BIOSAFETY & OPERATIONS

MANAGEMENTTHINKING OUTSIDE THE BOX

13TH CDC INTERNATIONAL SYMPOSIUM ON BIOSAFETY

January 25-29, 2014Crowne Plaza Ravinia, Atlanta, GA

eagleson.org/CDC#BIOSAFETY2014

OccupationalHealth

Ventilation Issues

Animal Facility Operations

Biosecurity

Production ofBiomolecules

TrainingPerspectives

WORKSHOPS

SATURDAY, JANUARY 25, 2014

8:00 AM - 5:00 PM | Workshop #1 | $295NIH Design Requirements Manual and ANSI/ASSE Z9.14-2013: Facilitating Biosafety and Operations Management of Biomedical and Animal Research FacilitiesSteven Breslin, AIA, PE, LEED AP, NIH; Farhad Memarzadeh, PhD, PE, NIH; Alamelu Ramesh, PE, LEED AP, NIH; Scott Taylor, PE, LEED AP, CEM, NIHThis full-day course will provide an overview of the updated NIH Design Requirements Manual. Participants will learn how the design requirements enhance biosafety and operation management at NIH and will benefit from hearing lessons learned from the design, construction and operation of NIH facilities. The course will also provide a brief overview and introduction to ANSI/ASSE Z9.14-2013, a new standard of interest to facility and design professionals who work in, design, and maintain ventilation systems for BSL3 and ABSL3 facilities.

8:00 AM - 12:00 PM | Workshop #2 | $195Basic Biosafety and DecontaminationCristina Bressler, MBA, CDC; Sabrina DeBose, MS, CDC; Paul Meechan, PhD, MPH, RBP, CBSP, CDC; Betsy Weirich, MS, SM(ASM), CBSP, CDCAn introductory biosafety class designed in two parts. The first section will explain basic Biological Safety Cabinet mechanics, describe how to work safely in a Biological Safety Cabinet, discuss ergonomic issues and provide training tips for Biological Safety Officers and Lab Safety Managers. The second section of the course will provide an introduction into decontamination and examine various decontamination strategies.

8:00 AM - 12:00 PM | Workshop #3 | $195Windows of Opportunity for Corrective Actions in High Containment Laboratories Michael L. Weiss, PhD, ABD, HCCP, WorkingBuildings; Debra Sharpe, MPH, CCHO, RBP, WorkingBuildings; Ronald Doherty, New Jersey Public Health, Environmental and Agriculture Laboratory; Idris El-Amin, DVM, David H. Murdock Research InstituteBiosafety Level 3 (BSL-3/ABSL-3) containment laboratories are the most expensive and difficult facilities to operate and maintain. The course will explore windows of opportunity that allow for planned and unplanned maintenance needs and challenges. From pre-planning activities, trial runs, and scheduling opportunities to actual verification metrics, the class will cover a broad list of topics that BSL3 laboratory operators, ROs, PIs, and animal care teams should plan for when conducting ongoing and annual maintenance and verification.

1:00 PM - 5:00 PM | Workshop #4 | $195Animal Biosafety 201Nathaniel Powell, Jr., DVM, DACLAM, CDC; George W. Lathrop, Jr., DVM, MS, DACLAM, CDC; James White, BS, MPH, CDC; Yvonne Reed, BS, MPH, CDCParticipants will review the distinctions between Animal Biosafety Level 3 (ABSL3) and Animal Biosafety Level 4 (ABSL4) working and housing environments. The course will emphasize disaster management for those facilities. It will also present novel approaches to performing clinical diagnosis under biocontainment, and provide guidance on developing and implementing standard operating procedures for maintaining research animals comfortably within the increased biocontainment requirements. A guided information exchange at the end of the course will provide a forum for attendees to share successful processes they have utilized in their facilities.

SAT JAN 258:00AM - 5:00PM

#1: NIH Design Requirements Manual and ANSI/ASSE Z9.14-2013: Facilitating Biosafety and Operations Management of Biomedical and Animal Research Facilities

SAT JAN 25 8:00AM - 12:00PM

#2: Basic Biosafety and Decontamination

#3: Opportunities for Corrective Actions in High Containment Laboratories

SAT JAN 251:00PM - 5:00PM

#4: Animal Biosafety 201

#5: Everyday Management and Operation of a Select Agent Program

#6: Laboratory Building Systems

SUN JAN 26 8:00AM - 5:00PM

#7: Intermediate Threat Assessment for Laboratory Biosecurity Programs

SUN JAN 268:00AM - 12:00PM

#8: So You Want Directional Airflow…

#9: Best Practices in Working with Mycobacterium Tuberculosis

SUN JAN 261:00PM -5:00PM

#10: Challenges and Issues in Establishing Occupational Health Programs for Immunizations

#11: Basic Elements of a Biosafety Management Program

#12: Designing to Withstand Extreme Events based upon Geographic Location

1:00 PM - 5:00 PM | Workshop #5 | $195Everyday Management and Operation of a Select Agent ProgramBarbara Fox Nellis, SM(NRCM), RBP, CBSP, Barb Nellis ConsultingThrough lecture, discussion, and group resolution of actual scenarios, participants will obtain practical advice for dealing with people working in a highly hazardous, tightly regulated and controlled environment, and receive helpful real life suggestions for effective training and compliance. This course will begin with the newest regulations and required forms, then explore risk assessment, biosafety, security, incident response, SOPs, drills, inspections and training – pointing out ways to deal with the challenges and stumbling blocks along the way.

1:00 PM - 5:00 PM | Workshop #6 | $195Laboratory Building SystemsMark Fitzgerald, HDR Architecture, Inc.; Jeff Owens, MPH, CSP, SM(NRCM), CBSP, HDR Architecture, Inc.; Jennifer Gaudioso, PhD, Sandia National Laboratories; Vibeke Halkjaer-Knudsen, PhD, Sandia National LaboratoriesThis course will provide a basic understanding of the systems required to support a typical laboratory and the specialized systems needed to enhance biosafety and biosecurity. Participants will learn how architectural, structural, HVAC (heating, ventilating and air conditioning), plumbing and electrical systems are influenced by laboratory design. Through guided discussions and interactive exercises they will learn what information is required to design the systems, how services are distributed through a typical laboratory building and what redundant features are needed in the event of power outages or component failures.

SUNDAY, JANUARY 26, 2014

8:00 AM - 5:00 PM | Workshop #7 | $295Intermediate Threat Assessment for Biosecurity ProgramsPatricia Delarosa, PhD, CBSP, RBP, Booz Allen Hamilton; James Dornak, At-Risk International; Jason Griffeth, Booz Allen Hamilton; Ben Perman, Booz Allen HamiltonLaboratories everywhere— whether or not they house Select Agent research—appreciate the need to protect research programs, facilities and staff from insider and external (outsider) threats. Utilizing case studies and tabletop exercises, this course will provide laboratory staff with the skills needed to assess threats and effectively implement personnel security procedures that effectively mitigate them. (While this course builds on “The Role of Threat Assessment in Laboratory Biosecurity Programs” offered at the 2012 CDC International Symposium on Biosafety, attendance at the prior course is not required.)

8:00 AM - 12:00 PM | Workshop #8 | $195So You Want Directional Airflow…Kevin Derrick, Research Air Flo, Inc; William T. Freeman, PE, Collaborative Engineering Solutions Inc.; Ben Watkins, LEED AP BD+C, McCarthy Building Companies, Inc.Directional airflow is vital for the safe operation of laboratory facilities. This course will provide participants with an understanding of the building construction elements and relationships that make directional airflow possible. Instructors will use their experience from multiple projects completed around the country to explain how directional airflow is related to room pressure and to room envelope construction, describe the inherent limitations of room envelope construction and the cost associated with tighter construction requirements, point out potential pitfalls on where negatively pressurized spaces are located, and provide tips for evaluating different control approaches for directional airflow.

8:00 AM - 12:00 PM | Workshop #9 | $195Best Practices in Working with Mycobacterium tuberculosisNoman Siddiqi, PhD, RBP, Harvard School of Public HealthThis course will begin with a risk assessment of research with Mycobacterium tuberculosis, then move into ways to tailor risk mitigation to deal with current and evolving technology. Best practices in method/protocol development and implementation for handling MTB will be discussed, including: PPE; primary and secondary containment barriers; the use of BSCs; methods of bacterium culture; inactivating the bacterium for different kind of downstream applications such as PCR, FACS analysis, and histo-staining, etc.; waste management and decontamination

1:00 PM - 5:00 PM | Workshop #10 | $195Challenges and Issues in Establishing Occupational Health Programs for Immunizations and Traveler SafetyRamana Dhara, MD, ScD, MPH, CDC; Deborah Davis, RN, CDCProviding occupational health resources to those involved in biological research can present unique challenges. This course will provide a general overview of vaccination programs, the risk assessment process involved in establishing a vaccination program, practical tips on vaccination issues, i.e. contra-indications, reactions, etc., as well as key health and safety topics for international travelers. Guidance on how to use the “CDC Yellow Book” will be provided, along with information on international travel immunizations and prophylaxis.

1:00 PM - 5:00 PM | Workshop #11 | $195Basic Elements of a Biosafety Management ProgramRobert Hawley, PhD, RBP, SM(NRCM), CBSP, Alliance Biosciences; Joseph P. Kozlovac, MS, RBP, SM(NRCM), CBSP, USDA-ARSThis course examines how to initiate and manage a biological safety program. Topics will include biosafety program vision, mission, goals, policies, risk assessment and management, training and education activities, as well as proposed structure and functions of a biosafety committee and mechanisms to review and evaluate program effectiveness. Group exercises will allow participants to practice the principles and recommendations discussed during the lectures.

1:00 PM - 5:00 PM | Workshop #12 | $195Designing Bio-Containment Space to Withstand Extreme Events Based Upon Geographic LocationSteven Freson, AIA, Flad Architects; Christopher Kronser, RA, NCARB, LEED AP, Flad Architects; Chad Zuberbuhler, Assoc. AIA, Flad ArchitectsThe major goal of a bio-containment operation is to maintain the primary and secondary facility containment systems that prevent the release of pathogenic material. During extreme events (such as earthquakes, hurricanes, tornados or floods) building systems may undergo stresses that challenge the upper limits of intended design. This course will describe a risk-based approach to the most vulnerable of these systems and explore design options for addressing dynamic loading as well as operational protocols to proactively address the potential impacts of these naturally occurring events.

Meet Our Sponsors and Exhibitors at the

Opening Reception 5:00PM - 7:00PM

SYMPOSIUM AGENDASUNDAY, JANUARY 26, 2014

5:00 Opening Reception (5:00 PM - 7:00 PM)Meet the Exhibitors

MONDAY, JANUARY 27, 2014

8:00 WelcomeCristina Bressler, MBA, CDC; Mary Ann Sondrini, EdM, Eagleson Institute

8:15 KEYNOTE #1: An Ounce of Prevention: Preventing Fatigue-Related Safety Accidents and Injuries in Containment LaboratoriesCasey Skvorc, PhD, JD, NIH

SESSION A: OCCUPATIONAL HEALTH ISSUESModerator: Casey Chosewood, MD, CDC NIOSH

9:15 Vaccination Programs for Associates: What are the Benefits and Risks?Martin Kuster, MD, Novartis

10:00 Break

10:30 Prevention of Laboratory Animal AllergyGregg Stave, MD, JD, MPH, Duke University Medical Center

11:15 Interactive Discussion on Outsourcing Occupational Health ServicesPRESENTATION: Ron Joines, MD, MPH, GlaxoSmithKlinePANELISTS: Paula DesRoches, ANP-BC, COHN-S, Emory University; Garry Greer, William A Hinton State Laboratory Institute; Nathaniel Powell, Jr., DVM, DACLAM, CDC; George W. Lathrop, Jr., DVM, MS, DACLAM, CDC

12:00 Lunch

SESSION B: OPERATIONAL ISSUESModerator: Garry Greer, William A Hinton State Laboratory

1:15 Risk Assessment and Risk Management LifecycleRobert Hawley, PhD, RBP, SM(NRCM), CBSP, Alliance Biosciences

More information online at eagleson.org/CDC

KEYNOTE #2: James M. Hughes, MD, FISA, Professor of Medicine and Public Health, Emory University

KEYNOTE #1: Casey Skvorc, PhD, JD, Behavioral Health Screening Authority, NIH

Emerging Microbial Threats: Issues, Challenges, and Opportunities at the Human-Animal-Ecosystem Interface

An Ounce of Prevention: Preventing Fatigue-Related Safety Accidents and Injuries in Containment Laboratories

2:00 Core Competency Training Perspectives• Animal Biosafety Training: Core Concepts and Competencies

Tim Mandrell, DVM, DACLAM, University of Tennessee Health Science Center

• Biosafety Competencies: Embraced or Abandoned? Michael A. Pentella, PhD, D(ABMM), Massachusetts Department of Public Health

• Core Competencies for Facility Engineers and Maintenance Staff John R. Henneman, MS, RBP, The Pennsylvania State University

3:30 Break

4:00 Introduction to Tuesday’s Participant-Nominated Breakout Sessions

4:15 Auditing as a Proactive Method of Improving Working Safely Kalpana Rengarajan, PhD, MPH, RBP, Emory University

4:45 Question and Answer Session

5:15 Conclusion

TUESDAY, JANUARY 28, 2014

8:00 WelcomePaul J. Meechan, PhD, MPH, RBP, CBSP, CDC

8:15 KEYNOTE #2: Emerging Microbial Threats: Issues, Challenges, and Opportunities at the Human-Animal-Ecosystem InterfaceJames Hughes, MD, FISA, Emory University

9:15 Greetings from ABSAPaul J. Meechan, PhD, MPH, RBP, CBSP, President, ABSA

9:30 Break

SESSION C: BIOSAFETY DURING THE PRODUCTION OF BIOMOLECULES IN RESEARCH AND DEVELOPMENT AND LARGE-SCALE MANUFACTURING Moderator: Rich Rebar, RBP, CBSP, GlaxoSmithKline

10:00 The Future of Biopharmaceutical ManufacturingNeil Brewis, PhD, GlaxoSmithKline

10:45 DISCUSSION: Scale-up Challenges for Pharmaceutical, Academic Institutions and Government FacilitiesPANELISTS: Francine Preston; Brian Petuch, Merck; Additional experts being confirmed

12:00 Lunch

SESSION D: ANIMAL FACILITY OPERATIONSModerator: Nathaniel Powell, Jr., DVM, DACLAM, CDC

1:15 The Challenges of Animal Modeling in Biocontainment: 20 Years of Putting Gerbils in the NERBLGeorge W. Lathrop, Jr., DVM, MS, DACLAM, CDC

1:45 Clinical Diagnostic and Research Specimen Retrieval in Biocontainment: In the Laboratory and in the FieldBrian Bird, DVM, PhD, CDC

2:15 Addressing Biosecurity: Roles and Responsibilities of the Science and Security CommunitiesEdward H. You, MS, FBI

2:45 Imported Animals and Unexpected DiseasesCAPT Brianna Skinner, DVM, DACLAM, CDC

3:15 Break

3:45 Attendee Nominated Breakout Sessions

5:00 Conclusion

6:00 Banquet (6:00 PM - 9:00 PM)

WEDNESDAY, JANUARY 29, 2014

8:00 Welcome

SESSION E: INTERNATIONAL ISSUESModerator: Lori Bane, CDC

8:05 The International Group of Experts on Biosafety and Biosecurity Regulation: Fostering International Dialogue in an Emerging Regulatory ArenaRobbin S. Weyant PhD, RBP, CDC

8:20 CWA (CEN Workshop Agreement) Biorisk Management System - Where Are We and What’s Next?Patty Olinger, RBP, Emory University

SESSION F: FACILITY ISSUESModerator: John R. Henneman, MS, RBP, The Pennsylvania State University

8:50 ANSI Z9.14 Standard for Testing and Performance-Verification Methodologies for BSL3 Ventilation SystemsPaul Jennette PE, RBP, Cornell University College of Veterinary Medicine

9:05 Ventilation Issues• Directional Airflow – What, Where, and When?

Paul Jennette PE, RBP, Cornell University College of Veterinary Medicine

• Getting the Air Out: Verifying BSL3 Ventilation System Performance Dan Frasier, PE, CCP AP, Cornerstone Commissioning

• Aerosol Generation, Ventilation and Risk Assessment Allan Bennett, MSc, U.K. Health Protection Agency

10:05 Break

10:25 Discussion of Ventilation IssuesFacilitator: Paul J. Meechan, PhD, MPH, RBP, CBSP, CDC

11:15 Designing Captive Housing with Animal EthologyGregory Langham, DVM, MPH, CDC

11:45 What if it Doesn’t Work? Post Construction Troubleshooting at the UCLA Global Bio LabMark Fitzgerald, HDR Architecture, Inc.; Natasha K. Griffith, University of California, Los Angeles

12:30 Conclusion

EXHIBITORS

Presented in Partnership by the American Biological Safety Association and the Eagleson Institute

MEET OUR SPONSORS AND EXHIBITORS AT THE OPENING RECEPTION ON SUNDAY, JAN 26 FROM 5:00 - 7:00 PM

SILVER SPONSORSThe Baker Company | bakerco.com | Booth #28The Elizabeth R. Griffin Research Foundation | ergriffinresearch.orgNuAire | nuaire.com | Booth #18

BRONZE SPONSORSALN Magazine ® | alnmag.com | Booth #17Art’s Way Scientific, Inc. | buildingsforscience.com | Booth #21Britz & Company | britzco.com | Booth #16ENV Services, Inc | envservices.com | Booth #6WorkingBuildings | workingbuildings.com | Booth #13

EXHIBITORSAllentown, Inc. | allentowninc.com | Booth #20Carter 2 Systems, Inc. | csimfg.com | Booth #34Certek, Inc. | certekinc.com | Booth #35ClorDiSys Solutions, Inc. | clordisys.com | Booth #19BioRAFT | bioraft.com | Booth #27Biosafety & Biosecurity Training Course | cvmbs.colostate.edu/mip/crwad/bbtc.htm | Booth #30DRS Laboratories, Inc. | drslaboratories.com | Booth #14Life Science Products | lspinc.com | Booth #15NIH OBA | oba.od.nih.gov | Booth #11

To Exhibit or Sponsor, please download our exhibitor packet at: eagleson.org/CDC

Exciting opportunities to connect with your colleagues are being

planned now. Stay tuned for details.

For late-breaking conference

information,join the conversation

#BIOSAFETY2014

BACK BY POPULAR DEMAND!

Again this year, the Biosafety Symposium will feature attendee-nominated breakout sessions. This participant-driven format allows attendees to help plan and participate in activities that match their needs in ways pre-planned sessions may not. How it works:

• Prior to the Symposium, those registered will go online to nominate a biosafety topic of special interest to them.

• During the Symposium, attendees will select topics for discussion, then meet with others who share the same interests or concerns in an hour-long structured session, facilitated by industry experts.

BREAKOUT SESSIONS

REGISTRATION INFORMATION

HOTEL INFORMATIONThe Crowne Plaza Ravinia is located in the heart of Atlanta’s Perimeter Center, across the street from the Perimeter Mall. It is surrounded by ten acres of lush Japanese gardens containing walking trails.

Amenities include: high-speed internet access in all rooms, an indoor pool and health club, and three restaurants. In addition, the hotel provides complimentary shuttle service to the MARTA train station. The MARTA provides continuous transportation to and from the airport, as well as a variety of other Atlanta locations.

A block of rooms has been reserved at the special rate of $133.

To make reservations, call 1-888-233-9527 or visit www.eagleson.org/CDC for a link to the hotel’s room registration website. Please indicate that you will be attending the CDC Biosafety Symposium. Reservations must be received by January 2, 2014.

SYMPOSIUM FEES: Fees include Opening Reception, Symposium Banquet, attendance at Symposium sessions and lunch on Monday and Tuesday

FEES By December 13, 2013 After December 13, 2013SYMPOSIUM $645 $6954 HOUR PRESYMPOSIUM WORKSHOP $195 $195FULL DAY PRESYMPOSIUM WORKSHOP $295 $295BANQUET GUEST $60 $60

REGISTRATION INFORMATION: To register for this symposium online, please go to www.eagleson.org/CDC or call 207-490-1076 to register by phone or request a registration form.

CANCELLATION POLICY:Individuals who cancel more than 15 business days prior to the class date will receive a full refund. For cancellations made 6 to 15 business days before the start of the program, a 50% refund will be given. For cancellations made 5 business days or less prior to the class date, no refunds will be given. Notification of cancellation must be received in writing. Substitutes for a registered attendee may be made at any time.

www.eagleson.org/CDC

January 25-29, 2014Crowne Plaza Ravinia, Atlanta, GA

eagleson.org/CDC#BIOSAFETY2014

EAGLESON INSTITUTEPO Box 954 • Sanford ME 04073

207-490-1076 • eagleson.org

NON PROFIT ORGUS POSTAGE

PAIDPORTLAND, MEPERMIT NO. 284

Presented in Partnership with the American Biological Safety Association and the Eagleson Institute