UB's School of Pharmacy and Pharmaceutical Sciences recently developed the nation's first master's degree program in pharmaceutics with a concentration in pharmacometrics, an emerging field that combines pharmacological studies with computational data analysis.
Pharmacometrics is comprised of pharmacokinetics, pharmacodynamics and biostatistics, and studies the disposition of drugs in the body and the time-course of drug effects.
"These kind of data are essential for understanding the action of drugs," said William Jusko, professor of pharmaceutical sciences and founder of the program. "Carrying out studies of these types is a major part of the drug development process by pharmaceutical companies."
The new program will help better prepare students for professional careers in the pharmaceutical industry, which has been hard-pressed to fill the high demand for students specializing in the area of pharmacometrics.
"I'm called or e-mailed at least once a week by people from across the nation looking for such graduates in the pharmaceutical industry," said Jusko.
"This [new program] is one of the key places where we would like to get new employees from," said Jill Fiedler-Kelly, vice president of Cognigen Corp., a Buffalo-based pharmaceutical company funding two fellowships at UB in the field of pharmacometrics.
"The research in this field is absolutely integral to drug development because it helps companies determine how their drugs are working, how safe and efficacious their drugs are, because they're responsible to report that to the Food and Drug Administration," said Fiedler-Kelly, adding that pharmaceutical companies are trying to streamline the process of marketing drugs to save money and get their drugs onto the market quickly.
Studies in pharmacometrics are data-intensive and seek to learn about the properties of a particular drug by studying its effects in different medical and demographic environments.
"Because of inherent variability between people and how a drug works, you could give the same dose of drugs to two people and get two very different responses," said Fiedler-Kelly. "We're looking at drugs and determining appropriate dosages in different populations."
Some studies test a multitude of measurements on a selective number of subjects, as little as 12 to 24, which provide researchers with the most complete picture of a drug's disposition. Other studies look for less data on thousands of subjects, helping researchers to see a more population-based and statistical method of qualitative analysis.
For example, the smaller groups of patients allow the pharmaceutical companies to perform intensive studies of specific areas such as medical ailments like hepatic disease or renal impairment, or any combination of age, gender and drug interaction, said Jusko.
Larger studies use a population approach to include other physiological factors like: presence of other diseases, use of oral contraceptives, role of obesity, role of race, and, most importantly, how combinations of these factors may affect drug response.
Because of its heavily computational methods of data analysis, pharmacometrics is expected to utilize UB's new Center for Excellence in Bioinformatics.
"Students being trained in pharmacometrics will be highly suitable to expand their interests into bioinformatics," said Jusko. "This holds particularly true for the area of pharmacogenomics, the study of the effects of drugs on genes and gene-mediated processes."
Jusko's lab is currently assessing the effects of corticosteroids - steroid hormones produced by the adrenal cortex - on approximately 12,000 genes in the rat liver that control various physiologic processes, including immunosuppression.
"Knowledge of pharmacodynamics, biostatistics, computer processing and relation of genomic changes to net biological effects is needed," said Jusko, adding that his department has applied for a special training grant in genomics and informatics related to pharmacometrics.
The program's inception is due in part to UB Provost Elizabeth Capaldi's push for the university to have more graduate programs and also because "the general area is what we've been doing extremely well for three decades," said Jusko.
UB's pharmacy program has been strong in the past thanks largely to efforts by professor Gerhard Levy, an internationally recognized researcher known as "the father of pharmacodynamics."
"He published some of the first papers that described the field of pharmacodynamics back in the '60s," said Jusko. "Since that time, other people who have been teaching and doing research in these areas at UB in the past 10 years have particularly blossomed."
For the past eight years, the School of Pharmacy and Pharmaceutical Sciences has been teaching a special course in pharmacodynamics and pharmacokinetics attended by students from around the world. Limited to 35 students, the course was another factor stimulating the creation of the new master's degree program in pharmacometrics.