CTSI Precision Health Initiative Pilot Award 2019-2020 Information Q&A Session April 10, 2019 Precision Health Leadership Team

CTSI Precision Health: Specific Aims Evolve Personalized Medicine Program into Precision Medicine Program Create Precision Public Health Program Implement Precision Health Initiative to explore and develop integrative models of precision medicine and precision public health

Precision Medicine Definition An approach for disease prevention and treatment that takes into account individual differences in lifestyle, environment, and biology. UF Health Precision Medicine Program Use genetic information to individualize healthcare to: - Improve treatment outcomes - Improve safety - Potentially reduce costs of medical care

Example Ongoing Projects in Precision Medicine Testing genetic variability influencing specific drug effectiveness and/or toxicity (clopidogrel/CYP2C19, opiates/CYP2D6) Genetic testing to understand renal disease Evaluating the impact of Pharmacogenetic-guided supportive care in cancer patients in a pragmatic trial Identifying a cohort of physicians and patients within GatorCare and implement a preemptive approach to genomic testing across targeted areas

Precision Public Health Definition Improving the ability to prevent disease, promote health, and reduced health disparities in populations by: 1) applying emerging methods and technologies for measuring disease, pathogens, exposures, behaviors, and susceptibility in populations; 2) developing policies and targeted implementation programs to improve health UF Health Precision Public Health Program - Integrate university-wide programs to develop infrastructure for PPH research and practice - Develop tools and methods to promote PPH research and practice

Example Ongoing Projects in Precision Public Health Library Guide: 120+ links to hundreds of datasets with geospatially identified data especially relevant to Florida Ontology project to categorize and allow searching of LibGuide for useful datasets Systematic review of Environment-wide Association Studies (EWAS) and comparison to Genome-wide Association Studies EWAS of hypertension in pregnancy in 2.1 million pregnancies in Florida

Award Opportunity This new RFA welcomes proposals that support the development of methods, interventions or integrative models with the potential to advance precision health, which include precision medicine and precision public health A total of $200,000 is available for this current grant year, a max of $50,000 per award with up to 4 awards * 1 at UF Health, Jacksonville 3 between UF Health, Gainesville and FSU *Based on quality of proposals and budget availability

Timeline Pilot Announcement: April 3, 2019 Application Due Date: May 13, 2019 by 5:00 p.m. Notice of Award: June 15, 2019 Award Funding Period: Up to 12 months from the date of NIH approval

Eligibility University of Florida and Florida State University investigators Principal investigators (PIs) must meet the requirements for PI status as specified by their home institution -Postdoctoral Fellows and Research Scientists are not eligible to serve as PIs Junior Faculty (Assistant Professor) must have a mentor listed on the application

Eligibility Applicants are strongly encouraged to include an investigator from each institution Teams must include investigators from at least 2 colleges and must include a trainee (i.e. graduate student, postdoc, resident) or junior faculty member for a mentored research experience Only one application as PI May be listed as Co-I on more than one proposal Past recipients may submit new proposals if previous awarded projects have been completed

Steps in the Pre-Award Review Process Initial triage of applications for completeness Complete proposals are sent for scientific review At least two scientific reviewers selected for each proposal based on area of expertise, background and conflict of interest Scheduled for Funding Committee review Award and Non-Award Notices sent on June 15, 2019

Pilot Budgeting and Spending Direct Costs only Cannot support faculty salaries Cannot be used for major equipment purchases Funds are non-transferable Funds must be used in the 12-month period following their release Unspent funds returned to CTSI Funds must be used according to approved activities Funds requested for CTSI services will be provided as non- transferable credit

Application Instructions Application Instructions and Forms (website) https://www.ctsi.ufl.edu/research/funding-opportunities/ctsi-funded-research/ Cover sheet Project title Area in which you are applying Previous CTSI awards Contact information for key personnel IRB status Proprietary/privileged information Signed and dated by PI and Department Chair

Application Instructions Abstract (200 words or less) Translational impact (200 words or less) External funding plan (one page or less) Mentoring plan for trainee(s), junior faculty (200 words or less)

Application Instructions Research Plan (6 pages or less): Specific Aims Background/Significance Innovation Approach (including preliminary studies, design & methodology) - For NIH-defined clinical research projects: Justify number of participants to be enrolled Include a recruitment strategy Include planned enrollment table Project Timeline References (not included in the 6-page limit)

Application Instructions Additional Documents: Biosketches – NIH format (each bio limited to 5 pages) https://grants.nih.gov/grants/forms/biosketch.htm Budget – use NIH “Detailed Budget for Initial Period” form http://grants.nih.gov/grants/funding/phs398/phs398.html Budget Justification Cost estimates Letters of support (required for junior faculty) Submission: 5 p.m. on Monday, May 13, 2019, to elizabetheddy@ufl.edu (UF) or terra.bradley@med.fsu.edu (FSU)

Steps in the Post-Award Period Submit IRB approval and other documentation required for NIH prior approval process Subaward requirements addressed (if applicable) Chartfield established Regular monitoring of fund accounts Reconciliation Progress Reporting – recruitment, general, changes, serious adverse events Review of project balances Close out of award

Awardee Expectations Publication(s) Poster/Presentation(s) Extramural Funding One or more publications in a peer-reviewed journal CTSI Research Day and/or UF Precision Medicine Conference Scientific meetings Provide critical preliminary data to support extramural applications NIH Requirements Compliance Reporting/Notifications NIH prior approval CTSI funding citation NIH Public Access Policy IRB approval NIH policies sharing model organisms and genomic data Progress reports Prior approval of significant changes Serious adverse events

Application Submissions Contact for Questions: please email Elizabeth Eddy, MPH at elizabetheddy@ufl.edu or Terra Bradley, PhD at terra.bradley@med.fsu.edu