The Alliance for Regenerative Medicine Releases Statement in Response to National Academies Report on Human Genome Editing

WASHINGTON, DC--(Marketwired - Feb 14, 2017) - The National Academies of Sciences, Engineering and Medicine today issued a report that examines the scientific, clinical, ethical, legal and social implications of human genome editing. The Alliance for Regenerative Medicine (ARM) believes that genomic medicines, including genome editing, hold great promise for the treatment of a multitude of hereditary and acquired diseases where there is presently no effective treatment available.

ARM issued the following statement:

The Alliance for Regenerative Medicine (ARM) applauds the National Academies of Sciences, Engineering and Medicine for its very thorough and thoughtful report on the current scientific, technical, ethical, and policy issues relating to human genome editing. We support the need for responsible and ethically appropriate approaches to research and clinical use of these technologies following the seven guiding principles outlined in the report, as well as the need for continued public engagement and dialogue. We also commend the Academies for recognizing the profound impact genome editing will have on the development of a new class of medicines for many patients with presently incurable diseases.

We believe the report's recommendations that "existing regulatory infrastructure and processes for reviewing and evaluating somatic gene therapy to treat or prevent disease and disability" are sensible and will help create a safe path toward eventual clinical adoption and regulatory approval of therapeutics based on somatic cell genome editing.

In addition, we note the report's recommendations on heritable germline genome editing and the strict criteria to be met before ever considering clinical study. ARM will continue to monitor developments related to these applications, but until safety is proven and the risks associated with long-term consequences, both intended and unintended, are fully evaluated, we will remain solely focused on realizing the full therapeutic potential of somatic cell genome editing. Further, we must be satisfied that all relevant moral and ethical issues have been addressed and that a broad societal consensus exists as to the benefits and risks associated with editing the germline.