NextGen cell and gene therapy

Cell and gene therapy (CGT) brings the promise of personalised precision medicine to life. As with any innovative, disruptive technology, however, developers face challenges along several dimensions—manufacturing, regulation, and reimbursement, among them—to become broadly commercially viable. How can life sciences organisations address these challenges and continue to advance CGTs?

Deloitte’s CGT experience spans the value chain

Our goal is to bring the best of Deloitte to help our cell and gene therapy manufacturing clients launch curative therapies that will benefit patients and humankind. Our capabilities and experience span the entire CGT value chain, from clinical operations and research and development (R&D) to technology and digital platforms to supply chain, logistics, and manufacturing.

Clinical Operations and R&D

Patient Journey Mapping
Decentralised Clinical Trial Readiness & Operations
Clinical Site Selection & Onboarding
Clinical Site Certification Approach
Clinical & R&D Financial Systems and Processes
Apheresis Network Strategy

Technology and Digital Platform

Clinical IT Process Mapping
Systems: MES, EQS, LIMS, CRM
Process and System Integrations
Lab Automation
ERP Design, Implementation and Remediation
CGT Vantage
CGT IAB

Supply Chain, Logistics, and Manufacturing

COI/COC & Labeling and Integration

Manufacturing Development and CDMO Strategy

Track and Trace (Cell Collection, Cold Chain Logistics, COI/COC Integration)

End-to-End Data Management and Analytics

Decentralised Clinical Trial Operations

Apheresis/Diagnostics Scheduling and Collection

Manufacturing Capacity Management

Medical Affairs and Long Term-Registry

Site Onboarding
Patient Referral & Enrollment
Order Creation
Patient Assistance Programs
Learning and Decision Support
Post-treatment Monitoring and Registry

Regulatory, Quality, and Compliance

Regulatory Intelligence & Interactions
Regulatory Strategy & Operations
Site Security Assessments
Data Governance and Analytics
Site Training and Change Management
Field Reporting/RWE Analytics
Clinical Drug Product QA Release Criteria
IND Preparation and Submission

Commercial Market Access

Launch Execution Toolkit
Omnichannel Engagement
Registry Strategy and Development
Reimbursement Tools and Reimbursement Strategies
Value Based Contracting Strategy
HEOR/ Value Quantification
Alliance Partnering/ Competitive Intelligence

How Deloitte can help

We have partnered both small and large industry players in identifying and resolving critical business and operational challenges across the cell and gene therapies value chain. Connect with us and leverage the extensive experience and insights we have gained across business functions by supporting clients in their clinical to commercial evolution for launch readiness.

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NextGen cell and gene therapy