March 28, 2023
Research pharmacists at Mayo Clinic facilitate clinical trials, and design and conduct research to address other questions in the fields of pharmacy and medicine. They often work behind the scenes but play a vital role in clinical research.
It's no secret that pharmacists dispense medications. Another type of pharmacist, the research pharmacist, works behind the scenes and plays a vital role in clinical research.
Research pharmacists make the clinical trial part of drug development possible. They are part of multidisciplinary teams that investigate new pharmaceuticals developed for patient use.
There are two types of research pharmacists at Mayo Clinic. One facilitates clinical trials involving medications through protocol review and supports the medication management process. The other designs and conducts research as a principal investigator, or conducts research to address other questions in the fields of pharmacy and medicine.
There is a lot of skill and training required to be able to correctly develop and prepare experimental therapeutics, These are medications that we administer to a patient in a vein or inject in somebody's tumor or brain. The research pharmacists make sure that the drugs are made correctly, and that they go to the right person in the correct dosage.
Svetomir Markovic, M.D., Ph.D.
Oncologist and principal investigator of the Melanoma Research Lab, Mayo Clinic in Rochester.
Pharmacists must complete a comprehensive and rigorous Doctor of Pharmacy, or PharmD, curriculum. They also can pursue additional elective postgraduate residency training to focus on specialty designations.
Mayo Clinic offers postgraduate pharmacy residency programs in Arizona, Florida, Rochester, and Mayo Clinic Health System. 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, PharmD, director of pharmacy services at Mayo Clinic in Florida.
Pharmacy research: New treatment options to patients with melanoma
Kristi Franta, PharmD, is a research support pharmacist at Mayo Clinic in Rochester. She joined Mayo Clinic in 2013 as a central pharmacist, and a year later, she moved to the position of clinical hematology/oncology pharmacist.
For Franta, the path to becoming a research pharmacist revealed itself over time. Her previous roles provided exposure to patients in clinical trials and allowed her to work alongside the research support pharmacy team while caring for those 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 phase 1 melanoma studies working with Dr. Markovic and Anastasios Dimou, M.D., an oncologist at Mayo Clinic in Rochester. One of the clinical trials involves a study to evaluate the use of an investigational device to administer ipilimumab, a monoclonal antibody medication, directly into the lymphatic system in patients with 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," Franta says.
She 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," she says.
Pharmacy Research: Working on personalized cancer vaccines
Vanessa Toncray, PharmD, is a research pharmacist who works on clinical trials. She joined Mayo Clinic in Florida in 2018 as a pharmacist in clinical practice, collaborating with physicians, other health professionals, and patients to ensure that the medications prescribed contribute to the intended health outcomes.
As a research pharmacist, Toncray says there is no such thing as a typical day. But 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 and obstacles, and problem-solve," Toncray says.
Toncray is part of a team of researchers working on a phase 1 clinical trial to determine the safety and tolerability of a personalized neoantigen peptide-based vaccine for patients with advanced cancerous tumors. A vaccine containing up to 20 unique peptides is manufactured for each qualifying patient. Yanyan Lou, M.D., Ph.D., an oncologist, is principal investigator of the study.
"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," Dr. Lou says.
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 to be a part of," she says.
Pharmacy research: A focus on pharmacogenomics
Christopher Grilli, PharmD, is a clinical pharmacy specialist and researcher at Mayo Clinic in Arizona with a specialty in pharmacogenomics, the study of how genes affect the body's response to medication. Grilli joined Mayo Clinic in 2015 as a manager in the Pharmacy Department, a position he held for six years before moving to his role as a pharmacist researcher.
He says research was not initially on his radar as a career trajectory. But he strongly disliked 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 allows 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.
He is course director of Mayo Clinic's Pharmacogenomics Certificate Program, an online continuing medical education course on how to integrate pharmacogenomics into clinical practice for pharmacists, physicians, nurse practitioners, physician assistants, nurses, and students. Grilli and colleagues developed the program, which is the first certification course in pharmacogenomics at Mayo Clinic.
"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," he says. "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."
Curiosity is a shared trait among clinical trial research pharmacists, as with all scientists.
"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 Dr. Ventresca. "I think curiosity on the part of a research pharmacist is really a key characteristic."
Pharmacy programs at Mayo Clinic
Mayo Clinic offers a variety of pharmacy programs across Arizona, Florida, Minnesota, and the Midwest at Mayo Clinic Health System. These pharmacy programs include an internship, technician program, and more than 20 PGY-1 and PGY-2 pharmacy residencies.