A professor with UST’s Master in Clinical Translation Management (MCTM) program played a key role on Houston Methodist Research Institute’s five-member team, which drew a collective Wow! in March of 2020 with its breakthrough news around Covid-19. At that time, Methodist announced that it was the first in the USA to transfuse donated plasma from a recovered patient into one who was critically ill.

Yes, the news was huge. So, too, was the expertise and know-how needed to guide the work and fast-track the submission through all regulatory requirements by the FDA. That accomplishment was led by Professor Christina Talley MS, RAC, CCRP, CCRC who teaches Regulatory Affairs In UST’s MCTM program and is director of Regulatory Affairs and Translational Management at Houston Methodist.

Partnering with Scientists and Engineers

Talley said, “What we do in the field of clinical translation management is partner with the medical professionals, scientists, and engineers. They come to us with an idea, medical technology or novel treatment, and we figure out what the FDA or other regulators will require for that idea to move forward and get to the patient care setting. In a nutshell, we aim to foresee potential roadblocks and find intelligent ways to clear the road.”

An Enthralling Career Field

Talley calls the work captivating. She first became intrigued two decades ago as a student working in a pharmacology research lab.

“I was enthralled by drug development and how they accomplished it,” she said. “I was swept up and wanted to learn more and more about how people take an idea and carry that through to clinical research and out to the market.”

The field is growing and will continue to expand.

“There aren’t enough people who understand and are familiar with this essential process, so there are lots of opportunities.”

Talley enjoys the complexity of the work and what she calls “the ever-changing landscape.”

Succeeding in Clinical Translational Management

While experience in healthcare or related fields would be helpful in the clinical translation management arena, it is not a pre-requisite for the program. Successful former students reflect a wide variety of backgrounds.

The class she teaches within UST’s MCTM program is called Regulatory Issues in Translational Management. Content centers on fundamental regulatory processes and critical thinking skills that are required in order to advance medical technologies.

“You’re connecting the worlds of business and life sciences.”

Bridging those two worlds makes for an exciting and meaningful career path.