An Accelerating 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 AC. 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. AVARs: develop strategy and operational processes for AVARs development (e.g., resource process, application forms and support AVAR development and implementation). The SCC has developed new processes to support business development, contracting, proposal development and project delivery. End-to-end processes have been developed for the following categories: Business Development 1. Verify candidate lead: the BD lead conducts initial outreach to potential SCC client to confirm potential interest in SCC services 2. Qualify lead: introductory meetings are conducted with the potential client to verify it is a qualified lead. 3. Scoping a lead: clear opportunity identified as qualified lead and more detail on required services is requested to support proposal development. Proposal Development 1. Proposal development process: decision tree to follow to understand which proposal development process should be followed depending on services included in the proposal; e.g., a core clinical services proposal, regulatory gap analysis proposal, medical writing, etc. 2. Proposal integration process: integration process by which final proposal from separate services / partners are summarized and brought together for delivery to the client. Contracting 1. CDA execution: operational process to complete a CDA to ensure proprietary documents and information can be shared between the potential client and the SCC. 2. Contract execution: once a proposal is won a contract is put in place with the client to outline agreed upon services. 3. Change order execution: if changes to original contract are needed a change order is initiated and executed. 4. Contract management and close: contracts are maintained from a financial management perspective and documented. Processes for service delivery leverage existing QuintilesIMS systems and the SCC has identified primary leads within each functional service area to support these service offerings. Service Delivery 1. Service delivery: the service delivery manual serves as a reference guide to the suite of services offered by the SCC. It outlines detail on key activities, their outputs, and estimated pricing. Key service offerings have been grouped by the menu of services that the SCC can provide, eligible for specific CIRM grants. The core services included in the manual are: Asset Development Strategy; Regulatory Services (for US and ex-US); Preclinical / Nonclinical Research; Process Development, Scale-up, Manufacturing & CMC Support; Clinical Study Conduct; Commercial Services; Integrated Program Management and CIRM Grant Application Services.