Accelerating Clinical Product Development through Centralized Content Work Streams

(Moderator) Alexandra Farrell, Regional Director, TransPerfect Life Sciences

Alexandra Farrell is the Regional Director at TransPerfect Life Sciences, a leading provider of global content solutions for the pharmaceutical, biotech and medical device sectors. With over 12 years of specialized experience, Alexandra has been instrumental in guiding pharmaceutical and medical device companies through the complexities of managing and localizing global clinical trial documentation.

Her expertise spans a diverse range of therapeutic areas and trial types, with a strong focus on optimizing content management workflows. Alexandra is deeply committed to accelerating the delivery of groundbreaking therapies to patients worldwide, ensuring that crucial innovations reach those in need as swiftly as possible.

Kathleen Ruddy, Process & Standards Lead, Global Site & Study Operations, Pfizer

Kathleen Ruddy’s career journey began in microbiology labs, where she spent a decade honing her expertise. A subsequent career transition led her into Clinical Research, starting as a Clinical Research Associate (CRA) in a Phase 1 Unit at a CRO.

From there, she advanced through Phase II-III studies and eventually into Study Management. A unique opportunity brought her to San Francisco, where she spent eight years gaining invaluable experience in biotechs and small pharma. The only experience missing from her CV was with a large pharmaceutical company, which ultimately led her to join Pfizer.

Kristofer Carilli, Senior Manager, Study Startup Management, AbbVie

Kristofer Carilli has been in the industry for 11 years and joined as a coordinator for site management. Over the subsequent years, he has held various roles in study start-up and management within AbbVie, ultimately leading to his role as Sr. Manager, Study Start Up Management here at AbbVie. He graduated from the University of Scranton with a BS in Marketing.

Quantes Randle, Associate Director, Clinical Operations, Alexion

With over a decade of experience in clinical research, Quantes Randle currently serves as Associate Director of Clinical Operations at Alexion Pharmaceuticals, Inc. In this role, Quantes excels in oversees the operational aspects of global clinical trials, guiding Clinical Trial Managers (CTMs) and leading efforts in process improvements. Their responsibilities include ensuring compliance with training requirements, defining work specifications and contributing to cross-functional excellence through SOP and workflow development.

Prior to joining Alexion, Quantes held positions at organizations such as IQVIA, GSK, InVentiv Health Clinical and Pfizer. These positions included Project Manager, ISSC Manager, Records Manager and Project Lead. Quantes is looking to continue his passion for process improvement and employee development through mentoring and collaborative innovation.