With its injectable biosensor technology well into the clinical development stage, Glympse Bio has its sights set on revolutionizing the way we diagnose diseases and track their progression throughout the body.
Helping Glympse along its path through trials, FDA approval and beyond will be Tram Tran, M.D., who joins the Cambridge, Mass.-based company as its first-ever chief medical officer.
At Glympse, Tran will combine her experience as both a practicing liver and viral specialist and a veteran of Gilead Sciences’ medical affairs team—where she served as the global head of liver diseases—to oversee clinical development of the biosensors, which have a lead indication for the detection of nonalcoholic steatohepatitis, the fatty liver disease known as NASH.
Once injected into the body, the sensors, which are composed of synthetic nanoparticles, are programmed to react with proteases within the liver linked to NASH. The reaction can be measured within an hour using a standard urine test, allowing physicians to not only diagnose NASH but also track its progression, since the size of the reaction varies based on the prevalence of the disease in the body.
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Swapping her post at Gilead—incidentally, a key partner of Glympse—to help develop a smarter diagnostic tool for NASH was an easy decision for Tran. As she explained to Fierce Medtech, there’s an urgent need for liver specialists like her to be able to catch the disease early, since NASH can quickly progress into fibrosis, then cirrhosis, before requiring a total liver transplant.
“I still see patients, and it’s always about, what do we really need in the patient space that I’m in? And for liver, every day, NASH is a huge problem. We’ve known that for a long time, but we continue to butt up against this diagnostic space where we can’t tell which patient is the one who has NASH,” Tran said.
“I’m also a transplant physician, so to see the end of the road and not be able to predict that is a real challenge,” she continued. “So, for me, it was just about moving into a space where I knew there was exciting science that was happening, where I could really help with figuring out that diagnostic space.”
In the new role, Tran will blend her decades as a clinician with the scientific development expertise she picked up at Gilead to build out the biosensors’ path to commercialization.
“It’s really about supporting the science from a medical standpoint: How do we develop a clinical program that will answer these scientific questions? We want to do it in the smartest and most efficient way,” she said. “My hope is to do that right off the bat and build a program and a strategy that helps us today but also will help us build the data and the science going forward, too.”
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That simultaneous focus on both achieving successes in the short-term and crafting a clinical development program that will last long into the future is crucial for Glympse, which already has its eye on expanding its technology’s indications well beyond NASH.
“Everything that we’re learning from NASH we will be applying to other things,” Tran said. “We’re taking the hard part of everything we’re learning, and we’re going to be able to use that and build very quickly on that.”
The company is at something of a watershed moment, CEO Caroline Loew told Fierce Medtech, where “it’s no longer a nascent technology, we’ve gotten beyond clinical proof of concept and we’re really looking forward into the marketplace.”
This rapid advancement is what led the former Fierce 15 winner to bring on its first chief medical officer, Loew said, as the company continues to “march toward commercialization” through increasingly complex clinical studies.
And beyond the already impressive work of improving diagnostics for NASH and other diseases, Glympse’s progress is also paving the way for an entirely new class of diagnostic tools, since its technology is one of the first to be based on analyzing proteins rather than DNA or RNA.
“The application is extremely broad, and we see a universe where, in five to 10 years, protein activity will have claimed its place in the everyday diagnostic toolkit for a really wide range of diseases,” Loew said. “The really exciting thing is that we can both detect diseases as well as help manage them. It’s such an exciting potential, and we’re now getting very close to bringing our diagnostics out into the market—and that’s just the start of that evolution.”