Clinical Development Plan – Metrics Update Massachusetts Biotech Council Meeting 29 October 2008

Original Meeting Objectives  Identify high level task/milestones/assumptions of a Phase 3 clinical study  Define deliverables for each Stage and task dependencies…establish timelines  Key component of MBC clinical tool box © 2003 Genzyme Corporation. All rights reserved.

Assumptions  Phase 3 global pivotal study  Sites in all regions of the world  May outsource some Services

Process  Project planned in four stages  Stage 1: Protocol/IB/ICF, Regulatory Submittals  Stage 2: Vendor Selection, Data Management, CRF Development, Site Selection, Drug/Device Supply, other clinical supplies  Stage 3: First Patient In to Last Patient Last Visit  Stage 4: Last Patient Last Visit through database lock and CSR  Attendees developed each of the stages

Result

Today’s Session  Handouts  Review and edit stages  Team: Ready for roll-out?