Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Rapid scientific advances are expanding the types of products that can be generated through biotechnology. The U.S. regulatory system for biotechnology products was originally designed in the 1980’s. A committee of experts will identify the types of products that may be produced with biotechnology in the next 10 years and provide advice on the scientific capabilities, tools, and expertise that may be necessary to regulate those future products.
Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct
The study will examine a range of questions and opinions about the science, oversight, governance, and ethics of gene-drive research. Gene drives, a type of gene editing, spread gene modifications throughout a population of organisms intentionally. This study is intended to provide an independent, objective examination of what has been learned since the development of gene drives based on current evidence. The committee’s report was released in mid 2016.
Gene Editing to Modify Animal Genomes for Research Scientific and Ethical Considerations: A Workshop of the Roundtable on Science and Welfare in Laboratory Animal Use
An expert workshop to explore challenges facing the use of animals in scientific research stemming from the widespread use of gene editing technologies, such as CRISPR/Cas9, TALENS and “zinc fingers.” This workshop was held on December 7-8, 2015 in Washington, D.C.
Human Gene Editing Initiative
A joint activity of the National Academy of Sciences and the National Academy of Medicine to inform decision making related to recent advances in human gene-editing research. The initiative includes
- a comprehensive study of the scientific underpinnings and clinical, ethical, legal, and social implications of human gene editing, and
- an international summit, was held December 1-3, 2015, where global experts will discuss the scientific, ethical, and governance issues associated with human gene-editing research.
Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases
An expert committee conducted a study to inform the US Food and Drug Administration in consideration of review of applications in the area of genetic modification of eggs and zygotes for the prevention of mitochondrial disease. The committee’s report was released in early 2016.