(108c) Driving the Future of US Biotechnology: Governance and Ownership Challenges in the Age of Gene Drive

More than 3 billion people live in regions afflicted by malaria and other mosquito-borne diseases. Despite tremendous efforts, the World Health Organization estimates between 655,000 and 1.2 million people die from malaria each year, many of them children. Traditional vector control mechanisms, such as Sterile insect techniques or habitat removal, suffer from high economic and human costs. The recent development of CRISPR/Cas9 gene drives offers a powerful new means for controlling the spread of vector borne disease by propagating traits that interrupt the vectorâ??s ability to serve as a host for disease. Gene drives work by aggressively converting organisms heterozygous for the drive and associated traits into ones homozygous for the drive and associated traits. This causes a target allele to spread rapidly throughout a population. Given their propensity for self-propagation, these systems also radically challenge the existing governance structures for biotechnology.

In this talk, I outline recommendations for governing this emerging technology, focusing specifically on issues relating to oversight and liability, confinement and monitoring, and biosecurity and risk assessment. Gene drive challenges our existing technology paradigms; as such, a holistic approach is needed that centers on public engagement at the local, national, and international level. Similarly, holistic approaches are needed in researching and governing this technology: funding agencies must not only focus on the engineering questions, but on the ecological ones as well. Regulators should expand their scope to include additional federal agencies underneath the Coordinated Framework for the Regulation of Biotechnology, and risk assessors should operate in tandem with threat assessors to understand the opportunities presented by this technology in the context of relevant challenges. Gene drives have significant potential to address major problems in public health by preventing the ability of mosquitos to serve as vectors for disease. However, this technology is still in its infancy and much must be done to engage the public and develop appropriate controls and governance regimes prior to proposed environmental release.