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GENOME EDITING AND THE BIOECONOMY (THEMES (Tool Development for R&D:…
GENOME EDITING AND THE BIOECONOMY
THEMES
Human Health
(biologist, pharmaceuticals, etc.)
Bottlenecks in Delivery
(technical [DARPA "hard problem"], etc.)
Agriculture
: GMO crops, plants, agriculture system is dominated by companies that are hyper-aware of the safety/security risks involved in changing food (PR issues around plants is very interesting...slo-roloing PR disaster for the last 30 years)
Insects
:
Livestock
: GM cows to make them not have horns [
Recombinetics
]
Tool Development for R&D
: companies are spring up to help people develop the tools they need to do what they want to do
[
platform technologies
] now people are trying to figure out delivery problems using platform technologies
GOVERNANCE CHALLENGES
What is the role of the government?
Regulations cover the end-product and has very little to say about the capabilities that are developed, leaving the US with incomplete tools to develop effective policies
#
It's not clear that the FDA will have regulatory authority over fine-tuned small edits
Partial solutions
are still good
If, and when, something happens, some scientists will be able to reply to the PR disaster saying that some of them are using the tech responsibly
Defining what the
product
is remains difficult
Identify the relevant stakeholders in the bioeconomy
Genome editing is a TOOL
Tool innovation is this field has outpaced regulation
Should look at intent and outcome - but that is recognizably difficult and hard to actually do
Risks to the Bioeconomy
How do we map the regulations and guidelines based on things that are truly dangerous and of great concern (not just what the public will likely be concerned about)?
DECLUTTER THE REGULATORY LANDSCAPE
Keep an eye on the emerging technologies may allow us to identify the potential end-points
ANTICIPATORY SELF-GOVERNING
#
DISCUSSION
Ritterson
: self-governance in industry is great, but industry developing their own self-governing principles may not actually work well because that's not what they're good at ...many more companies have thought about the risks of their customers using their tech to make their own drugs , not bioweapons... it's worth it to talk to industry to ensure that the regulations/governance options will actually work well for them...talking to them about "risks" may not resonate with them
Ritterson
: In some contexts "regulations" means "oversight"...in other contexts "regulations" means "legal [direction?]
Gormley
: Have you looked at regulations for GMO (ref. livestock example) ?
Carter
: YES, Europe has defined GMO in such a way that they're having to determine if genome editing fits within their strict definition
Palmer
: We also need to talk about how industry navigates regulations, not just how/what their doing and whether or not there's risks
Carter
: Working on a project where she's going to talk to industry and she imagines one of the primary topics will be liability
Weisman
: US-China differences in use of genome editing and how we are developing the tools and applying them are vastly different, which may well be due to geopolitical differences
Boyle
: setting standards and practices will likely be better received than regulations and rules (which can be arbitrary based on location and government)...in terms of overall biosecurity, developing better codes of conduct may be better than trying to institute rules form on high :star:
ANALOGY: GENOME EDITING AND COMPUTER CODE :star:
Breaker
: really likes Boyle's analogy and wants to develop it further
Relman
: which actors are we talking about here in the bioeconomy? (industry?, the public? (but there's different kinds of 'public') How do we serve the other kinds of public?
Palmer
: Models for options of governance (we'll need to look at other sources of inspiration), love to figure out how to bring in those other examples (examples of regulatory paradigms)...How do we actually prioritize the items that will be relevant to the discussion...she also struggles with the term 'bioeconomy' like Boyle....seems like ti's trying to get at the primary and binary effect (directly or indirectly targeted)
Koblentz
: regulation is the boogie-man for private industry...so we need to really define what we mean by the term because regulations don't have to be penalties, they can be incentivized (the US government can deincentivize certain behaviors (i.e., not doing research with nods to biosafety and biosecurity)