Stuart D. Blacksell MPH, PhD, RBP

1. International Cooperation in Strengthening & Mitigating Biothreats • Stuart D. Blacksell MPH, PhD, RBP • Mahidol-Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand. • Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Vientiane, Lao PDR. • Centre for Tropical Medicine, University of Oxford, United Kingdom.

2. MORU’s strategic position…. Half of the world’s population within 2000 miles….

3. MORU – 2011 Bangkok Unit Major field site / laboratory Laos project field site Collaborator’s site Mozambique AQUAMAT collaborative sites Sri Lanka

4. Diseases driving the needs? • Pandemic emergencies and preparedness (Diagnosis and Research) • Newly Emerging Infections • SARS • Nipah • Agents of increased virulence • Avian/Swine influenza • TB • RG3 Endemic diseases (Diagnosis and research) • Burkholderiapseudomallei • Rickettsia (Orientia tsutsugamushi) • Flaviviruses (Japanese Encephalitis virus)

5. BSL3 labs in SEA - The MORU experience • BSL3 & BSL2 laboratories • Thailand (4 sites) and Vientiane (Laos) • Cambodia (1), Bangladesh (1) • 2400m2 lab space (Bangkok) • 85 Lab staff (300 total) • Active Biosafety/Biosurity program • NSAR/CDC Select Agent Registered

6. “BSL3/4 labs” in South East Asia 2 1 1 8 5 1 2 5 13 7

7. Biocontainment facilities in SEA • At least 45 BSL3 labs in SEA • How many BSL4 or BSL3 Animal? • What standard where the labs built to? • Accredited to any standard? • What is the level of biosafety training? • What is the level of security? • Are the facilities appropriately managed? • Is a BSL3/4 lab really needed? • WHO KNOWS???

8. Biosafety challenges in SE Asia • Running a Biocontainment facility RESPONSIBLY is a huge investment of time, people, facilities and money. • Most facilities are not properly prepared • Legislation and Standards • Financial • Administrative • Personnel • Logistics • Facilities and Equipment • Enforcement

9. National legislation • Poorly enforced/Poorly understood • Thailand • Enacted in 2011 • MoPH “licensing” BSL2/3 labs • MORU first BSL3 lab accredited by MoPH • Laos • No legislation • Singapore • Biosafety Act • MOH-Approved Facility Certifier's List /MOH-BSL3 Laboratory Certification Checklist • Malaysia • Biosafety Act • Dual Use potential poorly understood.

10. International Standards • What standard to meet in SEA? • WHO, CDC, UK, Australian • Develop a regional standard? • National standard? • MORU (Funding imperative) • BMBL 5th Ed (Access to NIH funds) • US Select Agent (Access to NIH funds) • UK (Oxford University) • Thai (Based in Thailand)

11. Financial and Administrative Issues • Financial • Limited budgets • Maintenance • Training • Corruption! • Administrative • Institutional Biosafety Committee • Incomplete documentation • Biosafety manual • Emergency Response Plan • Interaction with First Responders (Police/Fire) • Standard Operating Procedures

12. Personnel • Severe lack of Biosafety administrators! • How to deal with this issue? • Training • Institutional • Donors (BEP, Sandia, WHO, AusAID) • Local or overseas • Partnerships • Twinning (Regional partnership – AAHL, MORU) • MORU • Full-time Biosafety Administrator • 50% time Registered Biosafety Professional • 7 Biosafety site representatives

13. Security/Restricting Access • Site specific security plan • Staff with access • USA • FBI clearance - Restricted person criteria (Criminal, Drugs, Terrorism) • US Dept of Justice registered “entity” personnel • Thailand • Local Police check using national and international databases • Laos • No capability

14. Training – MORU experience • New staff training – lack of “safety culture” • Robust induction procedure • Documented competency • “Dual use” awareness • Performed by experts in the area (hands on and A/V) • Onsite/Offsite • Consultants, BEP, Sandia, WHO, AusAID • Regular refresher training • Personnel Protective Equipment • Respirator fit tests • Standard Operating Procedures • Spills & emergency procedures • Decontamination • Document all training

15. Logistics – Infectious inventories • Baseline Inventory established • Agent, source, quantity, use • Audit trail • Checked periodically by RO’s • Quarterly check of inventory, people, security • MORU experience • Freezerworks software • Very labor intensive • 2 people – 24 months – 20,000 samples

16. Facilities maintenance and testing • Whatever is built must have locally available service! • Maintenance budgets - often overlooked • BSC testing/HEPA testing • NSF49 or other • Urgent need for accredited BSC/filter testers • Role for donors and partners • Routine upgrades and replacements • Money for new labs is simple! • Easy to see where money has been spent • Difficult to get maintenance budgets!

17. Other considerations • BSL3 Energy costs • Tropical climate • BSL3 single pass air = very expensive and wasteful • Why not recirculation 85% of the air with additional HEPA filtration • Regional training faculties • Biocontainment engineering/Biosafety Officers/Maintenance • Not for profit • Use facilities and experience that is already available locally • Assess the risks • Do we really need a BSL3 lab? • Can we use BSL2 lab with BSL3 practices

18. Conclusions • Focus areas for biosafety and biocontainment • Regulations and legislation • Biosafety Administration • Assess the risks – do we really need a Rolls Royce? • Training • Biosafety administration • Biosafety practices/PPE • Emergency response • Facilities maintenance and testing/certification • Forward planning for budgets • Appropriate physical security

19. Thank you