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http://2016.igem.org/Community - - PowerPoint PPT Presentation

http://2016.igem.org/Community http://www.businesswire.com/news/home/20170105005656/en/Takeda-PvP-Biologics-Announce-Development-Agreement-Therapeutic https://pvpbio.com/2016/12/20/uw-spin-out-seeks-to-develop-celiac-disease-therapy/


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http://2016.igem.org/Community

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http://www.businesswire.com/news/home/20170105005656/en/Takeda-PvP-Biologics-Announce-Development-Agreement-Therapeutic

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https://pvpbio.com/2016/12/20/uw-spin-out-seeks-to-develop-celiac-disease-therapy/

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http://2011.igem.org/Team:Washington

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http://igem.org/Facets

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The iGEM White List

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  • Works with iGEM participants to

strengthen safe and responsible synthetic biology

  • Reviews & approves safety forms
  • Performs safety checks on

Registry parts

  • Has the ultimate say on safety

issues The iGEM Safety Committee

http://2017.igem.org/Safety/Responsibility

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biosecu.re

www.biosecu.re | piers@biosecu.re | @biosec_re

iGEM Project Safety Screening

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http://pubs.acs.org/doi/pdf/10.1021/sb500058e

https://sgidna.com/archetype.html

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Case studies

  • A. Context specific risks
  • B. Cutting-edge technology
  • C. Differences in national rules
  • D. Preventing malign misuse
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Case study: Parts-based biotech

http://2016.igem.org/Team:Arizona_State

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http://2016.igem.org/Team:Minnesota

Case study: Cutting edge technology

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https://www.statnews.com/2016/12/14/gene-drive-students-igem/

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Gene Drives are not allowed in iGEM projects without a special exception from the Safety Committee.

http://2017.igem.org/Safety/Policies

For the purposes of iGEM, a gene drive includes Cas9 (and other endonucleases, such as dCas9 and Cpf1) integrated into the genome (including through the use of gRNA) of a sexually reproducing eukaryotic

  • rganisms (including organisms that reproduce both sexually and

asexually, such as yeast) and/or the use of a drive to impact the progeny.

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Teams will need to convince the Safety Committee that:

  • There will be no environmental release - This is existing iGEM policy for all projects and not

just on gene drives.

  • That the project is safe - The Safety Committee will evaluate your project proposals with

reference to host organism (chassis), modifications (including any associated parts) and containment measures.

  • Your team is implementing and adhering to the measures proposed by Akbari et al in

“Safeguarding gene drive experiments in the laboratory”

  • Your team has notified the Safety Committee that you are considering or planning to use gene

drives in your project and you and your faculty advisor have participated in a mandatory conference call with experts on drives and on safeguards.

  • Any orders for commercially produced genetic material placed by your team must be screened

for regulated sequences.

  • None of your parts submitted to the registry contain a functional gene drive – a drive in a single

part will not be accepted and this can have implications for medal criteria.

http://2017.igem.org/Safety/Policies

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Case study: International regulation

https://www.flickr.com/photos/51868421@N04/7401843836

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Animals should not be used in iGEM projects without a special exception from the Safety Committee.

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Use of animals in iGEM projects

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Case study: preventing malign misuse

http://2009.igem.org/Team:PKU_Beijing https://2010.igem.org/Team:VT-ENSIMAG_Biosecurity http://2013.igem.org/Team:Lethbridge http://2015.igem.org/Team:Bielefeld-CeBiTec

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  • iGEM takes safety and security very seriously
  • Reflexive policies help keep pace with changing risks
  • iGEM helps innovate better safety and security

→ Developing function-based risk management → Addressing risks prior to regulators

  • iGEM helps build consensus around risks

→ Using common standards based on best-practice

  • iGEM helps test tools for better safety and security

→ Practical efforts to test and improve biosecurity

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Our sincere thanks to our funder:

http://www.openphilanthropy.org/