Ethical challenges for a new generation of early-phase pediatric gene therapy trials

Author:

Iyer Alexander A.ORCID,Saade Dimah,Bharucha-Goebel Diana,Foley A. Reghan,Averion Gilberto ‘Mike’,Paredes Eduardo,Gray Steven,Bönnemann Carsten G.,Grady Christine,Hendriks Saskia,Rid Annette

Publisher

Elsevier BV

Subject

Genetics (clinical)

Reference72 articles.

1. Gene therapy comes of age;Dunbar;Science,2018

2. US Food and Drug Administration. FDA continues strong support of innovation in development of gene therapy products. 2020. https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products. Accessed 29 June 2020.

3. US Food and Drug Administration. FDA approves first cell-based gene therapy for adult patients with relapsed or refractory MCL. 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-relapsed-or-refractory-mcl. Accessed 26 January 2021.

4. American Society of Gene & Cell Therapy. Glossary. https://www.asgct.org/education/more-resources/glossary. Accessed 10 December 2020.

5. DAKuzminet al. The clinical landscape for AAV gene therapies. Nat Rev Drug Discov. 2021. https://doi.org/10.1038/d41573-021-00017-7. Accessed 22 March 2021.

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