Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture

Abstract

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://bioinsights.blob.core.windows.net/uploads/Thirkettle 200 x 200.jpg" data-image="1"></div><div class="author-det"> <!--StartFragment-->Jan Thirkettle is Chief Development Officer at Freeline, a clinical-phase AAV gene therapy company focused on the development of systemically delivered gene therapies for the treatment of chronic diseases. As such, Jan has responsibility for Programme Management and CMC/Manufacturing. Jan is a Director of the US, Irish and German Subsidiaries. Jan has extensive experience in the development of novel manufacturing platforms including natural product and enzyme-derived NCEs, biologics and gene therapies, and has enabled the launch of medicines in all of these areas. Prior to joining Freeline Jan led the establishment of GSK’s Cell &amp; Gene Therapy platform and was responsible for CMC/supply for Strimvelis, the first ex vivo gene therapy to receive an EU Marketing Authorisation Application. He has held pharma industry positions spanning from discovery to commercial manufacturing, but is most passionate about the cross-functional elements of late-state development and new platform deployment. Jan holds an MA in Chemistry and a PhD in Biological Chemistry from Oxford University.<!--EndFragment--> </div></div></div>