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.

Tricia Samaniego Martinez currently serves as a Senior Advisor for the Office of Biologics Inspectorate (OBI), Immediate Office, within the Office of Inspections and Investigations at the US Food and Drug Administration. After receiving her Bachelor of Science in Microbiology from Texas A&M University, she joined the FDA as an Investigator. She has worked in the Houston and San Antonio offices conducting inspections and investigations in the Biologics, Human and Animal Drug, and Bioresearch Monitoring programs, in both the domestic and foreign arenas.

Tricia most recently served as the Division Director of Investigations where she was responsible for leading a team of managers and investigators, primarily located in the western half of the US, during a time of quickly evolving technologies in the biologics industry. The staff under her management conducted inspections and investigations of establishments handling biological products, including blood and blood components, Source Plasma, and human cell, tissue, and cellular based tissue products.
As a Senior Advisor, she is responsible for working directly with OBI management, as well as cross-organizational leadership in developing, recommending, and coordinating operational priorities, activities and resources to ensure consistency and optimization throughout the program. In addition, she is responsible for advising OBI leadership on emerging and precedent-setting issues, representing OBI on Agency level work groups and leading multiple trainings.