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Companies Call for Genome Editing Regulations

Crispr genome edits illustration

(NIH.gov)

28 Aug. 2019. A group of companies developing treatments for disease using genome editing are calling for regulations and standards to govern these technologies in regenerative medicine. The Alliance for Regenerative Medicine in Washington, D.C. issued a Statement of Principles yesterday that the organization says offers an ethical framework for genetic modifications.

With genome editing, DNA is modified through deletion of mutated genes, insertion of healthy genes, or replacement or correction of genes. The use of these techniques for therapies is accelerating with advances in Crispr — short for clustered, regularly interspaced short palindromic repeats — that edits genomes of organisms by harnessing bacterial defense mechanisms using RNA to identify and monitor precise locations in DNA.

The group’s statement of principles makes a distinction between gene editing in somatic and germ line cells. Somatic cells are cells in the body other than sperm and egg cells involved in reproduction. Edited somatic cells do not pass along alterations to future generations. Germ line cells — eggs, sperm, and fertilized embryos — do pass on these changes. The Statement of Principles specifically endorses genome editing with somatic cells, but calls germ line editing “currently inappropriate in human clinical settings.” The group says “safety, ethical, legal, and societal issues” with germ line editing are unresolved.

In addition, the Statement of Principles calls for national and regional regulations through agencies such as the U.S. Food and Drug Administration and European Medicines Agency to provide oversight for further development of therapies with somatic cell gene editing. While the statement says these agencies should “act as the primary regulatory and enforcement mechanism” for gene editing, the group cautions against arbitrary oversight bodies that could delay research on gene editing and development of treatments for affected patients.

Alliance for Regenerative Medicine also calls for standards bodies including US Pharmacopeia, International Organization for Standardization, and the Genome Editing Consortium at National Institute for Standards and Technology to prepare technical standards for genome editing. The standards, says the statement, should cover issues such as off-target effects and genetic mosaicism, where a person has two or more genetically different sets cells in the body.

“As with all breakthrough biotechnologies,” says Janet Lambert, CEO of Alliance for Regenerative Medicine in a news release, “we need to exercise caution and good stewardship in our research and development practices and ensure that work involving the genetic modification of cells takes place within the bioethical framework outlined in these principles.”

The companies signing the statement include Audentes Therapeutics, bluebird bio, BlueRock Therapeutics, Caribou Biosciences, Casebia Therapeutics, CRISPR Therapeutics, Editas Medicine, Homology Medicines, Intellia Therapeutics, LogicBio Therapeutics, Precision Biosciences, Sangamo Therapeutics, and Tmunity Therapeutics.

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