Walnut Creek, CA—Dark Horse Consulting Group (DHC), a global consultancy specializing exclusively in cell and gene therapies (C>), announces their latest hire: CBER veteran, and now DHC Senior Practice Expert, Heath Coats, M.S.
Heath adds his 25+ years of industry experience to DHC’s formidable stable, which notably includes 30+ other regulatory and 20+ other quality systems consulting experts. Mr. Coats also joins two other former FDA staffers who are now Dark Horses: Donald Fink, Ph.D. and Kevin Whittlesey, Ph.D.
Mr. Coats’ extensive C> experience includes seven years spent as a Biologist with the Division of Manufacturing and Product Quality (DMPQ) in U.S. FDA's CBER: the Center for Biologics Evaluation and Research. There, he gained considerable knowledge of administrative and regulatory review procedures for INDs and CMC sections of biologics license applications (BLAs). During his time at the Agency, Heath reviewed applications and supplements for cell therapy products, HPC cord blood, plasma fractionated products, vaccines, allergenics, aseptic processing, and in vitro diagnostics.
While a member of DMPQ, Heath performed and led numerous pre-license and pre-approval inspections (PLI and PAI). Two of these manufacturing facility inspections were on behalf of what would, in 2017, become the first FDA-licensed CAR-T cell therapy product, Kymriah®.
His involvement with inspections has included compilation and review of relevant information from new applications and any previous inspections. During these inspections, he observed and documented any findings related to product manufacture, facility qualification, and quality systems. Heath’s inspection responsibilities also included preparation of establishment inspection reports and review of applicant’s responses to observations during inspections.
Coats would also routinely participate in pre-submission meetings with sponsors in order to evaluate facility design, operation, manufacturing and testing procedures, and compliance with GMP (Good Manufacturing Practices).
Prior to his tenure at the Agency, Heath was a hands-on manager for the validation program at a cell therapy contract manufacturing company that also manufactured endotoxin detection products and cell culture media. His department was responsible for all validation activities at the site including facility, equipment, computer, process, and cleaning, in addition to documentation, investigation, and facilitation of corrective actions for deviations when encountered. His department participated in factory and site acceptance testing of capital equipment, statement of work generation for cell therapy clients, and customer and Agency audits as facility and technical SMEs (subject matter experts).
Heath also has more than a decade of hands-on industrial experience in the manufacture of biologically active proteins. This experience includes protein expression through fermentation, protein purification, and QC (quality control) testing. Heath served as a fellow at the National Cancer Institute Frederick Cancer Research and Development Center (in addition to his time there as a biologist and senior researcher). Mr. Coats obtained his B.S. in Biology from Mount St. Mary’s University and M.S. in Biomedical Science from Hood College. Heath developed and characterized a hematopoietic stem cell line derived from fetal mouse liver for his M.S. thesis.
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About Dark Horse Consulting Group
Dark Horse Consulting—a global company with offices in both California and London—was founded in 2014 with the purpose of accelerating cell and gene therapies through unmatched consulting expertise. DHC’s collective knowledge spans manufacturing support, process development and comparability, analytical development, quantitative modeling, quality systems, device development, regulatory support, project and program management, market research, and financing and diligence. Dark Horse offers an unmatched understanding of the challenges faced by cell and gene therapy developers and is able to apply best practices from this and other industries to address a diverse range of client needs.
