By Brittani Wright

Nearly a year has passed since the second cohort of the Master in Clinical Translation Management (MCTM) graduates walked across the stage. Among those graduates, Carlotta Borsoi, clinical translation fellow, has been a force at Houston Methodist Research Institute.

Borsoi is the first award winner to hold her position in the Office of Regulatory Affairs and Translational Management. This position is funded by the Katz Foundation.

FDA Pathways and Project Management

“In the Office of Regulatory Affairs and Translational Management, we do a lot of complex project management with scientists and principal investigators,” Borsoi said. “We look at medical technology development projects from the beginning, and suggest the most appropriate FDA pathway to obtain future product approval. Scientists may submit funding applications and tell us about their projects, what they want to do with the discoveries and how much funding they will need. We make sure these project plans have a pre-clinical plan and proof of concept set in place, and that they are translational, meaning they start in the lab and built to go to the clinic,” she said.

The RATM's project portfolio includes medical technologies in the areas of cancer therapy, orthopedics, women’s health and diagnostics. The development landscape is extremely vast and is a great training environment for research fellows such as Borsoi.

The current projects that Borsoi and her team are working on are in different stages. Some projects are in development while other projects are ready to start pre-clinical work and are gaining interest from companies. Although many projects are very promising, it can take years to see breakthroughs.

Working in the Lab vs. Translating Lab Discoveries

Since the age of 15, Borsoi’s dream is to cure cancer. She studied to be a scientist and after working in the lab, discovered that she liked making new ideas practical. With her experience, Borsoi understands that many great discoveries happen in the lab, but only a small percentage actually translate to patients.

Altering Career Paths for a Deeper Cause

Recruitment to the MCTM program was an easy decision for Borsoi. She realized her pivotal role in getting multiple lab discoveries to patients much quicker than dedicating her efforts to one unlikely project in the lab.

“The MCTM program completely changed my career path,” Borsoi said. “I was really worried to leave the lab thinking that I would lose my place to help patients by finding cures. But I realized this career path is a better way for me to help people sooner rather than later rather than never having a project get off the ground. Now, I can use my expertise and background to help on multiple projects and be a hand to make them all work to save lives.”