crispr-cas the future of - houston foresight · 2020-06-05 · biohacking increase in crispr...

26
1 Miranda Mantey, University of Houston Fall 2019 The Future of CRISPR-cas 9

Upload: others

Post on 16-Jul-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

1

Miranda Mantey, University of HoustonFall 2019

The Future of CRISPR-cas9

Page 2: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Table of Contents

IntroductionSlide 3

Executive Summary

Slide 4

FramingSlide 5

HistorySlide 6

Current Conditions

Slide 7

ScanningSlide 8

Stakeholder Analysis

Slide 10

DriversSlide 11

ScenariosSlide 12

ImplicationsSlide 15

RecommendationSlide 18

2

Page 4: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Executive SummaryForming the Future

4

To what extent will CRISPR be utilized as a medical and cosmetic therapy?

The Drivers

Technological Capabilities— the potential size of impact CRISPR can have on the medical and cosmetic communities

Domestic Regulatory Freedom— how much freedom researchers, medical practitioners, and individuals will have to utilize CRISPR

Biohackers— the pressure put on regulators for loosening access and the amount of “blackmarket” CRISPR usage there is

Prevalence of Cosmetic Edits— whether or not people will be demanding for and accessing cosmetic editing therapies such as intelligence and appearance

Global Genetic Cohesion— whether or not there will be international alignment in both regulation and technological development

The Scenarios The Impact

Baseline— “Just the Right Dose?” Regulatory restriction limits the sophisticated technology

Transformation— “CRISPR: The New Vaccine” Industry self-regulation enables extensive, safe, CRISPR usage

Collapse— “Too Much Freedom Too Soon” Genetic chaos from an overhyped technology with no regulatory safeguards

New Equilibrium— “The Push and Pull for Stability” Self-regulation proven successful for somatic editing, but the government is stepping in for germline editing

Implications from the baseline show that regulation:

● Won’t stop the CRISPR momentum ● Could create economic productivity due to

an industry around regulatory compliance ● Won’t protect the alterations from entering

a country (risk of genetic tourism)● Backfire by harming physical health ● Widening of wealth gap and harming

mental health of the unedited

Recommendation to UNESCO’s International Bioethics Committee

1. Release standardized approval criteria for CRISPR-related research and therapies that any government can consume, in order to optimize speed of R&D and get cures to market sooner

2. Create an international coalition of regulators to discuss CRISPR, its implications, and the best way to regulate it on an international scale

Page 5: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

FramingRegulation at the Center

5

To what extent will CRISPR be utilized as a medical and cosmetic therapy? Key Question

● What will be the capabilities of the technology and how sophisticated will it be?● What will the regulatory landscape look like internationally?● What will be the demand for and cultural reactions to the tool?

UNESCO’s International Bioethics Committee

● Concerned with how to guide regulators on their approach to CRISPR

Client

GlobalScope● Framed around CRISPR having

some technological traction but sophistication may vary

● Time horizon 2026+

Project Domain Map Focus on human interventions

Page 6: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

HistoryThe Pace of the Past Accelerating the Future

6

2008Researchers

demonstrate that CRISPR fights off

attacking phages by targeting DNA as opposed to the

previously-thought RNA

2011Jennifer Doudna and

Emmanuelle Charpentier discover that under the right

circumstances CRISPR would cut any genome

2013 Feng Zhang, from the

Broad Institute publishes a paper showing that

CRISPR could edit cultured mouse or

human cells, and George Church from Harvard shows how a different technique could edit

human cells

2016The UK government

approves the first human studies that apply CRISPR

to human embryos, although they cannot be transferred to a woman

and it has to be for research purposes

2017National Academy of

Sciences and the National Academy of Medicine publishes a

report saying that genetic editing of the

heritable germline could one day be approved for serious conditions with

heavy oversight

2018Chinese scientist, He Jiankui,

announces that the first CRISPR babies (altered to be resistant to HIV) were born.

This creates international outrage and sparkes

conversations on the ethics of CRISPR. The act

reportedly broke many Chinese laws.

Page 7: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Current ConditionsA New Technology’s Ripple Effect on Society

7

There have only been three CRISPR-edited babies born and all are

around one-year-old. They were edited with medical purposes in

mind. This was considered a controversial and unethical move.

CRISPR can now splice entire chromosomes which is a significant

step-up from traditional genetic editing techniques

A moratorium by 18 scientists from seven different countries was published

in Nature. It requested for countries to temporarily ban heritable germline

editing until the technology develops more and an international framework

for genetic editing can be created.

The technology is far from perfect. Issues that have recently come to the forefront include instances of mass deletion, rearrangements, and CRISPR-edited cells causing cancer

Years of patent issues still aren’t over. Recently the United States Patent and Trademark Office declared interference between 13 patents and 1 application from the Broad Institute and 10 patents from the University of California

CRISPR has now entered human trials in the United States, although not in the embryonic stage. In these trials the technology is being used to combat cancer and blood disorders. Success would be fundamental to further experimentation at procreation.

Page 8: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

8

There is demand and the tech is advancing quickly for both medical

and cosmetic purposes, but accuracy is still a concern

Consumer trends outside the space could signal an increase in interest for

CRISPR for cosmetic purposes

● By the end of 2019, a Russian biologist wanted to alter babies who would be deaf and has five interested couples; a company claims to predict embryo’s intelligence; evidence that disabling a protein could “cure” the common cold

● CRISPR is still making mistakes in trials

● Increase in plastic surgery demonstrates a willingness to have serious medical procedures for cosmetic purposes

● Increase in IVF treatments which is the best method for cosmetic intervention

● Primary research shows 56% of those surveyed are comfortable with edits to intelligence but only 28% are comfortable with edits to appearance

Scanning and Research HighlightsA High-Demand Technology Quickly Advancing

The government is making it easier for scientific experimentation but harder

for self-experimentation

● Decrease in regulation of research proposals but beginning to regulate home CRISPR kits to warn against self-application

● Primary research shows that 72% of those surveyed are uncomfortable with biohacking

Increase in CRISPR products in the consumer market is ultimately decentralizing access to the

technology

● DIY CRISPR Kits coming to market, and a “CRISPR-Chip” to better detect genomic information is being developed and the founders’ plans include it being used in everyday life

CU

RR

EN

T T

RE

ND

S

PR

IMA

RY

RE

SE

AR

CH Highlights relevant to analysis (n=18)

Page 9: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

9

Researchers and organizations are

making a stand on the ethics of CRISPR

potentially to curb government regulation through self-regulation

● Researchers’ disapproval of editing germline cells aligns with primary research showcasing consumers’ disapproval

● The Alliance for Regenerative Medicine’s 13 members have pledged not to edit germline cells for the time being

● Primary research shows that 77% of those surveyed believe that the technology should be regulated in regards to use

Scanning and Research HighlightsA High-Demand Technology Quickly Advancing

There are layers of ethical considerations that we may not have

yet contemplated

● People are requesting to use CRISPR for the creation of saviour siblings— an ethically murky choice to birth another child to help the medical ailments of their older sibling

The greatest impact will likely be on single-letter

variation diseases

● CRISPR is projected to have an impact on nearly two-thirds of the over 50,000 genetically- based single-letter variation diseases

Upcoming trials are expected to advance

the technology and define its technological

constraints

Current/upcoming US trials include:

● Editing T Cells to fight cancer (Sept 2018 untill 2033)

● Boosting fetal hemoglobin for patients with sickle cell disease (concluding in 2022)

● Editing donor T cells to fight lymphoma

● Editing photoreceptor cells to treat inherited blindness— the first experiment where editing happens in vivo (in the body)

PL

AN

S

PR

OJE

CT

ION

S

ISS

UE

S

PR

IMA

RY

R

ES

EA

RC

H Highlights relevant to analysis (n=18)

Page 10: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Stakeholder Interest Implication Level of Impact

PEOPLE

Medical Recipients Directly impacted by the technology. It could have permanent, life-altering effects (positive or negative)

If it is a medical necessity, individuals are likely willing and demanding the regulatory freedom to take on the risk of experimental technology since it could have life-changing impacts

Moderate

Cosmetic Recipients Demand the technology as a way to improve their perceived happiness

For cosmetic recipients, the argument is weaker but the demand is the same as medical recipients— they want freedom Low

Biohackers Democratization of medical technology & quickly bringing cures to those that need it

Biohackers prioritize freedom over safety and act accordingly. CRISPR is an easily accessible tool, and with democratization being a key interest. They will continue to obtain and utilize the tool to push the limits of legality

Low

GOVERNMENTS

Regulators Keeping citizens safe and healthy

CRISPR brings a balance of health and safety unlike we’ve seen before in previous technology. CRISPR has the ability to cure the currently incurable disease, but also has the ability to adversely impact the genetic pool for eternity and increase socioeconomic challenges which drastically increases the risk of liberal regulation. Extra attention and concern is on how to regulate

High

MEDICAL EXPERTS

Medical Associations and Researchers

Prioritize innovation and the advancement of medicine, but also prioritize ethics and safety

Associations and researchers have demonstrated an understanding of the risks of CRISPR, however regulation is against their best interest for speed. Moves by associations that aim to stall regulation while prioritizing quick advancement and safety will continue. Researchers will continue to be vocal as to what falls within and what falls outside the bounds of ethics

High

Pharmaceutical Companies

Find new revenue streams amidst this technology which will potentially replace a significant amount of their current products

A significant portion of pharmaceutical companies’ revenue streams comes from consistently bought symptom remedies as opposed to cures. As CRISPR threatens their current business lines, big pharma will be looking for a space to play

Low

Stakeholder AnalysisThose Who Are in Control of the Future

10

Page 11: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Global Genetic Cohesion =

DriversThe Sparks of Alternative Futures

11

Technological Capabilities =

The technological capabilities of CRISPR are still being defined and contested, and is dependent on how much interest, funding, and freedom researchers receive along with the underlying technology potential. It will dictate the scope of impact the technology will have on every aspect of society

technology sophistication + research funding + domestic

regulatory freedom + success of alternative cures

Domestic

CRISPR has the potential to create everlasting implications, and regulators are hesitant to underregulate the field and have it lead to a genetic catastrophe, but are also hesitant to over-regulate the field and have it stifle innovation. A trusted industry promising to self-regulate and/or a government willing to take on risk are more likely to be attributed to regulatory freedom

industry level of self-regulation + trust in corporations + risk appetite of

governments + socioeconomic & eugenics concerns + momentum of biohackers

Biohacking =

With the increase of access to medical information, individuals are using these tools to experiment with their health in unorthodox manners. CRISPR is one focus of biohacking, and these biohackers are demanding the loosening of regulation

domestic regulatory freedom + technological sophistication +

momentum of biohackers

As CRISPR develops differently in countries that are uniquely regulated, this discrepancy (or lack of discrepancy) can create vastly different alternative futures with global implications. The drive for and ability to obtain global genetic cohesion is behind international societal effects

domestic regulatory freedom + international regulatory freedom + equal

technological development internationally + demand for cosmetic alterations

Regulatory Freedom =Prevalence of

There has been a rise in perfectionism especially within millennials, largely attributed to social media and manifested through things such as a rise in cosmetic procedures. Depending the demand for cosmetic alterations, regulatory freedom, technological sophistication, and socioeconomic/eugenics concerns, the tool could ultimately be leveraged for cosmetic alteration before or after birth

demand for cosmetic alterations + domestic regulatory freedom +

technological capabilities + socioeconomic & eugenics concerns

Cosmetic Edits =

Sub-driver Key Consideration

Demand for cosmetic alterations

Is society accepting of and willing to pay for cosmetic alterations?

Equal technological development internationally

Does each countries have access to the same technological developments?

Industry level of self-regulation

Is the medical industry proactively self-regulating?

International regulatory freedom

On average, are other countries more or less restrictive with regulation?

Momentum of biohackers Are biohackers proactively inventing new technology, or lobbying against/breaking regulation?

Research funding Does CRISPR have the capital investment to develop complex cures?

Risk appetite of governments

What will the government be willing to risk for medical innovation?

Socioeconomic & eugenics concerns

What impact will this have on the cycle of poverty and will it enable eugenics?

Success of alternative cures

Are alternative cures taking away funding and attention from CRISPR development?

Technology sophistication Will the CRISPR technology live up to its assumed potential?

Trust in corporations Do we trust corporations to follow through on their self-regulatory promises?

Sub-Driver Legend

Page 12: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

The ScenariosMapping Influence to Outcome

12

Bas

elin

e

Tran

sfo

rmat

ion

Co

llap

se

Ne

w E

qu

ilib

riu

m

- There will always be medical demand from those with genetic diseases- The government will always hear and understand the medical demand

- Pharmaceutical companies are always investing in and productionizing CRISPR

Scenario Givens:

Counteracts the Driver

Supports the Driver

No Influence

Page 13: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

●● In early years, research restrictions were loosened to prioritize innovation● This was void due to the 2021 death of a biohacker which led to an extreme

regulatory tightening including a permanent DIY CRISPR kit ban— biohackers have not quit and continue to break regulation for their therapies

● Although the technology was proven to be sophisticated and well-funded, fear of further deaths and eugenics, and a low-risk taking government led to an approval process for releasing new CRISPR therapies

● Currently only two diseases are permitted, sickle cell disease and deafness. They can be germline edits

● The government has no intention to ever permit cosmetic edits due to concerns of the technology compounding the cycle of poverty

● A strong and aggressive biohacking blackmarket and lobbyist movement has stemmed from sensitivity around regulation limiting the potential

● Particularly stringent domestic regulation, discrepancies in international regulation, and demand for cosmetic editing has created genetic tourism and concerns surrounding the potential creation of super races

●● Early and extensive industry self-regulation was pledged, and with no reneges

on these promises the government has continued to stay uninvolved ● The trendiness of the technology completely eclipsed other medical research

in regards to funding and notoriety, and without regulatory interference CRISPR was found to be highly sophisticated

● The technology has over 80% accuracy in editing hundreds of multi-gene illnesses ranging from polio to the common cold to intelligence

● “Biohacking” became less of a reproach and more of a way of life, with quickly innovating corporations offering multiple safe, customizable, in-home solutions that allow for literal “hacking” of each individual’s genetic code

● Although the technological capabilities and regulatory freedom are present, social and CSR movements towards self-love and natural lifestyles has led to cosmetic alterations being disavowed by the majority of associations

● Although it does not encompass the entire globe, alignment of global genetics is sought through international associations’ self-regulation pledges and any steps outside these bounds are shamed by the largest players

Baseline ScenarioJust the Right Dose?

Highlights Highlights

Transformation ScenarioCRISPR: The New Vaccine

13

Page 14: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

●● For years, self-regulation restricting research and therapies to somatic

edits has proven successful, but with more interest in germline edits and a lack of trust in the private sector, the government has chosen to develop germline regulation

● Due to this initial freedom, the technology is sophisticated for somatic edits but largely unexplored for germline edits

● The implementation of an application for bringing DIY CRISPR kits to market is limiting biohackers’ access to the technology, but is met with overall acceptance since 15 products are promised to be in market the first 6 months

● A significant demand for cosmetic edits coupled with serious intergenerational socioeconomic and eugenics concerns and an unproven technology has limited cosmetic edits to somatic cells only

● There are concerns about the global implications of this new regulation— North American technology has previously proven to be amongst some of the best in the world and there is a prospect that this regulation will restrict North America’s potential for the better or for the worse

●● After years of hype, CRISPR is proving not to be able to live up to its

rumoured potential as easily as expected, but no one is willing to admit or accept this

● Hesitation from the government and lack of initiative by industry has led to the absence of meaningful regulation from the private and public sector

● The industry is driven by the biohacker mentality, but companies and biohackers are finding their therapies are not performing as anticipated

● Demand for cosmetic alterations makes products promising cosmetic edits proliferate in the market, but with success rates often being low

● The few therapies that are finding some success are more expensive leading to higher-income individuals and their offspring having cosmetic and health advantages, ultimately widening the income gap

● Although the lack of regulation is consistent internationally, different countries are finding ways to develop the technology better or worse and murmurs of nefarious countries actively pursuing the creation of a super race are present

CollapseToo Much Freedom Too Soon

Highlights Highlights

New Equilibrium ScenarioThe Push and Pull for Stability

14

Page 15: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

The most provocative implication is that although this restriction will be expensive to taxpayers due to the cost of enacting and enforcing regulation, it may also boost the economy due to the litigation activity and the protection of big pharma’s current product lines. The regulatory protection of the technology brings the potential to spawn a new industry dedicated to getting CRISPR to market safely, and litigating against products that have broken the rules. Inefficient systems can create a significant amount of jobs and economic activity.

Most Provocative Implications

As much as we may try, it’s already too late to entirely stop the momentum, however effort towards protection could create economic productivity

15

Implications What the Baseline Means to Regulation

Baseline Shift: Little Regulatory Freedom

The most important issue on this wheel is that the presence of rogue hackers in a world of little regulatory freedom hinders the advancement of the field and damages our understanding of genomics. Instead of utilizing proper scientific and medical procedures so that edits are done in such a way to be confident in cause and effect, the majority of biohackers will be cutting corners and not sharing their findings for fear of repercussions. The movement to restrict access and use of CRISPR by regulators will appear to better ensure the scientific process is followed and to encourage the progress of the industry, however this implications shows that it could do exactly the opposite and muddy the genetic pool in such a way that researchers are not expecting

Key Takeaway:

Most Important Implications

Page 16: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

The most provocative implication is the potential for a new global hegemony due to disparate regulation enabling the creation of a “super race”. With a highly sophisticated technology, countries that have looser regulation will be able to utilize it and advance it significantly quicker than those with tighter regulation. By utilizing it on their citizens, these countries will experience an overall increase in intelligence, aesthetics, and physical capabilities that could enable citizens of these countries to move up in the world and gain more global influence.

Most Provocative Implications

Most Important Implications

16

Implications What the Baseline Means to Regulation

Baseline Shift: Differentiated Regulatory Policies Internationally

The most important implication is that differentiated regulatory policies will create genetic tourism leading to the widening of wealth disparity and genetic shifts will still end up back within domestic gene pools making the cost of enforcement meaningless. Under these circumstances, wealthier individuals will be able to afford to travel to get the therapies they desire, and then will return home to still represent that genetic shift within their country, ultimately still altering domestic genetic pools. As well, genetic tourism risks the health of participants since they will be travelling to foreign countries with likely less strict medical procedure requirements, leading to botched genetic procedures.

Restricting access to a technology in one country does not mean it won’t find its way to make a significant mark in the restricted country and globally Key Takeaway:

Page 17: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Most Important Implications

Most Provocative Implications

17

Implications What the Baseline Means to Regulation

Baseline Shift: Highly Sophisticated Technology

In a world where technology is sophisticated, regulation that is designed to protect the health of citizens could backfire for both physical and mental healthKey Takeaway:

Due to the level of sophistication of this technology, cosmetic edits will be feasible. As seen in the previous implication, even in a baseline world where cosmetic edits are restricted, consumers will still be able to access the technology internationally, ending up with cosmetic edits for the wealthy. This distinction between the edited and unedited may lead to mental health considerations for those that are unable to afford access to cosmetic edits.

In a world where CRISPR is highly sophisticated and the technology cannot be accessed easily, there are two important implications— the population will be sicker than needed, and people will be paying for band-aids rather than cures. Due to the hefty and expensive regulatory process, this sophisticated technology is struggling to come to the market, leading to more insurance payouts and welfare requests than needed, social unrest, and resentment of regulators. However it would benefit big pharma due to continued demand for symptom reliefs.

Page 18: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

How can we proactively regulate the space to best optimize health and safety of citizens?

$4 million Dedicated to salaries, expertise, and travel

18

RecommendationsHow Can UNESCO Form the Desired Future?

Regulators often restrict use of unproven technology, however this may backfire due to the grasp CRISPR already has on the market. Secondary impacts of restriction may lead to a sicker population, more healthcare/ welfare expenses, muddied genetic pool, resentment of regulators, and enforcement costs being void

Why It Matters:

Response:Release a standardized approval criteria for CRISPR-related research and therapies that any government can consume, in order to optimize speed of R&D and get cures to market sooner

Implementation:● Hire Project Lead (~3 months)● Industry Consultations— gain a better

understanding of the current regulatory state and the capabilities of the technology (6 months)

● Stakeholder Consultations— understand who will be impacted most by any changes (2 months)

● Compilation and Evaluation Process (1 month)

● Writing the White Paper and Recommendation— include how regulators can structure for efficiencies and actionable templates

● Enabling and Encouraging Key Countries to Take the Lead in Implementation— actively pursue world leaders in CRISPR to implement the recommendations (ongoing)

Timeline: 16+ monthsEstimatedCost:

Page 19: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

How can we best mitigate the risks of disparate international regulation?

$3 million Dedicated to salaries, marketing, travel, and event costs

19

RecommendationsHow Can UNESCO Form the Desired Future?

Plastic surgery tourism is already a common practice, and even if regulation is limiting CRISPR in one country it likely won’t shift internationally. This disparity can cause for an increased cycle of poverty, the potential for a shift in global power, and the rise of a super race

Why It Matters:

Response: Create an international coalition of regulators to discuss CRISPR, its implications, and the best way to regulate it on an international scale

Implementation:● Hire Project Lead (3 months)● Draft Tentative Purpose,

Structure, and Funding Model— define initial vision (1 month)

● Solicit Feedback from Regulators— determine who may be interested in participating (3 months)

● Implement Recommended Changes (1 month)

● Draft Membership Expectations and Contracts (2 months)

● Solicit a Second Round of Feedback and Have Members Officially Sign Up (3 months)

● Announce the Coalition and Host the First Meeting (1 month)

Timeline: 14 monthsEstimatedCost:

Page 20: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Executive SummaryForming the Future

20

To what extent will CRISPR be utilized as a medical and cosmetic therapy?

The Drivers

Technological Capabilities— the potential size of impact CRISPR can have on the medical and cosmetic communities

Domestic Regulatory Freedom— how much freedom researchers, medical practitioners, and individuals will have to utilize CRISPR

Biohackers— the pressure put on regulators for loosening access and the amount of “blackmarket” CRISPR usage there is

Prevalence of Cosmetic Edits— whether or not people will be demanding for and accessing cosmetic editing therapies such as intelligence and appearance

Global Genetic Cohesion— whether or not there will be international alignment in both regulation and technological development

The Scenarios The Impact

Baseline— “Just the Right Dose?” Regulatory restriction limits the sophisticated technology

Transformation— “CRISPR: The New Vaccine” Industry self-regulation enables extensive, safe, CRISPR usage

Collapse— “Too Much Freedom Too Soon” Genetic chaos from an overhyped technology with no regulatory safeguards

New Equilibrium— “The Push and Pull for Stability” Self-regulation proven successful for somatic editing, but the government is stepping in for germline editing

Implications from the baseline show that regulation:

● Won’t stop the CRISPR momentum ● Could create economic productivity due to

an industry around regulatory compliance ● Won’t protect the alterations from entering

a country (risk of genetic tourism)● Backfire by harming physical health ● Widening of wealth gap and harming

mental health of the unedited

Recommendation to UNESCO’s International Bioethics Committee

1. Release standardized approval criteria for CRISPR-related research and therapies that any government can consume, in order to optimize speed of R&D and get cures to market sooner

2. Create an international coalition of regulators to discuss CRISPR, its implications, and the best way to regulate it on an international scale

Page 21: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

21

Appendix

Page 22: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Technological CapabilitiesGlobal Genetic

Cohesion

Prevalence and Success of Biohackers

Domestic Regulatory Freedom

Prevalence of Cosmetic Edits

technology sophistication

high vs. low

research funding high vs. low

alternative cures successful vs. unsuccessful

momentum of biohackers high vs. low

industry level of self regulationtrust vs. distrust in

corporations

risk appetite of governments

level of socioeconomic &

eugenics concerns

demand or lack of

demand for cosmetic

alterations

international regulatory freedom

vs.restrictions

technological development internationally equal vs. unequal

The Scenario Framework

22

Page 23: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Technological Capabilities

Technology’s potential limited by regulation

Global Genetic Cohesion

Beginnings of genetic tourism

BiohackingCompletely restricted but

there’s still a blackmarket & lobbying

Domestic Regulatory Freedom

Tight regulation (only two approved diseases)

Prevalence of Cosmetic Edits

Strict rules only allow for medical edits despite

demand

high technology sophistication

initially high levels of research funding decreasing due to

regulation

alternative cures not successful

high momentum of biohackers leads to a

death

industry level of self regulation (not relevant)

trust in corporations (not relevant)

low risk appetite of governments

some socioeconomic &

eugenics concerns

demand for cosmetic

alterations

international regulatory freedom

equal technological development internationally

Baseline Scenario

23

Page 24: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

industry self-regulated

Technological Capabilities

Focus on CRISPR has led to extensive

capabilities

Global Genetic Cohesion

Alignment sought through international medical associations

BiohackingBiohackers have access to the

products they want

Domestic Regulatory Freedom

Promises of self-regulation are trusted

Prevalence of Cosmetic Edits

Disinterest in cosmetic edits

high technology sophistication

significant research funding

alternative cures have been unexplored

momentum of biohackers (not relevant)

trust in corporations risk appetite of

governments (not relevant)

some socioeconomic &

eugenics concerns

relatively low demand for

cosmetic alterations

international self-regulation

mostly equal technological development internationally

Transformation Scenario

24

Page 25: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Technological Capabilities

Cannot live up to its inflated expectations

Global Genetic Cohesion

Unequal technological development creating

beginnings of a super race

BiohackingPrevalent but not doing

what is expected

Domestic Regulatory Freedom

No restrictions public or private

Prevalence of Cosmetic Edits

Attempts for cosmetic edits not going

according to plan

technology is not sophisticated

excessive research funding

alternative cures have been unexplored

high momentum of biohackers calling

the shots

no promises to self regulate (not relevant)

trust in corporations high risk appetite of

governments

no consideration to socioeconomic &

eugenics risks

demand for cosmetic

alterations

international regulatory freedom

unequal technological development internationally

Collapse Scenario

25

Page 26: CRISPR-cas The Future of - Houston Foresight · 2020-06-05 · biohacking Increase in CRISPR products in the consumer market is ultimately decentralizing access to the technology

Technological Capabilities

Have confidence and freedom for somatic

edits not for germline

Global Genetic CohesionNorth American technology has

been most advanced, potential will be restricted by new regulation (for

the better or worse)

BiohackingFlourished, but new regulation will limit

Domestic Regulatory Freedom

Self-regulation is being replaced by government

regulation

Prevalence of Cosmetic Edits

Germline cosmetic edits disallowed

technology is sophisticated for somatic edits not germline

some research funding

alternative cures have shown some traction

Lower momentum due to having products already on market

promise to self regulate

little trust in corporations risk appetite of governments

has been pushed too far

Significant consideration to socioeconomic &

eugenics risks

demand for cosmetic

alterations

international regulatory freedom

unequal technological development internationally

New Equilibrium Scenario

26