Mark Kirstein, PharmD

In 2005, Mark Kirstein, assistant professor in the College of Pharmacy, was one of five researchers chosen to participate in the AHC-sponsored Clinical Research Scholars program. This program—a precursor to the University’s NIH-funded K12 known as the Career Advancement Program for Clinical Research program (CAPS)—provides mentoring and financial support to junior faculty pursuing clinical research.

Kirstein works with his mentor, thoracic oncologist Robert Kratzke, M.D., to investigate how anticancer agents are metabolized differently in patients. Together, they aim to find out what influences people’s responses to a commonly used chemotherapy drug, gemcitabine.

“We already know there is a large variability when the same dose of a particular drug is given to different patients,” says Kirstein. Those differences may be due to how ill a person is, what other medications they take, and whether they’ve had chemotherapy before. Other factors may be involved, too, such as genetics. “I’m particularly interested in DNA sequences,” he says, which could explain why some patients clear the drug from their system more slowly and experience higher toxicity than others.

So far, they have enrolled 17 participants in a clinical trial with a goal of 40 participants by late 2008. Kirstein is pleased with the recruitment process. He has taken a population-based approach to widen the inclusion criteria and narrow exclusion criteria, and is also working with several oncologists on co-enrolling participants from their studies. In fact, Kirstein anticipates going to the IRB for additional participant approval.

In the clinical trial, Kirstein and his team measure drug levels in patients’ blood over the course of treatment in order to understand gemcitabine’s pharmacokinetics. For the next step, they will assess DNA sequences in key genes involved with gemcitabine metabolism to determine whether genetics plays a role in variability of patients’ response and toxicity to gemcitabine. They hope this will lead to more effective, tailored drug dosage for patients.

Being a clinical research scholar has afforded Kirstein 75 percent protected
time to pursue his research. “My research is certainly further along than it would have been without being supported in this way,” he says. A biostatistics course that he took last year as part of the program was “very useful.” He also appreciates interacting with the other scholars and participates in the ongoing Clinical Research Conferences where investigators present their studies to other clinical and translational scientists. Kirstein presented his initial data late last year. “I was peppered with lots of questions,” he says, “but the whole process was very helpful.”