Cell/Gene Therapy Is Ripe For Real-World Data Given Length Of Follow-Up Required, Abernethy Says

The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.

real world data
Cell and gene therapy will push the evolution of real-world evidence use, Amy Abernethy said. • Source: Shutterstock

The growth in cell and gene therapy development will force industry and health technology providers to “get smart” about combining prospective clinical trial data with real-world data sources and addressing the “data quality mismatches” that will inevitably result, said Amy Abernethy, Verily clinical studies platforms president.

Abernethy, the former US Food and Drug Administration principal deputy commissioner under commissioners Scott Gottlieb and Stephen Hahn, said the...

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