International Biomedical Regulatory Sciences Has Story to Tell

One of the College of Pharmacy’s greatest assets is perhaps one of its best kept secrets. However, the College is working diligently to assure that this world-class program gets the recognition it’s due and its story told.

Housed at the UGA Gwinnett campus, about 45 minutes from the UGA Arches, is the College’s International Biomedical Regulatory Sciences (IBRS) and Clinical Trials Program. According to Director Dr. Grace Gowda, the mission of the program is to prepare a professional workforce who can help register medical products, assuring the health and safety of the general public. “IBRS provides graduate-level distance learning designed to increase knowledge and develop competencies in biomedical regulatory and clinical processes that meet government regulations and are critical to assuring the development, manufacturing, and marketing of safe and effective medical products and drugs,” she explained.

IBRS offers graduate-level degree and certificate programs in an online format, which allow students and working professionals flexibility in the learning environment. Course work uses a blended instructional approach of asynchronously delivered content and interactive project work taught by experts from industry, the university, and regulatory agencies who assure that the content is current and relevant for students.

Students interested in the graduate degree program can earn a Master’s in International and Biomedical Regulatory Sciences. Certificates include Clinical Trials Design and Management and International and Biomedical Regulatory Sciences.  Along with these programs, the College offers two DoubleDawg degrees for undergraduate pharmaceutical sciences and PharmD  students interested in simultaneously earning a graduate degree in Pharmacy, with a concentration in Regulatory Sciences.  

The IBRS program was established in 2005 but renamed and moved in 2019 to the Georgia Institute for International Biomedical Regulatory Sciences by Dr. Michael Bartlett, the College’s current Associate Dean for Science Education, Research and Technology.  According to Dr. Bartlett, “The recent growth of IBRS has come from students from other degrees discovering our IBRS program.  We are now drawing students from our undergraduate and PharmD programs, and from the UGA College of Engineering. This influx of students has doubled the size of IBRS.”  

Regulatory Science professionals are in high demand as biopharmaceutical, biotechnology, and academic organizations are striving to bring innovative medical products and maintain compliance with ever-evolving policies in novel product technologies. Caroline Stevens, a P3 and Clinical Trials Design and Management Certificate participant, noted, “I thought the program would be a great way to build and maintain my knowledge about FDA regulations and research ethics. I hope to pursue either a fellowship or residency, and then work within the drug research and development process. A background of Regulatory Science will give me an edge when finding an impactful career in this area after graduation.”

Graduates can expect opportunities at the associate, specialist, project manager, director, or executive level with many pharmaceutical and medical organizations or can be employed by the Food and Drug Administration as well as other government agencies.

Further enhancing the program’s prestige are the world-class faculty members, who have extensive experience in the regulatory industry.  A complete list of these faculty members is available here.  The newest faculty members are Dr. John Brennan and Dr. Monica Escobar.  

Dr. Brennan recently retired from a long career as a radiopharmaceutical scientist, medical director, and senior project leader at Ortho, Bristol-Myers Squibb, Solvay Pharmaceuticals, Inc, Abbott Laboratories, and AbbVie.  During the course of his career, he worked on several successful FDA new drug application projects that led to commercial drug product introductions in the pharmaceutical marketplace.  

In addition to joining the College, Dr. Brennan owns a consulting practice in which he advises clients on drug development strategies, clinical study planning and execution, and global regulatory interactions.  His areas of interest include diabetic disease progression,  therapeutic applications of Advanced Glycation Endpoint (AGE) inhibition, and the use of vasopressin analogs for cardio-renal syndrome. 

“I consider it a unique privilege and fantastic opportunity to share my professional experience and interests with students, faculty, and staff at the College,” said Brennan. “This is a special opportunity for me to “give something back” to the pharmaceutical science profession that has enabled me to have a successful and rewarding career.  I greatly enjoy working with the IBRS Team and admire the focus and commitment of the department to provide a challenging, meaningful, and results-focused educational experience for students.” 

Dr. Escobar has 25 years of pharmaceutical experience in Research and Development and Regulatory Affairs.  After completing a Ph.D. at the University of Florida in Analytical Chemistry and, she started her career working in analytical research, developing analytical methods for new pharmaceutical products.  She has been in Chemistry, Manufacturing, and Controls (CMC) in Regulatory Affairs for more than 17 years, supporting development candidates and marketed products. Dr. Escobar has worked with oral solid dosage forms, i.e. capsules and tablets; semi-solid dosage forms; transdermal patches; and liquid parenterals.  She has experience filing the CMC sections of the Food and Drug Administration’s investigational new drug applications, new drug applications, abbreviated new drug applications, drug master files, as well as preparing new drug applications and European Medicines Agency dossiers.  She will focus her teaching on CMC.

“I am happy to join the International Biomedical Regulatory Sciences program at the College and to be a part of this program, which is so valuable to the pharmaceutical industry,” she commented.

For more information on IBRS, visit the International Biomedical Regulatory Sciences and Clinical Trials Programs webpage.