Mathematical modeling speeds development of new medicines
Distinguished Professor and Chairman of Pharmaceutics
College of Pharmacy
The process of bringing one new drug to market can take a decade and hundreds of millions of dollars.
Hartmut Derendorf, a distinguished professor in the UF College of Pharmacy, is finding ways to tighten expenses and shorten timelines while balancing patient variability, drug safety and effectiveness against all possible risks.
Derendorf, who serves as chairman of the college’s pharmaceutics department, has developed a series of laboratory analyses and mathematical models of drug concentrations to predict which drugs show the best promise for patients, and at which dose.
“This can mean two to three years of savings compared with the traditional trial-and-error approach and expense of clinical trials,” Derendorf said.
The basis of drug development is in PK/PD modeling. PK, short for Pharmacokinetics, examines what happens to the drug—how the body metabolizes it. PD, or pharmacodynamics, describes the effects, good or bad, the drug has on the body.
“The Handbook of Pharmacokinetic-Pharmacodynamic Modeling,” authored by Derendorf and his colleague Günther Hochhaus and published in 1995, was the first textbook overview of this process. Today, his PK/PD methodology integrates preclinical and clinical science to streamline drug development and optimize dosing strategies for new medicines.
Using microdialysis, a patented drug monitoring method, he can measure drug concentrations at the treatment site rather than in the bloodstream. Recognition of his years of work has earned Derendorf the 2010 Volwiler Research Achievement Award from the American Association of Colleges of Pharmacy.
Derendorf received his doctorate in pharmacy, summa cum laude, from the University of Münster, Germany. His journey in academic research comes full circle from 1981, when he first joined UF as the postdoctoral fellow of Edward R. Garrett. Likewise, in 1980, his mentor received the AACP’s Volwiler award.
After nearly 30 years in pharmaceutical research, Derendorf believes that costs of new drug development are too high for any one country, and should be an international effort. In 1997, he established the Symposium on New Developments in Clinical Pharmacy and Clinical Pharmacology, as a collaborative meeting of his postdoctoral and graduate students. Co-hosted by a European university biennially, a Global Gator Award is given to an individual who best represents ‘Gator spirit’ internationally in clinical pharmacy and clinical pharmacology.
“It is rewarding to see so many of our former students being successful in their careers in academia, the pharmaceutical industry, and the regulatory agencies around the world,” Derendorf said. “They all are great ambassadors of the Gator spirit.”