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.

Melissa has 20+ years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization. She has experience in Quality System design, implementation, maintenance, and compliance. Melissa has held Quality leadership positions serving as the Management Representative, Head of Quality and official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc, a global manufacturer of adhesive-based Class II medical devices for would closure. During an 11-year tenure with Kimberly-Clark Health Care, Melissa held positions in Regulatory Affairs, Product Development, and Process Engineering. In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development, including pre-market approval requirements for U.S. and E.U. She is a member of the Regulatory Affairs Professional Society (RAPS) and holds an active RAC certification. Melissa holds a B.S. degree in Biological Sciences from the University of Georgia and an MS Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs. Melissa is a founding member and currently serves as the Chief Quality and Regulatory Officer for StimLabs, LLC based in Roswell, Georgia. In her current role, Melissa is responsible for all aspects of Quality and Regulatory Affairs for StimLabs including Quality Assurance, Quality Control, Quality Engineering, Quality Management Systems, Donor Services, and global regulatory affairs. Melissa is a member of the AATB Quality Counsel and has been serving as a member of the AATB program committee for the last three years and is the chair of the committee this year. In collaboration with AATB council membership and AATB Liaisons, Melissa was responsible for development of the agenda and speaker content for this year’s meeting.