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Patricia Tsang, PhD, RBPTuberculosis Research Section,
Laboratory of Clinical Immunology and Microbiology,NIAID, NIH
November 1, 2018
The Biosurety Program
AGENT PERSONNEL
BIOSAFETY BIOSECURITY
The Biosurety Program in TRS, NIH
MANAGEMENT
BIOSAFETY
Risk assessment and risk management
• Safe work practices (BMBL)• Biosafety manuals• SOPs
The Biosurety Program in TRS, NIH
The Gold Standard for Biosafety
Both a code of practice and an authoritative reference
1984 2007
Background investigations• eQIP
Safety trainings • Lab biosafety • Agent handling• Incident and spill procedures• Hands-on training
PERSONNELRELIABILITY
Medical and mental screenings• OMS (physical, IGRA, serum)• BHA interview
The Biosurety Program in TRS,NIH
Agent Specific Training: Objectives
BSL-3 usertraining
requirementsEntry and Exit
procedures
Working in the BSL-3 lab /lab specific
SOPs
Incident and SpillProcedures
and Reporting
Emergencyprocedures
Securityprocedures
Visitortraining
requirementsAgent specific
information
AGENTACCOUNTABILITY
Pathogen registrations• IBC approval
Limited access
Inventory management• Location records• Traceable records• Transfer records
The Biosurety Program in TRS, NIH
Inventory management - FreezerPro
BIOSECURITY
Facility security• Internal monitoring• External monitoring• Random search and inspections
Facility access• Authorized access• Biometric system
The Biosurety Program in TRS, NIH
MANAGEMENT
• Communications• Recordkeeping• Operations• Planning• Inspections
DOHS, NIH
Responsible Officer (RO)
Investigator (PI)
Lab Manager
Individual
The Biosurety Program in TRS, NIH
MANAGEMENT
NIH campus map (Bethesda, MD)
The C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases (Bldg 33)
http://www.whiting-turner.com/portfolio/industry/federal/9770/9770.html
NIH Design Requirements ManualChapter 4
The C.W. Bill Young Center for Biodefense and Emerging Infectious Diseases (Bldg 33)
http://www.thebellcompany.com/projects/11/building-33-national-institues-of-health/https://nihrecord.nih.gov/newsletters/10_14_2003/story01.htm
1
2
3
PH
B
MechanicalMaintenance
i
i
i
Labs
Labs
Labs
Labs/Vivarium
m
m
High-Throughput drug discovery screening facility
• Biomek Fx liquid handler• Viaflo 96 liquid dispenser• EnVision microplate reader
High-Throughput drug discovery screening facility
Fully automated HTS system
High-Throughput drug discovery screening facility
Conveyor belt‘Hotel’Cytomat automated incubator
Biomek Fx
High-throughput drug discovery efforts in TRS, NIH
• Whole-cell screening approach
• Determination of compound activity against live cells
• All physiologically available targets explored at once
• A true hit always exhibits antibacterial activity
• Quick and dirty
• Target has to be identified
• Main pathogen of interest: Mycobacterium Tuberculosis
• Other (re-)emerging pathogens that require BSL-3 containment labs, as concluded by DOHS
Tuberculosis
https://www.niaid.nih.gov/sites/default/files/TBStrategicPlan2018.pdf
Tuberculosis Research Section (TRS)LCIM, NIAID, NIH
The TBDA is a groundbreaking partnership between eight pharmaceutical companies, eight research institutions, and a product
development partnership that seeks to develop a new TB drug regimen through collaboration in early-stage drug discovery research.
What is the TB Drug Accelerator?
22
With Participation From:
Collaborative efforts in accelerating drug discovery for Tuberculosis
Middle East respiratory syndrome coronavirus (MERS-CoV)
• Middle East respiratory syndrome (MERS) is a viral respiratory disease caused by a novel coronavirus (Middle East respiratory syndrome coronavirus, or MERS‐CoV) that was first identified in Saudi Arabia in 2012.
• Coronaviruses are a large family of viruses that can cause diseases ranging from the common cold to Severe Acute Respiratory Syndrome (SARS).
• Approximately 35% of reported patients with MERS have died.
http://www.who.int/en/news-room/fact-sheets/detail/middle-east-respiratory-syndrome-coronavirus-(mers-cov)
https://www.cdc.gov/fungal/candida-auris/index.html
Challenges• More collaborators would like to use our HTS
facility for a variety of pathogens (especially drug resistance strains) : bacteria, virus, fungus…..
• Whole room decontamination after screen of each pathogen (downtime and cost)
• Influx of visiting fellow coming from different parts of the world who have prior BSL-3 lab experience and different definitions of safe work practices
• Being a lab on the NIH main campus
Acknowledgements
Tuberculosis Research Section,
LCIM, NIAID,NIH
Dr Clifton Barry
Dr Helena Boshoff
HTS screen team
Funding
Division of Occupational Health and Safety, NIH