United States of America
Katherine Turner has been with Cognate since 2002 and has served as Director of Clinical Operations since 2008. Ms. Turner’s responsibilities include providing appropriate leadership, expertise and strategic input in managing clinical operations in support of investigational studies contracted at Cognate facilities. Her specific activities include, but are not limited to, coordination of clinical patient events within Cognate, patient/donor tissue receipt and process scheduling at Cognate, serving as central contact for designated clinical projects, addressing resolution of questions pertaining to information provided by clinical sites with respect to patient materials, patient batch record initiation and label issuance. Ms Turner also serves as liaison between Cognate, study sponsor, and study sponsor contractor(s) to expedite exchange of study-specific patient/product information. From 2002 to 2008, Ms. Turner was Senior Director, Manufacturing for Cognate. Ms. Turner’s activities included managing cGMP operations associated with the production of clinical, cellular based products. Ms. Turner successfully coordinated the design and renovation of support areas for the cGMP compliant environment for Cognate’s operations. Ms. Turner has been involved in various aspects of the generation of operational documents and regulatory filings. In addition, Ms. Turner served as Facility Manager for Cognate’s Sunnyvale, CA facility, overseeing maintenance and repairs of the physical building and grounds .