Personalized Medicine Program
The last 10 years have seen substantial advances in defining genetic determinants of drug response, along with staggering advances in the technologies used to determine genetic information in an individual. Such advances have led to the expectation by many that eventually an individual’s personal genome will be part of their medical record, from which information can be pulled to guide personalized treatment decisions.
To make personalized medicine a reality will require a concerted effort on the part of health systems, informaticians, laboratory medicine, clinicians, geneticists and researchers, among others. To date, there has been minimal translation of this information into clinical practice.
In June 2011, the UF CTSI created its Personalized Medicine Program to prepare UF Health and the state of Florida to be leaders in this approach to patient care. Led by Julie A. Johnson, Pharm.D., the Personalized Medicine Program assembled a multidisciplinary team to develop the infrastructure required to generate electronic medical record alerts that allow doctors to take a patient’s genetic information into account when prescribing certain medications. The team also developed a process by which the health system can determine when sufficient evidence exists for pharmacogenetic findings to be considered clinically actionable.
On June 25, 2012, the new system launched in the cardiac catheterization laboratory at UF Health Shands Hospital (news release). Under a new standard of care, patients undergoing left heart catheterization are now routinely screened for eight genetic variations that influence how they might respond to a common anticlotting drug called clopidogrel, also sold as Plavix. Over time, the new approach will be expanded to more patients (Personalized Medicine at UF Health).
Researchers will be studying the program as it rolls out to assess and optimize its cost-effectiveness and impact on patient care. The program also will serve as a model for other health systems that want to implement personalized medicine, starting with Stanford University in July 2012. In addition, the program is creating a large genetics data repository to support future research and expansion of personalized medicine.
Amanda Elsey, MHA, Program Manager
Pilot Phase Funding
The UF CTSI received a one-year supplemental grant of $499,920 through the Clinical and Translational Science Awards program, which is led by the National Institutes of Health’s National Center for Advancing Translational Sciences, to support creation of the Personalized Medicine Program and replication of the program at Stanford University.
In addition, the National Institute of General Medical Sciences, as the lead institute for the NIH Pharmacogenomics Research Network, awarded UF a four-year grant of $351,600 in support of a collaboration with five other institutions to collectively gather data on the experience of launching personalized medicine programs: Vanderbilt University, Mayo Clinic, Ohio State University, University of Maryland and St. Jude Children’s Research Hospital.
- CAP Today, Jan. 2013: Building the case for PGx testing
- GenomeWeb’s Genome Technology, Oct. 1, 2012: Reality Check – Educating Physicians on Genomic Medicine
- Sept. 28, 2012: Personalized Health – A Supplemental Section to USA Today
- DARK Daily, Sept. 5, 2012: Genetic Testing Used at University of Florida to Deliver Personalized Medicine to Heart Patients
- WCJB-TV ABC 20, July 10, 2012: Interview with Dr. Julie Johnson about personalized medicine
- GenomeWeb’s Pharmacogenomics Reporter, June 27, 2012: UF to Genotype All Comers at Cath Lab to Personalize Treatment with Plavix, Eventually Other Drugs
- News release, June 25, 2012: UF delivers promise of personalized medicine to heart patients
- Nature Medicine, November 7, 2011: Preemptive genotyping trialed to prevent adverse drug reactions
- On the Same Page, June 17, 2011: Personalized Medicine
- News release, June 16, 2011: UF CTSI receives $1.25 million to advance clinical research and personalized medicine
- Johnson JA, Elsey AR, Clare-Salzler MJ, Nessl D, Conlon M, Nelson DR. Institutional Profile: University of Florida and Shands Hospital Personalized Medicine Program: clinical implementation of pharmacogenetics. Pharmacogenomics. 2013 May;14(7):723-6. doi: 10.2217/pgs.13.59.
- Johnson, JA. Pharmacogenetics in clinical practice: how far have we come and where are we going? Pharmacogenomics. 2013 May;14(7):835-43. doi: 10.2217/pgs.13.52.
- Shuldiner AR, Relling MV, Peterson JF, Hicks K, Freimuth RR, Sadee W, Pereira NL, Roden DM, Johnson JA, Klein TE. The Pharmacogenomics Research Network Translational Pharmacogenetics Program: Overcoming Challenges of Real-World Implementation. Clin Pharmacol Ther. 2013 Mar 19. doi: 10.1038/clpt.2013.59.
- Johnson J.A., Burkley B.M., Langaee T.Y., Clare-Salzler M.J., Klein T.E., Altman R.B. (2012). Implementing Personalized Medicine: Development of a Cost-Effective Customized Pharmacogenetics Genotyping Array. Clin Pharmacol Ther. advance online publication 22 Aug 2012. doi: 10.1038/clpt.2012.125.
- Johnson, J. A., Roden D. M., Lesko L. J., Ashley E., Klein, T. E., Shuldiner, A. R. (2012), Clopidogrel: a case for indication-specific pharmacogenetics. Clin Pharmacol Ther. 2012 May;91(5):774-6. doi: 10.1038/clpt.2012.21.
- Johnson, J.A. et al. Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 Genotypes and Warfarin Dosing. Clinical Pharmacology & Therapeutics (2011) 90 4, 625–629. doi:10.1038/clpt.2011.185.
- Scott S.A., Sangkuhl K., Gardner E.E., Stein C.M., Hulot J-S., Johnson J. A., Roden D.M., Klein T. E., Shuldiner A.R. Clinical Pharmacogenetics Implementation Consortium Guidelines for Cytochrome P450-2C19 (CYP2C19) Genotype and Clopidogrel Therapy. Clinical Pharmacology & Therapeutics (2011) 90 2, 328–332. doi:10.1038/clpt.2011.132.
- Nelson, D. R., Conlon, M., Baralt, C., Johnson, J. A., Clare-Salzler, M. J. and Rawley-Payne, M. (2011), University of Florida Clinical and Translational Science Institute: Transformation and Translation in Personalized Medicine. Clinical and Translational Science, 4: 400–402. doi: 10.1111/j.1752-8062.2011.00348.x
Program Leadership and Teams
- Julie A. Johnson, Pharm.D., Director, Personalized Medicine Program at UF Health
- David R. Nelson, M.D., Director, UF CTSI
- Michael Clare-Salzler, M.D., Chair, Department of Pathology
- Michael Conlon, Ph.D., Associate Director and Chief Operating Officer, UF CTSI
- Larry Lesko, Ph.D., Director for Pharmacometrics & Systems Pharmacology, UF College of Pharmacy
- UF Pathology Laboratories: Michael Clare-Salzler, Jane Dong, Jingda Shi, Rob Allan, David Nessl
- UF Center for Pharmacogenomics: Taimour Langaee, Ben Burkley
Bioinformatics and IT Teams
- Informatics Project Manager: David Nessl
- Epic: Ben Staley, Ellen Kershner, Amy Rosenberg, Ted Teimer, Alyson Widmer
- Genetic Computation: Felix Liu, Yang Li, Alberto Riva, Taimour Langaee
- Integrated Data Repository: Gigi Lipori, Dick Deason, Scott Sortino
- Research Permissions Management System: Colleen Ebel, Francesca Levey, Philip Chase, Xiuyao Song
Cardiovascular Implementation Team
- David Anderson, Ben Staley, Jenny Ashton, Rhonda Cooper-Dehoff, Aniwaa Obeng