Personalized Medicine Program

R. David Anderson, M.D., and Julie Johnson, Pharm.D.

UF Health has joined leading medical centers of the nation in taking a person’s genetic makeup into account during cardiac treatment. (Photo by Jesse Jones/University of Florida)

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:

  1. 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;
  2. Providing actionable alerts for healthcare providers through the electronic medical record system and backup support by clinical pharmacists;
  3. 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

The UF Health program is working with community-based health systems locally and throughout Florida to introduce similar genetic testing within their patient care processes, starting with clopidogrel and eventually expanding to other drug therapies. 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.

Program Milestones

  • 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:
  • 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

Jill Bischoff, Program Coordinator

Amanda Elsey, MHA, Program Manager

Personalized Medicine Program Leadership & Teams

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