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GENE DRIVES: READY OR NOT? Weston Kightlinger GeneMods Meeting 1/10/2016 Outline • • • • • • What are gene drives? A brief history of gene drives The CRISPR revolution in gene drives Pushback from scientific and regulatory communities How do we regulate gene drives? Discussion Gene drives stimulate biased inheritance of particular genes to alter entire populations. E. Otwell and M. Telfer. ScienceNews. 2015 The idea of gene drives has been around for more than 10 years, but CRISPR accelerated it’s development. 2003 2011 2014 The idea of gene drives has been around for more than 10 years, but CRISPR accelerated it’s development. Apr 2015 Nov 2015 Dec 2015 Jan 2016 Quick introduction to CRISPR: Bacterial Immunology Doudna & Charpentier. Science. 2014 Quick introduction to CRISPR: Biotech application CRISPR gene drives can be readily programmed more rapidly, more robustly, and with more versatility. Many safeguards to gene drives have been proposed and some have been employed. Actual proof of a gene drive safe guard in yeast Dicarlo et. al Nature Biotechnology 2015 Gene drives have many applications in diverse fields. How Do We Regulate Gene Drives? “Safe and effective”…whatever that means Don’t mess with plants! Toxic Substances! “peaceful purposes”… whatever that means No thanks UN, just don’t mess with anthrax. Veterinary Medicines!! USDA/APHIS • • • • FDA EPA Implement Physical and Molecular safety measures during testing Evaluate case-by-case and based on function Experts should do the regulating! Just don’t mess this up! UN US Security Scientists Oye et al. Regulating Gene Drives. Science. 2014. Remaining issues with gene drives • CRISPR often cuts off target. • The gene drives must not reduce the reproductive fitness of the carrier animal. • Gene drives must be robust and stable enough to get through the entire population without mutations. This might require periodic release. • In mosquito experiments, only males passed on the gene with high efficiency because of differences in preference towards non-homologous end-joining or homologous repair. Basically, this can depend on the organism. • Many agency approvals would be necessary to do this intentionally and legally. “If anyone messes up and a gene drive gets out into the wild, there will be a huge media circus. The message will be that scientists cannot be trusted to deal with this technology, and we will be set back by years.” -Esvelt Discussion Can we really know enough about our environment to make gene drives safe? What do you think would be the ideal characteristics of a gene drive regulatory strategy? What regulatory body would be qualified to make a decision about the use of a gene drive? Are there any issues with the currently advertised safety measures for gene drives? How can gene drives be implemented responsibly? Is there any new research in this area that I missed? How do we regulate gene drives: 3 Key Players Animal and Plant Health Inspection Service Food and Drug Administration Environmental Protection Agency (EPA) - Biopesticides Drugs - All intergenic microbes Any animal not covered by FDA - Jurisdiction only covers Food - Treated as “new plant pests Dietary Supplements chemicals” Cosmetics - Broadest safety considerations - Reviewers only consider - Environmental effects safety to other plants not considered - Some plants aren’t covered at all in this system! J. Craig Venter Institute. May 2014 “If anyone messes up and a gene drive gets out into the wild, there will be a huge media circus,” he says. “The message will be that scientists cannot be trusted to deal with this technology, and we will be set back by years.” -Esvelt Many safeguards to gene drives have been proposed and some have been employed.