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.

Kimberly Delk-Brooks is an Accreditation and Regulatory Affairs Manager at the American Association of Tissue Banks, where she leads the day-to-day management, maintenance, and efficient operation of the electronic systems and people processes involved in AATB’s accreditation program. With over 10 years of experience in FDA and quality auditing, Kim is a biologics subject matter expert and offers a strong commitment to delivering results that align with both business goals and customer needs. Before joining AATB, Kim held positions at the Food and Drug Administration as a Biologics and Tobacco Specialist and Program Monitor, where she contributed to the development and implementation of innovative inspection programs and tools for biologics and tobacco products, such as the simulated saline incident task force and the drug shortages mobile application. Her career has been defined by a focus on improving processes, solving problems, and enhancing analytical skills in the field of biologics and tobacco regulation and compliance.

Kim holds a Master of Public Administration with a concentration in Non-profit and Governmental Administration from Kennesaw State University and a Bachelor of Biology with a minor in Community Health from Georgia Southern University. She is actively involved in advocating for issues impacting children and military veterans in her community. Outside of work, she enjoys traveling with her family and attending concerts.