1. "When does new science become a threat?".

2. problem - experimentation - discovery The scientific process

3. problem - experimentation - discovery - dissemination The scientific process

4. problem - experimentation - discovery - dissemination The scientific process Where do …………….. intervene in the process to identify DURC

5. Jackson et al. 2001: Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus suppresses cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox Cello et al. 2002: Chemical synthesis of Poliovirus cDNA: Generation of infectious Virus in the Absence of a natural Template Tumpey et al. 2005: Characterization of the reconstructed 1918 Spanish Flu influenza Pandemic Virus Wein et al. 2005: Analyzing a Bioterror Attack on the Food Supply: The Case of Botulinim Toxin in Milk Herfst et al. 2012: Airborne Transmission of Influenza A/H5N1 Virus between Ferrets Imai et al, 2012: Experimental Adaptation of an Influenza H5 HA confers respiratory Droplet Transmission to a Reassortant H5 HA/H1N1 Virus in Ferrets Xiong et al. 2013: Receptor binding by a ferret-transmissible H5 avian Influenza Virus Bieringer et al. 2013: Experimental Adaptation of Wild-Type Canine Distemper Virus (CDV) to the Human Entry Receptor CD150 Zhang et al 2013: H5N1 Hybrid Viruses Bearing 2009/H1N1 Virus Genes transmit in Guinea Pigs by Respiratory Droplet Controversial biological publications

6. problem - experimentation - discovery - dissemination The scientific process Where do …………….. intervene in the process to identify DURC Vanity publishing

7. problem - experimentation - discovery - dissemination The scientific process Where do …………….. intervene in the process to identify DURC

8. problem - experimentation - discovery - dissemination - repetition - adoption The scientific process Funding Scientists Open innovation Science is a moving target – good science identifies new ground

9. Engineer a new functional organism from scratch Engineer an organism to do something completely new Introduce new traits into an organism at the genetic level Engineer an organism to modify to an existing pathway Use an existing pathway to make something new. 1 2345 The pace of change

10. The politics of 20/20 hindsight

11. Code of conduct – what is you want scientists to do differently? Security culture – responsible conduct The pace of change Can we prevent access to new sciences: e.g. oligonucleotide synthesis Interferon gamma 17kDa, 166aa, 498 bp

12. problem - experimentation - discovery - dissemination The scientific process Where do …………….. intervene in the process to identify DURC

13. Constant vigilance!! Provide education – at all levels Engender a community responsibility Provide a reporting framework Provide confidential contacts Provide a knowledge base Self policing

14. Categories of Experiments that might be DURC 1.Enhance the harmful consequences of a biological agent or toxin. 2.Disrupt immunity or the effectiveness of immunization without clinical and/or agricultural justification. 3.Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies. 4.Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin. 5.Alter the host range or tropism of biological agent or toxin. 6.Enhance the susceptibility of a host population. 7.Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent. National Science Advisory Board for Biosecurity (NSABB), USA, 2012; http://oba.od.nih.gov/biosecurity/biosecurity_documents.html A problem Emerging Science Makes Security a Moving Threat Beyond the 15 Key Pathogens/7 Core Experiments of Concern – moving target

16. No common framework in which to conduct sound risk/benefits analyses of science: In different countries In different cultures In different communities (e.g. science vs. security) Therefore probability that too risky experiments yielding too little benefit will be conducted. However, can we apply universal rules? Should the restrictions/expectations placed on a 3 rd world be the same as a developed nation? Rather do we really need common ethical guidance? A problem

17. Convergence of science Divergence of scientists - in interest/expertise - who is doing the science - including “the public” Safety RiskThreat Security Quid est veritas: What is truth Who provides the solution

18. Advise on risk/benefit assessment and risk mitigation don´t do it do it in another way Dissemination don’t publish it publish it with balancing/redacted information Advise on supporting structures, e.g. local/regional ethical review committees The language

20. What is the cost of security? “The biological world is displacing the machine as a general world of design.” DARPA – Living Foundries: Large U.S. investment in next- generation bio-based manufacturing Unknown unknowns – horizon scoping and the pace of scientific development Most science develops iteratively and easy to map. Some scientists work in a different way and think about where they want to be and describe the route to get there, real scientific breakthrough Step change is often serendipitous, or is unrecognized at the point of discovery. Nature as a threat – biggest bioterroist.

21. Discussion between science, policy and security …. Identifying a clear and present danger Horizon scoping 10 years and beyond less reliable – pace of change Coreponsibility ….. Dealing with potential issues in advance …. How good at this are we? Scientists are good at identifying where science is going in the near future