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

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2

3

PH

B

MechanicalMaintenance

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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