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 genomic medicine a reality will require a concerted effort on the part of health systems, informaticians, laboratory medicine, clinicians, pharmacists, 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 program’s multidisciplinary team developed and launched the clinical infrastructure required to generate electronic medical record alerts that allow UF Health doctors to take a patient’s genetic information into account when prescribing certain medications (Personalized Medicine at UF Health).
Three guiding principles shape the program’s approach:
- Ensuring a regulatory body is in place to evaluate the scientific literature and determine when sufficient evidence exists for the health system to consider genetic findings clinically actionable;
- Providing actionable alerts for healthcare providers through the electronic medical record system and backup support by clinical pharmacists;
- Developing the capacity to perform a one-time, evidence-based genetic test that screens for hundreds of genetic variations that can be used across a patient’s lifespan.
To assess and optimize the program’s cost-effectiveness and impact on patient care outcomes, researchers are studying implementation metrics and outcome assessments. The program is also creating a large genetics data repository to support future research and expansion of genomic medicine.
Program Initiatives (2013-2017)
Expansion at UF Health
Utilizing the program’s infrastructure—which facilitates the complex clinical, laboratory and information flows required for genomic medicine—UF Health will introduce routine genetic testing for additional medications for which there is strong evidence linking specific genetic variations to how the body responds to a drug. In 2013, the program will expand beyond clopidogrel to focus on azathioprine for adult and pediatric gastroenterology patients with Crohn’s disease and other conditions; and mercaptopurine for pediatric cancer patients with acute lymphocytic leukemia.
Expansion to Private and Community-based Practices in Florida
Beginning in 2013, the UF Health program will help Orlando Health prepare two of its cardiology practices to implement genetic testing for clopidogrel in 2014. Following the Orlando Health implementation, the program will work with the Florida State University College of Medicine to introduce similar genetic testing within its statewide network of community-based physician practices.
UF Health Pathology Laboratories, which developed the infrastructure to process the blood samples from patients, will offer its services and expertise for the expansion at UF Health and to external partners.
Development of Educational Programs
To complement its clinical implementations, the program will develop and offer a variety of innovative educational programs to prepare health-care professionals, health sciences students and patients for a future in which genomic medicine is commonplace.
- Jun 2011: UF Health receives two grants from the National Institutes of Health to support the creation and launch of a new Personalized Medicine Program led by the UF CTSI:
- One-year grant of $499,920 through the Clinical and Translational Science Awards program, led by the NIH National Center for Advancing Translational Sciences, to create the program and replicate it at Stanford University
- Four-year grant of $351,600 from the National Institute of General Medical Sciences, the lead institute for the NIH Pharmacogenomics Research Network, to collaborate 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
- Jun 2012: Program launches at UF Health Shands Hospital, which incorporates a simple blood test for interventional cardiology patients that provides genetic information indicating how an individual will likely respond to clopidogrel, an anticlotting drug commonly prescribed following treatment in the catheterization lab for blocked heart vessels
- Oct 2012: Program launches ongoing research study to test feasibility of preemptive genotyping
- Jun 2013: UF Health receives a four-year grant of $3.7 million to expand the program through the Genomic Medicine Pilot Demonstration Projects Program, which is led by the NIH’s National Human Genome Research Institute and supports a network of projects at Duke University and Mount Sinai plus a coordinating center at the University of Pennsylvania
Program Contact & Teams
Amanda Elsey, MHA, Program Manager
- GenomeWeb’s Pharmacogenomics Reporter, Sept. 11, 2013: Vanderbilt’s PREDICT program adds PGx testing for transplant rejection drug
- InformationWeek, Sept. 9, 2013: How UF Health turns genetics into actionable info
- GenomeWeb’s Pharmacogenomics Reporter, Aug. 21, 2013: After Plavix PGx Experience, UF Rolling out Similar Genetic Testing Program to Community Settings
- Florida Physician, Summer 2013: Personalizing Medicine
- Gainesville Sun, July 4, 2013: UF at forefront of using gene testing to tailor drugs
- GenomeWeb Daily News, July 3, 2013: NHGRI Funds New Clinical Genomics Consortium
- GenomeWeb’s Pharmacogenomics Reporter, July 3, 2013: UF Receives NHGRI Grant to Expand Personalized Rx Program
- News release, July 1, 2013: UF Health receives $3.7 million to bring genomic medicine to more Floridians
- Genome.gov web feature, June 28, 2013: New NHGRI grants focus on using genomic information in patient care
- 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
- Weitzel KW, Elsey AR, Langaee TY, Burkley B, Nessl DR, Obeng AO, Staley BJ, Dong HJ, Allan RW, Liu JF, Cooper-Dehoff RM, Anderson RD, Conlon M, Clare-Salzler MJ, Nelson DR, Johnson JA. Clinical pharmacogenetics implementation: Approaches, successes, and challenges. Am J Med Genet C Semin Med Genet. 2014 Mar;166(1):56-67. doi: 10.1002/ajmg.c.31390.
- 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