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Allogeneic Therapies: Can This be the Silver Bullet for All Future Cell Therapy Developers?
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Analysis
NextGen cell and gene therapy
Personalized precision medicine is here
Cell and gene therapy (CGT) brings the promise of personalized 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 organizations 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
• Decentralized 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
• Decentralized 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
Discover insights
Why elevating responsibility to the c-suite can help avoid manufacturing missteps
Designing a patient-centric digital ecosystem
Your operating model needs to be as innovative as your science
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NextGen Therapies Industry Working Group
Orchestrating cell and gene therapies to better manage patient treatment journeys
Life Sciences Home
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Get in touch
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Hussain Mooraj |
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Amit Agarwal |
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Omkar Kawalekar |
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Jennifer Rabin |
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Jessica Faust |
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