MSRS Graduate Spotlight

Navigate Master of Science in Regulatory Science

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Lisa Varughese, MSRS Student, Anticipated Graudation 2022

Your Current Position: I am currently a postdoctoral fellow in the Division of Translational Medicine and Human Genetics. As a pharmacist with both clinical and research experience, my work primarily involves implementing pharmacogenomics into routine care to improve patient safety and therapeutic efficacy.

Why you decided to enroll in the MSRS program: I decided to enroll in the MSRS program to learn how regulations and health policy affect clinical practice. Research in precision medicine has been around for quite some time but there are many barriers to clinical adoption of pharmacogenetic testing, including provider knowledge and clinical implementation factors both locally and nationally. Fortunately, there are initiatives for standardization in this field through guidances and collaborative networks with the FDA. With the MSRS degree, I hope to increase efficiency in the application of pharmacogenomics in the clinical setting. My goals include ensuring that stakeholders are educated and comfortable in using this approach, laboratory test panels include prevalent genetic variants that are inclusive to patient populations receiving care, and that access to testing is equitable to meet public needs so that appropriate clinical utility data can be used to facilitate sound regulatory decision-making.

What you have found valuable about the MSRS program: The MSRS program has been valuable in learning the latest trends in domestic and global regulation as well as quality practices in the pharmaceutical and biotechnology industries. Given that some of my coursework overlaps with the Masters of Translational Science and Masters of Regulatory Affairs programs, this interdisciplinary environment allows me to learn from my peers and their experiences from working in clinical and regulatory capacities. As a student in the MSRS program, I have also had the opportunity to participate in the Professional Skills Development Program, which has helped nurture both my workplace skills and personal goals for a holistic and successful career.

How has the MSRS assisted you/will assist you in your current research: The MSRS has provided additional structure to my fellowship program because I have opportunities for collaboration and mentorship in my research. Feedback from my program advisor and thesis committee members as opposed to a single primary research mentor-mentee relationship has enhanced the direction of my research project. The program’s core courses have provided a regulatory framework for the drug and device approval process as well as a foundation in clinical research, statistics, and project management. The MSRS program also allows for a lot of student autonomy in choosing electives and Penn, fortunately, offers many fascinating and relevant courses. For example, I opted to take an elective in the Master of Biomedical Informatics program to learn informatics approaches in precision medicine that I can use in my research. 

What you’ve found most applicable about the program this far: I am extremely grateful that I can apply what I learn in the classroom directly to my current work as a research fellow. After taking courses like Proposal Development, Introduction to Biostatistics, and Clinical Study Management, I use stronger critical thinking skills in my own projects and can provide more meaningful and thought-provoking feedback to my colleagues in their research and practice. The Proposal Development course helped hone my writing and presentation skills for research proposals and grants; the Biostatistics course reinforced my statistical knowledge in assessing scientific literature and applying biostatistical methods in my own work. The Scientific & Ethical Conduct course with IRB membership has also provided an enriching, hands-on experience in learning what goes into protocol approvals – it’s a unique privilege as a student to be on the other side of the regulatory process and evaluate human subjects research, study operations, and ethics. Overall, the MSRS program has taught me valuable research and professional skills that I will carry with me in my future as a pharmacist and research scientist.

Who you would recommend the MSRS program to: I would recommend the MSRS program to a student that is interested in leading research and regulatory efforts for innovative practices and strategies that may not have a standard in place or may be in need of new standards and policies to keep up with current trends. The COVID-19 pandemic demonstrated the world’s need to adapt to an ever-changing landscape, as did the rules and regulations governing the innovations that emerged during this time. By enrolling in the MSRS program, I believe students will be well-equipped to navigate the next generation of scientific advancements by understanding the science, methodological approaches, and quality of data and safety monitoring that encompass the regulatory process for new discoveries and practices.