Integration of Omics Data into Clinical Drug Development
Project Description |
This project aims to advance the adoption of omics data in clinical drug development by addressing key challenges in data integration, quality, analysis and standardisation. Current limitations, including the inability of CDISC standards to fully accommodate complex omics data types and workflows, highlight the need for complementary approaches. The project will focus initially on the implementation of the BioCompute standard, developed in collaboration with the FDA to document bioinformatics workflows. Activities will include defining best practices, developing guidance for creating and validating BioCompute Objects, and outlining submission considerations. The project will also support knowledge sharing and community engagement to improve understanding and adoption. In the longer term, the initiative will explore broader topics such as data integration frameworks, regulatory guidance, quality control, and training. Establishing this Working Group early will support consistent adoption, provide industry feedback and help prepare for increasing regulatory use of omics data. |
Project Leads | |
|---|---|
Adrian Czaban, Novonordisk | |
Bron Kisler, International Organization for Standardization | |
Jonathon Keeney, George Washington University | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |
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