Donna Haire appointed Chief Operating Officer

Donna Haire will join FluoGuide full time as Chief Operating Officer to lead development, including regulatory strategy and the U.S. clinical program toward the first approval of FG001 in high-grade glioma. Donna will withdraw from FluoGuide’s board of directors in connection with joining Corporate Management.

Donna has more than 30+ years of global R&D leadership experience, with a focus in regulatory affairs and clinical development. She has held senior and executive roles in healthcare, pharmaceutical, and medical device companies and she has a proven track record of designing, developing, and successfully commercializing innovative products.

Her previous executive roles include Executive Vice President of Regulatory and Quality at On Target Laboratories, Vice President, Head of Medical Care Global Regulatory Affairs at Bayer, and Senior Vice President of Regulatory, Quality, Clinical, and Medical Affairs at AngioDynamics. She held senior leadership roles at Philips Healthcare, Medtronic, and STERIS, and was a scientist at the Cleveland Clinic Foundation. Donna was appointed as a U.S. regulatory expert to lead international trade negotiations. She served on AdvaMed’s Technical and Regulatory Board Committee, was an Adjunct Professor at the University of Akron School of Law and has been recently appointed an Adjunct Professor at the University of the Pacific Pharmaceutical Sciences Department.

Donna holds an M.S. in Biology from Cleveland State University and a B.S. in Biology from The University of Akron. Donna currently serves on the boards of Sedana Medical AB and BioPorto A/S, and as CEO of The Eriah Group, Inc., a global consulting firm.

Proposed election of Camilla Harder Hartvig to the Board of Directors

To replace Donna on the Board, FluoGuide intends to propose the election of Camilla Harder Hartvig at the upcoming Extraordinary General Meeting. Camilla brings significant global commercial leadership experience that will support FluoGuide’s future market preparation and commercialization strategy.

Camilla has more than 30 years of operational and strategic commercial experience within the international life science industry. She has lived and worked abroad for most of her career. Her most recent roles include EVP & Chief Commercial Officer at Ascendis Pharma and EVP & Chief Commercial Officer at Theramex Ltd. based in London. Prior to that, she served as Senior Vice President for the International Region at Alexion Pharmaceuticals in Zurich. Earlier in her career, she was VP Global Marketing at AstraZeneca, leading multiple successful worldwide product launches.

Camilla has served on corporate boards for more than a decade, including Danish Crown and CWorldWide. She currently sits on the boards of Goddess Gaia Ventures (London), MagCath and Biobridge Partners (Copenhagen). She is also a member of the female investor group Angella Invest and is enrolled in their Angel and Venture Capital Investor Accelerator Programme.

Camilla holds a MBSc in economics and business administration – international marketing and management from Copenhagen Business School, a CEMS Master in International Management from HEC Paris, and board education programmes from Harvard and INSEAD.

“These changes mark an important step in strengthening FluoGuide for the next important tasks,” says Peter Mørch Eriksen, chairman of the board of directors. “Donna’s proven expertise in development and regulatory will ensure strong execution of our U.S. approval strategy, while Camilla’s extensive global commercial experience prepares us for future launch readiness. Together, they add highly complementary capabilities as we progress FG001 toward patients in need.”