Randall Thoma and Theodore Sand
Biography:
Randy is currently the Principal at VeeSquared (V2) Consulting Services. "VeeSquared" is Verification and Validation. His consulting practice includes development and remediation of Quality Systems (medical device, over-the-counter drug, and blood processing) and process (especially cleaning validation) and test method qualification and validation and education.
He has also been an inspector for the American Association of Tissue Banks (AATB) since 2016.
Prior to entering consulting, he was the Associate Director of Quality Assurance for Zimmer Biologics. In this role he was responsible for Quality at the product development facility and for teaching the scientists how do develop and commercialize products, including human tissue products, targeting orthopedic early intervention.
He served on the AATB Accreditation Committee and is a past-Chair of the committee.
He is also the author and technical contact for the ASTM "Guide for Validating Cleaning Processes used during the Manufacture of Medical Devices".
He is a past President and CEO for a bereavement camp for children and is currently a volunteer driver for the local blood center.
Theodore T. Sand, Ph.D. (Vice President Research & Regulatory Affairs) joined Greyledge Technologies, LLC in September 2016. He is responsible for expanding the network of in-clinic processing laboratories operated by Greyledge. Dr. Sand also handles implementation of Greyledge’s Quality Management System, manages its clinical studies and the company’s research program. He previously was VP of Cellular Therapies & Regulatory Affairs at Celling Biosciences (Austin, Texas). Dr. Sand started working in translational cell therapy and regenerative medicine in 2002 when he created, optimized and validated the autologous fat tissue-derived stem cell therapy service offered by Vet-Stem, Inc. (Poway, CA).
Dr. Sand received both his B.S. (Microbiology, 1975) and Ph.D. (Biochemistry, 1982) degrees from the University of Minnesota (Minneapolis, MN) and was a Postdoctoral Fellow in the Department of Immunology at Scripps Clinic and Research Foundation (La Jolla, CA) from 1982 to 1983.
Dr. Sand has been the inventor or co-inventor on 15 patents, has coauthored 14 scientific publications and writes posts covering scientific, clinical and regulatory aspects of translational cell therapy for a blog on the Greyledge Technologies website. Two book chapters on the regulatory aspects of the point-of-care regenerative medicine field are pending publication.