November 15-20, 2019

November 15-20, 2019

Birmingham, Alabama

Birmingham, Alabama

days
0
-4
hours
-1
-4
minutes
-1
-8
seconds
-4
0
REGISTER
NOW

Scientific Program Abstracts
(Abstracts are on locked PDF documents. Passwords will be distributed by the ABSA office.)

Sunday Courses

November 17, 2019

15 – Shipping Infectious Substances Certification Course

8:00 am  -  5:00 pm

Eric Cook, MPH, CBSP(ABSA), Sandia National Laboratories, Albuquerque, NM

This course is appropriate for those who have some experience with infectious substance handling or shipping, but may not have been certified within the past three years. The course utilizes group discussions and interactive exercises focused on the essential areas of infectious substance shipping. Participants will have the opportunity to mark, label, package, and complete documentation for a variety of infectious substances shipments (Category A, Category B, and Exempt Patient Specimens). Participants will review applicable regulations with a focus on IATA. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. A final written certification exam will be administered. Participants must score at least 80% in order to be certified.

Objectives:

  • Classify biological materials for shipping purposes as either Category A, Category B, Exempt, or not regulated based on the principles of risk assessment
  • Demonstrate how to package, mark, label, and document shipments for infectious substances, Category A, Category B, and dry ice
  • Complete a written exam to qualify for infectious substance shipping certification

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals

16 – Articulating the Value of Your Biosafety Program

8:00 am  -  5:00 pm

Robert Emery, DrPH, CBSP(ABSA), University of Texas Health Science Center at Houston, Houston, TX
Scott Patlovich, DrPH, CBSP(ABSA), University of Texas Health Science Center at Houston, Houston, TX

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

17 – Operationalizing Biosecurity: An Intensive, Scenario-based Biosecurity Threat Assessment

8:00 am  -  5:00 pm

Lauren Richardson, DVM, DACVPM, Merrick & Company, Greenwood Village, CO
Ryan Burnette, PhD, Merrick and Company, Greenwood Village, CO
Stephen Goldsmith, DVM, Federal Bureau of Investigation, Washington, DC

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 an opportunity for biosafety professionals and program managers to identify threats, risks, and vulnerabilities; develop strategic and tactical interventions; apply these biosecurity concepts; and design a plan for implementation of these interventions in a tabletop scenario. The scenario will allow participants to explore mechanisms and logistical challenges for assessment and implementation of a biosecurity program, and will demonstrate the importance of an integrated approach to biosecurity as a complement to existing biorisk programs. Participants will be given a hypothetical scenario and will work together to develop an integrated plan. Participants will identify stakeholders; assess biosecurity threats, risks, and vulnerabilities at the organizational level; determine potential mitigation strategies; prioritize activities and strategies; and develop a strategy for communication of needs to organizational leadership and relevant stakeholders. As a part of this, participants will apply the Five Pillars of Security (physical, personnel reliability, material control, transportation, and information security) as a framework for building an integrated security program (ISP). Participants will gain a deeper knowledge of the application of biosecurity assessment, ISP implementation, and strategies for integration into their existing programs.

Objectives:

  • List stakeholder roles in biosecurity planning and assessment as part of a comprehensive biorisk management program
  • Recognize, assess, and develop mitigations for risks, threats, and vulnerabilities to protect biological materials and other laboratory assets from unauthorized access, loss, theft, misuse, diversion, or intentional release
  • Develop strategies for prioritization and communication of needs associated with implementing an integrated biosecurity plan

Suggested Background: Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Risk Management Professionals

18 – Gene Editing and Risk Assessment: Application to IBC Protocol Review

8:00 am  -  5:00 pm

Jessica McCormick-Ell, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Rutgers University, Newark, NJ

Gene editing technologies have been used for decades by scientists in the field of molecular genetics and recombinant DNA technology. Recently, with the discovery of CRISPR-Cas 9 gene editing, this field has expanded and the ease to manipulate genes has changed significantly. There are multiple methods for editing genes and many times they are used together. Biosafety officers, although experts in safety and biorisk assessment, may need additional information in regards to the scientific and technical side of this new technology in order to understand the risks of a protocol more completely in order to provide adequate risk management recommendations. This course is designed to provide a brief, but detailed, overview of basic gene editing technologies such as plasmid based systems, RNA interference, viral vectors, CRISPR Cas9 technology and gene drives. After brief discussion of these technologies, participants will review a proposed project as it may be presented to the IBC. Participants will be expected to review, discuss risks and benefits, and be able to propose alternative ways for the research to be conducted in a safer manner. The goal of this course is to provide participants with comprehensive background knowledge of various gene editing and recombinant DNA technologies commonly used so they will be able to ask pertinent questions during protocol review. Additional details about off-targeting issues and streamlined protocol exercises will be offered. The course has been modified to reflect new technologies and previous participant comments.

Objectives:

  • Describe the different types of gene editing technologies including viral vectors, RNAi and CRISPR/Cas9
  • Explain why and how these technologies are used together in a research project
  • Restate the topics and questions needed to assess the risks of gene editing research proposals

Suggested Background: Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Biosafety Professionals

19 – Sustaining an Effective Biological Safety Program Utilizing all Tools within EHS and Beyond

8:00 am  -  5:00 pm

Maya Nair, PhD, RBP(ABSA), University of North Texas Health Science Center, Fort Worth, TX Antony Schwartz, PhD, CBSP(ABSA), SM(NRCM), Duke University, Durham, NC

Increasingly, biological safety professionals are faced with managing biological safety programs with limited resources and less than ideal number of staff. Additionally, with the ever-changing regulatory and technological landscape, more and more responsibilities are added to biological safety office’s oversight. This course will focus on identifying effective strategies for developing, managing, and sustaining a biological safety program with available resources. Throughout the course, instructors will focus on three Rs (Regulatory, Regional, and Realistic) and how these principles can maximize the use of resources and help focus the biosafety professional’s time and energy into efforts that sustain the biological safety program. Participants will analyze ways other EHS programs intersect with biological safety and how these common pathways can be “exploited” for resources and efficient use of an institution’s budget. Participants will discuss strategies on how to maintain a high-level of user engagement and compliance in the program. The three Rs will be used as a guide to prioritize resources for identifying changes in regulations, navigating institution-specific issues, and setting realistic goals for successful outcomes. Some of the tools reviewed in this section of the course will include inspection checklists, entity plans, emergency response procedures, and ideas on being prepared for the unexpected. Case studies and interactive group exercises will be used to reinforce concepts shared by the instructors and to learn from each other on how best to maximize our resources.

Objectives:

  • Identify strategies and tools for maintaining a biosafety program with available resources and in good standing with current regulations
  • Analyze and apply the three Rs strategy for a sustainable biosafety program
  • Discuss strategies on how to maintain a high-level of user engagement and compliance in the program

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals

20 – Advanced Topics in Animal Research for Biosafety Professionals: Hazard Identification, Risk Assessment, and Practical Control Strategies

8:00 am  -  12:00 pm

Susan Harper, DVM, DACLAM, DACVPM, USDA Agricultural Research Service, Beltsville, MD Lesley Colby, DVM, DACLAM, University of Washington, Seattle, WA

This course will provide participants with a variety of advanced scenarios and interactive exercises that demonstrate the range of biological and other (chemical, radiological, and physical) hazards routinely encountered in animal-based research including those inherent to animals and those associated with commonly utilized procedures and select specialized equipment. Participants will be guided through strategies for identifying potential hazards, assessing the magnitude and extent of induced risks, and developing effective and cost-efficient control measures to protect the safety of workers, animals, and the environment. The course employs “real world” examples to improve understanding of animal program operations and to facilitate the exchange of ideas and the development of constructive partnerships between safety professionals and key animal program representatives for optimizing safety program outcomes.

Objectives:

  • Review basic hazard identification and risk assessment techniques as they apply to research involving live animals
  • Learn how to incorporate effective hazard and exposure control strategies into animal protocol design and research facility management procedures
  • Identify ways that safety professionals can work constructively with animal program personnel to address common research safety issues

Suggested Background: An Introduction to Animal Research for Biosafety Professionals: Oversight, Accreditation, and Collaborative Groups
Target Audience: All Biosafety Professionals, All Safety Professionals

21 – Biocontainment Laboratory Operations

8:00 am  -  12:00 pm

Miguel Grimaldo, MEng, University of Texas Medical Branch—Galveston, Galveston, TX
Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA), Cornell College of Veterinary Medicine, Ithaca, NY

This course will discuss key insights and share instructor expertise in biocontainment facility planning, start-up, and operations from an operator’s point of view. We often hear from some of the best of architects and engineers on how to build a biocontainment laboratory, but what about their competency, have they ever operated a laboratory to evaluate their own design process? Where did they learn their craft? During the course, a discussion of the detailed questions to ask the design/construction team, the steps to follow, and lessons learned during all the stages of building or renovating a biocontainment facility. The course will conclude with a discussion on planning and requirements to implement scientific operations.

Objectives:

  • Summarize lessons learned in the design, construction, and start-up of a biocontainment facility
  • Identify the questions to ask when selecting the facility design, construction, commissioning, and operations teams
  • Recall the plans and requirements needed to initiate scientific operations

Suggested Background: Fundamentals of Biosafety, Risk Assessment, BSL-3 Design and Operations, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, Engineers, Architects, Operations Managers

22 – HGT Studies: Biosafety, Infection Control, and Pharmacy Safety Considerations

8:00 am  -  12:00 pm

Edward David, MPH, RBP(ABSA), Celgene Corporation, San Diego, CA

This course will outline regulatory and safety challenges in conducting human gene transfer research and offer strategies to address them. This 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 regulatory framework for human gene transfer research and perform basic 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 and Practices of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals

23 – Biosecurity in Academic Institutions

8:00 am  -  12:00 pm

Timothy Key, MD, MPH, University of Alabama—Birmingham, Birmingham, AL
Justin Roth, PhD, University of Alabama—Birmingham, Birmingham, AL
Judith McBride, MSPH, MT(ASCP), CIH, University of Alabama—Birmingham, Birmingham, AL Rani Jacob, PhD, MPH, University of Alabama—Birmingham, Birmingham, AL
Mark Sawyer, BA, Federal Bureau of Investigation, Birmingham, AL

Due to the innovative and open nature of academic research, institutions are vulnerable to a variety of security threats, diversion or release of agents, export control, loss of equipment or intellectual property, and unauthorized research. This course will provide the participants with ways to identify biosecurity threats common to academic institutions, information to help them identify risks present on their campus, and tools to help them mitigate these risks. The course will be team taught by professionals having expertise in biosafety, occupational medicine, and governmental enforcement. A discussion will be held about the roles and responsibilities of various positions in the institution, basic security components such as: access control, agent inventory, reporting, interface with enforcement authorities, and training; mitigation strategies including: research ethics, physical, and cyber security plans, and developing a robust culture of safety.

Objectives:

  • Identify biosecurity threats at academic research institutions
  • Perform a biosecurity risk assessment
  • Apply biosecurity risk mitigation strategies in a table top drill setting

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, Law Enforcement, Research Administrators

24 – Evolving Role of IBCs in the Oversight of Human Gene Transfer

1:00 pm  -  5:00 pm

David Emery, PhD, Clinical Biosafety Services, Wildwood, MO

There has been a recent explosion in the number and diversity of human gene transfer clinical trials, as well as FDA- approved therapies based on recombinant DNA. This has been accompanied by a serial reduction in the oversight of human gene transfer clinical trials by the National Institutes of Health (NIH), to the point that such trials are no longer subject to review by the NIH Recombinant DNA Advisory Committee, or required to even be registered with the NIH. The transition of gene transfer technologies from the laboratory to the clinic, and the replacement of biosafety oversight of human gene transfer from the NIH to the institutional level, has fundamentally changed the roles and responsibilities of Institutional Biosafety Committees at large and small institutions around the country. This course will provide an overview of the current status of human gene transfer research and FDA-approved clinical applications, review the biosafety risks unique to the application of gene transfer in the clinical setting, and outline the evolving regulatory environment for both clinical research and clinical applications that make use of gene transfer technologies. This will include an overview of the evolving changes in the NIH Guidelines involving the biosafety oversight of human gene transfer clinical trials at the national and institutional levels, and how local Institutional Biosafety Committees are evolving to meet new demands. This will include a review of the regulatory requirements surrounding the use of gene therapy drugs approved by the FDA in clinical trials and in clinical practice. Case studies and group discussion will be used to amplify the take home messages.

Objectives:

  • Restate the risks and challenges associated with human gene transfer
  • Identify the categories and risk groups of biological agents used in human gene transfer
  • Identify the key regulatory roles of IBCs in the oversight of human gene transfer research

Suggested Background: Micro/Molecular Biology 101, Institutional Biosafety Committee Basics
Target Audience: Experienced Biosafety Professionals, Clinical Professionals, IBC Administrators

25 – Flow Cytometry and High Speed Cell Sorting—Biosafety, Testing, and Validation

1:00 pm  -  5:00 pm

Geoffrey Lyon, MPH, Yale University, New Haven, CT

Flow Cytometry is a staple of both academic and biotechnology research. This course will help differentiate the between flow cytometers (analyzers) and cell sorters and identify the different biosafety concerns with analyzers and sorters. It will discuss the current ISAC Cell Sorter Biosafety Standards; including risk assessment, sorter selection, facility design, and methods of aerosol containment. Participants will review the different aspects of biosafety that need to be considered when looking at laboratories with stand alone equipment verse core facilities. There will be discussion of the new and evolving types of cell sorters and the safety features included, the various methods that have been used to test the aerosol containment of cell sorters and their associated biosafety cabinets. A review of the most recent paper for a bead based test, Novel Impactor and Microsphere-Based Assay Used to Measure Containment of Aerosols Generated in a Flow Cytometer Cell Sorter, Cytometry Part A, 18 December 2018 will be conducted.

Objectives:

  • Discuss and clarify the basic concepts and differences between flow cytometry and cell sorting
  • Describe the current ISAC Cell Sorter Biosafety Standards and the caveats to consider when managing a core facility or a stand alone laboratory
  • Discuss the history of aearosol containment testing along with the latest ISAC standard for testing AMS and BSC cabinets associated with cell sorters

Suggested Background: Risk Assessment, BSL-3 Design and Operations, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, New Biosafety Professionals

26 – Institutional Biosafety and Biosecurity—Enhancing Oversight Through Effective Governance

1:00 pm  -  5:00 pm

Kathryn Harris, PhD, RBP(ABSA), National Institutes of Health, Bethesda, MD
Michelle McKinney, MS, CBSP(ABSA), National Institutes of Health, Bethesda, MD
Kevin Ramkissopn, PhD, National Institutes of Health, Bethesda, MD

This course will discuss the importance of ensuring institutions have a robust and comprehensive biosafety and biosecurity governance structures in place. Information will be provided about the activities of the Federal Experts Security Advisory Panel (FESAP) related to strengthening biosafety and biosecurity practices and oversight. In this course, participants should be prepared to engage in discussions, information sharing, interaction, and sharing of best practices that institutions can employ to enhance biosafety and biosecurity programs. There will be small group discussions centered around a case study involving a biosafety incident occurring at an institution subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), which illustrates the importance of institutional biosafety oversight and how inadequate local oversight can result in significant problems.

Objectives:

  • Identify the activities of the Federal Experts Security Advisory Panel (FESAP) related to strengthening biosafety and biosecurity practices and oversight
  • Describe the tools and best practices that institutions can employ to strengthen their biosafety and biosecurity programs
  • Summarize the requirements for reporting incidents under the NIH Guidelines and the importance of ensuring robust and comprehensive biosafety and biosecurity governance structures are in place

Suggested Background: Background knowledge with IBCs and IREs; knowledge of U.S. biosafety and biosecurity research oversight
Target Audience: Experienced Biosafety Professionals, PIs, IBC and IRE members and others involved in life science research oversight

27 – Managing an Efficient BSL-3/ABSL-3 Facility Shutdown

1:00 pm  -  5:00 pm

Colleen Driskill, RBP(ABSA), CBSP(ABSA), SM(NRCM), University of Massachusetts Medical School, Worcester, MA
James Gardner, University of Massachussetts Medical School, Worchester, MA
Kim West, BS, University of Massachussetts Medical School, Worchester, MA

This course will focus on BSL-3/ABSL-3 facility shutdowns, deliver and convey real world information, examples, and knowledge to participants from experiences in the operation and oversight of a BSL-3 laboratory. There will be a review and discussion of real world shutdown scenarios, descriptions of how contractors, vendors, and tradesmen can work in conjunction with the facilities, and examples of what has and has not worked well. Forms and procedures will be reviewed to assist with the coordination, scheduling and efficient organization of shutdowns, repairs, and facility re- verification. Interactive exercises will provide reinforcement for participants to practice instituting the tools discussed. Instructors bring a variety of interesting viewpoints from different professional perspectives regarding shutdowns and will discuss the BSL-3 Annual Facility Reverification process. Instructors will speak to unique experiences with validating controls, alarms, and issues that have been experienced with various HVAC equipment. Specific examples of BSL-3 facility-related incidents the instructors have experienced associated with shutdowns, root cause identification, actions taken, and lessons learned will be discussed. Other important factors of safety and compliantly operating a BSL- 3 lab will be reviewed, such as risk assessments for facility repairs and maintenance work.

Objectives:

  • Describe procedures for facility shutdowns for BSL-3 and or ABSL-3 lab facilities and provide examples for efficient, safe, and orderly completion of repairs, preventative maintenance and or facility re-verification
  • Identify key standard operating procedures, policies, and forms that provide guidance for orderly and efficient shutdowns of BSL-3 labs
  • Describe real world BSL-3 facility related problems and incidents and offer examples of how these types of issues can be avoided

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Laboratory Workers, BSL-3 Facility/Engineering Professionals

Opening Reception

6:30 pm  -  10:30 pm
Exhibit Hall