Carmen I. Bigles

Founder, CEO, President and Chairman of the Board of Directors

Carmen I. Bigles is President and CEO of Coquí RadioPharmaceuticals (Coquí Pharma). Prior to founding Coquí Pharma, Bigles co-founded and served as CFO of Caribbean Radiation Oncology Center in Puerto Rico. The center is one of the region’s premier medical facilities for advanced oncological radiation technology. Bigles oversaw the $12 million construction of the center’s first facility in Bayamon, Puerto Rico, and ensured the clinic was opened one year ahead of schedule.

Bigles was born in San Juan, Puerto Rico. She earned a bachelor’s degree in mathematics from Interamerican University in San Juan in 1997 and two master’s degrees, the first in architecture and the second in suburban and town planning, from the University of Miami in 2000.

Bigles lives in Coral Gables, Florida, with her husband, Dr. Pedro A. Serrano-Ojeda, and their two daughters, Carmen Irene Serrano-Bigles and Caterina Isabel Serrano-Bigles.

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Coquí Pharma’s Support Team

INVAP

INVAP is an Argentinian nuclear engineering firm that will serve as Coquí Pharma’s designer and general contractor for construction of its Medical Isotope Production Facility (MIPF). INVAP was started 42 years ago as a spin-off from a nuclear research laboratory in Bariloche, Argentina. Its current main business areas are nuclear research reactors and associated facilities and space satellites. INVAP delivers many other facilities and services in high technology fields such as extractive metallurgy, metals processing, radars, nuclear medicine, radioisotope production plants, and chemical plants. Within the U.S., INVAP is a subcontractor of and consultant to Westinghouse Nuclear and B&W Nuclear and is a supplier of space satellites for the National Air and Space Administration (NASA).

The INVAP Nuclear Business Unit (NBU) delivers the company’s flagship products—nuclear research reactors for radioisotope production and scientific applications, radioisotope processing plants, and associated facilities. INVAP has built reactors in Argentina, Peru, Algeria, Egypt, and Australia as turnkey projects, with the NBU managing all project stages from conceptual design to construction, system integration, start-up, and initial operation.

 

Hogan Lovells US, LLP

Hogan Lovells is an international law firm whose experienced nuclear regulatory and environmental attorneys will assist Coquí Pharma with facility licensing and environmental review. Hogan Lovells has more than 2,500 lawyers in more than 40 offices in Africa, Asia, Europe, Latin America, the Middle East, and the United States. The firm helps corporations, financial institutions, and governmental entities with critical business and legal issues.

 

Gresham, Smith and Partners

Gresham, Smith and Partners (GS&P) is a comprehensive multi-disciplinary architectural, engineering, and environmental firm that will assist Coquí Pharma with site selection. GS&P’s primary responsibilities are to draft environmental reviews, collect site data, and prepare the Environmental Report for MIPF applications. GS&P is headquartered in Nashville, Tennessee and has more than 650 employees. The firm assists private and public sector clients nationally in developing new facilities including design, permitting, and environmental reviews.

 

MPR Associates

MPR Associates, based in Alexandria, Virginia, is a leading nuclear engineering firm that will serve as Coquí Pharma’s engineer, assisting with FDA and cGMP compliance and nuclear engineering and licensing support. For over 50 years, MPR has provided specialty engineering and management consulting to the commercial nuclear power industry, including the areas of quality systems and licensing. In addition, MPR brings years of experience in design, implementation, and validation of unique manufacturing processes for pharmaceutical and radiopharmaceutical products.

MPR’s experience extends to ANSTO’s manufacturing processes. In 2011, ANSTO engaged MPR to conduct an independent assessment of their quality program, along with the processes and practices used in radiopharmaceutical production. MPR’s combination of perspectives from the nuclear and pharmaceutical industries will be invaluable in assuring a well-defined and integrated compliance approach is planned and executed at Coquí Pharma.