Pharmacists play key role in clinical research
When people think of a pharmacist, they usually think of someone dispensing medication. Pharmacists do fill prescriptions, but there's another type of pharmacist who plays a vital role in clinical research. The research pharmacist is skilled in making the clinical trial part of drug development possible.
Indeed, research pharmacists are part of multidisciplinary teams that investigate new pharmaceuticals and drugs developed for patient care.
There are two types of research pharmacists at Mayo Clinic. One facilitates clinical trials involving medications through protocol review and support of the medication management process. The other designs and conducts research as a principal investigator, or research to address other questions in the fields of pharmacy or medicine.
"There is a lot of skill and training required to be able to correctly develop and prepare experimental therapeutics," says Svetomir Markovic, M.D., Ph.D., an oncologist and principal investigator of the Melanoma Research Lab at Mayo Clinic. "These are medications that we administer to a patient in a vein or inject in a tumor or the brain. The research pharmacists make sure that the drugs are made correctly, that they go to the right person in the correct dosage."
A pharmacist's role is multifaceted, but to be a trusted medication expert, pharmacists must complete a comprehensive and rigorous Doctor of Pharmacy (Pharm.D.) curriculum. After completion of Pharm.D. coursework, pharmacists can pursue additional elective postgraduate residency training to focus on specialty designations.
Mayo Clinic offers one- and two-year postgraduate residency programs. Research is a requirement of these programs.
"The residents complete a research project as part of the programs. I think that's where many times pharmacists decide whether research is for them or not," says Elizabeth Ventresca, Pharm.D., director of pharmacy services at Mayo Clinic.
Bringing new treatment options to patients with melanoma
Kristi Franta, Pharm.D., joined Mayo Clinic after her residency in 2013 as a central pharmacist; a year later, she moved to the position of clinical hematology/oncology pharmacist.
For Franta, the path to research pharmacist revealed itself over time. Her previous roles exposed her to clinical trials that allowed her to work alongside the research support pharmacy team while caring for patients. In her current role, Franta supports a wide range of adult oncology and pediatric hematology/oncology clinical trials.
Franta is part of a team conducting several studies working with Dr. Markovic and Anastasios Dimou, M.D., an oncologist at Mayo Clinic in Rochester. One of the clinical trials is evaluating the use of an investigational device for metastatic melanoma.
A phase 1 clinical trial, also called an early-phase clinical trial, might be the first time an experimental cancer drug or intervention is used with people. It tests the safety, side effects, best dose and timing of a new treatment. It also may test the best way to administer a new treatment — such as by mouth, infusion into a vein, or injection — and observe how the treatment affects the body.
"These melanoma studies are exciting to me because they have the potential for patients to be able to receive chemotherapy in a more convenient way and hopefully with less of the toxicities commonly associated with them," says Franta.
Franta enjoys being involved in studies from an early phase, such as protocol writing through activation, dispensing drugs to patients and publication of results. "My work provides a great deal of satisfaction knowing I’m contributing to potentially bringing another treatment option to patients who may have limited or no other options."
Working on personalized cancer vaccines
Vanessa Toncray, Pharm.D., is a research pharmacist who works on clinical trials. She joined Mayo Clinic in 2018 as a pharmacist in clinical practice. Before joining Mayo Clinic, Toncray worked as a pharmacist and in quality and patient safety.
As a research pharmacist, Toncray says there is no such thing as a typical day. But the one thing she knows for sure when it comes to her job is that communication is key.
"Something that most people don’t know about my job is the level of communication that is required. We are in constant communication with both internal team members and external contacts to determine timelines, obstacles and to problem-solve," Toncray says.
Toncray is part of a team of researchers working on a trial of a personalized vaccine for patients with advanced cancerous tumors.
"The research pharmacist provides expertise and invaluable insight from development and implementation of research protocols, which are critical to ensuring patient safety first and the quality of the study," says Yanyan Lou, M.D., Ph.D., an oncologist at Mayo Clinic in Florida.
Research pharmacists engaged in clinical trials also are guided by the Food and Drug Administration (FDA) rules for investigational drugs.
"There is a whole set of FDA regulations that these pharmacists must navigate as they’re working through different studies to determine the right path forward," says Ventresca.
Working on clinical trials aligns with what Toncray likes most about her job, which is being able to facilitate the treatment for patients who potentially have exhausted other options. "Having a small part in the advancement of science, as it relates to therapeutic options, is exciting," says Toncray.
A career pivot to research pharmacist
Christopher Grilli, Pharm.D., is a clinical pharmacy specialist and researcher at Mayo Clinic in pharmacogenomics, the study of how genes affect the body's response to medication, an emerging field within patient care.
Grilli joined Mayo Clinic in 2015 as a pharmacy department manager, a position he held for six years before moving to his current role as a pharmacist researcher. Before joining Mayo Clinic, he was a manager at a large retail pharmacy.
He says research was never on his radar as a career trajectory. Rather, it was his "extreme dislike" of not knowing the answer to a problem when he needed it most. "Pursuing scientific truth through data and asking lots of questions, coupled with a strong commitment to finding answers, is how I ended up at this place in my career," Grilli says.
Grilli is principal investigator of a study using whole exome sequencing data, which enables the analysis of all protein coding sequences in the human genome. This technology supports the investigation of cancer-related genetic abnormalities in the exonic regions, which carry information for a genetic code.
For Grilli, the process of scientific discovery has always been exciting.
"Identifying new ways to treat and, in some cases, cure disease for the sickest and hardest-to-treat patients is such a gratifying way to spend my time," says Grilli. "As an added bonus, working with some of the best and most skilled minds in Mayo research makes the process of discovery and translation enormously rewarding."
Like all scientists, curiosity is a shared trait among clinical trial research pharmacists.
"These folks are always thinking, surely there's something better, a medication with less side effects and toxicities to the patient that will deliver better outcomes," says Ventresca. "I think curiosity on the part of a research pharmacist is really a key characteristic."
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