Agenda

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PRECONFERENCE COURSES
SUNDAY, JUNE 4, 2017
8:00 AM – 12:00 PM

Fundamentals of IBCs
Kathryn Harris, PhD, RBP, National Institutes of Health
This workshop is delivered by expert staff from NIH OSP. Learn about the activities of the NIH OSP, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, and the function, administration, and responsibilities of Institutional Biosafety Committees (IBCs) under the NIH Guidelines.

1:00 PM – 5:00 PM

Evaluating Risks When Working With Biohazardous Materials
Dawn Wooley, PhD, SM(NRCM), RBP, CBSP, Wright State University
Risk assessment is a challenging task for the biosafety professional. There are different categories of biohazardous agents that may be encountered as well as personal differences in risk tolerance. This presentation will teach the meaning of risk group categories, what it means to perform a risk assessment and how to develop a strategy for measuring and estimating the acceptability of risk.

CONFERENCE
MONDAY, JUNE 5, 2017
8:00 AM

Welcome

SESSION 1: CRISPR
Facilitator: Ellyn Segal, PhD, Biosafety Manager, Stanford University
8:30 AM

KEYNOTE
New Stuff On Safety, Security and Environmental Implications of Next Gen Gene Editing Tools and Applications

Kenneth Oye, Director, Program on Emerging Technologies, PhD, MIT;
David Gillum, Associate Director EH&S, ASU
Gene editing tools are in the midst of a period of unusually rapid change, with movement from zinc fingers and TALENs to CRISPR and base editing. This talk will focus on novel applications made possible by advances in gene editing, with emphasis on next gen applications such as gene drives and xeno-transplantation that do not fit easily within existing regulatory frames. It will then turn to how biological engineers, civil society, regulators and educators including iGEM are seeking to mitigate risks. This presentation will also discuss biosafety and biosecurity implications of these emergent technologies and engage participants in an open conversation about the role participants will play in the future. 

10:00 AM

Break

10:30 AM

CONTINUED
New Stuff: On Safety, Security and Environmental Implications of Next Gen Gene Editing Tools and Applications

Kenneth Oye, PhD, MIT;
David Gillum, ASU

11:00 AM

CRISPR-Cas9 Guidelines
Help us develop a new template for CRISPR-Cas9 guidelines! Join us for an exciting opportunity to participate in a CRISPR-Cas9 forum on current policies and ultimately create updated, collaborative guidelines. Contribute your own experience and expertise and learn from other experts in the room in this workshop environment. The end product will be beneficial and available to all participants, ready for implementation.

12:00 PM

Lunch

SESSION 2: Regulations, Guidelines, and Best Practices
Facilitator: Karen Byers, MS, RBP, CBSP, Biosafety Officer, Dana Farber Cancer Institute

1:00 PM

When Two Committees Meet… the Intersection of the IACUC and the IBC
Lois Zitzow, MS, DVM, DACLAM, University of Georgia
This talk will cover some of the institutional advantages of the IACUC and IBC working in tandem to protect the people, the science, and the animals. It will include committee membership of both the IACUC and IBC and the interactions of these members to assist the institution in complying with the intersecting layers of regulations guiding biomedical research.

2:00 PM

Using Case Studies to Interpret Guidelines:

Performing Collaborative Risk Assessments
Carolyn Keierleber, PhD, University of Southern California
This discussion will focus on case studies in which the researcher has proposed a different biosafety level than the biosafety officer and IBC think is wise. We will discuss a couple of cases involving the isolation of an unknown bacterium and the proposed use of a recently identified emerging pathogen. This session is interactive and audience participation is encouraged. We will discuss the factors to consider as well as collaborative techniques involved in performing a risk assessment.

Vaccinia Virus: Challenges for Risk Assessment
Susan Vleck, PhD, Stanford University
Using 1-2 case studies, discussion will focus on uses of vaccinia virus in current research trends. Conversation will include the subsequent risk analysis, medical surveillance and use of applicable guidelines to implement best practices in vaccinia research.

TUESDAY, JUNE 6, 2017
SESSION 3: Issues in Human Gene Trials
Facilitator: Betsy Gilman Duane, MS, RBP, CBSP, Associate Director, Environmental Health & Engineering

8:30 AM

Recent Changes and Challenges in Human Gene Transfer Risk Assessment Reviews
Chris Jenkins, PhD, MPH, RBP, CHMM, Clinical Biosafety Services;
Kathryn Harris, PhD, RBP
Discover the recent revisions to the NIH Recombinant Advisory Committee (RAC) process for human gene transfer reviews. Learn the applicable changes necessary to administer these studies and to develop a strategy for evaluating risk. Discuss the process for soliciting the RAC for review of a human gene transfer study. Gain appreciation for measuring risk and estimating the acceptability of risk. Consider the different categories of biohazardous agents that might be encountered in human gene transfer research, from traditional microorganisms to novel, cutting-edge molecular agents, with case studies discussed.

9:45 AM

Break

11:15 AM

Lessons Learned Training Pharmacy and Nursing Staff Administering Oncolytic Viral Therapies
Karen Byers, MS, RBP, CBSP, Dana Farber Cancer Institute
This case study presentation dissects the lessons learned in training pharmacists and nurses who prepare and administer a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

12:00 PM

Lunch

SESSION 4: Best Practices in Animal Research
Facilitator: Carolyn Kierleber

1:00 PM

Molecular testing for viral vector sequences in animal specimens from Biocontainment
Dawn Wooley, PhD, SM(NRCM), RBP, CBSP, Wright State University
Detecting viral vector sequences in real animal biological specimens poses several challenges. Therefore, it is critical to be familiar with biocontainment options for infected animal specimens and to recognize the importance of internal controls and the limitations of negative detection results. This presentation will cover these challenges while examining the new molecular assay for detecting adenoviral and lentiviral vector sequences, the nature of quantitative polymerase chain reaction assays and the differences between singleplex and multiplex setups.

2:30 PM

Update on Reported Laboratory Acquired Infections
Karen Byers, MS, RBP, CBSP, Dana Farber Cancer Institute
A study of the literature published between 1979 and 2015 yields fascinating information about studies involving animal models. The presentation will delve into the details of 511 zoonotic infections from agents that were NOT experimentally introduced into the animal model under study, as well as details from animal studies using animal models.

3:30 PM

“A Triangle of Protection” – Observations from a Biocontainment Veterinarian
Lois Zitzow, MS, DVM, DACLAM, University of Houston
Examine case studies related to biosafety issues within a biomedical research environment. This presentation will involve discussion and audience participation.

4:45 PM

Conclusion