Mary J. Laughlin, M.D.
Founder and Medical Director
Mary J. Laughlin, MD, FACP, is the Founder and Medical Director of the Cleveland Cord Blood Center. Dr. Laughlin is internationally recognized as an expert in hematology oncology therapies for adults and children including autologous and allogeneic hematopoietic stem cell transplantation and genetically modified cell-based therapeutics for patients with cancer, inherited metabolic disorders, benign hematologic disorders including sickle cell disease, β-Thalassemia, and bone marrow failure syndromes. Dr. Laughlin’s clinical practice and research in hematology-oncology has spanned 34 years, focused on allogeneic and autologous cellular therapies, with specific expertise in umbilical cord blood studies, novel cell therapy based clinical development under FDA/EMA/PMDA regulatory guidance, as well as the design and implementation of human clinical trials for patients with life threatening malignancies.
Wouter Van’t Hof, Ph.D.
Director, Cord Blood Bank & CEO, Cleveland Cell Therapy Incubator
Wouter Van’t Hof has his Ph.D. in Cell Biology with over 25 years of biotech experience in translational research and development of adult stem cell therapies, including bone marrow stromal cells (MSC) and HPC, Cord Blood. He is accomplished in technology invention and transfer, product characterization, process development and scale up. His experience includes the management of projects with cross-functional teams in academia, biotech, and pharmaceuticals both in the U.S. and abroad. Van’t Hof was the Cleveland Cord Blood Center lead in acquiring FDA biologics license approval for the HPC, Cord Blood product CLEVECORD™ and oversees the organization’s CMC, Process Validation, Aseptic Processing, and GMP compliance. From 2002-2013, he was Director at Athersys (Cleveland, OH) and was responsible for technology transfer, product and process development, preclinical safety, regulatory discussion, clinical study design and management. Van’t Hof contributed to the CMC and Pharm/Tox sections of four approved IND applications for cell therapies.
Sara Shields, MPH, MLS (ASCP)
Associate Director, Processing Facility, CCBC & Director of Operations, Cleveland Cell Therapy Incubator
Sara Shields, a certified Medical Laboratory Scientist, is the Associate Director, Processing Facility of the Cleveland Cord Blood Center (CCBC) and the Director of Operations of the Cleveland Cell Therapy Incubator, a subsidiary of CCBC. She is responsible for the development and implementation of over 200 standard operating procedures, equipment and service contracts, process validations, production planning, and governmental reporting. Shields specializes in process optimization, contract manufacturing, and serves as a liaisons between clients, operations, and product distribution. With her start in human leukocyte antigen (HLA) testing and cross-matching for solid organ donors and recipients at The Cleveland Clinic, Shields has amassed over 20 years of experience in the clinical transplant and research field, and has focused 15 years on cord blood operations and manufacturing. She holds a Bachelor of Science in Medical Technology from The Ohio State University Honors Program and a Master of Public Health degree with a concentration in Health Policy and Management from Kent State University.
Dawn Thut, CMQ/OE (ASQ), CABP
Quality Manager
Dawn Thut oversees the performance of the quality systems for the Cleveland Cord Blood Center, including the evaluation of testing procedures for product qualification and aseptic processing under cGMP guidelines. Her responsibilities include regulatory reporting and compliance, audits, design and review validations, incident and deviation investigations, risk assessments, and determining appropriate corrective and preventative actions. With over 12 years of clinical laboratory experience, she understands the complexity of working with a biologic and the importance of quality, safety, and efficacy in the final product. Thut holds a Bachelor of Applied Science (B.A.Sc.) in Medical Technology from Youngstown State University, is an ASQ Certified Manager of Quality/Organizational Excellence, a Certified Advanced Biotherapies Professional, and has a Regulatory Affairs Certificate for Pharmaceuticals from the Regulatory Affairs Professionals Society.
Kathy Bobik-Kurz
Collection Site Manager
Kathy Bobik-Kurz manages the daily collection activities at CCBC’s six donating hospitals. Working closely with the collection site liaison team and the collection site coordinators, she oversees compliance with standard operating procedures and ensures that coordinators and collecting practitioners are current on training for collecting umbilical cord blood. Working with CCBC’s medical director, she helps to ensure donor eligibility standards for transplantation are met. Kathy also works with CCBC’s management team on the development and review of standards to maintain accreditations of FACT, AABB and FDA licensure. Kathy and her staff provide education to hospital staff and the public regarding cord blood donation and its uses, and interface with donating mothers pre-donation and post-donation. Kathy holds a BSN from Kent State University and received a Legal Nurse Consultant certificate from the American Association of Legal Nurse Consultants.
Kim Vincent (ASCP)
Laboratory Manager, Processing Facility
Kim Vincent manages the Cleveland Cord Blood Center’s cord blood processing facility, overseeing lab productivity, staffing, short- and long-range planning, laboratory equipment performance, record-keeping and quality control. With degrees in both clinical laboratory science and business administration, she brings 11 years of experience in diagnostics, testing, transfusion therapy, processing technology and project administration. She has been with CCBC since 2012 and was named Laboratory Manager in 2019. Prior to joining CCBC, she was a medical laboratory technician with the Cleveland Clinic and with Nationwide Children’s Hospital ChildLab.