Lantheus Medical Imaging Announces Appointment of Alexander E. Kuta, Ph.D., as Vice President, Global Regulatory Affairs and Nigel Williams as Vice President, Quality
“Both Alex and Nigel bring proven experience and strong track records in life sciences that will further advance our global regulatory affairs, quality and compliance,” said Don Kiepert, President and CEO, Lantheus Medical Imaging. “These new appointments reflect our ongoing commitment to meeting the highest possible safety and quality standards of our products for both physicians and patients on a global basis. Both positions also will support the regulatory process for our important development pipeline of products.”
As Vice President, Global Regulatory Affairs, Dr. Kuta will lead the regulatory function at Lantheus to ensure compliance with all regulatory standards, develop and advance the regulatory strategy for the Company’s currently marketed products and development candidates, and serve as the chief spokesperson with regulatory affairs agencies. He will report to Dana Washburn, M.D., Chief Medical Officer of Lantheus.
Dr. Kuta joins Lantheus with more than 20 years of regulatory affairs and drug development experience, including the U.S. Food and Drug Administration, Genzyme Corporation, and most recently AMAG Pharmaceuticals, Inc., where he was Vice President, Regulatory Affairs and Quality Assurance. While at Genzyme, Dr. Kuta held Regulatory Affairs roles of increasing responsibility, including support of the Rare Disease, Biosurgery and Multiple Sclerosis businesses. Prior to joining Genzyme, he was Chief of the Cytokine and Gene Therapies Branch at the FDA Center for Biologics. Dr. Kuta received a B.S. degree in Biology from St. John’s University, a Ph.D. from The Chicago Medical School in Immunology and performed his postdoctoral work at the National Cancer Institute.
In his new role as Vice President, Quality, Mr. Williams will lead the global quality function at Lantheus to ensure global standards and compliance as it relates to all operations, including drug discovery, clinical research, internal and external manufacturing, distribution and radiopharmacy operations. He will report directly to Mr. Kiepert.
Mr. Williams joins Lantheus with more than 30 years of industry experience in manufacturing, quality and supply of a wide range of healthcare and diagnostic products, including most recently Head of Quality for Merck KGaA Chemicals Operations, and Vice President, Quality Management at EMD Millipore. Prior to that, Mr. Williams held positions of increasing responsibility at Millipore Corporation, Celliance Limited, a division of Serologicals Corporation, Weston Medical Group PLC, Rhone-Poulenc Rorer, and Berk Pharmaceuticals. He received a B.S. honors degree in Applied Biology from Brunel University.
About Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The Company’s proven success in the field of diagnostic imaging provides a strong platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. Lantheus imaging products include the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease, TechneLite® (Technetium Tc99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.