Navidea Biopharmaceuticals Appoints Michel Mikhail as Chief Regulatory Officer, Effective October 1, 2021
September 27, 2021 at 07:30 am EDT
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Navidea Biopharmaceuticals, Inc. announced the appointment of Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea, effective October 1, 2021. Dr. Mikhail has more than 30 years of experience in the pharmaceutical industry and a track record of achievement in R&D and international regulatory affairs at large multinational research-based pharmaceutical companies. Prior to joining Navidea, Dr. Mikhail worked in global regulatory consulting for various pharmaceutical and biotech companies from January 2016 through September 2021. Before acting as a consultant, Dr. Mikhail served in senior regulatory executive roles at BioNTech AG, Fresenius Kabi, Ranbaxy Europe Ltd. (now SunPharma), Pharmacia & Upjohn (now Pfizer), Knoll AG (now Abbvie), SmithKline Beecham (now GlaxoSmithKline), and Boehringer Ingelheim. Dr. Mikhail is a global expert in Regulatory Affairs dealing with the U.S. Food and Drug Administration (“US-FDA”), the European Medicines Agency (“EU-EMA”) as well as national agencies in Europe, Japan’s Pharmaceuticals and Medical Devices Agency, China’s National Medical Products Administration, among other regulatory agencies worldwide. He is a Chartered Expert in Pharmacology-Toxicology. Dr. Mikhail served on the Safety working group and Efficacy working group of the European Federation of Pharmaceutical Industry Associations and as a Topic Leader for new guidelines. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America, on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (now Medicines for Europe), as well as on different associations and organizations. Dr. Mikhail is a lifetime member of The Organization for Professionals in Regulatory Affairs, and has contributed as volunteer at the Drug Information Association and the Parenteral Drug Association. Dr. Mikhail was part of the Transatlantic Trade and Investment Partnership negotiations aiming at harmonization of regulatory requirements and relying on each other’s inspections between the EU-EMA and US-FDA.
Navidea Biopharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. It is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of undetected disease. The Companyâs business is focused on two primary types of drug products, such as diagnostic substances, including Tc99m tilmanocept and other diagnostic applications of its Manocept platform, and therapeutic development programs, including therapeutic applications of its Manocept platform. It has developed processes for producing the first four therapeutic Manocept immuno-construct series, the Manocept doxorubicin (MAN-DOX) series, which is designed to specifically target and kill or modify activated CD206+ macrophages by delivering doxorubicin, a Manocept paclitaxel series (MAN-PAC), and a Manocept Bisphosphonate series (MAN-BIS).