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Genotoxicity evaluation of gene therapies: highlights from IWGT 2022
  • +2
  • Silvana Libertini,
  • Julie Jadlowsky,
  • Thomas Lanz,
  • Lauren Mihalcik,
  • Daniella Pizzurro
Silvana Libertini
Novartis Institutes for BioMedical Research Basel

Corresponding Author:silvana.libertini@novartis.com

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Julie Jadlowsky
University of Pennsylvania Perelman School of Medicine
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Thomas Lanz
Pfizer Global Research and Development
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Lauren Mihalcik
Aclairo Pharmaceutical Development Group Inc
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Daniella Pizzurro
Merck & Co Inc
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Abstract

At the 8th International Workshop on Genotoxicity Testing (IWGT) meeting in Ottawa, August 2022, a plenary session was dedicated to the genotoxicity risk evaluation of gene therapies, including insertional oncogenesis and off-target genome editing. This brief communication summarizes the topics of discussion and the main insights from the speakers. Common themes included recommendations to conduct tailored risk assessments based on a weight of evidence approach, to promote data sharing, transparency, and cooperation between stakeholders, and to develop state-of-the-art validated tests relevant to clinical scenarios.
24 Jul 2024Submitted to Environmental and Molecular Mutagenesis
24 Jul 2024Submission Checks Completed
24 Jul 2024Assigned to Editor
24 Jul 2024Review(s) Completed, Editorial Evaluation Pending
26 Jul 2024Reviewer(s) Assigned
19 Aug 2024Editorial Decision: Revise Minor
04 Sep 20241st Revision Received
05 Sep 2024Submission Checks Completed
05 Sep 2024Assigned to Editor
05 Sep 2024Review(s) Completed, Editorial Evaluation Pending
06 Sep 2024Editorial Decision: Accept