October 12-17, 2018

October 12-17, 2018

Charleston, SC

Charleston, SC

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Sunday Courses

October 14, 2018

Registration

7:00 am  -  5:00 pm
2018-10-14 07:00:00 2018-10-14 17:00:00 America/New_York Registration The Registration Desk will be open Friday through Wednesday from 7:00 am – 5:00 pm. Charleston Convention Center, North Charleston, SC ABSA International [email protected]

The Registration Desk will be open Friday through Wednesday from 7:00 am – 5:00 pm.

14 – Advanced Topics in Biocontainment Challenges in Agriculture Research

8:00 am  -  5:00 pm
Room 7
2018-10-14 07:57:00 2018-10-14 17:00:00 America/New_York 14 – Advanced Topics in Biocontainment Challenges in Agriculture Research Subject matter experts will review general biosafety, biocontainment, biosecurity, veterinary, and occupational health principles as they apply to agricultural research and that are relevant to consider in the design and performance of research activities involving agricultural species, pathogens, facilities, practices, and/or equipment. A major component of this course will include a series of interactive exercises, specifically designed to demonstrate unique challenges and hazards that are routinely encountered in agriculturally-based research, and then guide participants through the process of conducting an effective risk assessment and developing successful strategies to address potential worker safety, environmental, and public health concerns that are identified. Emphasis will be placed on the development of redundant (or multi layered) containment systems and the need for vigilance in continuously monitoring the adequacy of these controls to prevent accidental release of pathogens and/or pests into the surrounding community. The use of real world case studies will provide opportunities for discussion and exchange of ideas that reinforce practical application of knowledge, information, and concepts covered through formal presentations, and give participants actual experience in contributing to the development of environmentally safe and sound research practices and containment procedures. Objectives: Describe the unique challenges and hazards that pertain to research involving agricultural species, pathogens, facilities, practices, and/or equipment Identify, assess, and manage risks encountered in agriculturally-based research activities Develop effective strategies to prevent the accidental release of agricultural pathogens and/or pests Suggested Background: Introduction to Unique Biocontainment, Challenges in Agriculture Research Target Audience:  All Safety Professionals, Laboratory Workers, Veterinarians and Animal Caretaker Staff Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Subject matter experts will review general biosafety, biocontainment, biosecurity, veterinary, and occupational health principles as they apply to agricultural research and that are relevant to consider in the design and performance of research activities involving agricultural species, pathogens, facilities, practices, and/or equipment. A major component of this course will include a series of interactive exercises, specifically designed to demonstrate unique challenges and hazards that are routinely encountered in agriculturally-based research, and then guide participants through the process of conducting an effective risk assessment and developing successful strategies to address potential worker safety, environmental, and public health concerns that are identified. Emphasis will be placed on the development of redundant (or multi layered) containment systems and the need for vigilance in continuously monitoring the adequacy of these controls to prevent accidental release of pathogens and/or pests into the surrounding community. The use of real world case studies will provide opportunities for discussion and exchange of ideas that reinforce practical application of knowledge, information, and concepts covered through formal presentations, and give participants actual experience in contributing to the development of environmentally safe and sound research practices and containment procedures.

Objectives:

  • Describe the unique challenges and hazards that pertain to research involving agricultural species, pathogens, facilities, practices, and/or equipment
  • Identify, assess, and manage risks encountered in agriculturally-based research activities
  • Develop effective strategies to prevent the accidental release of agricultural pathogens and/or pests

Suggested Background: Introduction to Unique Biocontainment, Challenges in Agriculture Research

Target Audience:  All Safety Professionals, Laboratory Workers, Veterinarians and Animal Caretaker Staff

15 – Integrating Biosecurity into Biorisk Management Systems: A Threat Assessment Scenario-driven Approach

8:00 am  -  5:00 pm
Room 12
2018-10-14 07:58:00 2018-10-14 17:00:00 America/New_York 15 – Integrating Biosecurity into Biorisk Management Systems: A Threat Assessment Scenario-driven Approach Biorisk management programs should be implemented at any institution where the release, loss, or theft of biological material could result in serious negative consequences, such as harm to workers, the outside community, damage to institutional reputation, and/or financial/legal actions. This course provides biosafety and program managers with strategic and tactical approaches for creating an integrated approach that strengthens their biosecurity program as a complement to existing biorisk programs. Participants will be given hypothetical scenarios and work together to understand the differences between risk-based (biosafety) and threat-based (biosecurity) programs, as they contribute to system-wide concepts of threat and vulnerability. Participants will examine Five Pillars of Security (physical, personnel reliability, material control, transportation, and information security) to consider as a framework for building an integrated security program (ISP). The ISP model will be used to align security needs within biosafety programs that will enhance existing institutional safety and security systems. The ISP development will be augmented with templates on conducting threat assessments and vulnerability analyses, models for creating a biosecurity program, and strategies for integrating biosecurity functionality into biosafety programs. Participants will gain a comprehensive knowledge of the distinctions and intersections of biosafety and biosecurity, conducting threat assessments to complement to risk-based programs, building a biosecurity program framework, and ideas on steps to take at participant’s respective institutions to improve and integrate their biosecurity programs. Objectives: Describe the elements of risk-based (biosafety) and threat-based (biosecurity)programs fundamental to implementing a comprehensive biorisk management program Recognize threats and vulnerabilities to consider when protecting biological materials and other laboratory assets from unauthorized access, loss, theft, misuse, diversion, or intentional release Utilize Five Pillars of Security as a framework for recognizing gaps and opportunities for biosecurity program improvement Suggested Background: Fundamentals of Biosafety, Risk Assessment Target Audience: All Biosafety Professionals, Biosecurity personnel Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Biorisk management programs should be implemented at any institution where the release, loss, or theft of biological material could result in serious negative consequences, such as harm to workers, the outside community, damage to institutional reputation, and/or financial/legal actions. This course provides biosafety and program managers with strategic and tactical approaches for creating an integrated approach that strengthens their biosecurity program as a complement to existing biorisk programs. Participants will be given hypothetical scenarios and work together to understand the differences between risk-based (biosafety) and threat-based (biosecurity) programs, as they contribute to system-wide concepts of threat and vulnerability. Participants will examine Five Pillars of Security (physical, personnel reliability, material control, transportation, and information security) to consider as a framework for building an integrated security program (ISP). The ISP model will be used to align security needs within biosafety programs that will enhance existing institutional safety and security systems. The ISP development will be augmented with templates on conducting threat assessments and vulnerability analyses, models for creating a biosecurity program, and strategies for integrating biosecurity functionality into biosafety programs. Participants will gain a comprehensive knowledge of the distinctions and intersections of biosafety and biosecurity, conducting threat assessments to complement to risk-based programs, building a biosecurity program framework, and ideas on steps to take at participant’s respective institutions to improve and integrate their biosecurity programs.

Objectives:

  • Describe the elements of risk-based (biosafety) and threat-based (biosecurity)programs fundamental to implementing a comprehensive biorisk management program
  • Recognize threats and vulnerabilities to consider when protecting biological materials and other laboratory assets from unauthorized access, loss, theft, misuse, diversion, or intentional release
  • Utilize Five Pillars of Security as a framework for recognizing gaps and opportunities for biosecurity program improvement

Suggested Background: Fundamentals of Biosafety, Risk Assessment

Target Audience: All Biosafety Professionals, Biosecurity personnel

16 – Engineering For The Biosafety Professional Part II

8:00 am  -  5:00 pm
Room 10/11
2018-10-14 07:59:00 2018-10-14 17:00:00 America/New_York 16 – Engineering For The Biosafety Professional Part II In follow up to “Engineering for the Biosafety Professional-Part I,” this course demonstrates biocontainment engineering principles and their application to the proper operation and sustainability of a biocontainment laboratory. Included in the discussion will be concepts such as understanding various types of traditional HVAC design and emerging green design, comprehension of the purpose and information available from a building automation system, troubleshooting airflow reversals, understanding HVAC schematics, identifying redundancy needs, determining methodology for HVAC decontamination, deconstruction, and decommissioning. These basic concepts assist the biosafety professional in their interaction with facility personnel and designers of new construction, renovations, and ceasing of BSL-3 facilities operations using real-life examples and how they apply to biocontainment laboratories. More advanced engineering fundamentals will be discussed including HVAC sequence of operations, ventilation risk assessment, developing failure scenarios, integration of energy conservation into the laboratory and compliance to Testing and Performance Verification Methodologies for Ventilation Systems for BSL-3 and ABSL-3 Facilities (ANSI Z9.14). Group exercises will be conducted for practical application of principals presented. Building on “Engineering for the Biosafety Professional-Part I,” this course will integrate examples that show cause and effect in real-life scenarios. Objectives: Interpret HVAC schematics, understand the basics of HVAC control systems, and assess redundancy needs Develop HVAC failure scenarios, analyze test data and develop a risk assessment for an airflow reversal Paraphrase the methodology for troubleshooting HVAC systems Suggested Background: Engineering for the Biosafety Professional—Part I Target Audience: All Biosafety Professionals, Facilities Personnel   Charleston Convention Center, North Charleston, SC ABSA International [email protected]

In follow up to “Engineering for the Biosafety Professional-Part I,” this course demonstrates biocontainment engineering principles and their application to the proper operation and sustainability of a biocontainment laboratory. Included in the discussion will be concepts such as understanding various types of traditional HVAC design and emerging green design, comprehension of the purpose and information available from a building automation system, troubleshooting airflow reversals, understanding HVAC schematics, identifying redundancy needs, determining methodology for HVAC decontamination, deconstruction, and decommissioning. These basic concepts assist the biosafety professional in their interaction with facility personnel and designers of new construction, renovations, and ceasing of BSL-3 facilities operations using real-life examples and how they apply to biocontainment laboratories. More advanced engineering fundamentals will be discussed including HVAC sequence of operations, ventilation risk assessment, developing failure scenarios, integration of energy conservation into the laboratory and compliance to Testing and Performance Verification Methodologies for Ventilation Systems for BSL-3 and ABSL-3 Facilities (ANSI Z9.14). Group exercises will be conducted for practical application of principals presented. Building on “Engineering for the Biosafety Professional-Part I,” this course will integrate examples that show cause and effect in real-life scenarios.

Objectives:

  • Interpret HVAC schematics, understand the basics of HVAC control systems, and assess redundancy needs
  • Develop HVAC failure scenarios, analyze test data and develop a risk assessment for an airflow reversal
  • Paraphrase the methodology for troubleshooting HVAC systems

Suggested Background: Engineering for the Biosafety Professional—Part I

Target Audience: All Biosafety Professionals, Facilities Personnel

 

17 – Pathogen Inactivation Methods for Laboratory Applications

8:00 am  -  5:00 pm
Room 8/9
2018-10-14 08:00:00 2018-10-14 17:00:00 America/New_York 17 – Pathogen Inactivation Methods for Laboratory Applications Safe handling of highly infectious agents or toxins should be of paramount importance to every laboratory within both clinical and research settings. Consequently, the best alternative to manipulating and analyzing biohazardous materials (frequently requiring a high-containment environment) is effective inactivation of infectious agents or toxins rendering them safe for further laboratory analysis. The inactivation of biological materials intended for laboratory applications brings a challenge: although infectious properties of such samples are expected to be eliminated, at the same time, they should retain the integrity of target structures/molecules (peptides/nucleic acids, etc.) intended for analysis. This course addresses these challenges and provides a basic understanding of pathogen inactivation methods and their limitations deriving also from structures and properties of microorganisms and toxins. The course includes seven major topics: virion properties and microbial cell structures (eukaryotic/prokaryotic cells) as potential target sites for biocide action; physical (heat, radiation) inactivation and sterilization (filtration); mechanisms of biocide action and microbial resistance to biocides; toxin properties and inactivation of toxins; compatibility of inactivation methods with experimental laboratory assays; commercial nucleic acids/protein extraction kits as means of inactivation; and quality assurance and validation of inactivation methods. At the end of the course participants will be divided into workgroups and given hypothetical scenarios requiring the selection of appropriate inactivation methods. Objectives: Describe principle characteristics of bacteria, fungi, and viruses that affect inactivation Compare and contrast different inactivation methods and their limitations Restate the applicability of inactivation methods specifically to experimental laboratory assays Suggested Background: None Target Audience: New Biosafety Professionals, Laboratory Workers, All Safety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Safe handling of highly infectious agents or toxins should be of paramount importance to every laboratory within both clinical and research settings. Consequently, the best alternative to manipulating and analyzing biohazardous materials (frequently requiring a high-containment environment) is effective inactivation of infectious agents or toxins rendering them safe for further laboratory analysis. The inactivation of biological materials intended for laboratory applications brings a challenge: although infectious properties of such samples are expected to be eliminated, at the same time, they should retain the integrity of target structures/molecules (peptides/nucleic acids, etc.) intended for analysis. This course addresses these challenges and provides a basic understanding of pathogen inactivation methods and their limitations deriving also from structures and properties of microorganisms and toxins. The course includes seven major topics: virion properties and microbial cell structures (eukaryotic/prokaryotic cells) as potential target sites for biocide action; physical (heat, radiation) inactivation and sterilization (filtration); mechanisms of biocide action and microbial resistance to biocides; toxin properties and inactivation of toxins; compatibility of inactivation methods with experimental laboratory assays; commercial nucleic acids/protein extraction kits as means of inactivation; and quality assurance and validation of inactivation methods. At the end of the course participants will be divided into workgroups and given hypothetical scenarios requiring the selection of appropriate inactivation methods.

Objectives:

  • Describe principle characteristics of bacteria, fungi, and viruses that affect inactivation
  • Compare and contrast different inactivation methods and their limitations
  • Restate the applicability of inactivation methods specifically to experimental laboratory assays

Suggested Background: None

Target Audience: New Biosafety Professionals, Laboratory Workers, All Safety Professionals

18 – Articulating the Value of Your Biosafety Program

8:00 am  -  5:00 pm
Room 6
2018-10-14 08:01:00 2018-10-14 17:00:00 America/New_York 18 – Articulating the Value of Your Biosafety Program A recurrent challenge for biosafety professionals is the ability to garner necessary program resources. The basis for this difficulty is that on a good day in the world of biosafety “nothing happens,” so upper management may not fully appreciate or understand all of the effort that went into making “nothing happen.” Biosafety professionals experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course will focus on key management techniques that can be used within biosafety programs to help improve stakeholder understanding of the program and activities, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques discussed will be displayed for review and discussion. Objectives: Identify biosafety programmatic measures and metrics that can be easily captured and communicated Recall techniques used for displaying biosafety data in ways that others can readily understand and value Describe how basic safety and biosafety programs work together to avoid duplication of efforts and improve safety and client satisfaction levels Suggested Background: None Target Audience: All Safety Professionals, All Biosafety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

A recurrent challenge for biosafety professionals is the ability to garner necessary program resources. The basis for this difficulty is that on a good day in the world of biosafety “nothing happens,” so upper management may not fully appreciate or understand all of the effort that went into making “nothing happen.” Biosafety professionals experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course will focus on key management techniques that can be used within biosafety programs to help improve stakeholder understanding of the program and activities, which in turn can result in the provision of necessary programmatic resources. Numerous real-world examples of successful applications of the techniques discussed will be displayed for review and discussion.

Objectives:

  • Identify biosafety programmatic measures and metrics that can be easily captured and communicated
  • Recall techniques used for displaying biosafety data in ways that others can readily understand and value
  • Describe how basic safety and biosafety programs work together to avoid duplication of efforts and improve safety and client satisfaction levels

Suggested Background: None

Target Audience: All Safety Professionals, All Biosafety Professionals

19 – Practical Biosafety and Infection Control Considerations for Human Gene Transfer Studies

8:00 am  -  12:00 pm
2018-10-14 08:02:00 2018-10-14 12:00:00 America/New_York 19 – Practical Biosafety and Infection Control Considerations for Human Gene Transfer Studies This course will outline regulatory and safety challenges in conducting human gene transfer research and offer strategies to address them. The course will cover basic regulatory and risk assessment for human gene transfer studies, and expand on the practical aspects of conducting such studies including identifying key stakeholders such as the IBC, IRB, Infection Control, and Pharmacy, and how to coordinate safety activities between each group. The course will outline some of the differences between biosafety, infection control, and hazardous drug safety and how each can work together to achieve desired outcomes. The course will examine case studies that highlight some of the challenges one might encounter in the real world. Objectives: Describe the regulatory framework for human gene transfer research and perform a risk assessment Identify key stakeholders for conduct of human gene transfer research and strategies to coordinate activities between them Summarize real world pitfalls for human gene transfer research through examination of case studies Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of Biosafety Target Audience: All Safety Professionals, All Biosafety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

This course will outline regulatory and safety challenges in conducting human gene transfer research and offer strategies to address them. The course will cover basic regulatory and risk assessment for human gene transfer studies, and expand on the practical aspects of conducting such studies including identifying key stakeholders such as the IBC, IRB, Infection Control, and Pharmacy, and how to coordinate safety activities between each group. The course will outline some of the differences between biosafety, infection control, and hazardous drug safety and how each can work together to achieve desired outcomes. The course will examine case studies that highlight some of the challenges one might encounter in the real world.

Objectives:

  • Describe the regulatory framework for human gene transfer research and perform a risk assessment
  • Identify key stakeholders for conduct of human gene transfer research and strategies to coordinate activities between them
  • Summarize real world pitfalls for human gene transfer research through examination of case studies

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of

Biosafety

Target Audience: All Safety Professionals, All Biosafety Professionals

20 – Risk Assessment Considerations for Cutting Edge Fluorescent Microscopy Techniques: Intersection of Laser and Biosafety

8:00 am  -  12:00 pm
Room 13
2018-10-14 08:03:00 2018-10-14 12:00:00 America/New_York 20 – Risk Assessment Considerations for Cutting Edge Fluorescent Microscopy Techniques: Intersection of Laser and Biosafety From increased resolution to longer imaging sessions for live cell imaging to better in-vivo imaging techniques, the field of microscopy is rapidly changing. The types of fluorescent microscopes being developed today push the boundaries of physics, chemistry, and biology. In this course, we will discuss the importance of the advances in microscopy over the past few decades and how modern microscopes differ from traditional fluorescence microscopes. As these systems become commercially available, it will be important for safety professionals to understand the unique features of these microscopes and the integrated risk assessment approach needed to mitigate their hazards. We will discuss through lectures and case studies how to conduct a comprehensive risk assessment for new microscopy systems. We will cover laser safety basics including but not limited to: hazard assessment, selection of personal protective equipment, laser enclosures and curtains, signage, standard operating procedures, institutional policies, and relevant safety standards. We will also discuss considerations for biological hazards on these microscopes such as manipulation of the samples on the scopes, how to disinfect microscope parts, sample transport, signage, standard operating procedures, research collaborations, and room ventilation. Finally, we will discuss some of the other hazards associated with imaging techniques such as electrical, chemical, and other physical hazards. Objectives: Describe the scientific value and importance of novel microscopy techniques as research tools Define the basic components of laser safety controls and procedures as they apply to research laboratories who utilize novel microscope systems Perform a comprehensive and integrative risk assessment for biohazardous work requiring imaging with novel fluorescent techniques and lab built imaging systems Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of Biosafety Target Audience: Laboratory Workers, All Safety Professionals, Experienced Biosafety Professionals, Core Imaging Facilities Staff Charleston Convention Center, North Charleston, SC ABSA International [email protected]

From increased resolution to longer imaging sessions for live cell imaging to better in-vivo imaging techniques, the field of microscopy is rapidly changing. The types of fluorescent microscopes being developed today push the boundaries of physics, chemistry, and biology. In this course, we will discuss the importance of the advances in microscopy over the past few decades and how modern microscopes differ from traditional fluorescence microscopes. As these systems become commercially available, it will be important for safety professionals to understand the unique features of these microscopes and the integrated risk assessment approach needed to mitigate their hazards. We will discuss through lectures and case studies how to conduct a comprehensive risk assessment for new microscopy systems. We will cover laser safety basics including but not limited to: hazard assessment, selection of personal protective equipment, laser enclosures and curtains, signage, standard operating procedures, institutional policies, and relevant safety standards. We will also discuss considerations for biological hazards on these microscopes such as manipulation of the samples on the scopes, how to disinfect microscope parts, sample transport, signage, standard operating procedures, research collaborations, and room ventilation. Finally, we will discuss some of the other hazards associated with imaging techniques such as electrical, chemical, and other physical hazards.

Objectives:

  • Describe the scientific value and importance of novel microscopy techniques as research tools
  • Define the basic components of laser safety controls and procedures as they apply to research laboratories who utilize novel microscope systems
  • Perform a comprehensive and integrative risk assessment for biohazardous work requiring imaging with novel fluorescent techniques and lab built imaging systems

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles & Practices of

Biosafety

Target Audience: Laboratory Workers, All Safety Professionals, Experienced Biosafety Professionals, Core Imaging Facilities Staff

21 – ABSL-2 on the Farm

8:00 am  -  12:00 pm
Room 14
2018-10-14 08:04:00 2018-10-14 12:00:00 America/New_York 21 – ABSL-2 on the Farm Researchers and biosafety professionals at institutions involved with agricultural research are often challenged to provide biosafety guidance for large animal ABSL-2 work without clear guidelines or regulations. This course will provide a framework for working with large animal ABSL-2 research, discuss small animal ABSL-2 containment and how it relates to large animal ABSL-2 containment, describe the risk assessment process and how it differs from small animal ABS-2 risk assessments, define challenges unique to working with large animals, examine differing facility designs and challenges associated with adapting to existing facilities, discuss large animal waste and carcass management options, and delve into specify case studies with hands on activities. Course will be broken up into four modules: ABSL-2 basics and risk assessment, large animal husbandry, waste and carcass management, facility design, and case studies. Objectives: Describe basic principles of large animal BSL-2 research and containment Recognize differences between small animal and large animal BSL-2 containment and challenges unique to large animal containment Restate the ideal large animal BSL-2 containment facility design options and criteria Suggested Background: Fundamentals of Biosafety, Principles & Practices of Biosafety Target Audience: Experienced Biosafety Professionals, Animal Caretakers, All Safety Professionals, Farm and Animal Facility Managers, Supervisors, Technicians Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Researchers and biosafety professionals at institutions involved with agricultural research are often challenged to provide biosafety guidance for large animal ABSL-2 work without clear guidelines or regulations. This course will provide a framework for working with large animal ABSL-2 research, discuss small animal ABSL-2 containment and how it relates to large animal ABSL-2 containment, describe the risk assessment process and how it differs from small animal ABS-2 risk assessments, define challenges unique to working with large animals, examine differing facility designs and challenges associated with adapting to existing facilities, discuss large animal waste and carcass management options, and delve into specify case studies with hands on activities. Course will be broken up into four modules: ABSL-2 basics and risk assessment, large animal husbandry, waste and carcass management, facility design, and case studies.

Objectives:

  • Describe basic principles of large animal BSL-2 research and containment
  • Recognize differences between small animal and large animal BSL-2 containment and challenges unique to large animal containment
  • Restate the ideal large animal BSL-2 containment facility design options and criteria

Suggested Background: Fundamentals of Biosafety, Principles & Practices of Biosafety

Target Audience: Experienced Biosafety Professionals, Animal Caretakers, All Safety Professionals, Farm and Animal Facility Managers, Supervisors, Technicians

22 – Conducting Institution Biosafety and Security Inspections

8:00 am  -  12:00 pm
Room 3
2018-10-14 08:05:00 2018-10-14 12:00:00 America/New_York 22 – Conducting Institution Biosafety and Security Inspections The assessment of safety and security of an institution’s biorisk requires a comprehensive inspection conducted at least annually and anytime there are major changes to the institution. The results of the inspection must be presented to all appropriate individuals and corrections to deficiencies are made through changes in policies and procedures. There must be follow-up to corrections to ensure the identified risk has been addressed. This course will cover the organization of an inspection; describing the preparation prior to and a detailed description of areas covered during an inspection. There will be a review of the facilities (including animal facilitites) where work is conducted, where pathogens are stored, and the engineering facility support that is important. Emergency response planning, occupational health, personal competency evaluation, training, and personal reliability are critical elements to be reviewed. The course consists of a presentation on conducting a biosafety and security inspection punctuated by frequent scenarios for the participants to respond to and discuss that reinforce the points of the presentation. A detailed procedure manual for conducting safety and security inspections of biological institutions will be provided to participants as a reference to guide them in the application of course information upon their return to their institution. Objectives: Organize and conduct a comprehensive biosafety and security inspection Access each element of the institution related to safety and security risk Apply results of the institution inspection to improve the institution bio-risk program and reduce risk Suggested Background: Fundamentals of Biosafety Target Audience: All Biosafety Professionals, International Biosafety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

The assessment of safety and security of an institution’s biorisk requires a comprehensive inspection conducted at least annually and anytime there are major changes to the institution. The results of the inspection must be presented to all appropriate individuals and corrections to deficiencies are made through changes in policies and procedures. There must be follow-up to corrections to ensure the identified risk has been addressed. This course will cover the organization of an inspection; describing the preparation prior to and a detailed description of areas covered during an inspection. There will be a review of the facilities (including animal facilitites) where work is conducted, where pathogens are stored, and the engineering facility support that is important. Emergency response planning, occupational health, personal competency evaluation, training, and personal reliability are critical elements to be reviewed. The course consists of a presentation on conducting a biosafety and security inspection punctuated by frequent scenarios for the participants to respond to and discuss that reinforce the points of the presentation. A detailed procedure manual for conducting safety and security inspections of biological institutions will be provided to participants as a reference to guide them in the application of course information upon their return to their institution.

Objectives:

  • Organize and conduct a comprehensive biosafety and security inspection
  • Access each element of the institution related to safety and security risk
  • Apply results of the institution inspection to improve the institution bio-risk program and reduce risk

Suggested Background: Fundamentals of Biosafety

Target Audience: All Biosafety Professionals, International Biosafety Professionals

23 – Gene Editing, Logic Gates, and Synthetic Biology in Human Gene Transfer

1:00 pm  -  5:00 pm
Ballroom C1
2018-10-14 12:59:00 2018-10-14 17:00:00 America/New_York 23 – Gene Editing, Logic Gates, and Synthetic Biology in Human Gene Transfer Synthetic molecular biology involves the construction of novel artificial mechanisms to facilitate new biological functions. Some of these new mechanisms are now making their way into Human Gene Transfer (HGT) clinical trials, subject to the NIH Guidelines and requiring IBC review. The development of new synthetic biology techniques has been greatly accelerated by the advent of CRISPR and related gene-editing technologies. This course will cover cutting-edge examples of the application of synthetic biology in experimental clinical applications. Primary examples of such applications are found in the area of Chimeric Antigen Receptor (CAR) T cells. T cells bearing synthetic antigen receptors are designed to find and destroy cancer cells. What are the mechanisms that allow T cells to specifically target cancer cells without harming healthy tissue? What tools do researchers use to enhance on-target killing while avoiding off-target side effects? This course will review basic aspects of T cell signaling to allow for a discussion of how synthetic biology can be deployed on a molecular level to allow individual T cells to make logical decisions in the response to cancer. Additional discussions will look at other potential clinical applications such as creation of probiotic microbes. Interactive discussions will highlight how these new technologies are affecting biosafety activities at participants’ home institutions, and how IBCs can prepare to review these protocols. Objectives: Define the concepts of gene editing and synthetic biology Describe examples of the application of synthetic biology in the area of cancer immunotherapy Describe specific considerations for IBC review of gene transfer trials involving synthetic biology Suggested Background: None Target Audience: Experienced Biosafety Professionals, All Safety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Synthetic molecular biology involves the construction of novel artificial mechanisms to facilitate new biological functions. Some of these new mechanisms are now making their way into Human Gene Transfer (HGT) clinical trials, subject to the NIH Guidelines and requiring IBC review. The development of new synthetic biology techniques has been greatly accelerated by the advent of CRISPR and related gene-editing technologies. This course will cover cutting-edge examples of the application of synthetic biology in experimental clinical applications. Primary examples of such applications are found in the area of Chimeric Antigen Receptor (CAR) T cells. T cells bearing synthetic antigen receptors are designed to find and destroy cancer cells. What are the mechanisms that allow T cells to specifically target cancer cells without harming healthy tissue? What tools do researchers use to enhance on-target killing while avoiding off-target side effects? This course will review basic aspects of T cell signaling to allow for a discussion of how synthetic biology can be deployed on a molecular level to allow individual T cells to make logical decisions in the response to cancer. Additional discussions will look at other potential clinical applications such as creation of probiotic microbes. Interactive discussions will highlight how these new technologies are affecting biosafety activities at participants’ home institutions, and how IBCs can prepare to review these protocols.

Objectives:

  • Define the concepts of gene editing and synthetic biology
  • Describe examples of the application of synthetic biology in the area of cancer immunotherapy
  • Describe specific considerations for IBC review of gene transfer trials involving synthetic biology

Suggested Background: None

Target Audience: Experienced Biosafety Professionals, All Safety Professionals

24 – HVAC Systems to Enhance BSL3 Facility Performance

1:00 pm  -  5:00 pm
Room 14
2018-10-14 13:00:00 2018-10-14 17:00:00 America/New_York 24 – HVAC Systems to Enhance BSL3 Facility Performance Many features can be added to a BSL-3 laboratory HVAC system to increase its complexity, all with the purpose of improving the flexibility and resilience to function through a multitude of scenarios. The instructors of this course have discovered that complexity is rarely a good attribute for a BSL-3 HVAC system. In fact, in most cases, the simpler, the better, within reason. This course will present lessons learned in commissioning over 100 BSL-3 laboratory projects, including how to simplify the design, installation and operation to comply with industry best practices. Objectives: Create a list of important BSL-3 HVAC system attributes Identify HVAC system elements that enhance the ability to meet BSL-3 requirements Develop a control strategy for optimizing HVAC system performance Suggested Background: Fundamentals of Biosafety, Risk Assessment, Biosafety Level 3-Design and Operations Target Audience: Experienced Biosafety Professionals, All Safety Professionals, Facilities and User Staff Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Many features can be added to a BSL-3 laboratory HVAC system to increase its complexity, all with the purpose of improving the flexibility and resilience to function through a multitude of scenarios. The instructors of this course have discovered that complexity is rarely a good attribute for a BSL-3 HVAC system. In fact, in most cases, the simpler, the better, within reason. This course will present lessons learned in commissioning over 100 BSL-3 laboratory projects, including how to simplify the design, installation and operation to comply with industry best practices.

Objectives:

  • Create a list of important BSL-3 HVAC system attributes
  • Identify HVAC system elements that enhance the ability to meet BSL-3 requirements
  • Develop a control strategy for optimizing HVAC system performance

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Biosafety Level 3-Design and

Operations

Target Audience: Experienced Biosafety Professionals, All Safety Professionals, Facilities and User Staff

25 – International Biocontainment Challenges

1:00 pm  -  5:00 pm
Room 13
2018-10-14 13:01:00 2018-10-14 17:00:00 America/New_York 25 – International Biocontainment Challenges This course will begin with a brief review of the key principles underlying the design features of containment laboratories. Participants will be introduced to and have a discussion on the differences in prescriptive and performance based requirements. A discussion will be held on the common biocontainment challenges and shared experiences and challenges. In addition to examples provided by the instructors, participants will be able to learn from the experiences of everyone in the room and will help identify possible solutions to challenges shared by other participants. The course will include lecture, pictures of many examples of biocontainment challenges from around the world, and small group activities analyzing case studies and developing alternate solutions. The goal of this course is to give participants confidence in using critical thinking skills to tackle problems in biocontainment facilities in lower resource settings. Objectives: Recognize key biocontainment design and operation challenges for institutions in lower resource countries Identify alternate solutions to meeting ventilation and waste disposal needs Understand the difference between prescriptive and performance based requirements and how to decide what risk mitigation measures that will be adequate and prudent in relation to exotic or endemic agents Suggested Background: Fundamentals of Biosafety,Risk Assessment Target Audience: All Safety Professionals, Laboratory Workers, Stakeholders in future refurbishment or new design of a facility Charleston Convention Center, North Charleston, SC ABSA International [email protected]

This course will begin with a brief review of the key principles underlying the design features of containment laboratories. Participants will be introduced to and have a discussion on the differences in prescriptive and performance based requirements. A discussion will be held on the common biocontainment challenges and shared experiences and challenges. In addition to examples provided by the instructors, participants will be able to learn from the experiences of everyone in the room and will help identify possible solutions to challenges shared by other participants. The course will include lecture, pictures of many examples of biocontainment challenges from around the world, and small group activities analyzing case studies and developing alternate solutions. The goal of this course is to give participants confidence in using critical thinking skills to tackle problems in biocontainment facilities in lower resource settings.

Objectives:

  • Recognize key biocontainment design and operation challenges for institutions in lower resource countries
  • Identify alternate solutions to meeting ventilation and waste disposal needs
  • Understand the difference between prescriptive and performance based requirements and how to decide what risk mitigation measures that will be adequate and prudent in relation to exotic or endemic agents

Suggested Background: Fundamentals of Biosafety,Risk Assessment

Target Audience: All Safety Professionals, Laboratory Workers, Stakeholders in future refurbishment or new design of a facility

26 – Promoting Biosafety and Biosecurity Through Effective Governance

1:00 pm  -  5:00 pm
Room 3
2018-10-14 13:02:00 2018-10-14 17:00:00 America/New_York 26 – Promoting Biosafety and Biosecurity Through Effective Governance Discussion of the importance of ensuring institutions have robust and comprehensive biosafety and biosecurity governance structures in place. The course will include an overview of the roles and responsibilities of institutions, Institutional Biosafety Committees (IBCs), and Institutional Review Entities (IREs) for biosafety and biosecurity oversight of research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the U.S. Government Policy for the Institutional Oversight of Dual Use Research of Concern (DURC). Information will be provided about some of the tools and best practices institutions can employ to strengthen their biosafety and biosecurity programs. Participants will break into small groups to discuss how an incident occurring at an institution subject to the NIH Guidelines represents a failure to have adequate institutional biosafety oversight, resulting in significant problems. Participants should come prepared to engage in discussion, information sharing, and interactive Q&A with course instructors and other participants. Objectives: Identify the activities of the Federal Experts Security Advisory Panel (FESAP) related to strengthening biosafety and biosecurity practices and oversight Desbribe the general responsibilities of institutions and Institutional Biosafety Committees (IBCs) for biosafety oversight of research subject to the NIH Guidelines Summarize the U.S. Government Policy for the Institutional Oversight of Dual Use Research of Concern (DURC), and the roles and responsibilities of institutions and Institutional Review Entity’s (IREs) Suggested Background: None Target Audience: All Safety Professionals, All Biosafety Professionals Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Discussion of the importance of ensuring institutions have robust and comprehensive biosafety and biosecurity governance structures in place. The course will include an overview of the roles and responsibilities of institutions, Institutional Biosafety Committees (IBCs), and Institutional Review Entities (IREs) for biosafety and biosecurity oversight of research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the U.S. Government Policy for the Institutional Oversight of Dual Use Research of Concern (DURC). Information will be provided about some of the tools and best practices institutions can employ to strengthen their biosafety and biosecurity programs. Participants will break into small groups to discuss how an incident occurring at an institution subject to the NIH Guidelines represents a failure to have adequate institutional biosafety oversight, resulting in significant problems. Participants should come prepared to engage in discussion, information sharing, and interactive Q&A with course instructors and other participants.

Objectives:

  • Identify the activities of the Federal Experts Security Advisory Panel (FESAP) related to strengthening biosafety and biosecurity practices and oversight
  • Desbribe the general responsibilities of institutions and Institutional Biosafety Committees (IBCs) for biosafety oversight of research subject to the NIH Guidelines
  • Summarize the U.S. Government Policy for the Institutional Oversight of Dual Use Research of Concern (DURC), and the roles and responsibilities of institutions and Institutional Review Entity’s (IREs)

Suggested Background: None

Target Audience: All Safety Professionals, All Biosafety Professionals

International Session

1:00 pm  -  5:00 pm
Ballroom C2/C3
2018-10-14 13:03:00 2018-10-14 17:00:00 America/New_York International Session Please join us for a special session on Sunday afternoon before the Opening Reception. The focus will be on the challenges of maintaining sustainable and durable international outreach efforts in biosafety and biosecurity. The session runs from 1:00 – 5:00 pm on Sunday, October 14. Speakers from around the world will present on the challenges of implementing biosafety programs and how to sustain them in often resource challenging environments. There will be a special poster session with posters from over 20 countries and a roundtable discussion where all participants can discuss solutions with international biorisk management experts. Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Please join us for a special session on Sunday afternoon before the Opening Reception. The focus will be on the challenges of maintaining sustainable and durable international outreach efforts in biosafety and biosecurity. The session runs from 1:00 – 5:00 pm on Sunday, October 14. Speakers from around the world will present on the challenges of implementing biosafety programs and how to sustain them in often resource challenging environments. There will be a special poster session with posters from over 20 countries and a roundtable discussion where all participants can discuss solutions with international biorisk management experts.

New Member Reception

5:30 pm  -  6:30 pm
2nd Floor Foyer
2018-10-14 17:30:00 2018-10-14 18:30:00 America/New_York New Member Reception Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Opening Reception

6:30 pm  -  8:30 pm
Exhibit Hall
2018-10-14 18:30:00 2018-10-14 20:30:00 America/New_York Opening Reception Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Public Health Shared Interest Group

8:30 pm  -  9:30 pm
Room 13
2018-10-14 20:30:00 2018-10-14 21:30:00 America/New_York Public Health Shared Interest Group Following the Opening Reception, the Public Health Shared Interest Group will hold their meeting. All public health professionals that are responsible or involved in biosafety within public health or clinical labs are invited. The meeting will take place at the Charleston Convention Center starting at 8:30 pm. Charleston Convention Center, North Charleston, SC ABSA International [email protected]

Following the Opening Reception, the Public Health Shared Interest Group will hold their meeting. All public health professionals that are responsible or involved in biosafety within public health or clinical labs are invited. The meeting will take place at the Charleston Convention Center starting at 8:30 pm.