Chris Webster is a regulatory affairs consultant specialising in biologics and vaccines and principal of BioApprovals. Before founding BioApprovals, Chris led regulatory affairs groups at different companies for over 25 years, most recently heading biosimilars at Baxalta and previously leading development or policy programmes at Vertex, Novartis, Millennium and Pfizer. Chris’s involvement with biosimilars began in the late 1990s, when he represented Pfizer on the biotechnology committee of PhRMA and was the lead author of one of the group’s position papers on biosimilars. Chris believes that biosimilars can greatly enhance the access of patients to needed treatments and that patients benefit when product sponsors do not face unnecessary data burdens for the approval of their products. For the last few years, Chris’s published work has focused on simplifying the data burden upon biosimilar sponsors by the careful application of scientific realities and regulatory precedents. Chris graduated in veterinary medicine at the University of Edinburgh and holds a doctorate in immunology from the University of London.