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Table 2 Summary of key conclusions

From: Challenges in the translation and commercialization of cell therapies

Key Challenges

• 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