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Isabella Presch: A Step Toward Greater Regulatory Clarity in Genome-Editing Therapeutics

Isabella Presch/LinkedIn

Jul 3, 2026, 19:10

Isabella Presch: A Step Toward Greater Regulatory Clarity in Genome-Editing Therapeutics

Isabella Presch, Senior Medical Director Rare diseases, Advanced therapies and Pediatrics at Fortrea, shared a post on LinkedIn:

“A welcome step toward greater regulatory clarity in genome-editing therapeutics:

The continued advancement of genome-editing technologies will depend not only on scientific innovation, but also on the evolution of regulatory science.

Clear expectations for assessing off-target editing, chromosomal integrity, and genome-wide effects can help establish a common framework for safety evaluation, supporting both patient protection and the efficient development of transformative therapies for rare and genetic diseases.

The FDA‘s draft guidance, ‘Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing (NGS),” provides a scientifically rigorous framework for evaluating off-target editing, genomic integrity, sequencing methodologies, and bioinformatic analyses in support of genome-editing programs.

This guidance represents an important step in harmonizing expectations around the use of NGS-based methods to assess genome-editing risks.

Importantly, the FDA is currently seeking stakeholder feedback, with the public comment period open until 14 July 2026 offering sponsors, investigators, translational scientists, genomic technology developers, and bioinformatics experts a valuable opportunity to help shape the future regulatory framework for genome-editing therapies.”

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