BIO Statement on National Academies’ Consensus Study on Human Gene Editing
Washington, DC (February 14, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding the Consensus Study on Human Gene Editing, released today by the Human Gene Editing Initiative of the National Academies of Sciences and Medicine (NAS/NAM):
“We appreciate that the National Academies of Medicine and Science have taken the time to carefully review this cutting edge area of medicine. Independent, professional review has helped inform the legal, ethical, and regulatory aspects of recombinant DNA technology since the 1970s. For the past 40 years, with help from the scientific community, the United States has continuously added to a biomedical R&D framework of laws, regulations, and guidelines to keep pace with advances in genomics.
“Clinical applications of genomic editing in somatic cells (i.e. mature tissue cells such as eye, liver, lung, or blood cells) is on the cusp of providing groundbreaking new treatments for patients with a variety of diseases including sickle cell disease, hemophilia, cystic fibrosis, congenital blindness, cancer, and HIV.
“BIO shares the view reached by other leaders in the scientific and regulatory community that clinical applications of genome editing in somatic cells can be appropriately evaluated within existing, well-established regulatory frameworks for gene therapy.
“Regarding heritable modifications in human germline cells, BIO notes that there are safeguards in place in the United States to restrict such applications of genome editing.”
“Our members remain focused on clinical applications of genome editing in somatic cells (not inheritable cells).”
For further information, please see BIO’s FAQ on human genome editing.
About BIO
BIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members range from biotech start-ups to some of the world’s largest biopharmaceutical companies – all united by the same goal: to develop medical and scientific breakthroughs that prevent and fight disease, restore health, and improve patients’ lives. BIO also organizes the BIO International Convention and a series of annual conferences that drive partnerships, investment, and progress within the sector. Learn more at bio.org.