After earning a BS in microbiology from McNeese State University and finishing up 6 years as a special operations forward air controller in the Louisiana Air National Guard, Kip Hanks began employment with the FDA as a field investigator in 1997. After a few years as a generalist covering multiple FDA-regulated products, he became a district biologics specialist and then the Office of Regulatory Affairs (ORA) biologics national expert. In this role, Kip was responsible for providing regulatory and guidance interpretation and application to ORA staff, training and mentoring new investigators, serving on policy and document workgroups and advising ORA senior leadership on biologics-related matters. In July 2021, he joined the American Association of Tissue Banks as its first director of regulatory and governmental affairs. In this role, Kip establishes and communicates the AATB official position regarding regulatory issues that may impact AATB member organizations to the FDA and other applicable governmental and standard-setting organizations. He provides expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members.

Sharon O’Callaghan is a Consumer Safety Officer with the Division of Inspections and Surveillance, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research.  Ms. O’Callaghan has a Bachelor of Science degree in Medical Technology from the University of Maryland at Baltimore. Prior to joining FDA, she worked at a community hospital as a bench tech and supervisor in all areas of the laboratory.  She joined the FDA in 1988 as a medical technologist. Ms. O’Callaghan has managed the Biological Product Deviation Reporting since 1990.  She was instrumental in developing the regulation on Biological Product Deviation Reporting (21 CFR 600.14 and & CFR 606.171), which was published September 7, 2001.  She also developed two guidance documents to accompany this rule.  Ms. O’Callaghan also developed the deviation reporting system for the Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and was instrumental in developing the guidance for HCT/P deviation reporting (21 CFR 1271.350(a)). She has participated in many outreach efforts to the blood and plasma industry, the traditional biological product industry, as well as the HCT/P industry.