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Topic Summary

Demographics collected by the Biosafety Administrators Association suggest the scope of the IBCs continues to expand from year to year. In fact, 20% of those responding the 2023 BSAA survey indicated that it was the responsibility of their institutions IBC to oversee the use of controlled drugs used in research. During this discussion, Kelli Christman (Controlled Substance Monitoring Program Manager, University of Michigan) will discuss the primary points of compliance associated with controlled substances.

Brief Agenda and Discussion Points

During this webinar, Kelli will provide a brief overview regarding the use of controlled substances in research and their oversight. She will discuss, for example:

1. What is considered a controlled substance,
2. A summary of the governing regulations (e.g., from security to disposal) and bodies,
3. How does an individual get authorized to use controlled drugs in research
4. Who is required to oversee controlled drug use
5. Monitoring and oversight practices
   1. Sample records (good ones and bad ones)
   2. How to mark and separate expired vs. usable
   3. Any and all ideas
6. Should the institution validate compliance (e.g., monitoring program)
7. A compliance committee (e.g., IBC or independent group)
8. Handling non-compliance and your (tiering process)  - red, yellow, green ect.

Presenter(s) 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.

Ron E. Banks, DVM:  received his veterinary degree from Auburn University’s School of Veterinary Medicine, and retired a Colonel from the United States Army Veterinary Corps.  After postings as the Director, Center for Comparative Medicine, University of Colorado Health Sciences Center, Denver, Colorado; and Director, Office of Animal Welfare Assurance at Duke University, Durham, North Carolina; and the Director, Division of Comparative Medicine, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; he is currently retired.  Along his professional journey he has contributed as Council Member on AAALAC’s Council on Accreditation; Chairman of the American Veterinary Medical Association’s Institutional Animal Care & Use Committee; Board Member for the IACUC Administrator’s Association; and Fellow of the National Academies of Practice.  Dr. Banks is board certified with the American College of Laboratory Animal Medicine; the American College of Veterinary Preventive Medicine; and he is a Charter Diplomate of the American College of Animal Welfare.

Kelli Christman: Kelli currently serves as the Controlled Substance Monitoring Program Manager at the University of Michigan

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.

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