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BIO Statement on National Academies’ Consensus Study on Human Gene Editing

February 14, 2017

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 world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

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