Ethical, Societal, and Policy Issues in Germline Gene Editing

Wednesday, November 6 | 9 a.m.–5 p.m. | The Westin City Center, Washington, D.C.

A variety of stakeholders will present and discuss considerations surrounding germline gene editing, including current legal status for clinical research in the US and throughout the world; recent proposals to limit clinical applications; and potential mechanisms necessary to achieve societal consensus.

Objective: To begin to answer the following questions that arose from the announcement that came in November 2018 regarding the widely condemned clinical use of germline gene editing:

  1. How can future instances be prevented of clear crossing of the line of acceptable practice?
  2. What are possible governance structures and/or processes for prevention and enforcement?
  3. What should the current boundaries be on germline gene editing research, and what factors should be considered before changing limitations?

Full Agenda

Opening Remarks
9-9:30 a.m.

  • Tim Hunt, J.D.—Introduction to the Issues
    Senior Vice President of Corporate Affairs, Editas Medicine
  • Keith Joung, M.D., Ph.D.—Overview of the State of the Science of Somatic Gene Cell Therapies
    Associate Chief of Pathology for Research, Massachusetts General Hospital

The Need for an International Moratorium on Clinical Uses of Human Germline Gene Editing
9:30-10:30 a.m.

Keynote Speaker: Francis Collins, M.D., Ph.D., Director, NIHThe Need for an International Moratorium on Clinical Uses of Human Germline Gene Editing

Francis Collins, M.D., Ph.D., director of the National Institutes of Health (NIH) and a physician-geneticist, delivers his keynote address, “The Need for an International Moratorium on Clinical Uses of Human Germline Gene Editing,” at the ASGCT Policy Summit on November 6.

"This is a crucial moment in the history of science: a new technology offers the potential to rewrite the script of human life," Collins wrote for Nature with Carrie D. Wolinetz, Ph.D., Associate Director for Science Policy at NIH. "We think that human gene editing for reproductive purposes carries very serious consequences — social, ethical, philosophical and theological. Such great consequences deserve deep reflection. A substantive debate about benefits and risks that provides opportunities for multiple segments of the world’s diverse population to take part has not yet happened."

Collins has served as the director of the NIH since August 2009, and is noted for his landmark discoveries of disease genes and his leadership of the international Human Genome Project, which culminated in April 2003 with the completion of a finished sequence of the human DNA instruction book. He served as director of the National Human Genome Research Institute at NIH from 1993-2008.

Viewpoints on the Path Forward
10:15-11:45 p.m.

Patient Perspectives
12:45-2 p.m.

Ethical Perspectives on Clinical Use of Germline Gene Editing
2-3:15 p.m.

Approaches to International Governance and Engagement
3:30-5 p.m.

Keynote Speaker: Margaret Hamburg, M.D., Foreign Secretary of the National Academy of Medicine—WHO Expert Advisory Group on Developing Global Standards and Oversight of Human Genome Editing: An Overview and Update

Margaret Hamburg, M.D., an internationally recognized expert in medicine and public health, is the co-chair of the WHO advisory committee on governance and oversight of human genome editing, and currently serves as both foreign secretary for the National Academy of Medicine and chair of the board of the American Association for the Advancement of Science (AAAS). Hamburg was previously commissioner of the Food and Drug Administration, where she was known for advancing regulatory science, medical product innovation and the globalization of the agency.


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