Archives
"Big pharma" comes to UB to learn pharmacodynamics
By ELLEN GOLDBAUM
Contributing Editor
Every May since 1994, drug companies from around the world have selected handfuls of their best scientists to attend the School of Pharmacy and Pharmaceutical Sciences for an intensive, week-long course in pharmacodynamic modeling.
Described as the interface "where pharmacology meets physiology," pharmacodynamics uses mathematical models to capture the many details of how drugs affect the body's systems over time, starting with the moment of exposure after administration of the drug.
What draws the scientists to UB—in addition to the fact that pharmacodynamics originated here—is "Pharmacokinetic/Pharmacodynamic Modeling: Concepts and Applications," a workshop covering areas of study now so critical to industry that without them, "big pharma" could not do its work.
"No other institution teaches pharmacodynamics as extensively as UB," said William J. Jusko, professor and chair of the Department of Pharmaceutical Sciences and coordinator and primary instructor for the course.
By the time the scientists have completed the workshop, which began earlier this week, Jusko said, they will be able to understand and construct the mathematical and computer models that describe the time-course of drug effects in animals and humans.
UB began offering the course in 1994 and has since enjoyed steady interest from industry and government scientists. Each fall, Jusko teaches a similar course to European pharmaceutical scientists at Leiden University's Leiden Center for Drug Research in the Netherlands.
Jusko also has traveled to the Food and Drug Administration (FDA) and major drug firms to teach a condensed version of the course.
He estimates that to date, he has educated approximately 1,000 pharmaceutical scientists from around the world through such workshops.
The master's and doctoral students in UB's Department of Pharmaceutical Sciences, and especially those in the pharmacometrics program, receive even more intensive training in pharmacodynamics, which, Jusko said, has made them highly sought-after by industry.
"The pharmacodynamic models that UB's pharmaceutical scientists have pioneered are absolutely central now to the development of new drugs in the U.S.," said Wayne K. Anderson, dean of the School of Pharmacy and Pharmaceutical Sciences.
Pharmacodynamics was developed in the 1960s by Gerhard Levy, now SUNY Distinguished Professor Emeritus in the UB Department of Pharmaceutical Sciences and often cited as the "father of pharmacodynamics."
Jusko, a former student of Levy's, and his colleagues at UB have taken the field in new directions, authoring dozens of publications on the development of new methods of pharmacodynamic modeling.
Jusko said that about 10 years ago, the FDA began encouraging companies applying for new drug approvals to submit better pharmacodynamic data and models along with their clinical-trial results.
As a result, companies and the FDA have better data about a drug's biological mechanism of action and clinical effects and, in some cases, the companies don't have to supply quite as much data from clinical trials if they can supply the appropriate pharmacodynamic data and models.
"During the past decade, the FDA, prompted partly by industry and consumer concerns for better drugs developed faster, has sought new techniques that allow for the more efficient development of new drugs," Jusko said. "In cases where the clinical pharmacology of a particular drug is pretty well-understood, the FDA might now require one, not two clinical trials, so long as the company can provide adequate supporting models of the pharmacodynamic data."
Recently, Jusko and his colleagues began researching the pharmacodynamics and bioinformatics of pharmacogenomic systems, studying how drugs alter the action of individual genes at different points in time.
This month, in Drug Metabolism and Disposition, Jusko co-authored an invited review paper outlining the state-of-the-art in using mathematical models to describe drug responses in man. His co-authors are Donald Mager, postdoctoral fellow at the National Institute of Aging, and Elzbieta Wyska, research assistant professor in the Faculty of Pharmacy, Jagiellonian University in Poland.
"The science of pharmacodynamics has progressed to the point where it allows us to study properties of drugs at various physicochemical, molecular and tissue levels, and to better anticipate clinical responses with more complete information," said Jusko.
"Pharmacodynamic models now allow us not only to mathematically conceptualize and quantitate what's happening at the level of the whole body, tissues, molecules and genes, but also to make predictions about outcomes under both normal and disease conditions."