Industry's Cure For Biomarker Development Woes: Standards, Transparency, Incentives
Panelists at BIO also said FDA should leverage external expertise in designing biomarker development programs and adopt an advisory committee approach to reviewing qualification packages.
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FDA has been reluctant to lay out evidentiary standards for biomarker qualification, but its call for information on promising candidates may be an initial step toward creating such a framework.
Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.