patricia tsang, phd, rbp...patricia tsang, phd, rbp tuberculosis research section, laboratory of...
TRANSCRIPT
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Patricia Tsang, PhD, RBPTuberculosis Research Section,
Laboratory of Clinical Immunology and Microbiology,NIAID, NIH
November 1, 2018
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The Biosurety Program
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AGENT PERSONNEL
BIOSAFETY BIOSECURITY
The Biosurety Program in TRS, NIH
MANAGEMENT
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BIOSAFETY
Risk assessment and risk management
• Safe work practices (BMBL)• Biosafety manuals• SOPs
The Biosurety Program in TRS, NIH
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The Gold Standard for Biosafety
Both a code of practice and an authoritative reference
1984 2007
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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
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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
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AGENTACCOUNTABILITY
Pathogen registrations• IBC approval
Limited access
Inventory management• Location records• Traceable records• Transfer records
The Biosurety Program in TRS, NIH
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Inventory management - FreezerPro
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BIOSECURITY
Facility security• Internal monitoring• External monitoring• Random search and inspections
Facility access• Authorized access• Biometric system
The Biosurety Program in TRS, NIH
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MANAGEMENT
• Communications• Recordkeeping• Operations• Planning• Inspections
DOHS, NIH
Responsible Officer (RO)
Investigator (PI)
Lab Manager
Individual
The Biosurety Program in TRS, NIH
MANAGEMENT
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NIH campus map (Bethesda, MD)
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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
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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
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PH
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MechanicalMaintenance
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Labs
Labs
Labs
Labs/Vivarium
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High-Throughput drug discovery screening facility
• Biomek Fx liquid handler• Viaflo 96 liquid dispenser• EnVision microplate reader
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High-Throughput drug discovery screening facility
Fully automated HTS system
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High-Throughput drug discovery screening facility
Conveyor belt‘Hotel’Cytomat automated incubator
Biomek Fx
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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
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Tuberculosis
https://www.niaid.nih.gov/sites/default/files/TBStrategicPlan2018.pdf
Tuberculosis Research Section (TRS)LCIM, NIAID, NIH
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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?
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With Participation From:
Collaborative efforts in accelerating drug discovery for Tuberculosis
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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)
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https://www.cdc.gov/fungal/candida-auris/index.html
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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
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Acknowledgements
Tuberculosis Research Section,
LCIM, NIAID,NIH
Dr Clifton Barry
Dr Helena Boshoff
HTS screen team
Funding
Division of Occupational Health and Safety, NIH