When the Sanford-Burnham Medical Research Institute announced in 2006 that they would be adding East Coast operations in Lake Nona, those in the medical industry began to turn their heads toward Central Florida, taking note of the region that would become a new hub of clinical research and development. Announcements about the location of the University of Central Florida’s College of Medicine, Nemours Children’s Hospital and a new VA Medical Center soon followed, and members of the faculty and staff at the University of Florida – only a few hours north in Gainesville – started to consider establishing their own presence in Lake Nona. Less than 10 years later, Lake Nona Medical City has become a hotbed for research and innovation, and is now home to the University of Florida’s Research & Academic Center, which includes the Center for Pharmacometrics and Systems Pharmacology.
We caught up with the Center’s director, Dr. Lawrence “Larry” Lesko, to take stock in the translational research that is making big impacts on the development and approval of new medications.
Lake Nona: Why was it important for UF to establish a presence in Lake Nona?
Dr. Lawrence J. Lesko, Ph.D., F.C.P.: After seeing the long-range plans for Lake Nona and Medical City, it was clear that there was something special happening here. We wanted to be a part of those synergies; we wanted to establish partnerships with the other leading institutions that were coming to the area.
LN: What are the benefits of having a presence inside Lake Nona?
Dr. Lesko: Some of the world’s foremost researchers and health delivery professionals are located in Lake Nona’s Medical City. What’s more, we’re all starting this journey here together, with a clean slate, establishing relationships and exploring synergies from the ground up. It’s really exciting to be a part of this. From Nemours Children’s Hospital to the Sanford-Burnham Medical Research Institute to the VA Hospital and other health care organizations, we are working together to develop a truly multidisciplinary approach to health care. In addition, the proximity to the Orlando International Airport has been huge for us. The Pharmacometrics and Systems Pharmacology program brings pharmacy industry executives and senior FDA officials to the area for meetings and presentations on a regular basis, so being close to a major airport is a big benefit.
LN: How has your own background prepared you for your role within the University of Florida’s Center for Pharmacometrics and Systems Pharmacology?
Dr. Lesko: I spent 20 years with the U.S. Food and Drug Administration (FDA). Much of my time there was spent as Director of the Office of Clinical Pharmacology, which is a part of the Center for Drug Evaluation and Research. In that role, I oversaw the approval of applications for new drugs, conducted research on new methodologies for evaluating those applications and directed policy. Being on that side of the equation, I became inherently involved in the processes for evaluating and bringing drugs to market. As the Director of the Center for Pharmacometrics and Systems Pharmacology, it is my mission to train the future generation of scientists and clinicians who will work in the pharmaceutical industry and at the FDA. In my role at the University of Florida, I can bring my unique experience within the FDA and combine it with my passion for training and mentoring, and hopefully have an impact on producing some of the best-trained, multidisciplinary professionals in the industry.
LN: For students within the Center for Pharmacometrics and Systems Pharmacology program, what advantages/ opportunities do they have within Medical City?
Dr. Lesko: Our students have the opportunity to learn using a truly multidisciplinary approach, and we believe that makes them better professionals. We have students who spend time at Nemours Children’s Hospital learning the ins and outs of pharmacology as it relates to pediatrics. On the other end of the spectrum, we also have students who are learning within the VA Hospital, studying the impacts of new drugs and clinical trials on an aging population. The synergies between all of the health organizations here in Lake Nona Medical City are making this multidisciplinary approach possible. In the same vein, we tap into the expertise and knowledge of many of our partners in an advisory capacity. We engage our Center’s advisory board each year, and one of the major initiatives that has come out of that board’s feedback is a curriculum focus on developing soft skills. As a result, in addition to preparing our students for the real- world with training and coursework that focuses on the science and hard skills necessary to be an exemplary scientists and clinician, our students are now also exposed to unique learning opportunities that encourage the development of skills such as communication, business skills and strategic thinking. We believe this whole-person approach is helping to produce researchers who are truly “job-ready” when they graduate.
LN: What cutting-edge research methodologies are being employed by the Center for Pharmacometrics and Systems Pharmacology?
Dr. Lesko: As part of our translational research focus, we are often on the front-end of drug development and research. We use computational methods and mathematics and translate that data into predictive and meaningful analytics. Our approach generally starts with a question, and we then apply related data to develop, for example, clinical trial models for drug development or regulatory uses. The technical term for the process we employ is Model-Informed Drug Development and Regulatory Decision Making. It’s a cutting-edge approach in the field of clinical pharmacology that allows us to use exploratory analysis to then make informed recommendations about the drug that is being studied.
LN: In addition to the Center for Pharmacometrics and Systems Pharmacology, which University of Florida programs are also operating within Lake Nona?
Dr. Lesko: The Center for Pharmacometrics and Systems Pharmacology is a part of the University of Florida’s College of Pharmacy. The College of Pharmacy is also educating PharmD students from this campus, and additionally, houses the Medication Therapy Management program. The Institute for Therapeutic Innovation and the Institute on Aging are also located at the Lake Nona campus under the auspices of the UF College of Medicine.
LN: How is your work impacting residents within Lake Nona, and around Central Florida as a whole?
Dr. Lesko: At the end of the day, our mission is to improve health care delivery, and that impacts residents in Lake Nona and beyond. To meet this mission, we’re focusing on areas of unmet medical needs, and in our case, that means applying new research methodologies to clinical drug trials that enable new drugs to be approved. The Center for Pharmacometrics and Systems Pharmacology is facilitating the more successful development of medications that are being investigated for the treatment of obesity, diabetes and rare diseases like cystic fibrosis. So one day, when that pill you take for the treatment of your disease hits your tongue, you can know that the design of those cutting-edge trials were possibly performed in your backyard to safely and effectively help bring that medication to market.