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

2. 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

3. 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

4. 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

5. 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

6. Example Ongoing Projects in Precision Public Health
Library Guide: 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. Application Instructions
Application Instructions and Forms (website)
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

14. 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)

15. 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)

16. Application Instructions
Additional Documents:
Biosketches – NIH format (each bio limited to 5 pages)
Budget – use NIH “Detailed Budget for Initial Period” form
Budget Justification
Cost estimates
Letters of support (required for junior faculty)
Submission:
5 p.m. on Monday, May 13, 2019, to (UF) or (FSU)

17. 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

18. 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

19. Application Submissions
Contact for Questions:
please
Elizabeth Eddy, MPH at
or Terra Bradley, PhD at