UF recruits FDA senior scientist to advance Florida’s drug development, regulatory science efforts

Lawrence J. Lesko, Ph.D.
Lawrence J. Lesko, Ph.D., director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research (Photo by Jesse Jones/University of Florida)

By Linda Homewood

A leading scientist in clinical pharmacology at the Food and Drug Administration is taking a new academic role at the University of Florida College of Pharmacy to improve drug development and create tools and approaches to make sure new products are safe, effective and within FDA-regulated standards.

Lawrence J. Lesko, Ph.D., director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research, will lead the college’s new pharmacometrics and systems pharmacology initiative in the interdisciplinary Institute of Therapeutic Innovation at the UF Research and Academic Center, now under construction in Orlando.

Lesko, who assumes his new duties July 1, has influenced the profession and spurred scientific growth in clinical pharmacology, drug development and regulatory decision-making for the past 16 years.

“Pharmacometrics is an emerging science now at the forefront of the pharmaceutical industry and at the FDA,” said William H. Riffee, dean of the UF College of Pharmacy. “Dr. Lesko’s knowledge and experience will position us to build a strong graduate degree program while also cultivating new collaboration of academia with the FDA, other governmental agencies and the pharmaceutical industry.”

With his appointment as a professor of pharmaceutics in the UF College of Pharmacy, Lesko looks forward to establishing UF’s presence at Lake Nona Medical City, which he hopes will raise Florida into the national arena as a leader in drug development and regulatory science — the development of new tools, standards and approaches to assess the safety and performance of FDA-regulated products.

“What is exciting to me is defining a vision, setting up a strategic plan and implementing the tactics and actions that will lead to an entirely new academic model for advancing drug development and excellence in translational and regulatory science,” Lesko said.

A recent economic impact study by UF’s Institute of Food and Agricultural Sciences projects that over the next six years, Lake Nona Medical City will create more than 16,000 jobs that will generate more than $200 million in annual tax revenue for the state.

Hartmut Derendorf, Ph.D., a distinguished professor and chairman of pharmaceutics at the UF College of Pharmacy, said he is eager to work with Lesko and build a world-class graduate training program at UF’s Orlando research facility.

With the plans to add several faculty researchers and a dozen graduate students and postdoctoral fellows, the program will provide a vital pipeline in training the next generation of scientists skilled in drug-modeling simulation and translational science, Derendorf said.

“Dr. Lesko is one of the most visionary experts in the field of drug development and personalized medicine in the world,” Derendorf added. “At the FDA, he has had a tremendous impact on how new medicines are investigated, developed, and approved. We are excited that he is leading our efforts to further strengthen Florida’s biotech presence.”