Dr. Foster brings a unique blend of scientific knowledge and Quality/Regulatory experience to the Merakris team. From her scientific beginnings as a Medical Technologist, she transitioned to research before going to graduate school. Dr. Foster earned a Ph.D. in Immunology from the University of Texas Southwestern Medical Center followed by a post-doctoral fellowship at Duke University. She then spent 12 years in clinical-phase biotechnology companies in roles of increasing responsibility from pre-clinical research and product development to directing the manufacture of clinical trial material to leading Quality Assurance and Regulatory Compliance. She designed ISO 14644-compliant clean room facilities for the manufacture of cellular therapy products for clinical trials and implemented quality systems to support those activities. During her years in biotechnology, she served on medical device design control teams and has extensive experience in medical and regulatory writing. She has designed, written, and implemented process validations, operator qualifications, aseptic process simulations, comparability protocols, and has authored multiple CMC sections for INDs and briefing documents for FDA meetings.
Dr. Foster then started her own consulting company to leverage her scientific, Quality, and Regulatory skills. Over the past dozen years she has helped clients develop Quality Systems and implement electronic document control systems, led design teams for medical device product development, and authored DHF deliverables, potency assay development, stability studies, equipment qualifications, cGMP and GLP training. She’s translated R&D projects into cGMP-compliant manufacturing, and overseen SOP writing, gap analyses, supplier audits and preparing for pre-approval inspections. Recent projects included managing design controls for a successful 510(k) clearance, managing a CRO for the device side of a biologics/device combination product, leading the CMC team for a BLA, and working with a pharmaceutical CMO on pre-approval inspection readiness.