J.J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company employing several 100 people who develop and manufacture in vitro diagnostic reagents. Dr. Tobin therefore has extensive experience of working within an FDA and European medical device regulatory framework. Gary Walsh is chair of industrial biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries, as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena.