The Biosafety Administrators Association (BSAA) is a professional organization promoting collaboration, professional development, and continuing education in biosafety research compliance across diverse sectors like academia and industry. It serves as a hub for knowledge exchange and networking. Faculty focus on understanding applicable regulations, maintaining compliant biosafety research programs, and developing effective and efficient practices for program management.

Overall, the BSAA ensures well-rounded professional development opportunities for individuals at various stages of their careers in biosafety administration, equipping them with the expertise needed to manage and develop their institution’s Biosafety compliance programs.

Meeting Course Objectives:

For attendees to be able to classify the research conducted at their institutions into the appropriate NIH Guidelines Experimental Category. To gain an in-depth understanding of Section III, Experiments Covered by the NIH Guidelines. The primary objective of the meeting is to enhance the understanding of Section III of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, focusing on the types of experiments covered under these guidelines.

Key Topics Covered:

1. Overview of Section III of the NIH Guidelines:

Facilitators will provide a detailed overview of Section III, which outlines the categories of experiments involving recombinant or synthetic nucleic acid molecules that are subject to the NIH Guidelines. Included in the discussions will be common examples of experiments in each category and the potential consequences of non-compliance.

2. Categories of Experiments:

1. 1. Section III-A. Experiments that Require NIH Director Approval and Institutional Biosafety Committee Approval Before Initiation (Major Actions).

1. 2. Section III-B: Experiments That Require NIH OSP and Institutional Biosafety Committee Approval Before Initiation

1. 3. Section III-C: Experiments Involving Human Gene Transfer that Require Institutional Biosafety Committee Approval Prior to Initiation

1. 4. Section III-D: Experiments that Require Institutional Biosafety Committee Approval Before Initiation

1. 5. Section III-E: Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation

1. 6. Section III-F: Exempt experiments that do not require IBC review or approval.

3. Discussion on Compliance:

Emphasis will be placed on the importance of correctly identifying the category under which an experiment falls, as this determines the necessary approvals and oversight.

Guest Faculty

Dr. Kathryn Harris is the Senior Outreach and Education Specialist (contractor) in the Office of Science Policy (OSP) at the National Institutes of Health (NIH). Kathryn joined NIH in 2004. In her current role, she develops national and regional programs of stakeholder relations, education, and outreach strategies relevant to the oversight of recombinant and synthetic nucleic acid molecule research and research that has dual use potential. In addition, she advises on biosafety and biosecurity policy issues. She received her Ph.D. from Cornell University and completed two years of postdoctoral training at Washington University in St Louis. Prior to joining NIH, she was the Biological Safety Officer at Northwestern University. She is a registered biosafety professional was a founding member and first president of the Midwest Area Biosafety Network.

Who Should Attend: Researchers and scientists involved in recombinant DNA research, Institutional Biosafety Committee (IBC) members, lab managers and biosafety officers, institutional compliance officers. Any professionals responsible for oversight and conduct of recombinant DNA research. Join us for this intensive program to master the NIH Recombinant DNA Guidelines, ensuring rigorous compliance and advancing the safety and efficacy of your research endeavors.

Programs Support

The BSAA meetings and related activities are supported through BSAA memberships and event attendance fees.  To reduce your attendance fees at BSAA upcoming meetings, we ask that you please become a new member or maintain your current membership status (memberships are renewed annually). If you are a current member of the BSAA, you may attend this meeting at the reduced rate of $225. Individuals that are non-members or those with expired memberships are asked to provide $325 in support for each meeting they attend. Please confirm your active membership status at the following link (Current Membership?) prior to registering for this event.

Faculty Members Biographies

Bill Greer, Assistant Vice President for Research, University of Michigan

Bill graduated from The Pennsylvania State University in 1985 with a degree in Microbiology.  He currently oversees the animal care and use, biosafety, lab safety, controlled substances, and autonomous systems research compliance programs.  His previous roles included the Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at The Pennsylvania State University, and the production manager and safety director at Intervet, State College, PA (Formally Tri Bio Laboratories). Bill has overseen animal care and biosafety programs for over 30 years.

In 2005, he organized and held the very first research administrators Best Practice Meeting, which establish a venue for research oversight professionals to informally meet and discuss programmatic concerns.  He continues to facilitate at least five annual Best Practice meetings covering both biosafety and animal care and use programs.  In 2010, he chaired the founding committee for the non-profit education based IACUC Administrators Association (IAA), and continues to serve as the organization’s president and chair of the board of directors.  Since 2007, Bill has served as ad hoc consultant to AAALAC Council where he performs institutional program reviews, assessments, and status determinations.  He served as a member of the Council of Certified Professional IACUC Administrators (CCPIA).  Bill continues to serve as an educator for the IBC and IACUC Administrative communities and has lectures at multiple venues including PRIM&R, AALAS, BTAA, and C3, as well as facilitates IBC and IACUC Best Practice Meetings.

Jonah Lee, BS, MS, PhD:

As the Associate Director for the Animal Care & Use Office (ACUO), Dr. Lee brings experience and a proven track record in the biomedical sciences and academic research administration to provide thought leadership, program oversight, and process optimization with specific attention to researcher/user-experience coordination across the Animal Care & Use Program.

In collaboration with other U-M research administrative departments and academic department leadership, Dr. Lee is charged with the strategic development of research engagement infrastructure and resource support.

PROFESSIONAL BACKGROUND

PhD (Human Bioenergetics), Ball State University

MS (Pediatric Exercise Science), Ball State University

BS (Human Physiology), University of Oregon

Dr. Lee has an extensive background in the life sciences, where his research focus involves stem cell biology and regenerative medicine in aging skeletal muscle. Along with his postdoctoral research at the Center for Muscle Biology at the University of Kentucky, and his work at U-M, his animal research experience includes considerable diversity in both small and large animal models across multi-departmental, federally-funded research projects.

Andrew Maksymowych, Ph.D., Associate Director, Biosafety Programs

Andrew has been at the University of Pennsylvania since 2006.  He is Penn’s Associate Director for Biological Safety Programs, Penn’s Institutional Biosafety Officer, IBC Administrator, and the Institutional Contact for Dual Use Research.  He sits on the Vice Provost’s for Research, Human Research Advisory Committee, the Human Stem Cell Research Advisory Committee, and the Cadaver and Body Parts Oversight Committee.  Andrew obtained his B.S. and M.S. degrees from Villanova University, and his Ph.D. in Biochemistry from Bryn Mawr College.  He has more than 20 years of teaching and 35 years of research experience.  A major portion of which included oversight of research safety and compliance programs.  Prior to his journey at Penn, he held a faculty appointment at Thomas Jefferson University where his research focused on the analysis of structure-function relationships in proteins, including protein toxins that poison the human nervous system.  Most recently, the mechanism of action of botulinum neurotoxins.  Andrew attended his first Best Practice Meeting in 2015 and has since been continually involved with Biosafety Administrator’s Association.

Raymond F. Scheetz, MS, RBP is currently the Institutional Biosafety Officer and a Compliance Manager at The Penn State University College of Medicine in Hershey, Pa, located in the Research Quality Assurance office a division of the College of Medicine Office of Research Affairs.  He is responsible for the oversight of all Biosafety compliance aspects within the College of Medicine, providing ancillary reviews of IACUC and IRB protocols, biosafety training and required annual lab surveys, administration liaison for research lab activities and emergencies, and operation of the equipment and asset management plan. He is a member of the College of Medicine Institutional Biosafety Committee, Research Mission team and COVID 19 Ramp up Research task force.  Ray also serves as a Biosafety consultant for CBS (Clinical Biosafety Services)/Shield Consulting.  Formally the Lab Manager in the Department of Microbiology and Immunology at the Penn State College of Medicine for 25 years.  Responsibilities included the Management of the BL3 facility located within the Department.

Please note the meeting is virtual and the times are EASTERN TIME.