Designing Institutions and Processes to Enable Integrative Programs on the Societal Aspects of Biological Research

The National Science Foundation's (NSF) Directorate for Biological Sciences (BIO) recently requested ideas on fundamental biological research questions and topics poised for major advances, as part of their program to create Integrated Institutes for Cross-Cutting Biology (NSF 19-027). Kenneth A. Oye, Megan J. Palmer, and Sam Weiss Evans respond to the request for information.

Read the full article here

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CRISPR babies in China

In November 2018, Chinese scientist He Jainkui announced the birth of the first genetically tailored humans using the gene editing.

This announcement has already raised many concerns and questions. On Friday, November 30, 2018 at SV 1717 there was a discussion on this specific case and on long-term issues that it raises for science and policy.

The following topics were addressed:

What was claimed and what was actually done in China ? Didier Trono
What is the medical significance and ethical propriety? Roger G. Clerc
What risk, governance and consent issues are associated? Marie-Valentine Florin
What are the short and long-term policy implications? Ken Oye

Short bios of the panelists:

Didier Trono, MD, is a Professor for genetics and virology at EPFL and helps stir the Swiss efforts towards exploiting new technologies in the field of health. Once focused on HIV/AIDS and gene therapy, his research is now exploring how epigenetics is shaping human biology and how its understanding can open new avenues in medicine.

Roger G Clerc, PhD, is a Professor for molecular biology and epigenetics at the Biozentrum University of Basel and a former Hoffmann la Roche principal scientist in metabolic disease area.

Marie-Valentine Florin is the Executive Director of the EPFL International Risk Governance Center, a multi-stakeholder platform and a convening place at the interface between science and policy.

Kenneth Oye, PhD, is a Professor in social sciences and engineering and Director of the Program on Emerging Technologies at MIT. He is a research affiliate of the Synthetic Biology Center, the Center for Biomedical Innovation and the Broad Institute Foundry. He is currently a visiting professor in SV and in the EPFL International Risk Governance Center.

Watch the full video here

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A Splice of Life

November 30, 2018

“The genie is out of the bottle,” says George Church, and he should know. Dr. Church at Harvard Medical School has been a respected keeper of the keys to the miracle, or monster, that is gene editing. It is bio-medicine’s new-found power not just to read the human blueprint, but to rebuild, cell by cell, the evolved model of mankind. And now a rogue Chinese scientist, Dr. He, has shown the world how not to go about it - he worked in secret, without the consent of his patients, then unborn, who weren’t even sick, and haven’t yet been seen. Dr. He has shocked the medical chieftains, East and West. Yet they dream the same dream: better living through bio-chemistry, inside the chain of human reproduction.

Guest List

Jeantine Lunshof: Research Scientist-Ethicist at MIT Media Lab, Assistant Professor of genetics at the University Medical Center Groningen, and Ethics Consultant to the Department of Genetics, Church Lab, and the Center for Excellence in Genomic Science and Center for Genomically Engineered Organs (CGEO) at Harvard

Sheila Jasanoff: Professor of Science and Technology Studies at the Harvard Kennedy School

Daniel Kevles: Professor of History, History of Medicine, and American Studies at Yale

Listen to the 90.9wbur podcast here

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Revisit NIH biosafety guidelines

To celebrate the anniversary of an arcane federal guideline is a rare event. For an agency to use that moment to invite reflection on modifying policies is even rarer. Last month, the U.S. National Institutes of Health (NIH) did just that, with a workshop that marked the 40th anniversary of its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The meeting was an inspiring start for charting future oversight of nonclinical applications.

Access the article here

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On Sources and Implications of Accelerating Innovation in Biotechnology: U.S. Opportunities and Challenges

Kenneth A. Oye
16 March 2016

Prepared statement of Dr. Kenneth A. Oye, Director, Program on Emerging Technologies, Professor, Political Science and Data, Systems and Society, Massachusetts Institute of Technology.

Testimony for U.S.-China Economic and Security Review Commission March 16, 2017. Hearing on China’s Pursuit of Next Frontier Tech: Computing, Robotics, and Biotechnology.

This statement describes the development of synthetic biology and genomics within the United States and China, analyzes opportunities and challenges facing the United States and suggests how the United States might better support high-quality, advanced biotechnology research and industry development going forward.

Access the paper here

Access the U.S.-China Economic and Security Review Commission website here

Link to video streaming testimony here
Panel III Biotechnology begins at 04:27:00
Ben Shobert, Rubicon Strategy Group
Kenneth A. Oye, MIT Political Science and PoET
Edward H. You, FBI Weapons of Mass Destruction Directorate

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On Revision of the Coordinated Framework for the Regulation of Biotechnology

This white paper provides responses to questions posed in the October 2015 request for comment on revision of the Coordinated Framework and offers recommendations on long term strategies to foster innovation while addressing potential risks. It divides into three sections.
Priority regulatory issues: This section treats issues of immediate concern, as defined by five questions posed in the October 2015 request for public comment on updating the Coordinated Framework. For each question, we provide a distillation of issues raised in public comments, highlight gaps in discussion to date, point to useful resources, and offer recommendations.
Long term strategies for responsible innovation: This section responds to Part II of the July 2015 memorandum on the scope of inquiry for review of U.S. biotechnology policy. We recommend a strategy of planned adaptation, with research designed to provide a scientific basis for public policy and with tools, procedures and schedules to foster systematic reevaluation of policies in light of changing understandings of benefits, risks, and social/economic context.
Appendix with Analysis of Public Comments: This section provides a more complete analysis of public comments by industry, the academy and civil society.

Access the paper here

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Regulating 'Gene Drives'

Members of the Program on Emerging Technologies (PoET) team are calling for thoughtful, well-informed, public discussions to explore the responsible use of gene drive technology in two recently published articles.

Imagine a scientific technique that would alter the genes of mosquitos to render them unable to transmit malaria. Scientists have made notable progress in recent years in editing the genomes of organisms, substituting in variants of certain genes; these variants could then propagate throughout a population. Gene drives are a method for spreading altered traits through wild popultations over many generations. Such gene drives could potentially prevent the spread of diseases, support agriculture by reversing pesticide and herbicide resistance in insects and weeds, and control damaging invasive species.

The concept of gene drives has been around for more than a decade but has remained theoretical due to technical limitations. However, with the recent development of CRISPR-Cas9 RNA technology, gene drives now represent a more realistic possibility. The benefits of such technology must also be weighed against its risks. The possibility of unwanted ecological effects and the likelihood of spread across political borders demand careful assessment of each potential application.

Access the articles by clicking on the links below:

Regulating Gene Drives
Kenneth Oye, Kevin Esvelt, Evan Appleton, Flaminia Catteruccia, George Church, Todd Kuiken, Shlomiya Bar-Yam Lightfoot, Julie McNamara, Andrea Smidler, & James P. Collins