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GENE DRIVES:
READY OR NOT?
Weston Kightlinger
GeneMods Meeting
1/10/2016
Outline
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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
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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
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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.