62nd Annual Biosafety and Biosecurity Conference

Professional Development Courses

November 15-17, 2019

Professional Development Courses |
Scientific Program |
Posters

November 15, 2019

01 – BSL-3 Operations and Management

Paul Jennette, MS, PE, RBP(ABSA), CBSP(ABSA), Cornell College of Veterinary Medicine, Ithaca, NY
Carrie Smith, PhD, RBP(ABSA), CBSP(ABSA), USGS—National Wildlife Health Center, Madison, WI

This course will review the important aspects of the daily operation of a BSL-3 facility from two points of view; management of the facility and the daily operations. This assumes that you already have a facility built and have all required authorizations to work in it. The course will cover the different aspects you need to consider to operate a BSL-3 facility, such as: approval and training of a worker; maintenance support; occupational health issues; managing waste; maintenance of the HVAC and physical facility; periodic checks on the facility’s systems; and emergencies of different types. Daily operations in a BSL-3 such as: understanding when it is safe to enter and when you need to evacuate; what to do when the ventilation fails; practical aspects of entry and exit procedures; practical tips on selection and use of personal protective equipment (PPE); safety considerations within the experimental SOPs; waste handling; facility cleaning; and how to have equipment repaired or serviced will be discussed. This course will be conducted in a way that allows for interaction and exchange of experiences between participants and instructors. This course will not cover regulatory aspects from any specific country.

Objectives:

Describe the elements of BSL-3 Operations and Management, such as risk management, PPE, annual performance verification, emergency response, etc.
Recognize institutional responsibilities from management to user
Summarize the methods used to develop manuals, SOPs, and training

Suggested Background: Basic Risk Assessment and Biosafety Knowledge
Target Audience: All Safety Professionals

02 – International Biosafety, Biosecurity, and Biocontainment Challenges

William Arndt, PhD, Centers for Disease Control and Prevention, Atlanta, GA
Natasha Griffith, MS, Centers for Disease Control and Prevention, Atlanta, GA
Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM

This course is intended to focus on international laboratory biosafety, biosecurity, and biocontainment features needed to support the implementation of a successful laboratory biorisk management program. This course will begin with a brief overview of common biorisk management implementation challenges and gaps often observed in locations such as Sub-Saharan Africa, Middle East, South Asia, and Southeast Asia. The instructors will share their experiences working in an international setting and on developing sustainable solutions to support the implementation of biorisk management best practices in a laboratory setting. Participants will share their experiences and challenges with everyone in the room and gain experience from instructors examples and others in helping to identify possible solutions to experiences or challenges shared. The course will include lecture, pictures of examples of laboratory biosafety, biosecurity, and 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 biorisk management and biocontainment challenges in their respective facilities.

Objectives:

Restate key laboratory biosafety, biosecurity, and biocontainment facility challenges and gaps
Identify sustainable solutions to common biorisk management and biocontainment challenges and gaps
Summerize how risk assessment and a risk-based decision strategy can be used to support the implementation of a sustainable laboratory biorisk management program

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, International Participants

03 – Building Biosafety Leaders

Michael Marsico, MS, Association of Public Health Laboratories, Silver Spring, MD
Pandora Ray, MA, MPH, CPC, Association of Public Health Laboratories, Silver Spring, MD

In 2017, the Association of Public Health Laboratories (APHL) convened three Biosafety Leadership Workshops to facilitate the professional development of biosafety officers (BSOs) in state, local, territorial U.S. Affiliated Pacific Island public health laboratories. This multi-day workshop convened BSOs by region and provided a forum encouraging personal and professional growth with the overall goal to strengthen their leadership skills. The training included several group, interactive, and didactic exercises focused on: The Five Practices of Exemplary Leadership® Model (MICEE), Affinity Exercises, and Single Override Communication Objective (SOCO). Upon completion, participants gained an invaluable network and a broader skill set that directly benefited them and their work environment. Currently, APHL has condensed this multi-day training program into a complete one-day course. As a result of the ever-changing and increasingly complex environment, there needs to be biosafety leaders who embrace change, manage people, process efficiently, and anticipate future needs. Through skill development on leadership, project management, communications including: messaging and storytelling, building effective training programs, and implementing evaluation measures, the course will shape biosafety professionals into future leaders within the laboratory system.

Objectives:

Describe the Leadership Challenge and MICEE Leadership Model
Apply the elements of Single Overriding Communications Objective (SOCO) to deliver a message to laboratory management
Identify work preferences that contribute to team dynamics and the management of relationships, information, decision making, and organization

Suggested Background: None
Target Audience: All Safety Professionals

04 – Facility Commissioning and Certification: Using the WHO Lab Biosafety Manual

Joby Evans, PE, CAC, CxA, Georgia Engineering LLC, Atlanta, GA
Luis Alberto Ochoa Carrera, MS, Institute for Epidemiological Diagnosis and Reference (InDRE), Mexico City, Mexico

Laboratory commissioning and certification are identified in the World Health Organization’s Laboratory Biosafety Manual as quality assurance processes for the biocontainment laboratory. These processes are not always understood by biosafety professionals. Many biosafety professionals are, at times, spectators and bystanders in the commissioning and certification process of their facilities. The biosafety officer will benefit by having a fundamental understanding of the commissioning and certification process and the resulting documentation. This understanding should allow them to articulate the engineering control data they require from their commissioning agent and how to use that data in the certification process. The certification requires the understanding of the personal protective equipment and the administrative controls. This course will review the process of laboratory certification; documentation, investigation, review of operational documents, testing, and reporting. This knowledge allows the biosafety professional to understand how the certification process verifies and documents laboratory readiness and when to know it is ready for safe and reliable operation based on the guidelines and the accepted criteria. The instructors will present some of the commonly encountered issues observed in developed and developing countries; how the issues are identified, and present some specific means and methods to mitigate the issues. The understanding of these processes and their interrelation assist the biosafety professional to confidently bring the laboratory into full operation to perform the scientific program.

Objectives:

Identify the skills and knowledge required for regular recommissioning and certification process in containment labs
Summarize the data outputs and meaning, and how the certification process maintains a safe and reliable laboratory facility
Identify and propose practical solutions to the encountered issues observed during the inspection, commissioning, and certification process

Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, Facility Operations and Maintenance Personnel

BIOLOGICAL SAFETY FOR FIRST RESPONDERS

Presented by ABSA International and the Federal Bureau of Investigation

Biological Safety for First Responders is a two and a half hour workshop focusing on the history of biosafety, biosafety basics, research at universities, regulatory aspects and current infectious disease issues as it relates to First Responders. This year during the workshop, the Federal Bureau of Investigation will present on challenges to responder safety as research material, technology, and knowledge become more democratized.

Download Flyer (PDF 318KB)

The course is being provided FREE of charge to the First Responder community by ABSA International. Participation is limited. This course will be a great opportunity for the Birmingham area First Responders, Public Health officials and the local biological safety community to network and begin partnerships in emergency response. Please email firstresponder@absa.org if you are interested in attending.

05 – Introduction to the CEN Workshop Agreement (CWA15793)

Rawan B. Khasawneh, Jordan University of Science and Technology, Irbid, Jordan

In some international communities, there is a growing need to develop a robust laboratory biorisk management system. A recognized comprehensive guideline is required to be applied in countries who are in the process of implementing the system. In this course, participants will become familiar with the CWA 15793 as a voluntary biorisk management system approach that applies internationally, agrees with quality management, environmental and occupational health management systems, and does not contradict with standards or legislation. CWA 15793 will be converted to the new ISO standard 35001, the commitment to follow the CWA 15793 will enable participants to effectively assess, mitigate, and monitor the laboratory biosafety and biosecurity risks, using the concept of continual improvement through the PDCA (Plan-Do-Check-Act) principle in organizations that handle biological agents and/or toxins, regardless of type, size, and biological agents. The CWA 15793 has comprehensive requirements participants can use as a framework for training, raising awareness, and supporting lab certification, accreditation, audit, and inspections. The course will begin with an introduction to terms, advantages of the CWA 15793, and a brief introduction to the major sections including: planning, policies, implementation and operation, checking and corrective actions, followed by a discussion about how to initiate implementation to improve laboratory biorisk management system and the expected challenges.

Objectives:

Distinguish the CWA 15793 as an international reference document for laboratory biorisk management requirements
Recognize the main domains of and how to initiate using the CWA 15793 to improve overall lab biorisk management system
Conduct a self-audit to determine current adherence to the CWA 15793 and identify priorities

Suggested Background: Fundamentals of Biosafety
Target Audience: New Biosafety Professionals, All Safety Professionals, International Participants

November 16, 2019

06 – Engineering for the Biosafety Professional Part I

Juan Osorio, IE, World BioHazTec Corporation, Rockville, MD
Theodore Traum, PE, CCP, DGCP, World BioHazTec Corporation, Rockville, MD
Brynte Johnson, RBP(ABSA), CBSP(ABSA), SM(NRCM), World BioHazTec Corporation, Rockville, MD

Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance, and certification of their containment facilities and building systems. The biosafety professional may be called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. The biosafety professional’s training and experience is usually limited to the sciences and they often lack the knowledge of basic engineering principles. This course is intended to fill the gap by providing basic engineering principles that are useful in the planning, design, construction, maintenance, and operation of a BSL-3 or high- containment facility. In order for the biosafety professional to participate in these activities; a foundation of engineering fundamentals, a developed set of skills to ask questions in engineering terms, and the confidence to question the answers are needed. There will be step-by-step slide presentations on planning, design, and quality assurance. Some of the exercises will require calculations (calculator recommended).

Objectives:

Discuss engineering principles, design, and construction process of a BSL-3 laboratory in order to identify potential problems before construction begins
Identify the phases and strategies of BSL-3 laboratory design and construction
Describe the elements of a BSL-3 laboratory quality assurance program

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

07 – Advanced Risk Assessment

Chad Austin, PhD, CBSP(ABSA), SM(NRCM), University of Texas Health Science Center—Houston, Houston, TX
Anne-Sophie Brocard, PhD, RBP(ABSA), CBSP(ABSA), University of Texas Medical Branch—Galveston, Galveston, TX
Brandon Hatcher, PhD, GlaxoSmithKline, Vaccines R&D, Rockville, MD

In this advanced and interactive course, participants will evaluate a variety of challenging scenarios based on actual research protocol submissions and real world events from multiple risk perspectives. Participants will work in teams to conduct risk assessments on a diverse selection of scenarios that will include multiple systems used in research as a research project progresses from discovery, to cell culture, to small animal models using recombinant materials, and human clinical trials. Risk assessments will focus on the likelihood of exposure and the severity of consequences from exposure to the multitude of hazards encountered in increasingly complex research as well as the surprises that may come across the biosafety officer’s desk. Participants will be challenged to consider additional risks aside from infection and how best to mitigate them. Participants should have a thorough understanding of pathogenic microorganisms, rDNA principles, other infectious substances and the link between biosafety, risk assessment, and risk mitigation for this advanced course. There is an emphasis on the interactive nature of the risk assessment process and differing views of risk tolerance will be considered; participants should be prepared to participate in discussions and bring interesting or difficult examples of interest to them to discuss with the class.

Objectives:

Prioritize risks based on the likelihood and consequences of an occurrence
Identify risks requiring mitigation and mitigation strategies to minimize the unacceptable risks
Identify institutional and external partners to help implement mitigation strategies
Evaluate mitigation strategies for effectiveness, adjust strategies as warranted

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles & Practices of Biosafety
Target Audience: Experienced Biosafety Professionals, Laboratory Workers

08 – Disinfection, Sterilization and Inactivation: A Practical Guide for the Biosafety Professional

Althea Treacy, PhD, National Institutes of Health, Bethesda, MD
Antony Schwartz, PhD, CBSP(ABSA), SM(NRCM), Duke University, Durham, NC

This course will provide biosafety professionals with a strong foundation in disinfection, sterilization, and inactivation that will directly benefit them in carrying out their responsibilities. Course discussion will be on the history and current regulatory context of disinfection, sterilization, inactivation, validation strategies, quality assurance tests for each topic, and analysis of the factors that influence the effectiveness and potency of different treatment methods will be given. Subsequent material will cover the mechanisms of disinfection, sterilization, and inactivation, including chemical structures and classes of disinfectants sterilants and inactivation agents. Further discussion will describe the selection of appropriate methods and identification of associated safety hazards. Utilizing proven practices and procedures, participants will be led through a facilitated discussion leading to the development of standard operating procedures for executing sterilization, disinfection, or inactivation at their institution. Throughtout the course, participants will participate in didactice modules and hands-on exercises in small groups.

Objectives:

Identify and restate mechanisms of disinfection, sterilization, and inactivation
Select appropriate disinfectants and sterilants and appropriately evaluate inactivation methodologies
Choose the appropriate validation and quality assurance test for method of disinfection, sterilization, or inactivation

Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Laboratory Workers

09 – Emerging Technologies in Agricultural and Plant Sector: Biosafety and Biosecurity Challenges and Risk Management

Aparupa Sengupta, PhD, RBP(ABSA), University of California—Merced, Merced, CA
Luis Alberto Ochoa Carrera, MS, Institute for Epidemiological Diagnosis and Reference (InDRE), Mexico City, Mexico

Global food security and enhancement of food quality has been a pressing issue worldwide. Recent advent of powerful technologies like gene editing tool CRISPR/Cas9 have the potential of bringing unprecedented global impact in different industries starting from novel bioenergy production, new therapeutic intervention in medical world to biodiversity conservation. In the agricultural sector, these technologies have contributed significantly towards food security, reduction in pesticide use and greenhouse gas emissions, and in improvement of occupational safety in both industrialized and developing countries over the last two decades. Although extremely beneficial, these technologies are certainly not risk-free. They could be used for nefarious acts, such as bioweapon development to create new pathogenic organisms to render vaccines ineffective. These technologies may also have off-target effects, such as tumor suppressor gene silencing during cell culture experiment, or potential of changing biodiversity and invasion and disruption of local agricultural system by exotic or transgenic species. Since, outbreak of diseases, bioweapons, and emerging technology transfer of knowledge knows no borders, the beneficial use of the technology can become challenging in terms of biosafety and biosecurity, if the risks are not understood and addressed appropriately. The course will also include new emerging technologies, applicable to the agricultural and plant biotechnology field, where an appropriate risk assessment and communication strategies are imperative for preventing accidents from occurring or re-occurring.

Objectives:

Identify and implement the different regulations related to agricultural and plant biosafety/biosecurity when reviewing institutional research protocols
Evaluate and conduct a risk assessment of the potential impact of using emerging technologies and gene editing in agriculture and plant projects
Identify and manage risk with the fast-evolving scope of research, especially with the use of CRISPR/Cas9 technology

Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Laboratory Workers

10 – Keeping it Going: Maintaining and Improving a Select Agent Program Over the Long-Term

Amy Vogler, PhD, RBP(ABSA), Northern Arizona University, Flagstaff, AZ
Shelley Jones, MS, RBP(ABSA), Northern Arizona University, Flagstaff, AZ

Keeping a Select Agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Long-established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can prove even more advantageous, elevating a good program to a great program. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of “crises” sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing Select Agent program, including strategies for anticipating and responding to new requirements. Strategies will be based on the instructors’ experience with their institution’s program with additional input solicited from class participants during open discussions. Topics will include the history of the Select Agent program; effective oversight practices; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; a series of suitability program case studies; implementation of the recent inactivation requirements, including strategies for investigating inactivation “failures;” and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.

Objectives:

Identify strategies for efficiently maintaining a Select Agent program in good standing with ongoing requirements
Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns in accompanying exercises
Summarize new inactivation requirements and identify successful strategies for compliance

Suggested Background: Building a Select Agent Program: Safety, Compliance, and Efficiency
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals

11 – Building and Sustaining a Biohazard Accident Investigation Program in the Microbiology Laboratory

Sharon Master, PhD, Masthead Lab Solutions, Albuquerque, NM

Biohazard risk management is critical to a safe workplace. Conducting an investigation after a biohazard event is critical for effective risk management. However, there is limited guidance on this within the realm of biosafety. This course will educate participants on how to appropriately conduct all stages of an accident investigation, including root cause analysis, thus enabling them to build an effective investigation program at their laboratory. Through the use of real life scenarios and workbook exercises, participants will be able to identify a lab accident, a near-miss, and an exposure. Through the use of examples and real life scenarios from a clinical microbiology setting, participants will also learn tips and tricks to recognize laboratory-acquired infections. This course will help reinforce concepts, build, establish, and strengthen laboratory investigation programs resulting in more robust risk management programs.

Objectives:

Develop and establish an accident investigation program
Differentiate, using scenarios, between a near miss and an exposure
Recognize a laboratory-acquired infection

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

12 – Case Studies in Biocontainment Emergencies

David Harbourt, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), U.S. Army Medical Research Institutes of Infectious Diseases, Fort Detrick, MD

It is important that biosafety professionals understand how to respond to emergency response situations that could affect operations in containment laboratories. Biosafety professionals need to be able to understand how their facility and personnel function during normal operations to aid in preparation for significant events. It is also vital for biosafety professionals to know who the key decision makers are in their facility for situations that could potentially result in disruptions to operations. By understanding how their facility is intended to function, who the key decision makers are and the critical information that is needed during emergency scenarios, biosafety professionals can help ensure that they are prepared when situations arise in the future. This course is intended to cover some basics of emergency response situations along with the features of a containment laboratory that may be affected during an emergency. This course will go over important questions that biosafety and safety professionals need to be able to answer about their facility to help prepare them for emergencies. The course will be separated into two sections with the first covering the key questions of each of the facility components to include HVAC, plumbing, electrical failures, and potential occupational exposures. The second part of the course will cover a series of case studies based on real world emergency response situations in biocontainment laboratories. Individuals will be expected to work in groups to help solve each of the case studies and at the end of the course, the instructor will discuss how the emergency was handled in real time along with lessons learned.

Objectives:

Restate the basics of emergency response and how they relate to biocontainment laboratory operations
Identify potential system vulnerabilities in a biocontainment laboratory
Summarize lessons learned from case studies and apply them to their own facility if applicable

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

13 – Introduction to Biosafety in the Clinical Setting

Daniel Eisenman, PhD, RBP(ABSA), CBSP(ABSA), SM(NRCM), Advarra, Research Triangle Park, NC

The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Topics covered include common issues and lessons learned pertaining to: clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs and waste disposal facilities; PPE, disinfection, risk assessments and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials. The course will close with a focus on clinical trials including: the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines and gene therapy. The course is designed to be highly interactive with discussions, surveys, and team exercises.

Objectives:

Apply biosafety principles in the clinical setting
Perform risk assessments and identify gaps in occupational safety in the clinical setting
Discuss the regulatory oversight for clinical trials and the developmental process for investigational products

Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, Research Administrators, Clinical Professionals

14 – Emotional Resiliency in High-Risk Environments

Lisa Orloff, World Cares Center—Resiliency Advisors, New York, NY

Traumatic events have the power to overwhelm normal coping abilities of individuals and groups. Emotionally charged, high-stress jobs can have a negative impact on individuals if they are not aware of the risks or coping skills. Research shows that training can reduce the impact that disasters, disaster work and high-stress environments have on those that function within them. Fortunately, resiliency is not a trait that is inherited, each person has the ability to build their own resiliency. This course is the first step on your road to resilience and building resilient teams. As a result of participating in this interactive course, participants will take part in role play activities demonstrating the objectives of the course.

Objectives:

Identify the emotional risks related to disaster and high-stress work environments
Recognize the signs and symptoms of disaster and high-stress work environment related stress
Increase the ability to respond safely and effectively in disaster response and high-stress work environments
Describe the techniques to address emotional stress

Suggested Background: None
Target Audience: All Safety Professionals

November 17, 2019

15 – Shipping Infectious Substances Certification Course

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

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

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

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

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

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

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

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

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

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

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

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