Our doctors are dreamers. They dream of conquering cancer and adding meaningful years to our patients' lives. Our Investigational Pharmacy Services team helps them turn those dreams into reality.
This highly specialized team of eight pharmacists and 11 pharmacy technicians enables MD Anderson to have the largest clinical trials program in the world.
Every investigational drug that enters our institution travels through the Investigational Pharmacy Services area on Floor 1 of the Main Building. We have 1,100 clinical research protocols underway, involving more than 8,000 patients. That translates to 35,000 investigational doses a year, or one dose every 15 minutes.
By centralizing the way we administer investigational drug trials, the team enables breakthroughs in cancer care for doctors and researchers like Hagop Kantarjian, M.D.
Out of dreams come new directions
In December, Kantarjian celebrated the accelerated approval of blinatumomab by the Food and Drug Administration (FDA). He worked closely with Jason Reed, Pharm.D., assistant manager for Pharmacy Investigational Drugs, to put the pharmaceutical sponsor's unconventional protocol into practice.
The Bispecific antibody T-cell Engager (BiTE) medication activates the immune system's T cells to fight Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This rare form of cancer often affects children and young adults. Roughly a quarter of patients with ALL die from their disease.
The drug is given intravenously for four consecutive weeks followed by a two-week break, then additional cycles. In other words, patients on this clinical trial endure 28 straight days of IV infusion, Reed says, and that's not easy.
"The protocol looked beautiful on paper, but we had to figure out how to execute one of the most complex studies we've done here in a long time," says Sapna Amin, Pharm.D., clinical pharmacy services manager for Pharmacy Investigational Drugs.
According to Kantarjian, the Investigational Pharmacy Services team pulled off a huge effort, working out the treatment details, drug formulas, pumps, schedules and a plan for changing IV bags every 24-48 hours.
The Phase II trial resulted in complete remission in 32% of the study participants for about 6.7 months. This led to blinatumomab becoming the first FDA-approved bispecific T-cell engager drug.
Helping bring new drugs to life
Most of our investigational protocols are initiated by pharmaceutical companies. Others start as part of federally funded studies or originate with MD Anderson physicians as investigator-initiated trials.
Nearly all involve chemotherapy agents. And many target leukemia, like in the blinatumomab case.
The Investigational Pharmacy Services team's primary role is to meticulously track these drugs throughout the study. This involves:
- Tracking every agent that enters MD Anderson
- Overseeing quality checks, like temperature control, to ensure study drug integrity
- Keeping comprehensive medication records
- Writing drug summaries for pharmacists to ensure safe handling and accurate dosage preparation
Supporting the monitoring of accountability. This includes visits by sponsors of the study as often as 40-50 times a week.
Increasingly, our Investigational Pharmacy Services team is getting involved in the earlier stages of studies. That's because our doctors and pharmaceutical companies now often ask them to consult on the protocol's development. "We believe that if someone can come up with the plan (protocol), we should be able to translate it from paper protocol to the bedside," Amin says.
She's especially excited to be on the cusp of unprecedented immunotherapies, vaccines and personalized cancer therapies for patients.
"It's challenging," Amin says. "It's also exciting to go in these new directions."
This article originally appeared in Messenger, MD Anderson's bimonthly employee publication.