Michelle Foust is a pharmacist, but she doesn't dispense pills at the corner pharmacy. Instead, she distributes them worldwide. Foust is the director of new product development at Almac Group, a multinational company that packages and distributes experimental drugs for clinical trials. Behind the scenes, Foust and other pharmacists help coordinate the research and development process that brings new medication from the laboratory to the familiar corner pharmacy.
Foust and her colleagues have trouble explaining what they do, even to other pharmacists. That's mainly because they're largely invisible, and their career path is unfamiliar. "None of us knew about this opportunity when we were in school," says Foust. "And my parents still don't know what it is that I do."
Foust's career is just one of many that pharmacists fill in a research setting instead of in the much more familiar retail setting. Although pharmacists who pursue research careers are still a small minority, their ranks are expanding quickly within the pharmaceutical industry and the myriad organizations developing and testing pharmaceutical compounds.
"We are certainly hiring more pharmacists than we have in the past, driven by, frankly, a demand in the industry and our realization that people who go through the Pharm.D. training have a knowledge of the chemicals and the development process, and how it interacts with the patient, that adds a tremendous dimension to the clinical trials," says David Cooper, vice president of global staffing at Quintiles Transnational Corp., a clinical research organization that has more than 18,000 employees worldwide.
Many of today's clinical research pharmacists forged their careers during specialized fellowships they served after finishing their Pharm.D.s. More of these fellowship programs are cropping up, as are graduate fellowships within Pharm.D. programs. Such training aims to meet a growing need for pharmacists within the clinical research system.
Pharmacists occupy a variety of roles within Quintiles Transnational, Cooper says, some designing phase I, early-stage clinical trials, others occupying executive-level management positions. Still other pharmacists work as clinical research associates in late-phase clinical trials, traveling to investigator sites to oversee compliance with clinical protocols and investigating adverse drug events and safety concerns.
"In the post-Vioxx era, we have a lot more demand for pharmacists in the late phase," says Cooper.
Foust and others at her company give presentations at pharmacy schools to raise awareness of the growing career opportunities for pharmacists in clinical research. Often called clinical research officers or project managers, these scientists typically write protocols, choose investigators and study sites, monitor clinical trials, collect and analyze trial data, report adverse events, and write and publish clinical-study reports. Within the clinical research enterprise, pharmacists often move into leadership positions in drug-development studies, Foust says. But because the work is behind the scenes, few pharmacists hear about these job opportunities.
In addition, a number of pharmacists work as consultants to biotechnology or small pharmaceutical companies that have a promising compound and are trying to design the first clinical protocol to test the compound's safety in human subjects. "These companies need to think through 'What's the appropriate dose? What's the toxicology profile?' We have a lot of experienced pharmacists who can help consult on those types of issues," Cooper says.
On the fellowship trail
For Linda Chang, a 6-month internship at Genentech Corp. was the first step in her career in pharmacology research. This internship and a subsequent fellowship helped punch her ticket to a research scientist position at Johnson & Johnson's Pharmaceutical Research & Development division in Raritan, New Jersey.
"My internship was a positive experience because I was able to work with a lot of people in the field and to get an idea of the work environment in industry," says Chang, a recent Pharm.D. graduate of the University of California, San Francisco's Center for Drug Development Science. "They gave me a lot of freedom to explore the areas that I might like to [work in.]"
Her next step was to search for a postgraduate fellowship at the American Society of Health-System Pharmacists (ASHP) midyear meeting, which is held in December each year. The ASHP career fair offers on-site interviews for jobs and fellowships. There she met a representative for Johnson & Johnson, which led to an offer of a J&J-sponsored postgraduate fellowship. Due to an unexpected job opening up, Chang's intended fellowship quickly turned into a job in pharmacokinetic drug studies.
Nancy Sambol, an assistant professor at the UCSF Center for Drug Development Science, says that graduates of the UCSF program often have their pick of jobs after completing postgraduate fellowship training in clinical research. Her current fellows all have multiple jobs offers, she says.
Formalizing the career path
Many of the pharmacists now working in clinical research were trained in standard Pharm.D. programs and later carved out their career paths in clinical research. But now a few pharmacy programs, such as UCSF, offer a specialized research career track to pharmacy students.
"Based on history, what Pharm.D.s can do in research is really limitless," Sambol says. "What's new is that we have an actual pathway to train the students to go into research."
In the program at UCSF, "we do modeling of data that has to do with how drugs are handled by the body and how the body is affected by the drugs," Sambol says. "Those models are important to be able to simulate what would happen if we do the next study a certain way. ... It is information-based, data-driven study design, and it's a very hot field right now."
For most pharmacy students, however, experience and training in clinical research comes from a postgraduate fellowship. These typically are 1- to 2-year training programs following completion of a Pharm.D. that can open the door to positions in industry or academic research. Some programs allow fellows to rotate through several departments, whereas others offer intensive training in one area, such as regulatory affairs or drug labeling.
The Rutgers pharmaceutical industry fellowship program, which was one of the first such programs, coordinates perhaps two-thirds of all industry-sponsored fellowships for pharmacists. It also does its recruiting at the ASHP meeting, offering 70 fellowships to a national pool of applicants. Jim Alexander, director of the Rutgers program, says his biggest job is to raise awareness among students finishing their Pharm.D. that clinical research is a career option.
"Generally, we've seen only maintenance of the number of applicants for research fellowships in recent years," says Alexander. But opportunities for pharmacists to obtain postgraduate training within the pharmaceutical industry have increased dramatically since 1999, according to a 2004 survey conducted by graduate students at the Rutgers School of Pharmacy. Prior to 1999, industry-sponsored postgraduate fellowships for pharmacists had produced about 300 alumni, but in the subsequent 5 years, that number had grown to more than 700. Since then, says Alexander, the number of fellowship opportunities has grown even further.
Bridging the gap in drug information
Individuals trained in pharmacy are in the perfect position to bridge the gap between the flood of genomic information becoming available and the goal of personalized medicine, says Douglas Figg, a pharmacist by training and head of molecular pharmacology at the National Cancer Institute's Center for Cancer Research.
Figg recently organized a meeting that brought together 22 deans of U.S. pharmacy schools and others interested in pharmacy education to discuss how to train more pharmacists to become engaged in clinical research. The 2-day conference, held last December at the National Institutes of Health in Bethesda, Maryland, called on the nation's pharmacy schools to increase the quantity and quality of Pharm.D. scientists.
"If you [look at] the pharmacogenetic information that we now have, there is a tremendous need for clinical pharmacologists, and the only group that will be able to fill that gap is pharmacists," says Figg. "Pharmacy has to meet that challenge. They have to be better trained in basic science in order to do the pharmacogenetics that is out there."
Figg points out that his laboratory recently completed a study using a DNA chip that can rapidly profile 1243 single-nucleotide polymorphisms in 163 genes involved in drug metabolism and transport using a single DNA sample. "This vast amount of data is soon going to be available on each patient; who is going to interpret and modify therapies based on this information?" he asks.
It won't be physicians, according to Figg. Fewer than a dozen physicians train to become clinical pharmacologists each year. However, pharmacists are perfectly poised to bridge the knowledge gap between laboratory data, and opportunities for them in clinical practice are only going to expand. "The profession of pharmacy has a lot to offer," he says.
Karyn Hede is a freelance writer in Richland, Washington.
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Photos, top to bottom: Rodrigo Senna, courtesy David Cooper, courtesy Linda Chang