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.
Coquí Pharma’s Support Team
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.
Gresham Smith is a comprehensive multi-disciplinary architectural, engineering, and environmental firm that will assist Coquí Pharma with site selection. Gresham Smith’s primary responsibilities are to draft environmental reviews, collect site data, and prepare the Environmental Report for MIPF applications. Gresham Smith 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.
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.