Areas of focus: Cell Biology - Technology Transfer – Target Product Profile - Process Development – Manufacturing - Preclinical and Phase 1 Clinical Testing – FDA IND and License Approval
Areas of focus: Laboratory Management – Project Management – Cord Blood Processing – Method and Equipment Validation – Report Creation – Cellular Therapies – Document Control – Accreditations – FDA IND and license approval – Deviation and CAPA investigation
About Sara Shields Ms. Shields, a certified Medical Laboratory Scientist, came to the Cleveland Cord Blood Center (CCBC) after several years’ experience with the Cleveland Clinic, where she performed Human Leukocyte Antigen (HLA) testing, sequencing, panel reactive antibody (PRA) testing, and flow cytometry cross matching for solid organ donors and recipients. Initially hired as a Processing Technologist, she processed and stored the first umbilical cord blood units at the Cleveland Cord Blood Center in 2008. Over time, her responsibilities have grown with the organization. She is responsible for developing and implementing over 200 standard operating procedures and worksheets, equipment and service contract maintenance, developing and implementing validations; maintaining a robust training program; and is the point of contact for all laboratory inspections. As Project Manager, she works closely with vendors and researchers to develop new project collaborations, coordinates internal resources, manages timelines, and ensures projects are completed on time and within budget. Sara received a Bachelor of Science in Medical Technology from The Ohio State University.
About Hal Rogness Hal joined the Cleveland Cord Blood Center (CCBC) in 2019 to enhance awareness and use of Cell Therapy Incubator (CTI) services by academic research teams, small biotechnology companies and others that typically do not have the resources to justify large capital investments for the build out of facilities and infrastructure. With 20 years of experience in business administration and sales in cellular therapy and medical technology, and a vast network of relationships in the biotechnology and research arenas, Hal is responsible for helping to identify opportunities where CCBC’s leadership and experiences can help lead to revolutionary treatments. He has won numerous awards and been recognized for his mentoring and coaching. He received an MBA from Golden Gate University, San Francisco, and a Bachelor of Science in Nursing from University of California, San Francisco.