BSAA Brown Bag Discussion, Registration

Unanticipated Outcomes & dGOF Reporting: Are You Prepared to Recognize and Respond?

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Brown Bag sessions are exclusively available to active BSAA members.

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About BSAA Brown Bag Sessions

BSAA Brown Bag Discussions are designed to be interactive, practical, and community driven. These sessions are not traditional webinars. They are facilitated conversations where participants engage directly with peers to explore complex, real-world biosafety challenges.

Program Overview

Recognizing and responding to unanticipated research outcomes is becoming an increasingly critical responsibility for biosafety programs—particularly as expectations around dangerous gain of function (dGOF) oversight continue to evolve.

But in practice, identifying what truly constitutes a reportable event is not always clear.

This Brown Bag session provides a focused, discussion-based forum to explore this challenge.

The session will begin with a brief framing overview (1–2 slides) to establish key concepts, followed by an interactive discussion guided by a structured dGOF review rubric. Participants will work through practical considerations, decision points, and gray areas that biosafety programs are likely to encounter.

This is not a lecture. It is an opportunity to engage, question, and learn from others facing the same uncertainties.

What We’ll Explore Together

1. What qualifies as an “unanticipated outcome” in practice
2. When reporting is required—and when it may not be clear
3. How to apply dGOF criteria in real-world scenarios
4. Interpreting increased pathogenicity, transmissibility, and other EO criteria
5. Using structured rubric to support consistent, defensible decisions
6. Managing uncertainty and documenting rationale
7. Institutional expectations for rapid reporting and response
8. Common gaps and challenges across programs

Interactive Discussion Format

✔ Brief framing overview to set context

✔ Facilitated discussion using the dGOF Review Rubric

✔ Real-time Q&A and peer exchange

✔ Opportunity to compare institutional approaches

✔ Open dialogue on challenges, gray areas, and best practices

Who Should Attend

1. Biosafety Officers and Biosafety Professionals
2. IBC Administrators and Members
3. Research Compliance Professionals
4. Anyone responsible for reviewing or reporting unanticipated research outcomes

Why Attend

✔ Gain practical insight into identifying potential dGOF events

✔ Strengthen your confidence in making reporting decisions

✔ Learn how others are approaching these challenges

✔ Engage in open, candid discussion in a peer-based environment

✔ Take advantage of exclusive BSAA member programming

Key Takeaway

If an unanticipated outcome occurred in your program today—would you recognize it, and would you know what to do next?

Guest Speaker

Michael Betteken, PhD, CPBCA, Complinace Manager, IBC, ESCRO, DURC, Office of Research Integrity and Assurance, Cornell University

Standing BSAA Faculty

Bill Greer

Assistant Vice President for Research, University of Michigan

Bill Greer is a nationally recognized leader in research compliance with more than 35 years of experience spanning academia, industry, and nonprofit professional organizations. At the University of Michigan, he oversees institutional programs for animal care and use, biosafety, laboratory safety, controlled substances, and emerging autonomous systems.

Bill began his career in industry as a production manager and safety director at Intervet (formerly Tri Bio Laboratories) before transitioning to higher education, where he has held senior roles including Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at The Pennsylvania State University. He earned his degree in Microbiology from The Pennsylvania State University.

In 2005, Bill founded the Research Administrators’ Best Practice Meetings, creating a nationally respected forum for research oversight professionals to address real-world programmatic challenges. He continues to facilitate multiple Best Practice Meetings annually focused on biosafety and animal care and use programs.

Bill also chaired the founding committee of the IACUC Administrators Association (IAA) in 2010 and continues to serve as its president and board chair. Since 2007, he has served as an ad hoc consultant to AAALAC International, conducting institutional program reviews and assessments. A frequent speaker and educator, Bill regularly presents at PRIM&R, AALAS, BTAA, C3, and BSAA-sponsored programs, supporting both IBC and IACUC administrative communities nationwide.

Jonah Lee, PhD

Senior Associate Director, University of Michigan

Dr. Jonah Lee brings deep scientific expertise and administrative leadership to biosafety and animal research oversight, with a strong focus on enhancing researcher experience while maintaining regulatory rigor. In his role at the University of Michigan, he provides thought leadership, program oversight, and process optimization across the Animal Care & Use Program.

Working closely with research administration and academic leadership, Dr. Lee leads the strategic development of research engagement infrastructure and institutional support resources. His background in biomedical sciences includes extensive research in stem cell biology and regenerative medicine, with a focus on aging skeletal muscles.

Dr. Lee completed postdoctoral training at the Center for Muscle Biology at the University of Kentucky and has led federally funded research involving both small and large animal models across multiple departments. His combined experience as a scientist and administrator brings a practical, researcher-informed perspective to biosafety and compliance discussions.

Andrew Maksymowych, PhD

Associate Director, Biosafety Programs, University of Pennsylvania

Andrew Maksymowych has more than three decades of experience in research, teaching, and biosafety oversight. Since 2006, he has served at the University of Pennsylvania as Associate Director for Biological Safety Programs, Institutional Biosafety Officer, IBC Administrator, and Institutional Contact for Dual Use Research.

Andrew serves on multiple institutional advisory committees, including the Vice Provost for Research Human Research Advisory Committee, the Human Stem Cell Research Advisory Committee, and the Cadaver and Body Parts Oversight Committee. He holds a B.S. and M.S. from Villanova University and a PhD in Biochemistry from Bryn Mawr College.

Prior to Penn, Andrew held a faculty appointment at Thomas Jefferson University, where his research focused on protein structure-function relationships, including neurotoxins affecting the human nervous system - most notably botulinum neurotoxins. An active BSAA contributor since attending his first Best Practice Meeting in 2015, Andrew remains deeply engaged in advancing biosafety education and professional collaboration.

Raymond F. Scheetz, MS, RBP

Institutional Biosafety Officer & Compliance Manager, Penn State College of Medicine

Ray Scheetz serves as Institutional Biosafety Officer and Compliance Manager at the Penn State College of Medicine within the Research Quality Assurance Office. He oversees all aspects of biosafety compliance, including protocol reviews, biosafety training, annual laboratory surveys, emergency response coordination, and equipment and asset management.

Ray is an active member of the Institutional Biosafety Committee, Research Mission Team, and institutional research emergency task forces. In addition to his institutional role, he serves as a biosafety consultant for Clinical Biosafety Services (CBS) / Shield Consulting.

Previously, Ray spent 25 years as a Laboratory Manager in the Department of Microbiology and Immunology at Penn State College of Medicine, where he managed a BSL-3 facility and supported complex infectious disease research programs. His extensive operational experience provides a grounded, practical perspective on biosafety program implementation.