full application will be no more than 6 pages in length. Each program PI will be assigned a member of the Therapeutic Advisory Panel to help guide them through the proposal submission process. Full proposals must be submitted to Charolette Garland (257-5265, cawgarland@uky.edu) by January 15, 2014.

PRIORITIES FOR FUNDING: The primary objective of this RFA is to provide funding to support new drug discovery and development research with the goal of augmenting the translation of scientific discoveries to therapeutic development. Specifically, the purpose is to assist in the transition from biology and target identification to clinical targets and to facilitate the transition of discovery through development and delivery to all phases of clinical trials and subsequent commercialization. The areas of emphasis include: • Novel approaches in: identification and characterization of pharmacological targets, conceptualization and design of new compounds, optimization of lead compounds, and the stewardship of clinical candidate(s) through pharmaceutical development and through all phases of clinical trial and commercialization. • Pilot studies which generate critical preliminary data that will specifically build team synergy and thereby enhance the competitiveness of programmatic-based extramural funding for drug discovery and development. • Pilot studies addressing an important question in translational drug discovery and development research that impacts human health. Multidisciplinary translational research that integrates one or more of the core components available via the UK CPRI (see below). For more information regarding the CPRI please visit the following link (http://pharmacy.mc.uky.edu/cpri/) SCOPE: Within the general guidelines outlined above, the types of projects that might be considered within this mechanism include: • Pilot or feasibility studies with a particular emphasis upon team synergy. As examples, studies may include: novel target identification/validation, development/validation of new in vitro/in vivo models with translational potential, novel strategies/platforms for compound synthesis/biosynthesis/production, next generation delivery/formulation strategies, development/validation of novel biologics, cohesive discovery/development programs for translational advancement and/or clinical evaluation of agents.

FUNDING INFORMATION: Up to $125,000 in total direct funding may be requested for a 12-month project. Proposed costs should be commensurate with the work. ALLOWABLE COSTS • Funds are to be used for the conduct of the project, including supplies, animal costs, assays, subject payments, etc. • Funds may be used for components of research conducted by Research Core Facilities (e.g., Center for Pharmaceutical Research and Innovation (CPRI), Center for Clinical and Translational Science, Biomedical Mass Spectrometry Core Facility, Division of Laboratory Animal Resources, Behavioral Core, Flow Cytometry Core Facility, Imaging Facility, Magnetic Resonance Imaging and Spectroscopy Center, Microarray Core Facility, Proteomics Core Facility, or Survey Research Center). • Travel funds that are needed for study conduct are allowed, if essential.

NON-ALLOWABLE COSTS • Funds cannot be used to support salary of the Principal Investigator or other investigators with faculty appointments. • Facilities and Administrative costs, also known as indirect costs, are not permitted.

DRUG DISCOVERY AND DEVELOPMENT RESEARCH PROTOCOL SUBMISSION PROCESS: • Investigators are encouraged to contact Linda Dwoskin, PhD (257-4743, ldwoskin@email.uky.edu) to review the basis of your project. • If applicable, consult with Heather Bush, PhD (218-2080 heather.bush@uky.edu) or Dick Kryscio, PhD, (257-4064, kryscio@uky.edu) for biostatistical analysis, Jon Thorson (jsthorson@uky.edu) for more information regarding the CPRI and/or Robert Means, MD, (323-5079, Robert.Means@uky.edu) for help with your Data Safety Monitoring Plan during protocol development.

CCTS DRUG DISCOVERY AND DEVELOPMENT RESEARCH PROGRAM APPLICATION INSTRUCTIONS: If a Letter of Intent is accepted, a full application will be requested. Applications must follow the instructions below. Applicants are encouraged to review the instructions provided below carefully and to contact Charolette Garland (257-5265, cawgarland@uky.edu) with questions. Incomplete or incorrectly prepared applications may be returned without being review. Follow the steps below to apply for CCTS Drug Discovery and Development research support: • Margins must be no smaller than 0.5” at all points. • Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11 points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies). • 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. • EACH page should provide the applicant’s name in the upper right hand corner. The application should be numbered consecutively in the center bottom.

*APPLICATIONS SHOULD BE ASSEMBLED IN THE FOLLOWING ORDER* COVER PAGE (not included in the 6 page limit) Title of the Project: Total Amount Requested Applicant information: Name, Degree(s), Rank, Campus Address, and Contact Information including e-mail and telephone number Applicants Chair’s Information: Name, Campus Address, and Contact Information BUDGET- Requests and justification (1 page, not included in the 6 page limit) Allowable requests include: • Equipment essential for the conduct of the study • Data analysis costs • Research assistant salary support • Chemistry and biological lab supplies • Purchase of cell lines, cultures reagents etc. • Animal purchase and housing costs. • Specimen collection/analysis or testing • Participant reimbursement/recruitment costs **Budget must be approved by Elodie Elayi (elodie.elayi@uky.edu) or Jeanette Graham (jeanette.graham@uky.edu) BEFORE submission Applicants must account for fringe benefit costs when considering research assistant salary levels. NO INDIRECT COSTS ARE ASSIGNABLE THROUGH THIS MECHANISM.

ABSTRACT (250 word maximum, not included in the 6 page limit) The abstract should provide a brief summary of the project. Beneath the abstract, each of the key personnel and their departmental affiliation should be noted. The key personnel should minimally include the PI and co-PIs. Data analysis consultants (if included), collaborating investigators and others may be listed, if they will play a significant, active role in the conduct of the proposed work. Key personnel listed should provide a letter confirming their role (INCLUDE THESE LETTERS IN THE APPENDIX). NIH-FORMAT BIOSKETCH FOR APPLICANT AND KEY PERSONNEL The biosketch should follow NIH format, should include other active support and be limited to 4 pages.

BODY OF THE PROPOSAL- (6 page limit) The body of the proposal should have the following sections in the designated order: Specific Aims (one page), Significance (including a concise discussion of the clinical/translational relevance of the project), Innovation, Team/Programmatic Synergy, and Approach (include preliminary data in approach). Studies involving Human Subjects must include a description and address the NIH guidelines for Human Subjects.

REFERENCES- (no page limit) Authors, year, title and journal information is expected for each citation. Given the length of the application, investigators should strive to provide a relevant, although not exhaustive review.

APPENDIX- Relevant assessment materials may be included provided they are of reasonable length and significantly enhance the review of the application. DO NOT submit published manuals, materials in the public domain or similar materials. This is NOT a means of extending the length of the proposal itself.

REVIEW PROCESS & CRITERIA: Prior to proposal submission each lead PI must submit a Letter of Intent to Charolette Garland (257-5265, cawgarland@uky.edu) by November 1, 2013. The Therapeutic Advisory Panel will evaluate the proposed projects. Those projects viewed as competitive will be invited to submit a full proposal (which also will be reviewed by the Therapeutic Advisory Panel). Each applicant will be assigned a member of the Therapeutic Advisory Panel to help guide them through the proposal submission process. Full proposals must be submitted to Charolette Garland (257-5265, cawgarland@uky.edu) by January 15, 2014. Initially, full proposals will be administratively reviewed and investigators will be notified if portions of the application are missing or incomplete. All members of the Therapeutic Advisory Panel will evaluate each full proposal. A written summary of the discussion will be provided to the program PI. Applicants may be invited to the Panel meeting to present the project with the goal of addressing questions and providing additional clarity. Applications selected for full funding by the Therapeutic Advisory Panel will be submitted to the CCTS Executive Steering Committee for final consideration of funding. The general criteria for review include: Overall Impact What is the likelihood that the project will exert a sustained powerful influence on the research field(s) involved? Significance Is the study relevant to human health and the health of Kentucky citizens? Innovation Are the aims original and concepts novel? Are novel methodologies proposed? Team/Programmatic How is the integrated program greater than simply an additive Synergy sum of the individual components? Approach Do the specific aims test the hypotheses? Are there sufficient preliminary data to support the conduct of the pilot study? Are statistical considerations provided? Is the risk/benefit ratio acceptable? Investigators Does the investigative team have training, expertise, and experience to conduct the proposed study? Does the investigative team have a strong track record of innovative, high impact scientific accomplishment? Does the investigative team have record of collaborative accomplishment? Cores Does the use of CPRI or other cores serve/bridge all proposed projects? Environment Is the environment strong? Do the investigators take advantage of available expertise? Is there a transdisciplinary team involved in the study? Potential Will this proposed research advance translational science? How will the pilot funding serve to establish a collaborative record of innovative accomplishment? Will the pilot study generate new knowledge that can be published? Will completion of the study lead to external funding and/or discovery and development of a new therapeutics? Is there commercial potential?

AWARDEE RESPONSIBILITIES: • Once funding of the application is awarded, the investigator will be expected to interact on a monthly basis with the member of Therapeutic Advisory Council assigned as liaison to the project. Also, the investigator will be required to undergo review of progress every 6 months by the Therapeutic Advisory Council. Progress will be presented as a one to two page summary and a 20-min power point overview, followed by discussion/feedback. Should the Therapeutic Advisory Panel have concerns about the viability of the project, the PI will be required to consult with a member of the Panel to discuss what is needed to make the project viable. Should the question of viability not be resolved, the Therapeutic Advisory Panel will request that the project be terminated and remaining funds returned to the CCTS. • Contact Charolette Garland (257-5265, cawgarland@uky.edu) to schedule a working meeting with the CPRI and/or CCTS units who will be involved with your protocol • A final written one to two page report describing project accomplishments must be submitted within 60 days of the project end date. • The awardees are strongly encouraged to attend the monthly Clinical and Translational Science Seminar Series. The seminar series provides an opportunity for an informal discussion of their work with Physician-Scientist and Clinical Scholar recipients and obtain feedback on research grants, publication, etc. • The UK CCTS is evaluated by the NIH on its effectiveness in stimulating new research findings and publications. The following support acknowledgement must be included on all publications that result from CCTS support : “The project described was supported by the National Center for Advancing Translational Sciences, UL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.” RELEASE OF FUNDS: • Funding for successful application will be released upon receipt of applicable IRB/IACUC approval, if applicable. • If required IRB/IACUC approval is not provided within a period of 90 days after the announcement of the award, THE FUNDS WILL BE SUBJECT TO CANCELLATION. NOTE: In the event that additional intra/extramural funds are secured to support the study outlined in your application you must immediately notify Charolette Garland (257-5265, cawgarland@uky.edu).