2024 Access to Medicines Internship Spotlight
Roivant Sciences and Roivant Social Ventures (RSV) have partnered to host the Access to Medicines Internship and Fellowship Program, providing real-world drug development experience to talented PharmD students who are passionate about leveraging their career development to expand healthcare access to underserved patient groups.
This summer Amanda Bowlin served as a Regulatory Strategy Intern for Roivant's Regulatory Affairs and Drug Safety (RADS) team, where she:
Consolidated safety data across clinical trials from a clinical program and prepared adverse event tables for informed consent documents.
Assessed Roivant's clinical trial protocols in view of the International Council for Harmonisation (ICH) M11 guidelines on clinical study protocol templates and technical specifications.
Summarized key information from the FDA Summary Basis of Approvals for new drugs/indications.
Reviewed drug promotional guidance and crafted recommendations for external communications related to investigational drugs.
We sat down with Amanda to learn more about what drives her work and how her summer internship at Roivant has impacted her career development.
What type of impact do you hope to create with your work?
""Over the past five years, I have worked in both a community pharmacy and in an inpatient hospital setting. Within these roles I have made it a point to ask patients about the barriers they face in regards to their care within our conversations. Through interactions with my family members from rural areas, and the patients I have worked with, I have become highly aware of the day-to-day barriers faced by underserved populations in relation to their health. Whether it is due to cost, transportation, access, adherence or other concerns, it is evident that having a desire to be healthy is not nearly enough given today’s medical system. With each conversation I have, I am hopeful to make a difference in the health of my patients and to ultimately improve their quality of life. Through innovative ideas, strategic partnerships, and sustained improvements to healthcare delivery, I am committed to a future where all patients have the access to the medications they need."
What were your biggest takeaways from your RADS Internship with Roivant this summer?
"I have gained valuable insight into the pharmaceutical industry and a new understanding of cross-functional work and collaboration. It has been exciting to connect the direct patient care experiences I have had in pharmacy school with impactful decisions made in early drug development..."
"This internship provided me with new perspectives on patient care, patient advocacy, and barriers to care. I now have a new understanding of how decisions at the early stages of drug development directly impact patients and a greater appreciation for both the challenges and exciting opportunities within expanding access to medicines. My hands-on experiences have allowed me to apply my academic knowledge in a practical setting and develop a deeper understanding of regulatory affairs and protocol writing at a global level. It has been an honor and privilege to be a part of the Roivant team this summer."
What were your favorite takeaways from the "Making Medicines" class you took prior to your internship?
"In addition to gaining exposure to all of the different aspects of drug development, it was hearing from real people who are driving impact for patients through their professional expertise. I noticed the common theme between all of the experts that we got to hear from in class was that they were really focused on getting medications to patients as soon as they could, while making sure that those medicines are safe and efficacious. I found each of their roles to be impactful on a broad scale, which is really exciting to me. I could tell that the work they did was actually making it to the patients, which is really important to me."
Access to Medicines Internship/Fellowship Program
This May, Roivant Sciences and Roivant Social Ventures partnered to host our Access to Medicines Internship and Fellowship Program, providing real-world drug development experience to qualified PharmD students. The intentions of this program are to expand access to medicines to underserved populations, and to further UNC Eshelman School of Pharmacy's goal of providing future industry leaders with pharmaceutical experience during their PharmD tenure.
During the Spring 2024 semester all interns completed RSV's "Making Medicines" course at the UNC Eshelman School of Pharmacy, the top ranked School of Pharmacy in the United States. This innovative course was designed to introduce PharmD students to the new drug approval process and key issues in drug discovery, pre-clinical testing, clinical trials, FDA approval, and global access to medicines. The course is taught by Lindsay Androski, RSV Founder & CEO, and Scott Singleton, Associate Professor at the UNC Eshelman School of Pharmacy.