Master of Science in Regulatory Science (MSRS)

The primary objective of the Master of Science in Regulatory Science (MSRS) degree program is to produce a cadre of highly trained and sophisticated investigators adept in the skills necessary to become leaders in the field of regulatory science.

The MSRS provides trainees with in-depth instruction in the fundamental skills, methodology, and principles necessary to become a well trained investigator positioned for a future career as a successful academic researcher. The program is designed to meet these objectives through:

• The provision of didactic course work,
• A primary thesis project,
• A formal mentorship program,
• Specific ongoing guidance with hands-on exposure to protocol and grant development.

Upon successful completion of the MSRS program, graduates are expected to have developed a strong foundation in the fundamental techniques of research. They should be able to apply contemporary research tools to relevant areas of investigation. MSRS trainees will learn how to independently formulate meaningful hypotheses, design and conduct interpretable experiments, adhere to good laboratory and clinical practices, analyze results critically, understand the broad significance of their research findings, and uphold the highest ethical standards in research. The development of additional skills—including oral and written communication, grant writing, and laboratory management—are considered integral to this training.

Trainees are expected to complete a primary research project of their own design under the supervision of their primary mentor. Trainees are expected to develop, implement, and analyze the data collected from the research project and summarize the results in a publishable manuscript(s).

The primary focus of MSRS thesis projects is scientific endeavors that operate in and navigate through the regulatory environment. Thesis projects are an opportunity to demonstrate capacity for scientific rigor, experimental design, data analysis, manuscript preparation, good laboratory practices, and overall academic productivity.

Below are samples of thesis projects.

• Develop lab-developed test for CoV2 through regulatory approval for implementation as clinical test in UPHS
• Develop high-resolution companion diagnostic for anti-GD2 CAR T cell monitoring in humans
• Develop and study implementation of genomic profile testing for P450 enzymes in an academic medical center

Effective mentoring is critical not only for research training but also to allow the trainee to develop into an independent investigator. Mentoring requires that the primary mentor dedicate substantial time to ensure personal and professional development. A good mentor builds a relationship with the trainee that is characterized by mutual respect and understanding. Attributes of a good mentor include being approachable, available, and willing to share his/her knowledge; listening effectively; providing encouragement and constructive criticism; and offering expertise and guidance. We recognize the importance of these attributes and the significant time required to mentor effectively. For this reason we have in place a formalized mentoring program.

Prospective students will meet with the program director before or during the application process. The student’s research interests, plan of study, and mentoring committee composition will be discussed at this time. The student identifies the primary and secondary mentors at the time of application.

Lisa Varughese, MSRS Student, Anticipated Graduation 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.

Funding for the MSRS program is available. To learn more about funding opportunities please view the ITMATEd Funding Opportunities page.

Questions about the program may be addressed by viewing the Frequently Asked Questions page.

The Maser of Science in Regulatory Science program is offered by the University of Pennsylvania, an institution of higher education authorized to confer degrees and certificates conferring academic credit under applicable laws of the United States.  Students who are interested in participating in the program from countries other than the United States are advised that each jurisdiction may have its own laws and regulations governing online educational programs, and some jurisdictions may not recognize course credit or an online degree awarded by the University as satisfying local requirements for professional licensure, employment qualification, or other purposes. Before enrolling in this program, prospective students should investigate their jurisdiction’s treatment of foreign online programs to ensure that participation in this program will meet their objectives.

The Master of Science in Regulatory Science is a STEM OPT extension eligible program for holders of F-1 visas