Mark Frey, Ph.D.

Mark Frey, Ph.D. has over 20 years of experience in quality assurance and regulatory affairs. Starting in 2021, they have been Senior Director of Quality Assurance at Cleveland Diagnostics, Inc. From 2016 to 2021, they were Clinical Accreditation Quality Specialist at University Hospitals. From 2015 to 2016, they were Managing Principal at Arelben Quality/Regulatory Consulting. From 2014 to 2015, they were a Consultant at Cleveland Cord Blood Center, where they contributed strategically and in technical writing for successful submission of BLA to FDA within organizational timelines. Mark also developed SOPs and associated documents for cGXP compliance and BLA submission working across multiple disciplines. From 2012 to 2014, they were Head of Quality at Fate Therapeutics Inc, where they developed, implemented, and managed quality system for clinical trial compliance of modulated cord blood product for treatment of hematologic malignancies. From 2001 to 2012, they were Group Leader of Regulatory Affairs and Senior Scientist at Athersys, where they managed the quality system for Phase II studies in Ischemic Stroke and Ulcerative Colitis, and led the strategic development, management, and maintenance of a cGXP compliant document control system. Finally, from 2001 to 2002, they were Associate Scientist at Athersys, where they expressed and purified key chromosomal proteins for pre-loading onto synthetic microchromosome (SMC) vectors and microinjected protein/DNA complexes into cell nuclei.

Mark Frey, Ph.D. received their Bachelor of Arts (B.A.) in Chemistry from Case Western Reserve University in 1993. Mark then returned to Case Western Reserve University to obtain their Ph.D. in Cell Biology/Genetics in 2001. Additionally, they are a Clinical Compliance Certified Professional from The Center for Professional Innovation & Education (CfPIE).