John Montgomery, MS ‘15, is an alumnus and member of the inaugural class of the MS in Regulatory Science program at the University of Maryland School of Pharmacy.

John MontgomeryJohn received his bachelor’s degree in international relations from San Francisco State University. He began his career in pharmaceutical clinical research at the University of California, San Francisco’s AIDS Program in the mid-1990s. Since that time, he has developed a great interest in the public policy aspects of regulatory science, with particular emphasis on the challenges and potential public policy solutions designed to address antimicrobial resistance. He is currently the director of quality risk management for Good Clinical Practice in Research & Development at Biogen, Inc. in Cambridge, Mass.

What inspired your interest in the field of regulatory science?

I have been fortunate to work in the biopharmaceutical development industry for nearly 20 years, and have had the privilege of contributing to the approval of new therapies for human immunodeficiency virus (HIV), surgical hemostasis, and extremely rare orphan diseases. Collaboration between patients, advocacy groups, regulators, clinicians, and research scientists in academia and industry is absolutely critical to address unmet medical needs, and I believe that regulatory science is really the embodiment of that. After attending a panel discussion between the Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) where the topic of regulatory science was discussed, my interest in pursuing a master’s degree in this area was sparked. I continue to be extremely excited about the potential of this emerging field.

What interested you most about the MS in Regulatory Science program at the University of Maryland School of Pharmacy?

The MS in Regulatory Science program at the University of Maryland School of Pharmacy offers a number of unique advantages over other regulatory science graduate programs across the country. The program is housed within the School of Pharmacy, which has an excellent national reputation. In addition, the program’s well-established partnership with the FDA through the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) creates opportunities for students to interact with experts from the FDA and other government agencies, as well as pharmaceutical companies, in a casual learning environment. The overall design and format of the program with its pre-set semester courses also allows for a more intense and thorough examination of the topics and course material.

How would you describe your experience in the program?

As a member of the program’s inaugural class, I have to admit that I did experience some apprehension about the coursework and assignments. However, that apprehension quickly dissipated after the first online class session. The caliber of the lectures and the content presented truly exceeded my expectations. The program expertly balances the flexibility of an online program with the rigor one would expect of graduate level course work. As someone who has completed the program, I can honestly say I could not be more pleased with my decision to enroll. The course managers do an excellent job constructing the small teams in a way that reflects students’ diverse backgrounds, bringing different perspectives, as well as a nice synergy, to all of the courses. In addition, the technology supports the program's design and emphasizes small team research projects and collaboration. The program's management is also very supportive and open when seeking and responding to feedback from students.

What are your thoughts about the coursework offered through the program?

The coursework is interesting, challenging, current, and very relevant to my career and professional objectives. I always felt as though my time was well spent when engaging in team discussions, reviewing the pre-recorded lectures, reading the suggested materials, or taking deeper dives into projects. Although the courses could be stressful at times, I always came away from our projects knowing that it was an investment in myself, and that I truly added valuable knowledge to my existing skillset.

How do you believe the program has helped you take your career to the next level?

Having spent almost 20 years in the field, I did not see this degree as a way to take my career to the next level, but as a way to continue to feed my knowledge base and maintain my competitiveness. A long and diverse set of work experiences is advantageous for individuals to have in the field of drug development (or almost any field for that matter), but I believe it is equally as important to expose yourself to concepts and areas beyond your job description in order to truly be successful. The MS in Regulatory Science program at the School of Pharmacy certainly served me well in that regard.

What is your advice to prospective students who might be thinking about applying to this program?

Team collaboration is a very important element of this program, which may come as a surprise given its online format. You have to be flexible, willing to move out of your comfort zone, expose yourself to new ideas, and work with collaborative technology to excel in this program. You will “reap what you sow” in terms of the amount of time and effort that you put into this program. Most of the program’s students are working professionals with families and other commitments, so allocating the time necessary to complete projects and other assignments can be a challenge. In addition, some modules may be more accessible than others due to an individual’s previous experience and education. Being aware of the challenges and managing your time appropriately will be critical to your success and satisfaction with the program. The best advice that I can offer is to give every project your very best, regardless of what you think others are doing, stay current with the lectures, and soak up every bit of knowledge that the program has to offer – you will be through it before you know it.