An advocacy group focused on cell and gene therapy and regenerative medicine has issued what it called a bioethical framework for the use of gene editing in therapeutic applications, and more than a dozen biotech companies have signed on.
The Alliance for Regenerative Medicine released a statement Tuesday by its Gene Editing Task Force, signed by 13 companies, listing five of what they called key principles for ethical use of gene editing and genetic modification. Germline gene editing – modifications that can be passed on through multiple generations – received particularly close attention.
“Gene editing is a rapidly developing technology that represents one of the most exciting developments in medicine,” ARM CEO Janet Lambert said in a statement. “These techniques will be integral to the next generation of advanced therapeutics, and we welcome their potential to provide important, potentially life-saving treatments for patients.”
It’s not the first time that fears of the potential negative implications of gene editing have led to calls for stronger ethical frameworks. In March, a group of more than a dozen scholars called for a moratorium on human gene editing in the wake of last year’s “CRISPR babies” scandal.
The ethics of germline gene editing have become an especially hot topic in the field with the rise of technologies like CRISPR-Cas9. Indeed, it was the subject of a presentation at MedCity News’ CONVERGE conference in June, by Case Western Reserve University associate professor of bioethics Insoo Hyun.
Signatories to the ARM statement include Sangamo Therapeutics, whose CEO, Sandy Macrae, is co-chair of the gene-editing task force. Others were Audentes Therapeutics, bluebird bio, BlueRock Therapeutics, Caribou Biosciences, Casebia Therapeutics, CRISPR Therapeutics, Editas Medicine, Homology Medicines, Intellia Therapeutics, LogicBio Therapeutics, Precision Biosciences, and Tmunity Therapeutics.
Principles the signatories endorsed included investigation of therapeutic applications of somatic cell-based gene editing; use of standards to facilitate development of safe and effective therapies; continued evolution of national and regional regulatory frameworks government gene-editing techniques; opposition to germline editing; and common commitment to the idea that germline editing should not be condoned or supported until ethical and safety questions are addressed.
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