student in IDEAS Hub

Prem Ganesh, a senior bioengineering student with a concentration in engineering devices, came to Temple from Collegeville, PA, pursuing studies that combine work in the medical field with engineering. 

He found the perfect balance at the Food and Drug Administration.

This summer, he has taken on the role of an ORISE Summer Fellow for the CDER Biomarker Qualification Program at the FDA.

Prem's project involves creating a database of biomarker submissions for non-alcoholic steatohepatitis, or NASH, a rare and advanced form of non-alcoholic fatty liver disease. Biomarkers are ways to measure and document how someone feels, functions and survives, and these submissions can detect whether a patient has NASH or which stage they are at. The goal of the database is to sort, track and determine the most effective NASH biomarkers.

Much of the work in his industry is research-based, but at the FDA, he sees their work directly impacting people, he said.

"Ultimately for them, if the product works, then it's going to actually help people, so you want to push it through," Prem said. "The job you're doing is having a more positive impact on people."

During his work days, he may meet with his mentor, peer mentor and subject matter experts (SMEs), partake in an FDA drug development and regulatory course and code the database. 

"Because it's a project that I'm spending the summer on, it's more productivity-based," Prem said. "As long as I make progress on the project, then I'm on track for the summer."

Through his summer fellowship, Prem has learned about how the world functions in terms of FDA regulatory practices and what the agency looks for. Most importantly, he's learned a lot about the field he hopes to enter. 

He is currently applying for a graduate degree in bioinformatics, which closely aligns with the work he is doing now. "A lot of me wants to come back to the FDA once I do that," said Prem.

To find similar internship opportunities, Prem urges students to get involved and make connections.

"A lot of the opportunities you get are going to come from the people you meet and the people you talk to," he said. "Just making an effort to talk to and build a relationship with them opens a ton of doors because I applied to so many things, but the ones that I actually heard back from were with the people that I talked to face to face."