Project Director. Center for Excellence in Biosafety, Biosecurity and Biotechnology Royal Scientific Society (RSS). Amman - Jordan.
Effective Practices In Addressing Proliferation Risks In Biotechnology: A Tool For Stability And Development

In the context of international security, biosafety and biosecurity converge at the nexus of science and security and of health and security. This convergence has the potential to generate not only new opportunities, but also novel and unforeseen biological threats. Working with pathogenic microorganisms requires developing health and safety measures that adequately protect laboratory workers and others, and also the environment. In view of the complexity of both containments laboratories and the human, animal and agricultural health challenges, implementing biosafety and biosecurity measures can contribute to reducing the full spectrum of natural and man-made biological risks. However, there are numerous ways to combine the various elements of biosafety and biosecurity into a successful biosafety and biosecurity framework. Each region in the world proceeds from different starting point of current practice, legislative environment, levels of resources and facilities, cultures, and needs and demands. Thus, a detailed examination of specific situations often helps in optimizing allocation of resources.
National action, while absolutely necessary, cannot always be sufficient to contain or manage biological risks. The need for effective concerted supranational efforts means that cooperating countries need to have a common understanding of the global and regional risks which in turn requires a common risk assessment methodology and common prevention activities. While biological risks do vary from region to region and country to country, without a common methodology for assessing risks and formulating appropriate policies and practices to manage and mitigate these risks, any international effort will be neither concerted nor effective.
In appreciating the prevailing realities of the Middle East and North Africa (MENA) region, there might be some opportunities for taking positive steps in the form of Regional Network for Biosafety and Biosecurity. However, in order for the MENA region to follow the international development trend, it is necessary to understand the current level of capabilities of the laboratories and the status of biosafety and biosecurity regulations in the region.
This paper focuses on preventing the misuse of biological agents and toxins, and mitigating the risk of large outbreaks of diseases through increasing laboratory biosafety and biosecurity as a tool for stability and development. The paper describes biosafety and biosecurity needs that are common in MENA countries and the challenges associated with using available resources to address those needs. Regional biosafety and biosecurity networks can help communicate with the governments, establish local credentialing systems, offer twinning and mentoring services, and distribute training materials; however, the capacity in many MENA countries is still developing. Thus, the paper suggests a roadmap for building and sustaining networks in the region that encourage cross-border collaboration on technical policy issues in the biological field.

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Experimentelle Physik III, Technische Universität Dortmund. Dortmund, Germany
Military Uses of Bionanotechnology: Special Context of Potential Application and Regulation

Bionanotechnology and synthetic biology are active fields of research for potential applications in medical diagnostics and therapy, but also more generally in analysis of all kinds of life processes and of synthesis using life-like processes. Better understanding of e.g. mechanisms of infection as well as technology for synthesizing damaging agents in cells, in particular on recognition of certain traits, can help many patients. On the other hand, they provide knowledge and means that could be used for nefarious purposes. Discussions about safe and responsible research and development of (bio)nanotechnology take criminal/terrorist misuse into account, but generally miss state preparations. This is in part due to the strong norm that the Biological Weapons Convention provides. Together with the risk of infection of one’s own troops or population the probability of a state preparing offensive bioweapons was deemed low (however, very few violations of the prohibition did occur). With increasing knowledge about damage mechanisms and increasing capabilities to control and direct them, the hurdle concerning damage on one’s own side may decrease over time. This is troublesome because the attempt to add a compliance and verification mechanism to the Biological Weapon Convention faltered in 2001. Whereas codes of conduct and (general) publication of results can be useful to steer civilian bionanotechnology and other life-science research away from applications for intentional harm, a time may come when military planners feel tempted to intensify research and development therefor – either because of the outlook for effects with much reduced risk, or because of the fear of potential adversaries acting in this direction. As seen in many cases, secrecy of military work under the security dilemma will aggravate the problem.
In order to assess such dangers to the BWC and the potential time frame when they may become relevant, it may be useful to define certain feats that would need to be achieved. Examples can be:
- Agent-loaded nanoparticles for nasal application;
- Release of a harmful agent on a certain trigger – already existing in a target organ or organism or distributed selectively;
- In-vivo recognition of protein or DNA patterns that are specific of a certain potential target group or even of an individual;
- New types of protective mechanisms against (new types of) biological agents.
In addition, military research should be perused. Such assessment of research and potential technology paths would best be done with public funding in a (generally) public setting. If institutions and regular funding will not be available soon, academia could play an important role in going forward. Research centres could devote a small part of their budgets to such studies; existing work on ethical, legal and societal implications could be opened up to look at potential military uses, too.

Italian Army. Commander of 7TH CBRN Defence Regiment in Civitavecchia (Italy)
The 7th Regiment: Tasks And Capabilities

During the 20th century and up to the end of the cold war, the NBC defense was oriented to “detect to treat”, to protect allied forces territory and populations against the use of NBC weapons, in particular nuclear weapons. The defense was focused on passive defense and mitigation measures in order to permit military operations in a contaminated environment. Furthermore, the evolutions that occurred in the geo-strategic scenarios led to the inauguration and adoption of crises response operations and the necessity to guarantee personnel safety and security to military and civilian populations. The new policy introduces the “preventing concept” as a new approach to CBRN defense and there was an evolution regarding the NBC concept. In fact in the past we used acronyms such as NBC defense, then CBRN defense and now we use CBRN-e defense which includes all improvised explosive devices containing CBRN agents. In this contest the 7th CBRN regiment operates as an NBC specialist unit, which carries out detection, (provisional/confirmatory) identification and monitoring (DIM), warning and reporting, physical protection and hazard management operations. Moreover it concurs with Italian civil authorities (ministry of interior) to detect and decontaminate areas and/or personnel in cases of toxic industrial hazard (TIH) releases, either deliberate or not, as well as in cases of CBRN terrorist attacks.
In particular, sampling and identification of biological, chemical, radiological and nuclear agents (SIBCRA), are conducted by well trained personnels who operate in accordance with NATO procedures, ensuring consistency, safety and accountability and are obtained through peculiar instruments and deployable CBRN analytical laboratory (D-Al). For example SIBCRA Teams collect suspected biological materials and transport them, within the chain of custody, to the biological mobile laboratory to be analyzed. This analysis laboratory is capable to operate in a contaminated or un-contaminated zone and it is characterized by a high degree of safety for the operators.
The biological samples are analyzed in order to detect bacteria using Real Time Polymerase Chain Reaction techniques and immuno-precipitation assay.
As said previously, the 7th Regiment provides decontamination activities, articulated around three level (immediate, operational and thorough) over personnels, vehicles and installations using, as biological decontaminant BX24, SX34, sodium chloride and hydrogen peroxide vapour (only inside glove box). During the decontamination activities, the challenge is to reduce the risk of secondary contamination by water spray and the production of waste. This issue has, recently, led to develop environmentally friendly technologies (ex. based on enzymatic activities) and integrated systems in order to contain waste.
In conclusion, in order to effectively respond to a WMD attack or CBRN event, it is crucial to improve cooperation and collaboration with allies, partners, international and regional organizations, address CBRN defense capabilities for more rapid, flexible, agile and sophisticated forces/units tailored to the mission, increase military and non military cooperation and exploit new technologies.

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Nonproliferation Programs Manager. Agricultural University of Georgia, Tbilisi (Georgia)
Educational Programs in Dual Use of Life Sciences: Ways of Biosecurity Risk Mitigation

Biological life sciences have experienced enormous growth over the last 30 years, as biotechnology has become a global enterprise; they offer tremendous promise for meeting many 21st century challenges. Under these circumstances it is very important to modernize education in the field of life sciences and biotechnologies. Young scientists in the field of life sciences and professionals of public health must acquire the sense of responsible science at the very beginning of their professional education. On the example of Georgia we can judge that in developing countries the level of biosafety and biosecurity education needs improvement, new disciplines must be introduced in the curricula of high schools and universities, giving the students knowledge on codes of conduct for life scientists, dual use concerns, and biorisks. This goal can be reached by cooperation among universities, lecturers, through the information exchange on international standards and good laboratory practices, improving biosafety of society and environment, fostering the social and civic role of scientists in society, with special attention to the “next generation of scientists”.

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Medical Officer. World Health Organization, Geneva (Switzerland)
Responsible Global Prepardness and Response to Emerging pathogens

Global preparedness and response to the risks from emerging pathogens rely upon long term investments in public health including the science that underpins it. At the same time, the detection of threats often occurs from astute clinicians or field workers. Scientific aims should incorporate facilitating them. Similarly, mechanisms which facilitate the responsible use of samples, isolated pathogens and their components may be most effective when reconciling the breadth of field to laboratory venues, as well as the importance of flexibility to conduct a timely, robust public health response.

Chief of Aeromedical Isolation Unit. Italian Air Force, Pratica di Mare (Italy)
Aeromedical Evacuation Of Patients With Highly Infectious Diseases

Highly infectious diseases represent clinical syndromes ranging from single to multi organ infections and pose a constant threat to the public. In the absence of a definite treatment for most causative agents patients benefit from maximum supportive care as clinical conditions may deteriorate in the short term. Hence, following initial case identification and isolation, rapid transportation to a specialised treatment unit must be considered in order to minimise the risk of secondary infections but is limited by available infrastructure, accessible care en route and the patient’s clinical condition. Despite the development of consensus curricula for the clinical management of highly contagious patients their medical transportation lacks a common approach. The Italian Air Force (IAF) provides a rapid response team (Aeromedical Isolation Team, AIT) located on Pratica di Mare Air Force Base for both international and domestic AE in order to relocate HID cases and provide medical care under high level containment.
The AIT consists out of two teams, each comprised of three physicians (one team leader and two specialists in infectious diseases and anaesthesiology) and six infectious diseases nurses. Patients are transported in an Aircraft Transit Isolator (ATI, picture 8), a self contained plastic isolation facility provided with negative pressure and HEPA filtration of exhausted air. Currently two ATI for AE and one STI for ground vehicle transportation are in use. The ATIs are connectable to the STIs used by INMI, thus reducing contamination risks during the passage of patients from ATIs to STIs (picture 9). Military components of the AIT are trained every 15 days at Pratica di Mare Air Force Base in close relationship with homologous units of civilian organization such as INMI. In addition, international training activity in collaboration with the US-Army AIT is conducted.

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EBSA President 2013-2014. European BioSafety Association (EBSA), Brussels (Belgium)
EBSA - The EU Network for Biosafety & Biosecurity Experts

The European Biosafety Association (EBSA) is the European platform for information exchange, discussion and debate on biosafety and biosecurity issues, with the goal to enhance the knowledge and understanding of biological safety and security throughout Europe and the world. EBSA is a non-profit organisation with members representing a wide range of sectors e.g. academia, industry, health care and regulatory affairs from over 24 countries in Europe, as well as from other regions. EBSA is striving to establish and communicate best biosafety practices in microbiological laboratories through annual conferences and pre-conference training workshops and is one of the driving forces behind development of new standards and guidelines. Implementation of such standards is a prioritized EBSA activity.
CWA 15793, a tool for implementing best biosafety practices The ́Laboratory Biorisk Management standard ́ was released in 2008 as a CEN Workshop Agreement CWA:15793. Workshop participants represented 24 countries in North and South America, Europe, and Asia. CWA 15793 is a performance oriented management document in alignment with widely accepted ISO/EN standards on quality, environment and health and safety. It is developed to help organizations to effectively manage risks of accidental or intentional harm associated with work involving biological agents and toxins. EBSA was one of the key driving forces behind this document.
EBSA Administration Office: DECHEMA e.V. Phone: +49 69 7564 381 Fax: +49 69 7564 299 e-Mail: [email protected] website: www.ebsaweb.eu.
The widespread recognition and acceptance of the ́Laboratory Biorisk Management document ́ demonstrates a high potential to increase biosafety and biosecurity in laboratories in Europe and across the world. The standard is suitable for self-audit and for third party certification ensuring that organizations comply with the requirements of the standard which might in turn provide an increased level of assurance that organizations in States Parties abide by e.g. the BTWC prohibitions and obligations. In 2011, CWA 15793:2008 was reviewed and its validity extended for a further 3 years in the form of CWA 15793:2011. It is now being discussed how to make sure the CWA will remain in a valid form after expiration date in 2014. One option would be to make it become an ISO standard.
Interpretation of and compliance with international and national biosafety/biosecurity regulations and guidelines varies greatly between laboratories not only between countries but also within one country, partly due to lack of internationally accepted standard documents.
The ́Laboratory Biorisk Management ́ document, which was the first of these CWAs to be adopted, has achieved wide international recognition. However, international and cross-sector recognition and adoption of CWA 15793 must increase further in order to maximize its impact.
EBSA, with its wide network of members with high professional competence in the areas of biosafety and biosecurity has a potential to increase its input and take active part in a worldwide dissemination of biosafety and biosecurity best practices.

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Kathleen Eggleson
Biological Scientist and Practical Ethicist. University of Notre Dame, Indiana, (USA)
Societal Trends Influencing Access to Dual-Use Nanotechnologies by Non-State Actors

Globalization of communication and commerce and a socio-technological trend toward deskilling have offered access to leading edge technologies of unprecedented breadth. For many capabilities and materials, financial barriers have been lowered as the obstacles to free sharing, including social norms about privacy, have been drastically reduced. These phenomena have major safety and security implications, particularly with regard to non-state actors. With explicit and organized dispersion of know-how, the DIY (do it yourself) Bio movement exemplifies these trends with respect to biology on the nano scale, in the form of synthetic biology. Synthetic biology takes biotechnology beyond genetic engineering (built on discrete sequences) to customization at the level of entire genomes and organisms, including the design and proliferation of life forms not shaped by evolution or other natural forces. Concerns about safety and security apply to other emerging technologies as well. The nanoscale size range includes natural entities that act upon and within cells, such as viruses and macromolecules; for this reason heightened biological vulnerability to nanotechnology-enabled weapons is of particular concern. Advances in cognitive science and brain- based therapies have opened the way for strategic military use and nefarious misuse of neurotargeting. The plausibility of concerning scenarios increases when these biological aspects are combined with the fast-approaching threshold for mainstream use of autonomous vehicle technologies. The same “angry libertarian” ethos that decries restrictions on DIY Bio practices is manifest in Defense Distributed, a crowd-sourced effort toward 3D printing of operational firearms led by a Texan law student. Common sense safety measures and security policy changes are needed to compensate for advances in dual-use emerging and converging technologies, but the mutually reinforcing nature of these changes, even if not driving toward imminent singularity, are accelerating and complicating the situation beyond the adaptivity of existing governance systems.

Analyst. United Nations Interregional Crime and Justice Research Institute, Turin (Italy)
CBRN National Action Plans: Enhancing Biological Risk Mitigation through Coordination at the National and International Level
This presentation will focus on UNICRI’s role in assisting countries currently developing CBRN National Action Plans – strategic documents developed by countries to establish a coherent vision for CBRN risk mitigation – as part of the EU’s Centres of Excellence (CoE) initiative. In particular, it will focus on how countries currently envision biological risks in this context, and the value placed on ensuring biosecurity through coordination at the national and international level.

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Program Manager. Federal Bureau of Investigation (FBI), Washington DC (USA)
Bridging the Gap Between Biosafety and Biosecurity

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Ambassador. Coordinator for Threat Reduction Programs. U.S. Department of State, USA
Countering Biological Threats, the Global Partnership, and the Global Health Security agenda

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Co-funder and President. La Paillasse- Paris Community Lab for Biotech, Paris (France)
Do-It-Yourself Biology: Challenges and Promises for an Open Science and Technology Movement

The Do-it-yourself Biology (DIYbio) community is emerging as a movement that fosters open access to resources permitting modern molecular biology, and synthetic biology among others. It promises in particular to be a source of cheaper and simpler solutions for environmental monitoring, personal diagnostic and the use of biomaterials. The successful growth of a global community of DIYbio practitioners will depend largely on enabling safe access to state-of-the-art molecular biology tools and resources. In this paper we analyze the rise of DIYbio, its community, its material resources and its applications. We look at the current projects developed for the international Genetically Engineered Machine (iGEM) competition in order to get a sense of what amateur biologists can potentially create in their community laboratories over the coming years. We also show why and how the DIYbio community, in the context of a global governance development, is putting in place a safety/ethical framework for guarantying the pursuit of its activity. And finally we argue that the global spread of DIY biology potentially reconfigures and opens up access to biological information and laboratory equipment and that, therefore, it can foster new practices and transversal collaborations between professional scientists and amateurs.

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Head of Department. Army Medical and Veterinary Research Center, Rome (Italy)
European BioDefence Laboratory Network (EBLN)

Biological agents pose a daily threat to humans, animals and plants in Europe as elsewhere. Distinguishing deliberate and accidental release of B-agents from natural outbreaks is a difficult task. In order to identify, trace, and characterize B-agents in various types of samples including environmental samples, with high background microbial levels, there is a need for a high degree of knowledge, certified competence and cooperation, not only, on pathogenic potential B-agents. The objective of this project is the establishment and management of a European Biodefence Laboratory Network (EBLN) for increased European preparedness for protection against Biological Warfare Agents (BWA).
This project resulted by combining of 10 European defence research laboratories sharing their own knowledge and scientific capabilities on BWA, developing libraries of standard microbiological reference materials required also for forensic comparisons to known isolates.
Currently the Project is mainly focussed on bacteria, activities are planned also for viruses. Technical work include whole genome sequencing (WGS) of strains derived from the reference collections, identification of variable single nucleotide positions SNPS) as genetic fingerprint for BWA genera and inventory, description and sequence collection of harmful viruses that discriminate individual strains, implementing new additional genetic data from emerging and/or atypical microorganisms into verified reference collections.

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Maurizio Martellini
Director. Insubria Center on International Security (ICIS), Como (Italy)
The Imperative of Scientific Responsibility, the Dual Use Biological Research of Concern and the Milano’s Declaration on the Life Scientists’ Oath

The intrinsic dual-use nature of many biological researches of concern, like synthetic biology, nanobiotechnology, etc., cannot be dealt with an arms control paradigm, and requires a multidisciplinary vision: there is no one-size-fits-all. In this context, the dilemma between unquestionable benefits of Dual-Use Bio Researches of Concern (DUBRC) and professional responsibility, demands a critical reading of the philosophical masterpieces, like the Ethics of Responsibility of Max Weber and the Imperative of Responsibility of Hans Jones. The main conclusion is that modern science and technology demand to the scientific community awareness and an ethic of responsibility (Verantwortungesethik). In the case of the modern Life Science courses, a sort of Hippocratic Oath, but now tailored to the biological community, would be recommended (the “Milano Declaration”).

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President. Observatory Security and Defense CBRNe (OSDIFE), Rome (Italy)
A Multidimensional Approach in Securing CBRNe, WMD and Dual-Use Knowledge and Materials in Laboratories and Researches Activities

The protection and defence of individuals, society and the community can be achieved if we consider , in the same time, both the safety and security. In fact they are the two fundamental elements to identify the methods and models for the prevention, management and mitigation of risks and also to deine the individual, organizational and contextual variable that can cause dangerous situations.
On the other side, over the past decades, the risk scenarios have addressed the world to a much wider and complex vision of security and safety. In recent years, global environmental, geopolitical and economic changes lead to signiicant increase, at international as well as at national level, in the general risk proile and with a great influence on the global chemical, biological, radiological and nuclear and weapons of mass destruction threat.
For this reason, CBRNe, WMD and Dual-Use knowledge and materials in laboratories and researches activities, should be handled with special care in order to reduce the likelihood of misuse for terrorist or criminal activities.
Actually we can see how, while government and military organization have strict rules, practices, methodologies and tools to secure and protect their facilities and work, others (e.g. university research laboratories) present a lack of speciic security setup.
For these the prevention pass through the development and implementation of an appropriate security framework in all sites and laboratories where potential dual-use activities are being developed. This means the adoption of special measures for accesses control, infrastructure surveillance and protection, employees clearance, information/data classification, secure working procedures etc.
The principal objective of this paper is to investigate and propose new possibilities, methodologies and solution for an effective and efficient defence for all public and private laboratories and researches related to the CBRNe and WMD fields.

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Research Associate. Bradford Disarmament Research Centre, University of Bradford, Bradford (UK)
Effective and Sustainable Biosecurity Education: The Benefits of Active Learning

An effective strategy to encourage engagement among those engaged in the life sciences and in the chemical sciences with the issues of the safe use of the life sciences and of the chemical sciences and to empower them to take a pro-active approach in recognising, addressing and reducing the potential security concerns related to their work is to switch from passive to active learning. These arguments are equally valid for those engaged in the chemical sciences.
The presentation reports on a recent interactive seminar, whereby a Team-Based Learning (TBL) approach was adopted to engage students with biosecurity and dual-use issues. It concludes by setting out how active learning can be effectively and efficiently utilised globally for teaching biosecurity in higher education institutions – and will be equally applicable for teaching the corresponding issues for those engaged in the life sciences.
It further suggests that the development of a small suite of Team-Based Learning exercises could be used in many different places and thus allow the use of the most efficient and effective method to be applied to correcting the present deficiency in the education of life scientists. To this end, a two-tiered integrated course in Bio-Risk Management covering both the technical competencies and skills related to life science practice and the broader social, ethical and legal responsibilities of life scientists could be developed using the Team-Based Learning format. Likewise, an online Team-Based Learning short course in chemical security could be instrumental in raising awareness of the CWC among those engaged in chemistry around the world and fostering a culture of responsibility in chemistry.

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Special Advisor. Center for Biosecurity and Preparedness, Copenhagen (Denmark)
Biosecurity in Denmark: training, education and outreach

In Denmark, the handling of biosecurity issues has been vested in a single, national government agency, the Centre for Biosecurity and Biopreparedness (CBB).
One main task of the CBB is the execution of the Danish legislation on biosecurity, ie to carry out regulation of controlled (weapons-related, dual-use) biological material and technology in Denmark. CBB issues licenses to and performs audits of, all institutions, private as well as public, working with or handling material or technology with dual use in Denmark. License conditions include appropriate biosecurity standards and appointment of dedicated biosecurity officers, trained by the CBB.
The vision of the CBB is to ensure that life sciences only serve beneficent purposes, and are not deliberately used to the detriment of anyone. To accomplish this, the CBB believes that in addition to tangible, “hard” biosecurity measures at (eg legislation, physical securing of laboratories and biological stocks, etc), establishment of a biosecurity culture is also very important, to ensure optimal compliance with regulation, and pro-active alerting to emerging misuse potential of new technology.
Establishment of a biosecurity culture implies raising public awareness about scientific research that has serious potential for misuse to develop biological weapons. The practical challenges in establishing a biosecurity culture are thus (at least) twofold: First, the weighting of risks and benefits associated with research with serious dual-use potential can be difficult, exemplified eg by the recent controversy on “gain-of-function” research with the potential for generating highly pathogenic avian influenza H5N1 that is transmissible between humans by aerosol. Thus, education, outreach and public debate are required to reach a consensus on such questions. Second, the continued, rapid development in biotechnology and synthetic biology, and the easy access to technology through the internet, while providing enormous benefits for public health, society and science, also continuously increase the misuse potential. Thus, training, education and outreach activities need to evolve at an equally rapid pace, and need to reach a very broad audience indeed, spanning from the public layperson, through “do-it-yourself” biologists, university students, to public agencies, private institutions and legislators, nationally and internationally.
For the reasons given above, training, education and outreach comprise key elements in CBBs vision for biosecurity in Denmark. The themes outlined in the abstract above will be discussed in more depth during the presentation, and concrete examples of CBB training, education and outreach activities will be given.

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Director-General. The Hillel Yaffe Medical Center, Hadera (Israel)
Capacity building for biological events: Are we doing it effectively?

Introduction: Creating and maintaining preparedness to detect, identify and manage biological events is of global concern. Extensive resources are being invested in most nations in the aim to achieve a high emergency preparedness for communicable diseases. A significant component of these efforts is training and exercising of healthcare workers in order to establish and retain knowledge and competencies. There is a crucial need to examine such programs to ascertain their effectiveness.
Methods: The Ministry of Health in Israel coordinates the development and dissemination of policies, establishment of standard operating procedures in all healthcare facilities, procurement of equipment, installation of vital infrastructure and conduct of a compulsory, continuous training and exercise program. Knowledge of medical, nursing and administrative teams from primary care clinics was tested before and after the implementation of the program.
Results: Significant differences were found between mean levels of knowledge before and four months after the implementation of the training and exercises program among nursing and administrative teams. Two major elements in which significant differences were found included the correct order of undressing personal protection gear and return of functionality of the clinic after identification of a suspicious biological event. No difference was found among physicians in mean knowledge scores before and after training. Prior experience in treating infectious diseases did not correlate with levels of knowledge four months after the training and exercise.
Conclusions: Building and retaining knowledge of healthcare personnel poses a challenge to policy makers. Creating training programs must be based on a specific needs-assessment of each professional sector. Effectiveness of the training programs should be monitored over time, in order to assess the level of knowledge retention and accordingly tailor-made programs should be established.

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Scientific Advisor. General Sub-direction of Non Proliferation and Disarmament, Ministry of Foreign Affairs and Cooperation, Madrid (Spain)
Prevention: biosecurity elements and the societal model

The most efficient way to fight against terrorism is to improve on a national level all those elements that might minimise the possibility of that attack to take place. When considering the risk of a potential biological attack, prevention measures need to be in place and reaction measures should be anticipated to reduce the impact of such an attack. Therefore, a national plan on biosecurity is required which must include a minimal core of preventive elements. Any possible reaction plan to a potential attack should contemplate the societal structure and evaluate the magnitude of the potential different effects, in order to be prepared to react to such a circumstance as to maximise societal resilience.

Programme Director. Wilton Park, Steyning (UK)
Balancing open science with responsible security - a report from Wilton Park

This meeting brought together government and law enforcement officials, practising scientists, NGOs and academics, to conduct an appraisal of security concerns surrounding real world examples of past dual-use research of concern as well as hypothetical experiments. Options for managing concerns at all stages, from conception of an experimental question to publication of results, were assessed. The security risk surrounding dual-use research appears to be generally recognised by those who are aware of the issue, but widening and targeting such awareness is still a challenge, as is reducing scepticism. This issue can be managed and ameliorated, but not resolved. Risk and hazard, and perhaps threat, is something that will have to be lived with not discounted; the price to be paid for the benefits of biological research. The growing multi-disciplinary character of biological research means that any regulatory management system that is developed to concentrate on work involving certain dangerous pathogen may fail to capture much future research of concern. This also has implications for outreach and education. Dealing with dual-use research cannot be done by any one community, and no single set of actors can or should (or would want to) own this problem. An assessment of what such a process of knitting together disparate communities would look like should thus be a priority. Collaborative risk assessment and the acknowledgement of inherent uncertainties and different costs benefit analysis at the start of research is potentially the most fruitful and effective stage at which to intervene, and should involve security input where appropriate

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Chairman of the board. Active Technologies Transfer Europe
Managing Security Threat Information

Sharing security threat information is a challenge for governments and their agencies. Especially in biotechnology and microbiology the agencies do not know how to classify or to disclose collected information on potential bio-threats. There is vague border between man-made and natural biological threats. An example is the several month delay of the publication of research on the transmissibility of H5N1 avian influenza virus in the leading scientific journal Science by researchers of the Erasmus Medical Centre in Rotterdam, The Netherlands. The publication was delayed in 2012 by several months due to the fact that various organizations first wanted to investigate whether the details could be misused by malicious individuals. In the study the researchers show that only a small number of mutations were necessary to change the H5N1 virus so that it can spread through the respiratory system between mammals. This implies that the risk of a H5N1 pandemic cannot be ruled out. On the other hand this information can be used to develop new therapies and/or vaccines for influenza. It gives also insight into the disease mechanism, which helps in the prevention.
The same arguments are valid for therapeutic antibodies, like the antibodies, which are developed to treat anthrax. They have an extreme high affinity for the lethal factors of the bacterium and stop the disease, but the same antibodies could be misused to select the most pathogenic strains.
Micro-organisms have from nature itself the capacity to reorganise and change their pathogenicity, which could lead to a pandemic spread of a disease. But if the disease is too infectious and too deadly, like some stains of Ebola are, the lethality will be locally limited.
The knowledge of these natural mutation mechanisms could be misused to weaponize micro-organisms. It enables the engineering of the lethality like it is done with some anthrax strains. Are these laboratory techniques considered as public science or should it be classified? Academics want to publish and to share information for the progress of science and to find useful applications. The Rotterdam scientists were really annoyed when their research was blocked for publication and feared that other groups would be first in publishing a part of their obtained experimental results.
Biosafety is already common practice in micro-biology, but biosecurity is often still questionable. A ‘Code of Conduct’, like the Dutch Academy of Science has developed, would help; especially for the so-called insider risk. Educational programs for the identification and assessment of risks and threats to security have to be developed to give scientists bio-threat awareness and for government officials to rationalize the real threat, without damaging the progress of science.

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Executive Director. International Council for the Life Science, McLean, Virginia (USA)
Responsible Approaches to Biological Research, Development and Business: Promoting Progress Through Managing Risks

Synthetic Biology is a field that, if its goals are realized, will revolutionise virtually every aspect of life:
Public health, through: cheaper and quicker production of better medicines and vaccines; development of biological indicators to assist in diagnosis and hence earlier treatments; and development of personalized treatment regimes to improve medical outcomes and to treat cancers, autoimmune diseases and hereditary conditions;
Nutrition, through the development of higher yield, more nutritious crops with greater resistance to salinity, high temperature, and drought and pests; Energy, through the development of eco-friendly, renewable fuel production methods such as synthetic photosynthesis or petroleum-producing algae;
Materials, through the development of new materials, or the cheaper biological production of existing scarce or expensive materials, or for alternative renewable production of currently finite depletable resources; and for biological production of chemicals, such as turpenes, which are difficult to produce through chemistry;
Information Technology, through the development of biological data storage, computation and encryption methods;
Environment, through the development of environmental remediation tools, low energy solutions for desalination of water, or through more species-specific and hence less environmentally damaging pest control methods;
Entertainment and Education, such as the development of pet miniature elephants or the synthetic biology equivalent of home chemistry kits.
While synthetic biology promises revolutionary benefits to society, the same enabling technology could also be misused. Society will have to address:
Moral issues over creating new forms of life, or with interfering with natural life (eg gene treatments to enhance natural human attributes) or evolution (through giving endangered species enhanced genetic toolkits to survive such as immunity to a disease, or through de-extinction – bringing back extinct species such as the passenger pigeon and the woolly mammoth);
Equity and fairness issues over the ownership of genetic materials (IP issues), and to whom the spoils go/by whom the costs of risks are borne;
Safety issues of working with new genetic materials;
Environmental issues with releasing new genetic materials into farms or watercourses, the soil and the air;
Privacy issues, e.g. full exploitation of medical applications of synthetic biology will require explicit tracking of named individual’s medical data; and Security issues – the same technology which permits us to understand and fight diseases could also enable the design of ‘better’ biological weapons.
This paper will examine these issues and current efforts to address them.

Associate Political Affairs Officer. United Nations Office for Disarmament Affairs, Geneva (Switzerland)
Outcomes of the Seventh Review Conference and the 2012-2015 Intersessional Programme
The Biological Weapons Convention: Outcomes of the Seventh Review Conference and the 2012-2015 intersessional programme The speech will focus on the 2012-2015 intersessional BWC work programme established by the Seventh Review Conference in 2011. This programme expands and builds upon similar programmes that started a decade ago, and is the central means by which the BWC

Director of Research. Institute for Convergence of Information, Science, Technology, and Knowledge and International Clean Water Institute, Herdon, Virginia (USA)
Nanobiosecurity – Spectrum of Challenges and Nexus of Technological Innovations as Countermeasures
The challenge posed by the geopolitical landscape of the 21st century is more complex, dynamic, and unpredictable than those faced in the previous hundred years. Securing life-sustaining ecosystems tends to present significant challenge for the scientific and defense communities. Tactically, the unsophisticated

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Director of Research. Trinity College of Dublin, Dublin (Ireland)
NANOTOOLS FOR ADVANCED DIAGNOSTICS AND THERAPY: BENEFITS AND SAFETY CONCERNS

Nanomedicine as a rapidly expanding area of science provides a unique chance to exploit the diverse properties of engineered nanomaterials for the ultimate benefit of the patients. Light-emitting nanoparticles, including second harmonic generating nanoparticles and fluorescent semiconductor quantum dots offer outstanding opportunities for diagnostic applications and biomedical imaging. Magnetically barcoded nanowires provide an excellent tool for multiplexed biomarker detection assays. On the other hand, optimistic expectations are associated with the applications of nanoparticles as a new class of multifunctional drug delivery systems, arising from the fact that the finite, but tunable size of the engineered nanostructures used as drug delivery vehicles can impose very precise nanoscale drug distribution barriers at the level of cells, tissues and entire organism, thereby eliminating undesirable side effects pertinent to most contemporary medicines. In this context, the components of the cardiovascular system, gastrointestinal and respiratory tract are the first line candidates to encounter these new nanomedicines, therefore justifying in-depth experimental investigations in this field.
On the other hand, a steady worldwide rise in manufacturing and use of nanomaterials emphasizes the requirements for thorough assessment of health outcomes associated with novel nanoparticle applications. However, there is still a lack of definitive systematic information about the consequences of interactions of emerging nanoscale objects with human cells of diverse origin and therefore safety-related issues have a high priority on the nanomedicine agenda. We will provide here an overview of several nanoparticle application scenarios for improved diagnostics and advanced therapeutic use, along with the contemporary approaches to safety screening of nanomaterials with promising biomedical application potential.

AAAS Fellow. Nuclear, Chemical and Biological Defense Programs, US Department of Defense, Falls Church Virginia (USA)
Prevent, Detect, Respond: Reducing Global Health Security Threats

The Office of the Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs (NCB) is working toward a world safe from biological threats. NCB collaborates with other US Government agencies, non-governmental organizations, and international partners to improve global capacity to prevent avoidable epidemics, detect threats early, and respond rapidly and effectively to contain outbreaks. NCB efforts include the development of technical capabilities to detect and respond to biological threats, as well as collaborative engagements with international partners to reduce these threats. This presentation will provide examples of NCB activities in each of these areas and discuss how they contribute to a comprehensive Global Health Security (GHS) agenda. The GHS agenda is focused on reducing global risks posed by infectious disease outbreaks, whether they emerge naturally or result from a deliberate biological attack or accidental release. This requires a whole-of-government approach that brings together numerous sectors—including security, human health and animal health—to collaboratively build an integrated system that serves the broad range of biosecurity, biosafety, and one-health needs.

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