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The Digitization of Biology: Defining A New Risk Landscape

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2018 Annual Meeting of the Council of Sponsoring Institutions
Diane DiEuliis, Ph.D.
Center for the Study of Weapons of Mass Destruction
National Defense University

Published in: Government & Nonprofit
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The Digitization of Biology: Defining A New Risk Landscape

  1. 1. 1Center for the Study of Weapons of Mass Destruction 1Center for the Study of Weapons of Mass Destruction UNCLASSIFIED The Digitization of Biology: Defining A New Risk Landscape Diane DiEuliis, Ph.D. Center for the Study of Weapons of Mass Destruction National Defense University March 2018
  2. 2. 2Center for the Study of Weapons of Mass Destruction 2Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Hope comes with Hype MEDICINE CRISPR Could Turn Viruses Into Unstoppable Bio Weapons White House science advisers warn of possible risks and ask for faster vaccine development and more vigilance. Hacking the President’s DNA MIT Technology Review The Dangers of Synthetic Biology Nobel Prize winner David Baltimore explains why building smallpox from scratch is a key safety concern in synthetic biology. Designer babies: an ethical horror waiting to happen? Synthetic biology - what to expect and fear?
  3. 3. 3Center for the Study of Weapons of Mass Destruction 3Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis What is changing? • Digitization of biology enables its engineering; • Synthetic biological manufacturing is a growing industry that will impact health care and other sectors - and “biodata” is its primary currency; • Spheres of human privacy and security are now connected.
  4. 4. 4Center for the Study of Weapons of Mass Destruction D. DiEuliis Digitization of Biology • Genomic data is just one piece: relational metadata sets are required for meaningful engineering: “Biodata” includes: epigenomics, transcriptomics, proteomics, metabolomics, microbiome, etc. DESIGN BUILD TEST LEARN 010101001001111 • VS ATCGCCTTAACAG
  5. 5. 5Center for the Study of Weapons of Mass Destruction 5Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Other rapidly emerging novel technologies enable beneficial applications • Automated systems, microfluidics • Complex computation • Bioinformatics • Mass Spec • 3D printing
  6. 6. 6Center for the Study of Weapons of Mass Destruction 6Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Biotechnology is highly accessible • Growing global industry; • State Actors developing National synthetic biology strategies, programs, and investments; • iGEM, DIY Bio: (essentially “incubators” for innovation)
  7. 7. 7Center for the Study of Weapons of Mass Destruction D. DiEuliis7 Accidental exposure to pathogens, toxins, or genetically engineered organisms could adversely affect: Laboratory workers General public Plants and animals Environment Deliberate misuse of technology to cause harm to: Humans Plants Animals Environment Controversial uses and consequences of technology, e.g., Germline interventions Enhancements Genetically modified organisms Biosafety Biosecurity Societal Norms What are the implications of Biodata’s compilation and use? • Pathogen or other bioweapon threats • New vulnerabilities associated with biological manufacturing • Novel threats associated with human biodata
  8. 8. 8Center for the Study of Weapons of Mass Destruction 8Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Lowered bar to traditional biothreats? • Enable a virus to evade a vaccine • Make an agent resistant to antibiotics or antivirals • Make an agent more infectious; make a virus more virulent • Increase the transmissibility of a pathogen • Alter the host range of a pathogen • Enable the evasion of diagnosis or detection • Enable the weaponization of a biological agent or toxin • Synthesis of pathogenic micro-organisms • Recreate a past/eradicated pathogen (e.g. 1918 flu) *Host/pathogen relationships can be revealed through biodata studies.
  9. 9. 9Center for the Study of Weapons of Mass Destruction 9Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis A new technology industry • Bioinformatics • Automation • Networking (cloud computing or lab work) • Customer interface • Etc. Ø Any point in the process can be a security vulnerability, along with traditional liabilities: corporate espionage, corporate sabotage (theft, env. exposures, product tampering, insider threats, hacking, etc.) Ø Critical infrastructure considerations? Ø Considerations for product safety?
  10. 10. 10Center for the Study of Weapons of Mass Destruction 10Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Synthetic biology involves new products and new business models • Dozens of start-ups, some creating products, others selling tools; • Blurred jurisdictions between product sponsor/developer/manufacturer (i.e. at-home and direct-to-consumer biotech products, crowd sourced funding models, decentralized production facilities, DIY medical therapeutics, etc.) *regulation is challenging at best
  11. 11. 11Center for the Study of Weapons of Mass Destruction 11Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Human Biodata harms • Understanding genotype/phenotype and meaning of Biodata forms the foundations of Precision Medicine; could form the foundation of “Precision Maladies” – Agents could be tailored to harm humans through understanding of pathogen/host biology; – Agents could be created to generate harms in situ (think microbiome and related here); – Agents could be targeted to harm specific individuals or groups based on their genetic identity; related to this, known health vulnerabilities could be leveraged for harm. – DIY or at-home biologists could do inadvertent harm.
  12. 12. 12Center for the Study of Weapons of Mass Destruction 12Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Privacy & security are not distinct • People can be identified from (even small) portions of their DNA* • People’s DNA can potentially be used for physical harms, as well as privacy harms (but unlike getting a new credit card, you cannot change your DNA once compromised) • Human subject protections do not include genomic data: – Common Rule – genomic data not included – HIPAA – genomic data is not considered PII *Lippert, C. et al. Identification of individuals by trait prediction using whole-genome sequencing data. PNAS 2017 114 (38) 10166-10171.
  13. 13. 13Center for the Study of Weapons of Mass Destruction 13Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Where is the Biodata? Assembly BioProject dbSNP GenBank Nucleotide Database PopSet RefSeqGene Reference Sequence (RefSeq) Sequence Read Archive (SRA) Trace Archive UniGene GenBank BLAST E-Utilities Genome Workbench Primer-BLAST ProSplign Splign
  14. 14. 14Center for the Study of Weapons of Mass Destruction 14Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Genetic data sharing: lack of norms? • 23andMe, Ancestry – Data can be sold, used for other purposes in exchange for inexpensive genome sequencing • International data sharing: – Is not reciprocal; – Norms do not exist thus far; – Data is not really part of the BWC per se – Countries are struggling with rights in the era of synthetic biology (i.e. Nagoya)
  15. 15. 15Center for the Study of Weapons of Mass Destruction 15Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Data use is still challenging (at this time) • Biodata understanding is still fraught with ambiguity; • Biodata is large, fragmented, associational; – requires very complex analytics for useable applications. – Requires sophisticated informatics and hardware • Quantity ≠ quality • Data management/storage is still challenging
  16. 16. 16Center for the Study of Weapons of Mass Destruction 16Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis What does the future of biodata look like? • It depends…. – How much will the newly emerging synbio industry share data, analytics and algorithms vs keeping it proprietary? – How much will remain in the complex computation (especially hardware) arena? – What will our adversaries (outside the US) do? – If biodata information can enable harm through biology, what does it mean for the BWC?
  17. 17. 17Center for the Study of Weapons of Mass Destruction 17Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis
  18. 18. 18Center for the Study of Weapons of Mass Destruction 18Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis
  19. 19. 19Center for the Study of Weapons of Mass Destruction 19Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Thank you Questions Diane DiEuliis, PhD. Diane.dieuliis.civ@ndu.edu
  20. 20. 20Center for the Study of Weapons of Mass Destruction 20Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Back up slides
  21. 21. 21Center for the Study of Weapons of Mass Destruction 21Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis Significant barrier still exists Lowered barrier with genomic or other tools tacit knowledge has key role Traditional BW Acquisition Modification Testing Scale up Delivery Novel BW Creation Testing Scale up Delivery “Genetic” weapon Targeting Creation Testing Delivery DEFINITIONS: Acquisition: theft from lab or transport, harvest from nature, synthetic recreation Creation : wet-bench laboratory work Testing: animal models, field testing? Scale up: mass production, freeze drying, encapsulation, storage/stockpiling? Delivery: sprayer, point delivery mechanism, filling Targeting: bioinformatics targeting of specific group *attribution will be a potential challenge
  22. 22. 22Center for the Study of Weapons of Mass Destruction 22Center for the Study of Weapons of Mass Destruction UNCLASSIFIED D. DiEuliis What’s the real market?

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