NAS Meeting on Human Germline Modification Taking Shape

The US National Academy of Sciences (NAS) will hold a meeting on heritable human genetic modification on December 1-3, 2015 in Washington, D.C. Invitations to the NAS meeting to individuals starting going out last week.

The upcoming NAS meeting seeks to address these issues and discuss the possibility of a moratorium on clinical use of genetic modification technology. It could play a crucial role in shaping both national and global policy on human genetic modification.NAS gene editing

The meeting was sparked in part by rising concerns over the possibility that some scientists may race ahead to clinical use of new gene editing technologies such as CRISPR-Cas9. Such clinical use of human genetic modification technology could pose serious risks to both individuals and to science. Others have the opposite view and favor allowing heritable human editing to proceed as a natural course of science delineated only by existing regulations rather than a moratorium. An international meeting would have the goal to reach consensus on prudent policy in this area, just as the 1975 Asilomar meeting did on genetic engineering.

The NAS has announced that both the Royal Society and the Chinese Academy of Sciences are partnering on the new 2015 meeting. This is a positive step as it will increase the diverse, global views on the key issues. Leaders of both the new partners indicated their enthusiasm for the meeting:

“Human gene editing offers great promise for improving human health and well-being but it also raises significant ethical and societal issues,” said Royal Society President Paul Nurse.  “It is vital that we have a well-informed international debate about the potential benefits and risks, and this summit can hopefully set the tone for that discussion.”

Chinese Academy of Sciences President Chunli Bai said, “Both Chinese scientists and the government are aware of the pros and cons of human gene editing.  CAS scientists have organized a panel discussion and coordinated with related government agencies for regulatory policies on this issue.  We would like to work together with international communities for the proper regulation and application of such technology.”

One issue, however, is whether it could be a challenge for a meeting with such a broad spectrum of views and constituents to reach a focused consensus.

Details on the meeting are starting to come out on social media too.

Bioethicist Tetsuya Ishii tweeted about his invite to the meeting.

From the NAS website here are the meeting organizers:

  • David Baltimore (chair), president emeritus and Robert Andrews Millikan Professor of Biology, California Institute of Technology, Pasadena United States
  • Françoise Baylis, professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie University, Nova Scotia Canada
  • Paul Berg, Robert W. and Vivian K. Cahill Professor Emeritus and director emeritus, Beckman Center for Molecular and Genetic Medicine, Stanford University School of Medicine, Stanford, Calif. United States
  • George Q. Daley, Samuel E. Lux IV Professor of Hematology and Oncology, and director, Stem Cell Transplantation Program, Boston Children’s Hospital and Dana-Farber Cancer Institute, Boston United States
  • Jennifer A. Doudna, investigator, Howard Hughes Medical Institute; and professor, department of molecular and cell biology, Lawrence Berkeley National Laboratory, and department of chemistry, University of California, Berkeley United States
  • Eric S. Lander, president and director, The Broad Institute of Harvard and MIT, Cambridge, Mass. United States
  • Robin Lovell-Badge, group leader and head, division of stem cell biology and developmental genetics, The Francis Crick Institute, London United Kingdom
  • Pilar Ossorio, professor of law and bioethics, University of Wisconsin; and ethics scholar, Morgridge Institute for Research, Madison United States
  • Duanqing Pei, professor and director general, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Guangzhou China
  • Adrian Thrasher, professor of paediatric immunology, University College London United Kingdom
  • Ernst-Ludwig Winnacker, professor emeritus and director emeritus, Gene Center, Ludwig-Maximilians University, Munich Germany
  • Qi Zhou, professor and deputy director, Institute of Zoology, Chinese Academy of Sciences, Beijing China

Baltimore, et al. propose path forward for human germline engineering in Science

In a new perspectives piece in Science, Nobel Laureate David Baltimore and co-authors including Jennifer Doudna and George Church, chart a potential path forward for human genomic engineering involving germline modification. See also accompanying Bioethics piece by Gretchen Vogel as well, “Embryo engineering alarm”.

human germline editing policy

In the piece, entitled “A prudent path forward for genomic engineering and germline gene modification” calls for further discussion and assessment of key potential benefits and risks to moving forward with this technology. The illustration included here is from the piece.

The piece is reflective to a large extent of conclusions from a recent meeting held in Napa on this issue.

The summary statement is as follows:  “A framework for open discourse on the use of CRISPR-Cas9 technology to manipulate the human genome is urgently needed.”

They make 4 more specific recommendations.

  1. Strongly discourage clinical application of this technology at this time.
  2. Create forums for education and discussion
  3. Encourage open research to evaluate the utility of CRISPR-Cas9 technology for both human and nonhuman model systems.
  4. Hold an international meeting to consider these issues and possibly make policy recommendation.

This statement seems mostly in synch with the recently released ISSCR statement, but perhaps not quite as strong as it does not call for a moratorium on clinical use as ISSCR does and instead “strongly discourages” such applications.

In addition, this piece by Baltimore, et al. conveys more of a sense of optimism and somewhat of a more relatively positive vision that eventually CRISPR-Cas9 human germline editing might have safe, effective and ethical clinical applications. Even so they are relatively cautious about that possibility:

“At present, the potential safety and efficacy issues arising from the use of this technology must be thoroughly investigated and understood before any at-tempts at human engineer-ing are sanctioned, if ever, for clinical testing.”

The full list of authors include David Baltimore, Paul Berg, Michael Botchan, Dana Carroll, R. Alta Charo, George Church, Jacob E. Corn, George Q. Daley, Jennifer A. Doudna, Marsha Fenner, Henry T. Greely, Martin Jinek, G. Steven Martin, Edward Penhoet, Jennifer Puck, Samuel H. Sternberg, Jonathan S. Weissman, and Keith R. Yamamoto.

One interesting thing to ponder is the potentially more diverse views amongst this list of scientists and bioethicists even though have come to a consensus clearly on key issues.

For example, in Vogel’s piece, Church is quoted with what might be viewed as somewhat of a dissent on at least one level:

“Those uncertainties, together with existing regulations, are sufficient to prevent responsible scientists from attempting any genetically altered babies, says George Church, a molecular geneticist at Harvard Medical School in Boston. Although he signed the Science commentary, he says the discussion “strikes me as a bit exaggerated.” He maintains that a de facto moratorium is in place for all technologies until they’re proven safe. “The challenge is to show that the benefits are greater than the risks.”

What are your thoughts on this new Science paper and the ISSCR statement, both out today?

Vote For Stem Cell Person of the Year 2013 to Determine Finalists

Stem Cell SymbolHappy Stem Cell Day!

I’m using this occasion to introduce today an important element of my new book, Stem Cells: An Insider’s Guide, and that is a new international stem cell symbol and logo (see at right).

More on that later this week.

Also on this day, online voting begins on a great group of nominees for the Stem Cell Person of the Year 2013.

Please vote in the poll below on your choice from the list as to who should be the semifinalists.

You can vote up to 4 times in any 24-hour period.

Voting will close in 2 weeks on Wednesday October 16 at 11:59PM PT.

The top group of 12 vote getters will move on in the process as Finalists.

You can read a bit about each nominee in alphabetical order by first name with one or two sentences about them, often taken from the nominator(s) here. 

Feel free to post comments on your favorites.



Nominees for Stem Cell Person of the Year 2013: scientists, advocates, physicians, and the Pope

Nominations for Stem Cell Person of the Year 2013 closed last night.

stem cell logo

I ended up with a remarkable list of 30 nominees.

I have included a few sentences about each one below, often taking verbiage directly from the nominator.

The online voting on these nominees will start soon. The top vote getters will move on as finalists.

Stay tuned!

Nominees in alphabetical order by first name.

Alexey Bersenev. Leading blogger, expert, and global educator about clinical applications of stem cells. Thoughtful, knowledgeable, and balanced approach to the field.

Beth Brinkmann. Deputy Assistant Attorney General of the US who led the administration’s successful case in Sherley v. Sebelius, the case challenging the legality of federal funding for embryonic stem cell research.

Chris Centeno. Physician doing stem cell treatments, founder of predecessor to ICMS, and a leader in efforts aimed at FDA reform to broaden the use of stem cells.

Don C. Reed. Tireless spinal cord injury and stem cell research advocate instrumental in the creation of CIRM and promotion of innovative stem cell research. An unsung hero. Blogger and frequent speaker at stem cell meetings.

Duane Roth (posthumous). Energetic Vice Chair of CIRM Board and leader of CONNECT, an organization promoting entrepreneurship in the San Diego area. Passed away at age 63 on August 4, 2013 from injuries sustained from a cycling accident during a fund raising event.

Elena Cattaneo. Professor of Pharmacology and Director of UniStem, the Centre for Stem Cell Research at the University of Milano, Italy. Took a courageous stand on the Stamina case and is the driving force behind UniStem Day. A “Senator for life” member of Italian Senate, meaning appointed for the rest of her life as a Senator.

George Q. Daley. Leading stem cell researcher, Professor at Harvard, Director of Stem Cell Transplantation Program HHMI/Children’s Hospital Boston, and former ISSCR President. Outstanding voice for the stem cell field.

Hideki Taniguchi. Scientist who led the team that made the first bioengineered micro-liver like structures that have functional properties with huge clinical implications for the future treatment of liver disease, an enormous growing problem in the world.

Hongkui Deng. First stem cell researcher to achieve all chemical cellular reprogramming to make iPS cells, which may lead to safer iPS cell-based therapies.

Jacob Hanna. His lab at the Weizmann Institute has reported the first essentially perfect reprogramming efficiency to make iPS cells with big clinical implications.

Jeff Sheehy. Member of CIRM Governing Board. HIV/AIDS patient advocate. Communications Director of UCSF AIDS Research Institute. Very effective, wise advocate for stem cell research.

Joanne Kurtzberg. Professor and Co-Director of Stem Cell Laboratory at Duke. Pioneering stem cell researcher in the area of clinical application of stem cell technology.

Juergen Knoblich.  Scientist who led the team that made first human “mini-brains” from stem cells, a discovery that could have far-reaching medical implications.

Lee Buckler. Global stem cell and cellular therapy expert who is also a dedicated educator and advocate for advancing the field. Makes real things happen in the stem cell field.

Leigh Turner. Bioethicist who has been leading efforts for appropriate FDA regulation of stem cell therapies. A powerful advocate for ethical stem cell research and protection of patients.

Manuel Serrano.  Scientist who led the team that conducted in vivo reprogramming to make iPS cells in living mice. This innovative work could help make in vivo reprogramming-based medicines a reality in human patients.

Marion (Joe) Riggs. Founder of Student Society for Stem Cell Research (SSSCR). Scientist and advocate who is strongly dedicated to educational outreach and inclusivity in the stem cell field.

Masayo Takahashi. Scientist leading the first ever in human iPS cell-based clinical trial. Vision researcher who may help develop new treatments for blindness and vision impairment.

Patricia Olson. Executive Director of Scientific Activities at CIRM and active in CIRM scientific leadership from day 1. A driving force in the stem cell field.

Pope Francis. Leader of Worldwide Catholic Church. Strong supporter of adult stem cell researcher.

Robert Klein. Visionary stem cell advocate. Leader of successful Prop. 71 effort that led to formation of CIRM and now Chair Emeritus of CIRM ICOC Board.

Robert Lanza. CSO of Advanced Cell Technology (ACT) and top global stem cell thought leader. The man who will make regenerative medicine a household word.

Robin Smith. CEO of NeoStem, biotech company focusing on therapies developed using adult stem cells including VSELs. Innovator and pioneer in the stem cell field.

Sabrina Cohen.  Spinal cord injury patient and stem cell research advocate for more than a decade as well as amazing educator and motivational speaker.

Shoukhrat Mitalipov. Scientist whose lab published the first successful human somatic cell nuclear transfer-based human therapeutic cloning to make human ES cells, the most important research development in stem cells of 2013. Also pursuing research into oocyte transfer-based therapies for mitochondrial disorders.

Sonia Vallabh. Incredibly brave advocate for stem cell research. Stem cell scientist at Mass General Hospital. Co-Founder of Prion Alliance and

Sonia Skarlatos (posthumous). Long-time scientific leader at NIH with the National Heart, Lung, and Blood Institute where she was a tireless supporter of stem cell research. Passed away at age 59 on August 6, 2013.

Susan Solomon. Co-Founder and CEO of The New York Stem Cell Foundation (NYSCF). Remarkably effective advocate for stem cell research.

Ted Harada. Leading stem cell research advocate and very effective ALS patient advocate. Brings unmatched energy and enthusiasm to the field. Promoting intelligent reforms to the FDA process for stem cells.

Ulrich Mueller. Stem cell researcher and Chair, Dept. of Molecular and Cellular Neuroscience at Scripps.

Disclosures. Only those nominees listed above will be voted on starting this week. Some other nominations were also sent to me that I chose for various reasons not to move forward on and hence those nominees are not listed. It is also important to note that I do not endorse any specific nominee and just because someone is a nominee does not mean I support all of their specific efforts. I also do not necessarily agree with all the language used to describe the candidates.