Wednesday, December 06, 2017
Subject: DARPA Safe Genes Research
In light of the accusations you’re making about our Safe Genes program, particularly that we are targeting African communities with gene drive, I wanted to reach out to you directly and hopefully clear up the aims of our work. Our feeling is that the science of gene editing, including gene drive technology, has been advancing at a rapid pace in the laboratory. These leaps forward in potential capability, however, have not been matched by advances in the biosafety and biosecurity tools needed to protect against potential harm if such technologies were accidentally or intentionally misused, nor does data exist on how such technologies would actually function in the far more complex real world. DARPA, whose mission is to prevent strategic technological surprise, created the Safe Genes program to develop a toolkit to address potential health and security concerns related to the misuse of gene editors and to collect empirical data through laboratory-based demonstrations to gain a fundamental understanding of how gene editing technologies function.
Recent reporting on DARPA’s investments in gene editing technology under the Safe Genes program has painted this research as secretive. This, however, is patently false. DARPA publicly announced the program in September 2016, and made another announcement describing the proposed research when contracts were awarded in July 2017. Additionally, each of the teams receiving a DARPA contract made their own announcements describing their proposed research plans. All of the teams are university-led, perform fundamental research, and are welcome and encouraged to publish.
Contrary to opposing claims, DARPA and the research community we support are exquisitely aware of the need for transparency and engagement when conducting gene editing research, which is why we structured the Safe Genes program to emphasize open communication, data sharing, engagement, and ethics. Each Safe Genes team has resources and personnel dedicated to discussing ethical issues that may arise during the course of the program. The teams are also required by DARPA to regularly engage with potential stakeholders, including government regulators and communities that have expressed interest in gene editing technologies, so that their questions and concerns can be incorporated into Safe Genes laboratory-based experiments, thus increasing the value of the science. It is in this context that Safe Genes team members deliberately exchange information and ideas with their colleagues and other members of the research community, and DARPA fully supports that ongoing communication.
Although gene drive is one thrust of the program, Safe Genes is focused on gene editing technology more broadly. Among the seven teams, five work directly on novel biosafety and biosecurity measures for gene drive technologies. This work is being conducted exclusively in contained, bio-secure facilities, including simulated natural environments. DARPA is not funding any open release of modified organisms. Additional efforts aim to develop technology to enable precision medicine and other therapeutic and prophylactic uses of gene editors by protecting against unauthorized or unintentional edits to the genome and gaining greater control over where, when, and how gene editors are expressed in the body. The teams are pursuing tools to measure and restrict off-target effects of editors; detect, prevent, and reverse mutations caused by radiation exposure; develop natural and synthetic drugs to inhibit gene editing activity; develop novel treatments for viral infectious diseases; and improve delivery of gene editing treatments, all under the umbrella of the Safe Genes program.
As stated in our July 19, 2017, announcement of Safe Genes contracts to seven teams, DARPA anticipates investing $65 million in the Safe Genes program over four years. That investment covers not only gene drive, but also the other biosafety tools for gene editing that DARPA is pursuing. DARPA’s planned investment in Safe Genes is typical of a DARPA research program, which tend to range between $30-$100 million over three to five years, depending on the nature and complexity of the research. Some media reports have inaccurately stated that DARPA is funding the GBIRd organization. The gene drive research community is small, and as is typical of many fields of study, researchers are frequently funded by multiple sources to pursue different lines of research. While there are members of the GBIRd consortium that are also funded by DARPA in their roles at their home institutions, DARPA neither funds GBIRd nor directs its work, and the objectives being pursued under Safe Genes are separate and distinct from study pursued independently by GBIRd.
DARPA understands that Department of Defense funding is viewed with concern by some, which is another reason why we have placed such an emphasis on transparency, engagement, and data sharing. DARPA is not and should not be the only source of funding for gene editing research. However, the Safe Genes program addresses critical gaps in basic knowledge of how gene editing technologies function and in capabilities for mitigating potential threats posed by these technologies.
Jared B. Adams
Chief of Communications
Defense Advanced Research Projects Agency (DARPA)