A Translating Center designed to expedite the development and delivery of high quality stem cell therapies to patients

QuintilesIMS Consulting Services resources have been dedicated to provide general oversight, program management, and work stream support to facilitate core build activities for the Translating Center, which is a part of QuintilesIMS's Stem Cell Center (SCC). Specific work streams and the scope of activities pertaining to each are listed below: 1. Program management: :facilitate program and work stream level activities to ensure continued alignment with SCC’s goals. 2. Governance: build and stand-up all governance processes (e.g., SCC Governance Committee, Governance Charters and SCC Operating Committee). 3. Business operations: build and stand-up business model and operation processes (e.g., business manual that lists the SCC organization structure, contractual and financial processes, roles and responsibilities of SCC staff). 4. Business development: build and stand-up business development model and associated processes (e.g., client identification, outreach, proposal development processes, marketing collateral). 5. Service delivery: develop the menu of core services and underlying service delivery model (e.g.,finalize menu of services and delivery model, develop tools to optimize service execution). 6. Alliance management: develop strategy and operational processes for alliance management (e.g. finalize and execute legal documents, define roles and responsibilities, schedule regular alliance partner teleconference and in person meetings, alliance manual that describes alliance structure and operating procedures)

The goal of this award was to develop a Cell and Gene Therapy Center (CAGT) within IQVIA to facilitate translational and IND-enabling stage work in the area of cell and gene therapies. As a metric of achievement of this goal, the CAGT Center needed to demonstrate signed contracts with a specified number of CIRM grantees for services in the areas of manufacturing, IND-enabling GLP studies, regulatory operations & strategy and project management. With the four additional contracts recently signed, the CAGT has met the final milestone of the CIRM award.