David Hallinan
Vice President, Regulatory Affairs
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Dr. Hallinan has been the Vice President, Regulatory Affairs at Idenix Pharmaceuticals, Inc since September 2000. In that capacity, he is responsible for all interactions with Health Authorities worldwide (e.g. US FDA, European EMEA, Japanese PMDA, Chinese SFDA etc.) regarding all Idenix drug development activities especially regarding the conduct and reporting of clinical trials and final marketing authorization applications (e.g US NDAs; EU MAAs etc.). He also oversees the Quality Assurance function at Idenix with responsibility for ensuring compliance with all applicable Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) requirements. Prior to joining Idenix, Dr. Hallinan was the Vice President, Regulatory Affairs & Quality Assurance at PAREXEL International Corporation, a global pharmaceutical Contract Research Organization.
Dr. Hallinan has a B.Sc (Hons.) in Biochemistry and a Ph.D in Pharmacology from the National University of Ireland.
Idenix has focused its efforts towards HCV due to the global unmet medical need for this viral disease. It is estimated that more than 170 million people worldwide are chronically infected with HCV.