As a medical devices and diagnostics regulatory consultant, Kenneth Butz provides diagnostics lifecycle management services from early development through marketing authorization and post-approval product support. He specializes in the development, manufacture, validation and commercialization of in vitro diagnostic and companion diagnostic products.
Mr. Butz provides product-specific regulatory strategy and submissions for translating biomarkers into diagnostic products through integrated therapeutic/diagnostic co-development processes and pathways.
Prior to joining PPD® Consulting in 2012, Mr. Butz worked for Conatus Consulting as a regulatory affairs and quality systems associate and founded Vista Bioconcepts to provide regulatory, scientific and technical consultation. He began his career in the diagnostics industry at Gentris Corporation and ParagonDx LLC., involved in lifecycle management of pharmacogenomics-based molecular diagnostic assays and reagents and cell line-derived products.
Mr. Butz earned a master’s degree in biological sciences from Marshall University and a bachelor’s degree in natural sciences from Muhlenberg College.