Meg Powell talks to participants in the School’s Young Innovators Program about FDA Phase 4 clinical trials.
Meg Powell, Pharm.D., M.B.A., a 2000 graduate of the UNC Eshelman School of Pharmacy, visited the Young Innovators Program on Monday, July 17, to talk about her work as CEO of TARGET PharmaSolutions and her journey as a pharmacist.
Powell spoke to the interns and answered their questions for about 75 minutes. Her presentation focused on clinical trials, offering insight into their history and the way they operate today under Food and Drug Administration regulation. Specifically, she discussed the fourth phase of clinical trials and the new model her company created for it.
Powell said she was excited to share her experiences in research and development, and she hoped the interns learned more about career paths and options that may exist for them in nontraditional pharmacy settings.
“As a student at UNC, there were several alumni presentations that had a significant impact on my career choices as they exposed me to paths I was not aware of. I am forever grateful, and it is important for me to pay it forward,” Powell said.
Jimmy Xu, Pharm.D. candidate and institute intern at the Eshelman Innovation Institute who organizes YIP, said the program is working to help interns develop role models with the idea that the interns see someone with their same background succeed in pharmaceutical sciences and know they can, too.
Interns asked questions about clinical trials and the drug development process, but they were also interested in Powell’s experience building her career and the obstacles she overcame to eventually become CEO of TARGET Pharmasolutions.
The interns said they were inspired by Powell’s journey. Some things that stuck with them were the hundreds of emails she sent in search of a nonclinical pharmacy internship while earning her Pharm.D. and her experience being the only woman in the internship she eventually found.
“She pursued what she wanted no matter what obstacle,” one intern said.
Young Innovator interns learn about Meg Powell’s career path from Pharm.D. graduate to CEO.
Phase IV of clinical trials in medicine comes after the FDA has approved the drug’s new drug application, a process which is supposed to demonstrate the drug’s safety and effectiveness for its intended use. At this point in the drug approval process, the drug has already been through one phase of preclinical and three different phases of clinical trials.
In Phase IV, the drug developers study the long-term safety in diverse patient populations, but in populations of people who begin using the drugs in a real-world context once it has become available. Since 2007, the FDA has required more and more Phase IV trials, and they have increased in cost by more than $1 billion in the last five years. In addition, they’re often slow to enroll and time-consuming, Powell said.
TARGET PharmaSolutions’ model is disease focused rather than drug focused and collaborates with an academic steering committee and investigative sites to streamline the process and decrease the price while increasing the efficiency, she said.
Xu said YIP is focused on bringing in accomplished alumni who can not only explain the pharmacy industry to interns but show them that they can be an accomplished pharmaceutical scientist in a variety of ways. It’s important, Xu said, that interns hear why professionals are involved in the industry in addition to how they got there