Gilbert Lefèvre, PhD

Twenty-five years pharmaceutical development experience in both the early and late development arena with scientific expertise in Translational Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics and Dose/Exposure-Response relationships. I also have a solid regulatory experience with nine successful NDAs including Revasc, Femara, Dapsone, Egaten, Exelon (oral, patch), Coartem/Riamet (adults, pediatrics) with completion of Nonclinical and Clinical Pharmacology and Biopharmaceutics components for regulatory submissions, and defense and negotiation with Health Authorities worldwide. I am leading international teams dedicated to projects in Neuroscience, Tropical Medicines and Infectious Diseases. I review Health Authority guidances (incl. WHO), and I am at the editorial board of international journals, and member of peer review panels. As a member of the Malaria R&D Program, I was awarded the Prix Galien US for the antimalarial Coartem/Riamet. I received my PhD in Biology and Life Sciences in 1989 at the University of Paris Jussieu, France, and was trained in General Immunology at Pasteur Institute. After my PhD, I have been instrumental in building a Biotech start-up to develop and manufacture antibodies and immunological diagnostic tests for infectious diseases for hospital use. I joined the pharmaceutical company Ciba-Geigy in 1991 in Paris as Head of Immunobioanalytics and Pharmacokinetics, and later moved to Novartis Headquarters in Basle, Switzerland.