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Clinical Program Manager
14 May 2015 GS-US (RESCUE) Investigator’s Meeting Welcome and Introductions Allison Fidelholtz Clinical Program Manager 08 December 2015 Confidential
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Agenda – Tuesday December 08 2015
Time Discussion Item Presenter 9:00- 9:15 am Welcome, Introductions & Operational Structure Allison 9:15- 9:45 am Therapeutic Background & Study Rationale Lorenzo 9:45-10:35 am Protocol Overview Amanda 10:35-10:45 am Medical Monitoring 10:45-11:15 am Gilead Overview Enrollment Expectations Vendor Overview Electronic Data Capture Bracket IWRS Covance/Central Lab 11:15-11:30 am Q&A Session GSI Team
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Gilead Study Team Structure
Isobel Lakatos Director Allison Fidelholtz Clinical Program Manager Alis Vazquez Project Manager Anu Ghosalkar Sr. CTM Associate Winnie Tse Clinical Project Assistant Clinical Contracts & Finance Jennifer Clin Cntrcts & Finance Data Management Mark Gambino Clinical Data Associate I Medical Affairs Amanda Copans, Pharm D Study Director Lorenzo Rossaro, MD Medical Monitor
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PRA Study Team
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