Source: | Tom Ballard | July 22, and July 23, 2019

(This is combination of a two-part article series Tom Ballard ran in his blog about ETEC member Coqui Pharma.)

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.

An interview with Carmen Bigles starts-off on a low key, but it quickly reaches a new level as she talks passionately and animatedly about her plans to open the nation’s only source for medical radioisotope, Mo-99, in Oak Ridge by 2025.

As noted in the first article in the series, the Puerto Rico native spent three days in the nation’s capital exploring the possibility of addressing the challenge of ensuring the U.S. had a reliable, scalable, domestic source for the isotopes that are needed for diagnostic and treatment procedures.

Weeks after those meetings, Bigles willingly accepted the herculean challenge and founded Coquí RadioPharmaceuticals. “It’s an intense, beautiful company focused on saving lives,” she told us in a recent interview.

Noting that she is not an expert in nuclear medicine, Bigles first explored the feasibility of building the facility in her native Puerto Rico. Those plans were quickly dismissed, and the possible locations shifted to three states – Florida, Louisiana and Tennessee.

“The first site that I was offered was Duct Island in 2010 or 2011,” she said. The island is part of the old K-25 gaseous diffusion site, now known as the Heritage Center, and the offer came from Kim Denton, then President and Chief Executive Officer of the Oak Ridge Economic Partnership.

“Tennessee . . . that’s so far away,” Bigles thought. Two incumbent Governors – Rick Scott (Florida) and Bobby Jindal (Louisiana) – called with offers, and Bigles ultimately settled on 40 acres near the University of Florida in Gainesville.

Yet, that was obviously not the end of the story.

“I was invited to ORNL (Oak Ridge National Laboratory) to make a summer presentation,” Bigles said. As she drove from the Knoxville airport to ORNL, she thought, “It’s so peaceful here. This is really where I need to be. Everybody (here) understands me; they speak the same language.”

As many may recall, ORNL, then known as Clinton Laboratories, sent the first official shipment of a medical radioisotope, in this case Carbon-14, to Barnard Free Skin and Cancer Hospital in St. Louis in 1946. That established what is now a more than 60-year history in the isotope scientific space.

So, in October 2016, Coquí Pharma announced that it was shifting its construction plans from Florida to Oak Ridge. Two years after making the decision, the U.S. Department of Energy (DOE) approved the transfer of the Duct Island site to the company. That decision was announced in April as noted in this article.

The DOE support also is funding research projects underway at both ORNL and the Y-12 National Security Complex that focus on a number of areas.

“This could not be a better place for the company to be,” Bigles said. She even has a big vision for the region – a nuclear medicine center of excellence.

For the mother of two teenagers who lives in Coral Gables, FL but visits the region at least once a month, it’s clearly a cause.

“When you walk with people who are dying,” Bigles says, and then pauses before adding, “There’s no stopping me. My husband taught me the importance of really being alive. Respect life, respect people. I love life. God is the key; faith is the key.”