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Former FDA Official Larry Lesko to Lead Pharmacology, Personalized Rx Studies at U of Florida

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Originally published Oct. 4.

Lawrence Lesko, former director of the Office of Clinical Pharmacology at the US Food and Drug Administration's Center for Drug Evaluation and Research, is leading an academic and research program focused on quantitative clinical pharmacology, systems pharmacology, and personalized medicine at the University of Florida's newly launched Institute of Therapeutic Innovation.

Lesko retired from his post at the FDA in June after nearly 20 years at the agency. He joined UF's Medical City campus in Lake Nona in July as the director of the Center for Pharmacometrics and Systems Pharmacology.

"The cool thing about Medical City is the collaborations I’m building with the other new institutions on campus," Lesko told PGx Reporter this week. These research entities so far include the Sanford-Burnham Medical Research Institute, University of Central Florida Medical School, Nemours Children's Hospital, VA Hospital, and MD Anderson Cancer Center.

In particular, UCF and UF are developing "realistic simulations of clinical scenarios" that can teach medical students how they can apply patients' genomic data to personalize healthcare, Lesko said.

UF broke ground on the $44 million, 100,000 square-foot Lake Nona research and academic center a year ago. The Medical City campus will house UF's College of Pharmacy and the Institute of Therapeutic Innovation. Approximately half the monetary backing for the center was funded by the state, while the rest will come from other sources.

The new Institute of Therapeutic Innovation will be ready for occupancy in May 2012. Graduate students will be able to enroll in pharmacology and personalized medicine coursework in January 2012 and PharmD students will be able to enroll in the program starting August 2012.

One of Lesko's immediate efforts at UF will be working with Julie Johnson, an expert in heart drug pharmacogenomics, to establish a clinical translational program for genetic information stored in patients' electronic medical records. The effects of CYP2C19 SNPs on patients' ability to metabolize the anti-platelet drug Plavix (clopidogrel) will serve as a practice model for this project.

During his tenure at the FDA, Lesko was a leading supporter of personalized medicine and spearheaded efforts to update of labels of approved drugs with new genetic information. Guidance documents released under his stewardship include “Clinical Pharmacogenomics: Premarketing Evaluation in Early Clinical Trials” and “Pharmacogenomics Data Submissions.”

Lesko also launched the FDA's Division of Pharmacometrics, which conducts drug-disease modeling and investigates the dose-response and pharmacokinetic/pharmacodynamics characteristics of drugs to inform drug labels and new drug approvals.

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