Dr. Irbe assumed the role of Vice President, Regulatory Affairs for EmphyCorp in August of 1996. He demonstrated exceptional multi-disciplinary skills that resulted in the FDA approval of the first clinical trials for N115, in less than 18 months, in December 1997. He managed the entire process from manufacturer, of the drug to the execution of the protocol. He served as the primary contact with the FDA during this crucial period.
Dr. Irbe has extensive experience in microbiology, food safety, quality assurance and working with FDA, USDA and other regulatory agencies. He has worked for major companies including, Nabisco Brands, Kraft General Foods, Monsanto and ConAgra. He has also worked for food and pharmaceutical companies and, contract laboratories and as an independent consultant. He has the ability to integrate concepts and knowledge from different disciplines and apply to the issue at hand. He has strong analytical and decision-making skills, which results in informed interpretations and resolutions to issues.