The University of Buffalo (UB) has announced the development of the nation's first master's degree program in pharmaceutics with a focus in pharmacometrics, a new field that fuses pharmacologic studies with computational and statistical methods of data analysis at the university's School of Pharmacy and Pharmaceutical Sciences.

What is Pharmacometrics?

Pharmacometrics is a new field that merges computational approaches (mathematical models) with pharmacodynamics (e.g. drug efficacy and potency) and pharmacokinetics (drug absorption, distribution, and metabolism). It is useful for optimizing drug development and therapeutics in both the pre-clinical and clinical stages of drug discovery. Much of the data produced in pre-clinical and clinical trials now is generated through computationally intensive tools such as bioinformatics.

According to William J. Jusko, professor of pharmaceutical sciences and founder of the program, "Pharmacometrics lies at the heart of what drug companies do, collecting data from animals, normal volunteers and patients, quantifying it and then being able to determine what those data mean for optimizing drug efficacy and minimizing toxicity."

What Do People Trained in Pharmacometrics Do?

According to Jusko, pharmacometrics, which requires proficiency in mathematical, computational and statistical methods, as well as in pharmacokinetic and pharmacodynamic modeling, involves interpreting diverse types of data relating to the disposition and effects of a particular drug, often in large populations of patients, on the order of hundreds or even thousands.

He noted that although intensive and detailed studies of small groups of individual patients (groups as small as from 12 to 20) still provide the most complete picture of a drug's essential properties, the much larger studies provide important information as well.

"These population studies involve taking a small amount of information from a large number of patients - hundreds or even thousands - and summarizing the main factors that affect their exposures and responses to a drug," he said. "The question they are designed to answer is, what are any special characteristics that show up when a particular drug is taken by the broad patient population for whom it is being designed?"

Population studies are designed to answer that question based on just one or two measurements, say, of the blood concentration of a drug.

Individuals skilled in pharmacometrics know how to properly analyze and interpret those data to determine, for example, whether or not a particular drug is metabolized differently by one or another race, ethnicity, gender, age group (young, elderly) or those taking other drugs.

Industrial Demand

Drug discovery and development is time consuming and expensive. The Pharmaceutical Research and Manufacturers Association (PhRMA) reported that in 2001, research-based pharmaceutical companies spent approximately $30.5 billion in R&D, 36% of which was allocated to pre-clinical functions: synthesis and extraction (10%), screening and testing (14.2%), toxicology and safety testing (4.5%), and dosage formulation and stability (7.3%).

According to Lisa Benincosa, director of Clinical PK/PD (pharmacokinetics/pharmacodynamics) at Pfizer Global R&D, in recent years, more attention is being directed toward the role of modeling and simulation in drug development. Presentations at national and international conferences have includes examples of the value of integrating these methodologies to optimize clinical trials, leading to greater efficiency (i.e., decreased cost and time to market new drug products).

"Many companies have begun to recruit specifically in this area in order to leverage these methodologies as part of their drug development process," said Benincosa.

Arturo G. Porras of Merck concurs. "Over the last few years, regulatory agencies have become substantially more interested in pharmacokinetic and pharmacodynamic (PK/PD) correlations on new drug applications. This increase in interest has taken place both for individual and population correlations. Correspondingly, the workload in these areas has increased substantially."

"Enthusiasm for PK/PD-driven clinical trial design has fueled internal demand for this type of work," he said. "Traditionally, these efforts would be carried out by the pharmacokineticists in the group. Biopharmaceutics people, however, are not necessarily trained in PK/PD correlations or on modeling, thus providing a niche for people with this kind of expertise." Porras noted that the interest in PK/PD has been steadily on the rise for the last five to ten years.

This new program focus comes just in time to meet an explosion of demand in the pharmaceutical industry. "Because of skyrocketing demand, this area of pharmacokinetic and pharmacodynamic pharmacometrics offers some of the highest entry-level salaries in the entire pharmaceutical industry," said Jusko. "Entry-level pharmaceutical scientists with a pharmacometrics background are being hired for as much as $80,000 per year and, because companies want to retain these people, pay raises tend to be generous."

UB is recognized as the international leader in PK and PD. Emeritus professor Gerhard Levy is considered the father of PK and PD and was instrumental in introducing PK into the clinical arena.

The new master's degree focus fuses the relevant courses at UB into an intensive program for pharmacometrics, one that most students will be able to complete in just one year. Students in this new program will also benefit from access to the state-of-the-art Buffalo Center of Excellence in Bioinformatics.

Applicants should be interested in the computational aspects of pharmaceutical research and should have at least a bachelor's degree in pharmaceutics, pharmacy, pharmacology, biology, chemistry, biochemistry, mathematics, statistics or another suitable discipline. Work and computer experience in a research or clinical laboratory is a plus.

Corinne Marasco is Content Manager of JobSpectrum.org.

Related Reading

Learn more about the new M.S. focus in pharmacometrics offered by the University of Buffalo.

The American Association of Pharmaceutical Scientists has a section dedicated to Pharmacokinetics, Pharmacodynamics and Drug Metabolism.

Pharmacogenomics examines the genetic basis for individual variations in response to therapeutics. "Pharmacogenomics: Changing the health care paradigm" published in the July 2001 issue of Modern Drug Discovery examines this field in detail.