Atomic Show #227 – Carmen Bigles, Coqui Radiopharmaceuticals

CarmenBigles-headshot-205x300Coqui Radiopharmaceuticals is a start-up company founded in 2009 with a laser focus on solving a problem affecting the health of tens of thousands of people. The founder, Carmen Bigles, noticed that many of the patients arriving at her clinic had not been properly diagnosed and discovered that the reason for that condition was an insufficient supply of molybdenum-99 to provide technetium-99 for diagnostic nuclear medicine. She recognized that the problem was a solvable one and believed that she had the experience and ability to build a team capable of producing a long term solution.

Ms. Bigles determined that there were proven solutions available, and recognized that the already existing shortage of Mo-99 could not be reliably and promptly solved by starting up a research and development project using novel, unproven ideas.

Her approach to problem solving in this case was to adopt the same solution that had worked for others and to determine the straightest path towards implementing that solution here in the United States.

The path she and her team have chosen is not without risk, but much of the risk in the project comes from regulatory uncertainty and the financial uncertainty that is inherent in a boutique market that has, up until now, been dominated by government-owned, multipurpose facilities that can often afford to sell product at a price that cannot be matched by a private industry.

The perceived regulatory risk can be illustrated with a quote from an article in the November 2014 issue of Nuclear News titled “The Campaign to Resume Domestic Production of Molybdenum.”

Taking on what may be the biggest regulatory challenge is Coqui Pharmaceuticals, a Puerto Rico-based venture that would not only produce reactor-based fission product Mo-99, but would do so in reactors that do not yet exist, and therefore must be permitted and licensed through the NRC.
(Nuclear News, Nov 2014, pg 41)

Despite the doubters, Coqui Radiopharmaceuticals has developed what appears to be a very workable plan, built a strong team, and has engaged consistently with the Nuclear Regulatory Commission.

Just before Ms. Bigles and I spoke, I received a copy of the following press release indicating the achievement of one more milestone on a lengthy, but rewarding journey.


FOR IMMEDIATE RELEASE CONTACT:

Ashley Torres – atorres@krepspr.com
Laura Stace – lstace@krepspr.com
305.663.3543

COQUÍ RADIOPHARMACEUTICALS INKS DEAL WITH INVAP
Nuclear Engineering Firm Chosen as Designer and General Contractor for Florida
Medical Isotope Production Facility

Coral Gables, Fla. (Nov. 20, 2014) — Coquí RadioPharmaceuticals Corp., a medical isotope company working to become the first U.S. commercial producer of Molybdenum-99 (Mo-99), is proud to announce it has formally signed a contract with INVAP to design its Medical Isotope Production Facility (MIPF) in Alachua, Fla. Mo-99 is the parent isotope of Technetium-99, which is used in 80 percent of nuclear medicine procedures worldwide. In 2012, Congress passed legislation making it a national priority to produce Mo-99, an isotope necessary to detect a wide range of diseases, including cardiovascular disease and cancer.

Argentine nuclear engineering firm INVAP has been involved in nuclear development for more than 30 years. During that time it has worked on more than 15 nuclear reactors and related facilities across the world, including several reactors used to produce medical isotopes. Among these is the OPAL reactor in Australia, the ETRR-2 reactor in Egypt, and the NUR reactor in Algeria. Coquí Pharma’s MIPF will use an open pool reactor technology similar to that employed in the INVAP-designed OPAL facility in Australia.

“The signing of this contract cements a key step in implementing proven technology to produce Mo-99 for patients requiring lifesaving medical diagnostics,” said Carmen I. Bigles, Coquí Pharma President and CEO. “Today, Coquí Pharma together with INVAP has built a bridge between the U.S. and Argentina, uniting our efforts to ensure the availability and reliability of the most essential radioisotope in nuclear medicine and with the added benefit of making the world a safer place for generations to come by utilizing proven non-proliferation, low-enriched uranium technologies.”

Coquí Pharma is preparing its construction permit application for submission to the U.S. Nuclear Regulatory Commission. Coquí Pharma will utilize existing commercially proven technology with tested designs to license and build a facility that has the capability of reliably supplying a large portion of the U.S. market and international needs.

Due to recent and future projected shortages, the issue of U.S. domestic medical isotope production has been discussed at great length within the industry and U.S. federal government. Coquí Pharma reviewed options available to manufacture Mo-99 and determined that only the INVAP process provides a real, tangible and reliable solution to solve the medical isotope crisis.

# # #

Coquí RadioPharmaceuticals Corp.

Coquí RadioPharmaceuticals Corp. is a medical isotope company, dedicated to the production of Molybdenum-99, which is used in 20 million procedures each year in the U.S. The Puerto Rican company is based in Coral Gables with the mission to bring the foremost medical isotope production facility in the Western Hemisphere to Alachua, Florida, and to create a commercially scalable, reliable supply of medical diagnostic and therapeutic radioisotopes in the U.S. For more information on Coquí RadioPharmaceuticals, visit www.coquipharma.com.

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Northwest wind takes a week-long vacation

Some Atomic Insights readers don’t like it when I use the term “unreliables” to describe weather dependent power sources like wind and solar energy. They believe that word is demeaning and not entirely accurate, especially in certain system designs where wind turbines are partnered with hydro or pumped storage.

Even in that situation, however, the wind is not under the control of automated systems or human operators, so it can disappear when it is most needed or blast in when it is not wanted. Recently, the Bonneville Power Administration (BPA) which operates a grid supplied with a large fraction of hydro, 4,500 MWe of distributed wind turbines and a small amount of thermal generation experienced some of the wild weather gyrations that are not actually uncommon.

Here are the tweets I posted to highlight the challenges the weather was imposing on the system operators.

After a week in which the wind barely whispered, it returned with a vengeance, ramping from zero to 4,000 MWe within 12 hours. During part of that time, the slope of increased generation approached a vertical line.

I suspect that the dip in wind production at midnight on November 22 came as a result of curtailing wind generators to prevent grid instability as the wind generation approached 75% of the total load on the system at that time of day.

It must have been an interesting time to be in the grid control room.

Update: (Posted 11/25/2014 at 17:00) An Atomic Insights reader reviewed the detailed history files available at the BPA web site and informed me that there was no curtailment of wind turbines at midnight on November 22. I responded to his comment. The above post has also been modified to remove the phrase “In fact,” before the words “I suspect.”

Paul Wilson & Bret Bennington vs Arnie Gundersen & Heidi Hutner on Nuclear Sustainability

On Nov 20, 2014, Hofstra University hosted its annual Pride and Purpose Debate. This year’s proposition was the following – “Should nuclear energy be expanded to help create a more sustainable future?” The debate included the following panelists: For – J Bret Bennington, professor of geology, Department of Geology, Environment and Sustainability at Hofstra University. […]

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Shaping public perceptions of radiation risk

Note: The below is part of a longer work in progress. Comments and corrections are greatly appreciated. On Monday, November 17, the US House of Representatives passed H.R. 5544, the Low Dose Radiation Research Act, which called for the National Academies to “conduct a study assessing the current status and development of a long-term strategy […]

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Power In New England: Why are Prices Increasing so Rapidly?

On October 20, IBM announced that it was spinning off its chip division by paying GlobalFoundries $1.5 billion. GlobalFoundaries appears to have won the deal with its geographic position of owning fabrication facilities in New York as well as in Germany and Malaysia. The move didn’t surprise many, as there have been rumors that IBM […]

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Atomic Show #226 – Nuclear tour de France reunion

On Wednesday, November 12, I got together with two friends. The three of us were 60% of a group of five writers and bloggers given the opportunity to visit a sampling of nuclear facilities in France owned and operated by Areva. That experience helped form a strong bond. We missed our other two companions from […]

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World Nuclear Association discussion on radiation protection

I just received a link to a fascinating podcast from the World Nuclear Association about the risks associated with attempting to protect the public from low doses of radiation. It was posted almost a month ago on October 14, 2014. I apologize for initially missing this important recording and failing to bring it to your […]

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Atomic Show #225 – ANS Winter Meeting Leadership Perspectives

The American Nuclear Society Winter Meeting is in progress in Anaheim, CA. I was not able to attend the meeting this year, but I was able to arrange to talk to a couple of people who were there. Guests on this episode of the Atomic Show include Gene Grecheck, the Vice President and incoming President […]

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Atomic Show #224 – Dr. John Boice NCRP

From front page of June 13, 1956 New York Times. Right column headline.

On November 11, 2014, I had the pleasure of speaking with Dr. John Boice, the President of the National Council on Radiation Protection. Dr. Boice has had a long and distinguished career in radiation protection and is currently leading a multi-decade effort known as the Million Worker Study to investigate the evidence that has been […]

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Who fights energy abundance? Why?

On November 6, 2014, immediately after the midterm election results became available, National Review Online published an article by Kevin D. Williamson titled With Energy, More Is More: An Economic Agenda for the New GOP Majority. Long time readers of Atomic Insights will know that I lean way to the left on the political spectrum […]

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Open letter to advisory bodies about LNT consequences – revised

Last week I pointed out that Scientists for Accurate Radiation Information (SARI) had submitted a letter to a number of scientific advisory groups requesting that they provide clear guidance to governments on the lack of harm associated with exposure to the residual radioactive materials released from the Fukushima Daiichi accident. That initial post also provided […]

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Stephen Burns sworn in as NRC commissioner

Stephen Burns, whose nomination to serve as an NRC (Nuclear Regulatory Commission) commissioner was confirmed by the US Senate on September 16, 2014, was sworn in yesterday to become the 35th person to serve as an NRC commissioner. His 5-year term expires on June 30, 2019. The ceremony took place at the NRC’s office building […]

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