By Nancy Dahlberg
The Miami Herald.
With her two daughters playing and singing together at a desk off to the side, Carmen I. Bigles explains what motivates her to juggle two large healthcare ventures at the same time.
“The reason I do it is right over there — those two little girls,” Bigles said in her makeshift office in a construction trailer as workers were building the Caribbean Radiation Oncology Center in Doral.
She has co-founded the center for advanced oncological radiation technology with her husband and “best friend,” Dr. Pedro A. Serrano-Ojeda, a radiation oncologist. The state-of-the-art Doral center, set to open in the second quarter of this year, is the second center; the first site opened in Bayamón, Puerto Rico in 2007. “It’s a work of love with a mission to cure,” she said.
With a growing company to run, her husband practicing medicine half the week at their clinic in Puerto Rico, and an 8- and 10-year-old to raise, Bigles doesn’t need another challenge. But in 2009, a big one came onto her radar.
Mo-99 is the parent isotope of Technetium-99, which is used in 80 percent of nuclear medicine procedures worldwide. Globally, only a small number of facilities have the capacity for the commercial production of radioisotopes. Yet the U.S., the largest market for medical radioisotopes, has no domestic supply and in turn relies on imports from Europe and elsewhere.
Essential to nuclear medicine, radioisotopes are applied in the diagnosis and treatment of diseases of the brain, heart, lung, liver, among many others. Having a half-life of only 66 hours after production, Mo-99 cannot be stockpiled and presents unique distribution challenges when imported into the U.S.
In recent years, Mo-99 shortages deprived patients of lifesaving diagnostics and treatment. And time is of the essence: Many reactors around the world are aging and set to go offline by 2016.
Still, there are only 24 hours in a day — Bigles wasn’t convinced she was the one to take this on until team and family members urged her on.
“We went to our daughter’s school, and my husband grabs me by my hands, and says ‘you know, uranium. That’s what people are fighting over getting to make weapons. A superhero would be really good right now to save this. If you brought this to the States, you would be creating manufacturing jobs in the U.S and you would help stop the proliferation of weapons-grade uranium and the future of those two little girls would be saved.’ I cried, dried my tears went inside and said ‘let me think about it.’ Then I said, ‘let’s do it.'” Bigles recalled.
So Bigles started Coquí Radiopharmaceuticals, with the mission of establishing a domestic source of Mo-99 by 2020 or sooner. The regulatory hurdles are high, as are the financing requirements — the overall cost of the project is in the $330 million range and Coquí is financing it in stages, she said.
Coquí just signed a contract with INVAP [an Argentinian nuclear engineering firm] to design Coqui’s Medical Isotope Production Facility in Alachua on land gifted by the University of Florida Foundation. Coquí is beginning the licensing application for the Nuclear Regulatory Commission and the construction plans for local regulators. At any given time there are about 200 people involved in Coquí, she said.
In that trailer she shared the triumphs and struggles of her entrepreneurial journey, which she said would only be possible because she is part of “Team Bigles-Serrano.” The Miami Herald followed up with additional questions by email.
Q. What was you and your husband’s biggest challenge developing the first Caribbean Radiation Oncology Center and what did you learn for your second center now under construction?
A. There were many challenges and we risked everything financially. The bank basically had everything we owned for collateral. In that situation, you either sink or swim. I am happy to say we became gold medalist swimmers.
Q. How did co-founding Caribbean Radiation Oncology Center in Puerto Rico prepare you for your current endeavor with Coquí?
A. The principles employed for the Caribbean Radiation Oncology Center — perseverance, organization, sacrifice, faith and empathy for patients and their families — all apply for Coquí as well. The success of the oncology center gave me the heart to continue to seek endeavors to assist people that are in the battle for their lives. It also gave us an understanding as to the importance of nuclear medicine. Patients need the precious, scarce medical isotope (Technetium-99m, the daughter of Molybdenum-99) for diagnostics as do scientists and doctors who are arduously working on treating and finding cures to Parkinson’s disease, Alzheimer’s disease, cancer and cardiac diseases, among others.
Q. What is Molybdenum-99?
A. Mo-99 is the parent isotope of Technetium-99m, which is used in 80 percent of nuclear medicine procedures worldwide. Technetium-99m is used in approximately 50,000 medical diagnostic procedures each day in the U.S. However, the U.S. has no production source for Mo-99. International production facilities are old and frequently unreliable and this delays delivery.
Q. What would happen if the U.S. is not in control of its own supply of radioisotopes?
A. In 2012, Congress passed legislation making it a national priority to produce Mo-99. When the Canadian reactor goes offline (expected 2016) there will be no major reactor this side of the hemisphere that can supply substantial amounts of Mo-99. The scenario is gearing up for supply shortages and the price is more than likely going to increase significantly due to the fact that current suppliers may need to rent more time in existing reactors for the fission production of the isotope.
Q. Why did you name your company Coquí?
A. Coquí is the common name for a small frog endemic to Puerto Rico. They are onomatopoeically named for the very loud mating call the males make at night. I believe they are the loudest amphibian. I am Puerto Rican and just like the Coquí, our company started small but we look to be very loud in our industry.
Q. There is certainly a long regulatory and licensing process, not to mention a capital intensive one, involved with developing Coquí. Was there ever a time you thought about giving up?
A. I have to confess, yes, but I persevere. I believe that when Coquí is operative what we produce will save lives, so that certainly keeps me going. We have a spectacular team of individuals helping us through this process — INVAP, MPR Associates, Gresham, Smith & Partners, Hogan Lovells, ENERCON, CHW and the University of Florida, among others — and to that end I am truly inspired to see this through.
Q. I am sure you have faced a number of naysayers. What keeps you going?
A. I have unshakable faith in Coquí. I know from the bottom of my heart that I will leave this legacy for future generations. We are making history and those naysayers have only encouraged me to go further, to be louder, and to say that with my team we will make Coquí thrive. We work so hard because the U.S. patients need this product and the world needs non-proliferation of nuclear weapons.
Q. How do you balance raising two young girls, helping to run the construction of the second Caribbean Radiation Oncology Center underway in Doral and running Coquí all at the same time?
A. I belong to another team, the Serrano-Bigles team. This team is comprised of my husband and best friend, Dr. Pedro A. Serrano, my two daughters Carmen Irene and Caterina Isabel and yours truly. The girls travel with me to meetings around the world and they are humble, very well behaved, have empathy and are of pure heart. I am very organized, I listen well, I ask questions, I do not do well with drama and I do not like to waste time.
Q. What stage are you at with Coquí?
A. We recently signed the official land transfer declaration with the University of Florida Foundation for the 25-acre parcel in Alachua County which Coquí will call home. We are currently in the licensing process and the environmental report is 85 percent complete. Much time and work goes into the environmental report and licensing. For example, the migrations of birds on the site had to be evaluated for 12 months. The licensing application is about 40 percent complete and we are on schedule to submit our application to the Nuclear Regulatory Commission by the last quarter of this year.
Q. Tell me a little about your board of directors.
A. Luis Reyes sits on the board and has more than 35 years of nuclear experience and has served in various Nuclear Regulatory Commission senior management positions. Most recently appointed to the board is Ian Turner, the former head of the radiopharmaceuticals business for the Australian Nuclear Science and Technology Organization (ANSTO). Michael Matte has served as the chief financial officer, executive vice president and secretary of QuePasa Corp. since 2007 and is a director of Iris International and GelTech Solutions.
And we have two prestigious radiation oncologists on our board, Dr. James Welsh and my husband, Dr. Pedro Serrano-Ojeda. Welsh is a board certified radiation oncologist and neuro-oncologist, president of ACRO (American College of Radiation Oncology) and has been a member of the Advisory Committee on the Medical Uses of Isotopes, which advises the U.S. Nuclear Regulatory Commission on medical issues, from 2007-2014. Serrano-Ojeda is a certified radiation oncologist who founded Caribbean Radiation Oncology Center Puerto Rico with me in 2007 and has a patent pending medication that will hopefully cure cancer.
Q. I know Louisiana and the world of gumbo was trying hard to lure Coquí as well as other states. Why did you decide to build in Florida on land given by the University of Florida Foundation?
A. There is a long history of the site selection process and many individuals worked to bring Coquí to Florida, including Governor Rick Scott. The research and synergy with the University of Florida, their Nuclear Engineering Department and all the local hospitals and medical research that is conducted at the university is very impressive. I am truly grateful to the University of Florida Foundation. It is as if our relationship was always meant to be.
Q. What does your architecture and urban planning — plus mathematics — background bring to the table?
A. It has been a great confluence for me. I’m able to look at all aspects of this project from the micro to the macro. It’s like viewing a movie with 3-D glasses, you have a better perspective.
Q. I imagine the world of nuclear medicine is rather male dominated. If that’s so, what’s that like for you? Do you have other women on your team?
A. Yes, it is dominated by men. I also work very closely with the government and that is also predominantly male dominated. I am not intimidated and I believe most recognize that, so for the most part, I believe it gets us past any gender issues. I do have many brilliant women in my team, but mainly as of coincidence. I also have many brilliant men that are part of the team as well.
Q. What’s the best advice you have ever received and from who?
A. It was from a man who passed away some time ago, he was a father figure for me. He said, “Always get to yes and leave your emotions on the side.” In other words, make intelligent decisions and leave your ego on the sideline.
