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ADVISORY BOARD Outsourcing in Clinical Trials


ROSALIE FILLING, VICE PRESIDENT, SENIOR GLOBAL HEAD R&D OPERATIONS AT ENDO


In her over 25 years of experience, Rosalie ‘Rosie’ Filling has transformed R&D operations in every company she has worked for, developing clear- cut strategies to help advance clinical trials with high-quality operational execution and scientifi c excellence. Rosie is the Vice President, Senior Global Head R&D Operations


Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master fi le/inspection readiness, and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products. Rosie’s main focus at all times is on the end users—the patients. Bringing new and even life-


saving medications to patients drives Rosie’s sense of purpose. Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director,


Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly fi ve years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD. Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.


KATHLEEN COHEN, SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AT MARINUS PHARMACEUTICALS


Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals. Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.


THOMAS TREMBLAY, RN BSN, VICE PRESIDENT OF CLINICAL DEVELOPMENT AT TREFOIL THERAPEUTICS


Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, and drug safety and quality. He is currently Vice


President of Clinical Development at Trefoil Therapeutics and former adjunct faculty at San Francisco State University.


4 | Outsourcing in Clinical Trials Handbook


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