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    Advanced therapies: ‘Trip hazards’ on the development pathway

    This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call “the trip.” The authors examine at strategic levels the importance of some of the fundamental building blocks for the development program and highlight some commonly encountered challenges (trip hazards) for cell and gene therapies and offer “bench-to-bedside” and chemistry, manufacturing, and controls (CM...
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    FDA Regenerative Medicine Policy Framework and Advanced Therapy Designation

    This article discusses the policy framework established by the US Food and Drug Administration (FDA) for the regulation of regenerative medicine and advanced therapies. The four guidance documents supporting regenerative medicine regulation are summarized against the background of FDA's regulation of human cells, tissues and cellular and tissue-based products. Introduction In November 2017, FDA published a comprehensive Regenerative Medicine Policy Framework to stimulat...