As School of Pharmacy Prepares for Alumni Reception, Inaugural Graduate Shares Path to Leadership Position at FDA

By: Erik Pedersen, Senior Communications Manager

BALTIMORE – As part of Alumnae and Alumni Weekend 2023, Notre Dame of Maryland University’s School of Pharmacy will hold a special reception for all pharmacy graduates, especially its inaugural graduates celebrating their 10-year reunion, on Saturday, September 23 at 4:30 p.m. in the newly renovated Knott Science and Innovation Center. Register online for the reception and all other Alumnae and Alumni Weekend events through September 17. The reception will recognize the many accomplishments of the School of Pharmacy and its first graduating class.

Dr. Holly Thai D’13 is one of several graduates from that inaugural class planning to return to campus this fall. Dr. Thai is currently a Senior Regulatory Health Project Manager at the Division of Filing Review for the United States Food and Drug Administration, a leadership role that she began following several years as a clinical pharmacist.

In her position, Dr. Thai helps perform an initial review of generic drug applications to determine if they are acceptable to advance further in the approval process. Learn more about Dr. Thai’s role at the FDA, her career trajectory after graduation, and what inspired her to enroll in NDMU’s inaugural class of pharmacy students:


What positions have you held since graduating from NDMU?

After graduation in May 2013, I attended a residency program at Meritus Medical Center. That was an inaugural program as well. I was one of two residents that started there and helped get the program accredited by the American Society of Health-System Pharmacists. After residency, I became a clinical pharmacist for Meritus’ Transitions in Care program. I then spent some time at Holy Cross Hospital in Silver Spring, and after that I got an opportunity to move over to Frederick Memorial Hospital as a clinical pharmacist working in their anticoagulation clinic and internal medicine. I worked there for a few years before taking a pharmacist position at the FDA. After a year I was promoted to my current role.

There are a lot of different job opportunities for pharmacists – is this the path you expected to end up on?

Not at all. I was very pro-clinical. Clinical pharmacists do a lot in regard to interacting with physicians and nurses, and ensuring that patients are getting the right medications and dosages. I also had the opportunity to start a transition care program for discharge counseling. When I was working in the anticoagulation clinic, though, I started to get into doing more analysis of metrics and administrative work, and that triggered a part of my brain that was like, ‘Oh, okay, this is interesting.’ This position with the FDA opened a different career path, and I have enjoyed it a lot.

What are some of the primary responsibilities associated with your current role?

I’m in the Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Regulatory Operation, Division of Filing Review (DFR). We are one of the first divisions to review generic drug applications. I see our division as the gatekeeper for the FDA generic drug approval process to ensure it is safe and effective for approval. DFR ensures that the application meets the minimum criteria to move on to the next step with the other disciplines, such as bioequivalence, pharmaceutical quality, and microbiology. This helps streamline the FDA’s time and resources for the drug approval process.

As part of these reviews, I do qualitative and quantitative reviews and ensure the applications meets the law and regulations for approval. In addition, I am also the project manager for investigational new drugs applications. I do a primary review, correspond with other disciplines, and communicate with the drug sponsors. Within a 30-day review period, I communicate with the sponsor if their study is safe to proceed or not. It is a rewarding opportunity, as I am one of a few dozen people who touch each application that comes in until approval.

When did you realize that you wanted to become a pharmacist?

I actually wrote about this in my pharmacy school application essay. In that essay, I talked about how I recalled drinking from what I called the magic pink bottle as a child, and being fascinated with how the medicine worked in the body to make me feel better. I also had an uncle diagnosed with lung cancer. He had to take a bunch of medications, and I remember my family looking at the instructions and not understanding what they were supposed to do.

Those experiences helped lead me to volunteer at the Walter Reed Medical Center Outpatient Pharmacy, where I shadowed pharmacists and worked alongside technicians. Volunteering there evolved into me having an interest in becoming a pharmacist, and that only grew as I learned more about the different ways that pharmacists can impact the general population.

What inspired you to start your journey as a member of NDMU’s inaugural pharmacy class?

During my interviews, I enjoyed the opportunity to have personalized, 1-on-1 conversations with faculty, and I also appreciated the smaller class sizes relative to other programs. I liked the fact that it was a new program, with fresh ideas starting from the ground up.

Were there any classes or leadership positions at NDMU that were particularly helpful in setting you up for success in the profession?

The most beneficial class for me was Drug Information with Dr. Sharon Park. She taught us the importance of finding reliable resources, the importance of knowing where resources are, and being able to analyze and utilize those resources. I also enjoyed my Pharmacist’s Care Lab course, where we learned about applying our pharmacy knowledge and practice skills for patients and case studies.

I held numerous leadership positions. I was the Vice President and AdvoCaring & Advising Team Leader for the Class of 2013, Chapter’s Vice President for Phi Lambda Sigma (PLS), and I held an officer position in the Student Senate. It was a rewarding experience being a student at Notre Dame and taking advantage of all the opportunities available as an inaugural class.

Have you returned to campus at all since graduation? What are you most looking forward to do at the 10-year reunion reception for the School of Pharmacy?

I haven’t been back to Notre Dame too often, but I did recently virtually attend a CV Workshop hosted by PLS where I reviewed student’s CVs, and I have also presented both to PLS and at Dean’s Hour regarding the role pharmacists play at the FDA.

It will be nice to see some familiar faces and catch up with where everybody has been at the reception, especially within my former AdvoCaring group. Hopefully some former faculty members can come back as well. It’s great to see how successful the pharmacy program has been since our first class graduated 10 years ago.

Established in 1895, Notre Dame of Maryland University (NDMU) is a private, Catholic institution in Baltimore, Maryland, with the mission to educate leaders to transform the world. Notre Dame has been named one of the best "Regional Universities North" by U.S. News & World Report.