Heath Coats has over 35 years of industry and consulting experience, seven of which were as a Biologist with the Division of Manufacturing and Product Quality (DMPQ) in U.S. FDA's CBER. There, he gained extensive knowledge of administrative and regulatory review procedures for INDs and CMC sections of biologics license applications. 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.
For DHC clients, Heath's experience has enabled him to provide support by performing audits and mock audits to support due diligence, vendor qualification, and preparation for regulatory inspection. His extensive inspections history (as delineated in the next paragraph) makes him a natural fit for clients either preparing for inspections or working to remediate processes for future rounds of inspection. He also provides support in the form of regulatory strategy and review.
While a member of DMPQ, Heath performed and led numerous pre-license and pre-approval inspections. His involvement with inspections has included compilation and review of relevant information from new applications or previous inspections for discussion during pre-inspection meetings and during the inspection. During these inspections, Heath observed and documented deviations in product manufacture, facility qualification, and quality systems. Heath has also prepared inspection reports and reviewed manufacturer’s responses to observations during inspections.
Heath would also routinely participate in pre-submission meetings with sponsors in order to evaluate facility design, operation, manufacturing and testing procedures, and compliance with Good Manufacturing Practices (GMP).
Prior to his tenure at FDA, Heath was a hands-on manager of the validation program for eight years 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. His department documented, investigated, and facilitated corrective actions for deviations when encountered as well as participating in factory acceptance testing of capital equipment, statement of work generation for cell therapy clients, and customer and Agency audits as facility and technical subject matter experts.
Heath also has over ten years of hands-on industrial experience in manufacture of biologically active proteins. This experience includes protein expression through fermentation, protein purification and quality control testing. Heath’s responsibilities during this time period included development and optimization of procedures and then creating accompanying procedures and batch records. As part of his master's theses, Heath generated and characterized a hematopoietic stem cell line.