The field of nuclear medicine has traditionally been a male dominated industry. However, Coquí Pharma, which was incorporated in September 2009, is turning that tradition upside down. Led by CEO, Carmen Bigles, and with three other female senior members of the project team, women are steering the company towards its goal of producing American-made isotopes by 2020.

“The makeup of the Coquí team is an exciting example of how things have changed in our industry and in the United States. With hard work, determination and an entrepreneurial spirit, we are proving that women can lead the way on this important issue facing the US," said Carmen Bigles, CEO of Coquí Pharma.

Prior to founding Coquí Pharma, Bigles co-founded and served as chief financial officer of the Caribbean Radiation Oncology Center in Puerto Rico. There, she became aware of the shortages related to Mo-99 – when it began to affect their patients. Technetium-99m, the decay product of Mo-99, is used in about 50,000 medical procedures a day in the US. However, because of the short half-lives of the isotopes involved (66 hours for Mo-99 and just six hours for Tc-99m) they cannot be stockpiled and once produced must be moved quickly to the patient.

In 2012 US Congress passed legislation making it a ‘national priority’ to produce Mo-99. Among all the companies considering production of the isotope, only Coquí Pharma is planning to construct a facility using already-demonstrated reactor technology.

Coquí’s MRPF development team includes Amy Roma, an attorney with Hogan Lovells, who will assist Coquí with facility licensing and environmental review.
“I have worked on nuclear reactor licensing and regulatory issues for eleven years and 90 percent of the time, I am the only female at the table," said Roma.
“A woman’s perspective adds a different point of view that is helpful in facility planning and soliciting community support."

Bigles says she did not set out to build a company supported by so many women in leadership positions. It just evolved that way.

Coquí selected INVAP, an Argentinian firm to design and construct the proposed facility, bringing on board Veronica Garea, Coquí’s lead reactor safety engineer. While Garea has been involved in many nuclear projects, she says that this is the first time she has shared responsibility with ‘so many experienced and creative women committed to technical excellence.’

Gresham, Smith and Partners, the architecture, engineering and planning firm brought in Blair Everett, Coquí’s environmental planner.

More recently, Coquí engaged MPR Associates to serve as the Owner’s Engineer for the project and the company assigned project manager Kimberly Keithline. Kimberly recently joined MPR from the Nuclear Energy Institute where she served as a senior project manager for new plant deployment.

Nuclear engineering firm ENERCON is also contracted to assist Coquí in the preparation of its Nuclear Regulatory Commission licence applications. The company’s new plant division has supported more than ten new plant projects, including by preparing an early site permit or combined operating licence applications for the NRC.

Facility plans

Coquí’s Medical Radioisotope Production Facility will comprise two pool-type materials testing reactors, a radioisotope processing plant (RPP) and a waste conditioning facility, plus administrative buildings.

The reactors, which operate at just below 10 MW (but will not operate simultaneously), will be used to produce Mo-99, the precursor of Tc-99m, which as already noted is used in medical procedures.

The preliminary design envisages a compact reactor core (active height 50 cm) with an estimated six fuel assemblies. The average fuel cycle is expected to be around 30 full power days, with one to two fuel assemblies expected to be replaced per cycle. The fuel design itself will be standard MTR type with U3Si2 fuel meat, enriched to 19.8 wt% LEU. The reactor will likely have a beryllium reflector, although other options are under analysis.

Once the Mo-99 is produced in the reactor it will be moved to the RPP for processing and shipment to Tc-99m distributors. The planned capacity for the MIPF will be 7000 six-day curies per week. The facility will have a number of lines to guarantee production availability and offer flexibility to increase production as needed.

The facility itself will be delivered as a turnkey project by Argentinian firm INVAP. The company built the OPAL research reactor in Australia and RA-3 in Argentina, the only fully functional research reactors built to use LEU. INVAP is under exclusive contract with Coquí to construct the MIPF in the United States.
Coquí says is on track to submit a construction application to the NRC in mid to late 2015. Once submitted, the NRC review process for the construction permit application generally takes 18-24 months.

The facility is planned for construction in Alachua, Florida, on land owned by the University of Florida and near its Gainesville campus. The university has one of the premier nuclear engineering departments in the US, and Coquí will benefit from their involvement, Bigles says.