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Background: The rapid global growth of biotechnology and the heightened global concern about human and animal infectious diseases, such as SARS and avian influenza, have caused many countries to consider establishing or expanding high containment biological research laboratories capable of handling highly dangerous pathogens. Although these laboratories are needed to isolate some highly dangerous pathogens, they are complex systems with inherent risks. Even in advanced technological societies like the United States, new laboratories have been challenged and criticized as posing unnecessary threats to populations and enlarging the number of locations from which biological materials could be obtained by those wishing to cause harm. In less developed countries, the potential for increasing, rather than decreasing, biological threats through the establishment of high biocontainment laboratories is even greater. Additionally, many countries lack even basic legal and regulatory systems that would govern such facilities. Current Project: An ad hoc committee, under the oversight of CISAC and working with the Board on Life Sciences and international colleagues, will organize an international workshop to examine issues related to the design, construction, and operation of high containment biological laboratories—equivalent to U.S. Centers for Disease Control and Prevention Biological Safety 3 or 4 level labs. Although these laboratories are needed to isolate some highly dangerous pathogens, they are complex systems with inherent risks. The workshop will aim to engage scientific experts and policy makers both from countries experienced in operating laboratories and from countries, particularly in the developing world, that are contemplating or undertaking the construction of new facilities. Possible areas for discussion include: - Technological options to meet diagnostic, research, and other goals;
- Laboratory construction and commissioning;
- Operational maintenance to provide sustainable capabilities, safety, and security;
- Measures for encouraging a culture of responsible conduct
Additionally, some workshop participants will develop and present case studies. Case studies may describe a country’s facilities, capabilities, and regulations as well as past accidents, safety and security issues, and lessons learned. Workshop participants will explore possible strategies for enhancing biological safety and security worldwide and will offer practical suggestions to countries considering constructing or expanding their high biocontainment facilities. An individually-authored workshop summary will be issued. Organizing Committee: Dr. Adel A. F. Mahmoud (Chair) Professor of Molecular Biology and Public and International Affairs Princeton University Dr. Michael V. Callahan Tropical and Disaster Medicine Physician DARPA Dr. Teck-mean Chua Treasurer and former President Asia-Pacific Biosafety Association Dr. David R. Franz Vice President and Chief Biological Scientist MRIGlobal Dr. Katsuhisa Furukawa Senior Fellow, International Assessment and Strategy Center Rebuild Japan Initiative Dr. Jennifer Gaudioso Principal Member of the Technical Staff Sandia National Laboratories, International Biological Threat Reduction
Dr. Barbara Johnson Owner and Consultant for Biosafety and Biosecurity Barbara Johnson & Associates, LLC Dr. Ingegerd Kallings Senior Medical Officer and Biosafety Adviser Swedish Institute for Infectious Disease Control Dr. Serhiy Komisarenko National Academy of Sciences of Ukraine Palladin Institute of Biochemistry Dr. James W. Le Duc Professor of Microbiology and Immunology The University of Texas Medical Branch at Galveston Dr. Anwar Nasim Advisory Scientist Ministerial Standing Committee on Scientific and Technological Cooperation (COMSTECH) Dr. Peter Palese Professor and Chair of Microbiology Mount Sinai School of Medicine
Dr. J. Craig Reed President Inspirion Biosciences Dr. Willy Tonui Health, Safety, and Environment Coordinator and Principal Research Officer Kenya Medical Research Institute This project is sponsored by the U.S. Department of State’s Biosecurity Engagement Program.
AGENDA Anticipating Biosecurity Challenges of the Global Expansion of High Containment Biological Laboratories Istanbul, Turkey 11-13 July 2011 Some Participants Arrive 20:00 Informal Reception (Jolly Café, Point Hotel) 8:30 Registration (Remaining Participants Arrive) 9:00 Plenary: Welcome - Adel Mahmoud (NAS Committee Chair, Princeton University, U.S.)
- Sevket Ruacan (Koç University, School of Medicine, Turkey)
- Suman Paranjape (Biosecurity Engagement Program, U.S.)
9:20 Plenary: Framing the Issue, Part 1: The function of high containment labs and factors encouraging and constraining the creation of new labs This session will start by reminding the participants that lab practices are intended to keep the worker safe, buildings are designed to keep the community safe, and that there are often many ways of achieving those objectives. The session will then describe the recent expansion in the number of high containment biology labs including the types of labs, the standards and designs used, factors driving and restraining the expansion, and safety and security concerns. Chair: Katsuhisa Furukawa (Rebuild Japan Initiative, Japan) - Russian and U.S. biosafety experiences during the last two decades: Lessons and achievements: Peter Palese (Mount Sinai School of Medicine, U.S.) and Sergey Netesov (Novosibirsk State University, Russia)
- Containment labs - Who wants them, Who funds them, and Why: Jennifer Gaudioso (Sandia National Laboratories, U.S.)
- Discussion
10:30 Break 11:00 Plenary: Framing the Issue, Part 2: The current status and opportunities for the future This session will describe how well currently operating labs are meeting their objectives and what challenges they are encountering. Additionally, speakers will summarize current discussions in the area and ask if we are at the beginning of the next paradigm where countries are looking at new ways of achieving and maintaining the necessary containment. Chair: Anwar Nasim (Ministerial Standing Committee on Scientific and Technological Cooperation [COMSTECH], Pakistan) - Laboratory capacity, biosafety, and biosecurity in Africa: Gaps, goals, needs, and progress: Willy Tonui (Kenya Medical Research Institute, Kenya)
- Current thinking and trends ahead: Teck-Mean Chua (Asia-Pacific Biosafety Association, Malaysia [Singapore])
- Discussion
12:15 Lunch 13:15 Plenary: Assessments of Needs, Challenges, and Resources This session will provide an overview of local assessments including: what they are, what purpose they serve, who should be involved in a local assessment, and what information might be included. Chair: Seval Korkmaz (Abdi Ibrahim, Turkey) - Challenges and suggestions for sustainable biosafety and biosecurity capacity in low resource countries: Craig Reed (Inspirion Biosciences, U.S.)
- Biosafety and biosecurity challenges in the Caribbean region: Valerie Wilson (Caribbean Med Labs Foundation, Trinidad & Tobago)
- Discussion
14:15 Breakout Sessions (Rapporteurs will prepare brief summaries for later presentation) Paths from assessments to functional labs While the previous sessions examined assessments broadly, this session will provide specific examples of the process by which countries and corporations decide where and when to build labs, the degree to which their original objectives have been achieved, and the lessons they have learned along the way.
Each speaker will focus mainly on a single lab and describe that lab’s strengths, ongoing efforts to sustain and improve capabilities, and key obstacles that have been successfully overcome. Topics to be discussed may include how well the lab is fulfilling its original research and public health goals; where the lab is situated within country and regional networks; whether initial and on-going costs and funding have been as expected; and ongoing biosafety, biosecurity, and maintenance efforts. Session #1: Eastern Asia (Room: Babylon I) Chair: Leila dos Santos Macedo (ANBio, Brazil) Rapporteur: Fran Sharples - Meeting international biosafety and biocontainment standards in low-resource settings - The southeast Asian experience: Stuart Blacksell (Mahidol Oxford Tropical Medicine Research Unit, Thailand [Australia])
- Establishing and operating a BSL-3 facility in South Korea: The International Vaccine Institute experience: Soh Jin Lee (International Vaccine Institute, South Korea)
- Biocontainment for clinical and research activities: Sunee Sirivichayakul (Chulalongkorn University, Thailand)
- Discussion
Session #2: Africa (Room: Fuji I) Michael Ugrumov (Institute of Developmental Biology RAS, Russia) Rapporteur: Ben Rusek - Veterinary Serum and Vaccine Research Institute in Egypt: Present & future prospects: Seham El-Zeedy (Veterinary Serum & Vaccine Research Institute, Egypt)
- A medical research center in the heart of a tropical rainforest: Jean-Paul Gonzalez (CIRMF, Gabon [France])
- Morocco Biopharma RL for diagnostic and veterinary vaccines: Current situation and future challenges: Mehdi El Harrak (Biopharma, Morocco)
- Discussion
Session #3: Eastern Europe and Western Asia (Room: Fuji II) Chair: Greg Smith (CSIRO, Australian Animal Health Lab, Australia) Rapporteur: Alison Hottes - Central Public Health Research Laboratory: Art Lyons (WRAIR, U.S. [Republic of Georgia])
- Planning a cost-effective and sustainable BSL3, lessons learned- Kyrgyz Republic: Ken Ugwu (Foreign Affairs and International Trade Canada, Canada)
- Why we need a BSL-3 Laboratory at the Pendik Veterinary Control and Research Institute: Ayse Selma Iyisan (Pendik Veterinary Control and Research Institute, Turkey), and Aysen Gargili (Marmara University, Turkey)
- The history and current status of the Chumakov Institute of Poliomyelitis and Viral Encephalitides: Evgeniy Tkachenko (Chumakov Institute of Poliomyelitis and Viral Encephalitides, Russia)
- Discussion
16:00 Break 16:30 Plenary: Available resources, regulations, and guidelines This session will characterize the international, regional, and local resources available to countries; will describe sources of guidance on how to build, operate, and improve labs; and will examine alternatives to relying exclusively on within-country labs. Chair: Serhiy Komisarenko (Palladin Institute of Biochemistry, Ukraine) - International regulatory frameworks, standards, and guidelines: Ingegerd Kallings (Swedish Institute for Communicable Disease Control, Sweden)
- The IFBA's biocontainment engineering network: Ken Ugwu (Foreign Affairs and International Trade Canada, Canada)
- Sustaining regional & national biosafety associations: Challenges and considerations: Teck-Mean Chua (Asia-Pacific Biosafety Association, Malaysia [Singapore])
- Discussion
Country Overview Writers: Panel Discussion on Local Resources, Regulations, and Guidelines Chair: Serhiy Komisarenko (Palladin Institute of Biochemistry, Ukraine) - Biosafety laws and regulations in Turkey: Hüseyin Avni Öktem (Middle East Technical University, Turkey)
- High containment laboratories in Ukraine- Local resources and regulations: Olena Kysil (Taras Shevchenko National University of Kyiv, Ukraine)
- Overview of biosafety and biosecurity in high containment labs in Brazil: Leila dos Santos Macedo (ANBio, Brazil)
- Bio-technology and bio-security initiatives in Pakistan: A country report: Anwar Nasim (Ministerial Standing Committee on Scientific and Technological Cooperation [COMSTECH], Pakistan)
- High containment microbiology laboratories in Europe: Ingegerd Kallings (Swedish Institute for Communicable Disease Control, Sweden)
- Panel Discussion
Additional Country Overview Writers (All overviews will be published with the workshop summary): - High containment laboratories - Sweden case study: Ingegerd Kallings (Swedish Institute for Communicable Disease Control, Sweden)
- Overview of High Containment Biological Laboratories in Russia: Michael V. Ugrumov (Russian Academy of Sciences, Russia) and Sergey V. Netesov (Novosibirsk State University, Russia)
- High containment laboratories – U.K. case study: Neil Davison (The Royal Society, United Kingdom) and Filippa Lentzos (London School of Economics, United Kingdom [Norway])
- United States High Containment Biological Labs and Regulations: U.S. National Academy of Sciences Staff
18:30 Break 19:00 Dinner (Point Hotel Restaurant) 20:00 Keynote Address: Pandemic Influenza: The origin, spread, and response to the 2009 H1N1 strain: Peter Palese (Mount Sinai School of Medicine, U.S.) 9:00 Summary from Day 1 (Plenary) 9:45 Movement to Breakout Sessions 10:00 Breakout Sessions (break from 10:45-11:15) (Rapporteurs will prepare brief summaries for later presentation) Public health needs: Costs, effectiveness, and biosafety requirements for diagnostic procedures These sessions will (1) describe the public health needs lab workers are attempting to meet, the range of tools being utilized, and the challenges regularly encountered and (2) examine the spectrum of molecular, immunological, and culture-based assays available as well their associated costs, effectiveness, and biosafety requirements. Session #1: Human Diseases Part 1 (Room: Babylon I) Chair: Ingegerd Kallings (Swedish Institute for Communicable Disease Control, Sweden) Rapporteur: Alison Hottes - Preparedness for the detection of emerging and re-emerging pathogens in Croatia: Alemka Markotic (University Hospital for Infectious Diseases, Croatia)
- Biorisks connected with wild birds: Results of Avian Influenza virus surveillance in South-West Siberia (Russia) in 2010: Alexander Shestopalov (State Research Center of Virology and Biotechnology "Vector," Russia)
- Biosafety recommendations for laboratory testing for tuberculosis: Tom Shinnick (Centers for Disease Control, U.S.)
- Discussion
Session #2: Human Diseases Part 2 (Room: Fuji II) Chair: Peter Palese (Mount Sinai School of Medicine, U.S.) Rapporteur: Michael Callahan (DARPA, U.S.) - Biosafety and the southeast Asian infectious diseases clinical research network: Rogier van Doorn (Oxford University, Vietnam [Netherlands])
- SARS Coronavirus: Diagnosis, antibody responses and biosafety concerns: Cheng Cao (Beijing Institute of Biotechnology, China)
- Crimean Congo Hemorrhagic Fever- Pakistan perspective: Birjees Mazhar Kazi (National Institute of Health, Pakistan) and Sohail Zaidi (National Institute of Health, Pakistan)
- EHEC O104:H4 in Germany 2011: Large outbreak of bloody diarrhoea and haemolytic uraemic syndrome by Shiga toxin-producing E. coli via contaminated food: Reinhard Burger (Robert Koch Institute, Germany)
- Discussion
Session #3: Animal and Livestock Diseases (Room: Fuji I) Chair: David Franz (MRIGlobal, U.S.) Rapporteur: Fran Sharples - The work and capabilities of the High Security Animal Disease Laboratory at Bhopal: Gaya Prasad (Indian Council of Agricultural Research, India)
- Diagnostic capability on exotic and emerging animal diseases of the Mexico official laboratory network: Marco Antonio Rico Gaytan (Mexico-US Commission for the Prevention of Foot & Other Exotic Animal Diseases (CPA) – DGSA, Mexico)
- Coping with deadly viruses: Supaporn Wacharapluesadee (Chulalongkorn University, Thailand)
- Discussion
12:30 Lunch 14:00 Breakout Sessions (Rapporteurs will prepare brief summaries for later presentation) Identifying areas for action Collectively, these sessions will 1) generate strategies and suggestions for countries building/improving or considering building/improving labs 2) consider what data on biosafety would be most useful to generate and (3) identify areas where current biosafety practices are not well-matched to actual needs. Session #1: Determining necessary and appropriate precautions (Room: Babylon I) Chair: Michael Callahan (DARPA, U.S.) Rapporteur: Craig Reed - Evidence based biosafety - Ensuring precautions are adequate and appropriate: Allan Bennett (Health Protection Agency, United Kingdom)
- Risk based design of facilities for high consequence animal pathogens: Uwe Mueller-Doblies (Institute for Animal Health, United Kingdom [Germany])
- Emerging Infections in Turkey: Do we need biosafety labs?: Onder Ergonul (Koç University, School of Medicine, Turkey)
- Discussion
Session #2: Improving organizational culture and practices (Room: Fuji I) Chair: Serhiy Komisarenko (Palladin Institute of Biochemistry, Ukraine) Rapporteur: Ben Rusek - Enlightened laboratory leadership: More powerful than guns, gates and guards: David Franz (MRIGlobal, U.S.)
- Singapore's response to biorisk events at home and abroad: Presented by Teck-Mean Chua (Asia-Pacific Biosafety Association, Malaysia/Singapore) on behalf of Ling Ai Ee (Singapore General Hospital, Singapore)
- OIE Laboratory twinning - A tool to improve global disease security: Keith Hamilton (World Organisation for Animal Health [OIE], France [United Kingdom])
- Discussion
Session #3: Design and operational options for improving sustainability, biosafety, and biosecurity (Room: Fuji II) Chair: Willy Tonui (Kenya Medical Research Institute, Kenya) Rapporteur: Jennifer Gaudioso - Maintenance, certification and cost-saving issues for BSL3 labs in southeast Asia: Stuart Blacksell (Mahidol Oxford Tropical Medicine Research Unit, Thailand [Australia])
- The BSL3 lab at Institut Pasteur du Maroc: Mohammed Hassar (Pasteur Institute of Morocco, Morocco)
- A rational and attainable approach to successfully implementing biosafety in laboratory settings worldwide: Barbara Johnson (Biosafety Biosecurity International, U.S.)
- Engineering control: Challenges in maintaining BSL3 (country experience): Pretty Sasono (Litbangkess, Indonesia)
- Discussion
15:30 Break 16:00 Plenary: Requirements for and challenges associated with BSL4 Labs This session will discuss how many BSL4 facilities are needed in a region; construction and maintenance costs; biosecurity issues, environmental risks (especially for pathogens affecting domestic animals where the potential economic impact is striking); training; strategies to manage an individual who may become infected with a BSL4 agent; community relations; whether existing and planned networks are adequate; how much and what kinds of “surge capacity” are ideal; whether existing facilities can be re-tasked during a crisis; and if BSL4 labs can be safely made less technology-intensive or easier to sustain. (Panel Discussion) Chair: James Le Duc (University of Texas Medical Branch, U.S.) - From the detection of BSL-4 pathogens to the development of preventive and curative strategies: Gary Kobinger (Public Health Agency of Canada, Canada)
- Requirements for and challenges associated with BSL4 laboratories: Maintaining an aging facility: Greg Smith (CSIRO, Australian Animal Health Lab, Australia)
- Needs, potential, and constraints for developing an advanced laboratory in a challenging technical and social environment: Jean-Paul Gonzalez (CIRMF, Gabon [France])
- The high containment laboratory in the National Institute of Infectious Diseases, Tokyo, Japan: Activities, circumstances, and future challenges: Masayuki Saijo (National Institute of Infectious Diseases, Japan)
- Panel Discussion
18:30 Break 19:30 Conference Dinner (Haci Baba Restaurant) 9:00 Summary from Day 2 (Plenary) 10:30 Break Chair: Adel Mahmoud (NAS Committee Chair, Princeton University, U.S.) 12:00 Meeting Adjournment/Lunch (Some Participants Depart) 13:00 Bus Departs for Optional Group Visit to Pendik Veterinary Control and Research Institute (estimated return to hotel at 18:30) Remaining Participants Depart <
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