From: Challenges in the translation and commercialization of cell therapies
Key Challenges | |
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• Pre-market: Persevering through lengthy developmental timelines and navigating the regulatory environment | |
• Post-market: Securing reasonable reimbursement and encouraging adoption | |
• Manufacturing: Scaling up production, addressing distribution logistics and managing cost of goods sold | |
• Interactions among these various challenges complicate the process of commercializing cell therapies | |
Preliminary Best Practices | Policy Considerations |
• Preparing for commercialization early in the development process | • Improving coordination and communication between relevant agencies |
• Adopting strategies to use capital efficiently | • Promoting international harmonization of cell therapy regulations |