Stories of Technology, Innovation, & Entrepreneurship in the Southeast

(EDITOR’S NOTE: This is the first article in a two-part series focused on Carmen Bigles and her plans to build the nation’s first facility to produce medical radioisotopes in Oak Ridge.)

By Tom Ballard, Chief Alliance Officer, PYA

Carmen Bigles is not a household name to many of our readers, but she is certainly a very important person for those in the Oak Ridge community who are focused on reindustrialization of the former K-25 gaseous diffusion site.

If all goes according to her timeline, the Puerto Rico native plans to have Coquí RadioPharmaceuticals Corporation producing a reliable domestic supply of Molybdenum (Mo-99) by 2025 from its new facility on Duct Island. That will ensure that patients have access to the low-cost diagnostics and treatments they need, when they need them.

“I’m on a mission to solve a health problem,” the articulate and passionate Bigles told us during a recent interview.

As Coquí Pharma explains on its webpage, Mo-99 “is the world’s most widely used medical radioisotope” that are used for procedures nuclear medicine scans to diagnose and treat diseases. With no domestic production of Mo-99, the U.S. is dependent solely on other countries as a source for the lifesaving diagnostic and treatment isotope.

Mo-99 is used to for a variety of diagnosis and treatment procedures including brain, heart, lung, liver, renal, oncologic, and muscle skeletal diseases. In addition to its focus on the well-being of individuals, Coquí Pharma also represents a significant economic development impact – 200 high-wage jobs.

For Bigles and her husband, Pedro Serrano-Ojeda, the facility is part of their long history in the healthcare sector. He is Radiation Oncologist who joined with his wife to found the Caribbean Radiation Oncology Center in Puerto Rico in 2007. In 2015, the couple opened a second location in Doral, FL. Earlier this year, the U.S. Patent and Trademark Office issued a patent for a radiation enhancer medication that Serrano-Ojeda developed to starve cancer cells. It is externally activated by radiation therapy to increase tumoricidal (cancer killing) capacities.

“We began the first oncology center with a spirit of helping others,” Bigles said. Their focus was on patients who otherwise would not have the best care to treat their cancer.

So, how did Bigles progress from two oncology treatment center in Florida and Puerto Rico to building the first of its kind facility in the U.S. to produce diagnostic and therapeutic radioisotopes including Mo-99?

“It’s a long story that keeps on evolving,” says Coquí Pharma’s Founder, Chair of the Board, Chief Executive Officer and President.

Rewind to 2009 when Bigles says patients with a previous history of cancer were returning to one of the two centers with a need of Iodine 131, another radioisotope. “We were experiencing a medical crisis,” she explained, noting there was not enough of the radioisotope available.

Several people urged her to do something to address the shortage.

“Carmen, there’s this crisis and you can solve it,” she recalls one person telling her. Then, Bigles’ brother weighed-in and finally her husband joined the band. “He knows when to push the button,” she says with a laugh.

Convinced that she should not turn her back on the challenge but also unsure if she could be successful, Bigles agreed to spend a maximum of three days in Washington, DC meeting with a variety of people to assess the opportunity to bring a solution to the table.

Those meetings included representatives from the National Academy of Sciences, INVAP, National Nuclear Security Administration, and the Congressional representative from Puerto Rico.

NEXT: How those discussions turned Bigles from a skeptic that she could change the picture into a passionate driver who is clearly focused on making a difference through her sheer willpower.

---