This chapter covers the considerations beyond the scientific and clinical challenges that academic researchers, in particular, may face. Regardless of cartilage type, successful translation from benchtop to bedside requires a comprehensive understanding of the regulatory landscape, intellectual property, and funding and resource requirements during different phases of development. Here, the framework for regulating tissue-engineered cartilage products in the United States is discussed with a description of the United States Food and Drug Administration (FDA) regulatory pathway for cartilage products. The chapter also highlights important considerations for intellectual property management and funding and resource requirements throughout translation. Overall, these sections equip researchers with the foundational knowledge needed to navigate the complex translational and regulatory landscape for tissue-engineered cartilage products.

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Translational Considerations

  • Takumi Takahashi,
  • Rachel C. Nordberg,
  • Jerry C. Hu,
  • Kyriacos A. Athanasiou

摘要

This chapter covers the considerations beyond the scientific and clinical challenges that academic researchers, in particular, may face. Regardless of cartilage type, successful translation from benchtop to bedside requires a comprehensive understanding of the regulatory landscape, intellectual property, and funding and resource requirements during different phases of development. Here, the framework for regulating tissue-engineered cartilage products in the United States is discussed with a description of the United States Food and Drug Administration (FDA) regulatory pathway for cartilage products. The chapter also highlights important considerations for intellectual property management and funding and resource requirements throughout translation. Overall, these sections equip researchers with the foundational knowledge needed to navigate the complex translational and regulatory landscape for tissue-engineered cartilage products.