FACILITATING SAFE AND

SECURE SCIENCE

Practical Approaches for IBCs

June 16-19, 2013Seattle, WA

Presented by the Eagleson Institute featuring staff from the National Institutes of Health Office of Biotechnology Activities (NIH OBA)

Sponsored by: American Biological Safety Association (ABSA)Campus Safety Health and Environmental Management Association (CSHEMA)

current program information online at

eagleson.org/IBC

Samuel L. Stanley Jr., M.D., is the fifth president of Stony Brook University. He earned his medical degree from Harvard Medical School and attended Washington University School of Medicine in St. Louis for a fellowship in infectious diseases, where he later served as Vice Chancellor for Research. He has been engaged with institutional biosafety programs from many perspectives, not only as a senior research administrator but also as a highly distinguished biomedical researcher, focusing on enhanced defense against emerging infectious diseases. Dr. Stanley is the current chair of the National Science Advisory Board for Biosecurity, which advises the United States government on issues related to the communication, dissemination and performance of sensitive biological research. Dr. Stanley was a member of the National Advisory Allergy and Infectious Diseases Council at the NIH and a member of the NIH Director’s Blue Ribbon Panel on the National Emerging Infectious Diseases Laboratories.

KEYNOTE SPEAKER

TOUR OF UW BIOCONTAINMENT LABORATORYWEDNESDAY, JUNE 19, 2:00 - 5:00 PM Visit the University of Washington’s brand new state-of-the-art BSL-3 / ABSL-3 biocontainment facility! The tour will include a brief bus ride to the facility, an introduction to the facility floor-plan and process flow protocols, small-group guided tours of the facility, and ample time for questions. For a complete description of the facility and tour, go to www.eagleson.org/UWTOUR. Space is limited, so register now!

This biennial professional development conference offers a unique forum to explore the challenges faced by institutional biosafety oversight programs and to find creative, practical, solutions to implement at your institution to enhance the functioning of your IBC!

Issues ranging from the implications of recent biosafety and biosecurity policy developments to how to ensure ongoing compliance with existing federal requirements will be discussed. The conference will provide an excellent opportunity to interact with colleagues from other institutions to share, examine, identify and develop best practices, strategies and tools for running an effective and efficient program.

WHY ATTEND?

PHOTO CREDITSFront Cover from Top to Bottom: Stock Photo; Stock Photo; James Gathany, CDC; Stock Photo; Stock Photo.Inside Flap: Stony Brook University; David Emery, University of WA.Inside Right Pannel: Stock Photo; The Renaissance Seattle Hotel.

SCIENCE AND SAFETY IN SEATTLE

SUNDAY, JUNE 16, 2013

1:00 PM - 5:00 PM

IBC FUNDAMENTALSKathryn Harris, Ph.D., RBP, (contractor) and Ryan Bayha, Office of Biotechnology Activities, National Institutes of HealthThis workshop is delivered by expert staff from NIH OBA, and provides an introductory overview of the history, function, and administration of Institutional Biosafety Committees (IBCs).•Learn about NIH OBA and the content of

the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines),

•Understand the requirements for IBCs and their responsibilities for biosafety review and oversight

WEDNESDAY, JUNE 19, 2013

8:00 AM - 12:00 PM

INTRODUCTION TO VIRAL VECTOR BIOSAFETYDawn Wooley, Ph.D., SM[NRCM], RBP, CBSP, Associate Professor of Virology, Wright State University Boonshoft School of MedicineThe workshop will focus on the basics of viral vectors, safety considerations for working with viral vectors in research studies, and points to consider for institutional review of viral vector protocols. At the conclusion of the course, participants will be able to:•Explain different types of viral gene

delivery systems;• Identify potential hazards associated with

viral vectors;•Describe methods of regulating gene

expression;• Interpret targeted vector system

technology; and•Recognize the advantages, disadvantages,

and limitations of viral gene delivery.

2:00 PM - 5:00 PM

UNIVERSITY OF WASHINGTON HIGH CONTAINMENT LAB TOUR

CONFERENCE AGENDA

MONDAY, JUNE 17, 2013

8:00 AM WELCOME AND INTRODUCTIONSAllan Shipp, M.H.A., Director of Outreach, Office of Science Policy, NIHMary Ann Sondrini, Ed.M., Executive Director, Eagleson Institute

8:15 AM OPENING ADDRESSJacqueline Corrigan-Curay, M.D., J.D.,Acting Director, Office of Biotechnology Activities, NIH

8:50 AM KEYNOTE ADDRESSSamuel L. Stanley, Jr., M.D., President, Stony Brook University

10:00 AM MANAGING AND EVALUATING YOUR INSTITUTIONAL BIOSAFETY PROGRAMMODERATOR:Kathryn Harris, Ph.D., RBP,Senior Outreach and Education Specialist (contractor), Office of Biotechnology Activities, NIHPANELISTS:“NIH Site Visit Program: Overview and Observations”Ryan Bayha, Outreach and Education Analyst, Office of Biotechnology Activities, NIH“Institutional Biosafety Program Evaluation”Kalpana Rengarajan, Ph.D., M.P.H., RBP, Associate Director and Biosafety Officer, Emory University“IBC Peer Review”Dennis Nolan, M.P.H., CBSP, Assistant Director, Environmental Health and Safety, University of Texas at Austin, and Patrick Conley, Assistant Director, Biological and Chemical Safety Officer, University of Texas Southwestern Medical Center“After a Site Visit: One Institution’s Response to OBA Recommendations”Katia Harb, M.S., Assistant Director, Research and Occupational Safety, EnvironmentalHealth and Safety Department, University of Washington

CONFERENCE WORKSHOPS

12:00 PM LUNCH

1:00 PM VIRAL VECTORS – BASIC BIOLOGY AND RISK OF REPLICATION-COMPETENT VIRUSESA number of experts in viral vectors and their applications, including Hans-Peter Kiem, M.D. of the Fred Hutchinson Cancer Research Center and current member of the NIH Recombinant DNA Advisory Committee, will present on the basic biology of commonly used vector systems and discuss the likelihood of replication-competent virus formation and other potential biohazards.MODERATOR: David W. Emery, Ph.D., Research Associate Professor and IBC Chair, University of Washington

3:30 PM BUILDING BETTER BIOSAFTEY PROGRAMS - AN INTERACTIVE GROUP DISCUSSION Conference participants will break into small groups to discuss a series of topics aimed at enhancing biosafety oversight programs. Groups will share information and compare strategies to address issues ranging from promoting and ensuring IBC and investigator compliance, to effectively solving administrative challenges and maximizing resources. Bring, share, and compare your IBC and biosafety training documents, standard operating policies and procedures, committee charters, registration documents, inspection checklists, and other materials. This aims be a highly practical session in which we will all work together to identify and create tools to use!TOPIC 1: Training Programs, Strategies and

ToolsTOPIC 2: IBC Documentation, Policies and

Procedures, Registration SystemsTOPIC 3: IBC Challenges - Practical

Solutions

5:00 PM CONCLUSION OF DAY ONE

5:30 PM RECEPTION WITH EXHIBITORSA great opportunity to network with colleagues! Hors d’oeuvres will be offered.

TUESDAY, JUNE 18, 2013

8:00 AM INSTITUTIONAL OVERSIGHT OF DUAL USE LIFE SCIENCES RESEARCHThis session will feature an update on policies related to the oversight of dual use research (DUR). Panelists from several institutions that have instituted programs for the oversight of research with dual use potential will discuss their approaches and experiences reviewing DUR.MODERATOR: Allan Shipp, M.H.A., Director of Outreach, Office of Science Policy, NIH

10:00 AM IBC IN ACTIONObserve our very own Conference Biosafety Committee in Action! A series of research protocols will be reviewed real time. Other IBC business will include a discussion of an incident report and the development of IBC policies. This will be a highly interactive session with input from the audience expected to help assess and manage the biosafety risks!MODERATOR: Dawn Wooley, Ph.D., SM[NRCM], RBP, CBSP, Associate Professor of Virology, Wright State University Boonshoft School of MedicineIBC CHAIR: Jan Vleck, M.D., Director, IBC Services, Western Institutional Review Board

12:00 PM LUNCH

1:00 PM ASSESSMENT OF HAZARDS ASSOCIATED WITH THE USE OF VIRAL VECTORS IN RODENTSViral vectors are potent basic research tools and are used as gene delivery vehicles in many laboratory animal models. Little information has been available on the potential shedding of these vectors and the consequent exposure risk to investigators and animal care staff from animals over time. Data will be presented from a study conducted to provide empirical information to IBCs and animal care programs performing risk assessments for laboratory animals treated with viral vectors.Daniel Gibbs, Ph.D., Assistant Professor, University of California, San Diego

2:00 PM UPDATES TO THE NIH GUIDELINES An overview of recent and planned updates to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules Jacqueline Corrigan-Curay, M.D., J.D., Acting Director, Office of Biotechnology Activities, NIH

3:00 PM REGULATORY ROUND TABLEUpdates and information from several Federal agencies will be provided, including the Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT), the United States Department of Agriculture (USDA) Biotechnology Regulatory Services (BRS), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) and Center for Veterinary Medicine (CVM). The audience will have the opportunity to discuss biosafety related issues with the representatives from the Federal agencies.MODERATOR: Christine McFarland, Ph.D., Biosafety Officer, Texas A & M University

4:30 PM WRAP-UP AND IDEAS FOR FUTURE DIRECTIONSAttendees are encouraged to share suggestions and ideas for shaping future policy.PANELISTS:Dennis Nolan, M.P.H., M.S., Assistant Director, Environmental Health and Safety, The University of Texas at AustinDavid Silberman, Director, Health and Safety Programs, Stanford University School of MedicineRyan Bayha, Outreach and Education Analyst, NIH OBA

5:00 PM CONCLUSION

REGISTRATION INFORMATION

CONFERENCE FEES:Conference fees include attendance at all conference sessions, reception on Monday evening, and lunch on Monday and Tuesday.

Conference (by May 10, 2013) $675Conference (after May 10, 2013) $725Conference Workshops (each) $195High Containment Lab Tour $45

Register online at eagleson.org/IBC or by calling 207-490-1076

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.

The Renaissance Seattle Hotel is a AAA Four Diamond hotel near Pike Place Market, featuring guest rooms with stunning views of the mountains, Puget Sound and downtown Seattle. The family and pet-friendly hotel offers a full fitness center and proximity to many of Seattle’s top attractions. A block of rooms has been reserved at the special rate of $189. To make reservations, call 206-583-0300, or go to www.renaissanceseattle.com. Please mention the “IBC Conference” to receive the event rate. To qualify for the special pricing, reservations must be received by May 16, 2013.

HOTEL INFORMATION

EAGLESON INSTITUTEPO Box 954 • Sanford ME 04073

207-490-1076 • eagleson.org

NON PROFIT ORGUS POSTAGE

PAIDNO READING, MAPERMIT NO. 234

Founded in 1989, the Eagleson Institute is a nonprofit foundation with a mission to promote the principles and practices of laboratory safety. The Eagleson Institute carries out its mission by offering seminars/conferences,

producing DVDs and web-based software, awarding scholarships, and sponsoring lectures.

FACILITATING SAFE AND SECURE SCIENCE

Practical Approaches for IBCs

JUNE 16-19 2013 Seattle, WA

Spend the entire week in Seattle! The professional development conference “FACILITATING SAFE AND SECURE SCIENCE: PRACTICAL APPROACHES FOR IBCS” will be followed by the three-day “PREVENTING AND TREATING BIOLOGICAL EXPOSURES” colloquium at the same venue. For information about this conference, go to www.eagleson.org/OCCHEALTH

JUNE

16 WORKSHOPIBC Fundamentals

JUNE

17 &

18CONFERENCEFacilitating Safe and Secure Science: A Practical Approach for IBCs

JUNE

19HIGH CONTAINMENT TOUR & WORKSHOPSViral Vectors / Occ Health Issues

COLLOQUIUMPreventing and Treating Biological Exposures: An Occupational Health Colloquium

JUNE

20 &

21

JOIN US FOR THE WEEK!