Professional Profile
Dr. David Eaker is a board-certified toxicologist in ToxStrategies’ Pharmaceuticals practice with more than 35 years of professional experience. His expertise includes in vitro and in vivo toxicology for devices and drugs, large animal functionality and clinical suitability models, PK/PD, device biocompatibility, and design of overall preclinical/nonclinical strategies aimed at regulatory approval and market access. His work has supported drug-device combination products, device coatings and drug delivery, biologics delivery, quality and regulatory compliance (GLP, GDP, GMP), and direct engagements with global regulatory bodies.
Other specific areas of experience include materials characterization (extractables and leachables; degradation studies), overall toxicologic health hazard risk assessments, and engagement with applicable standards-setting bodies (e.g., ISO; AAMI). Dr. Eaker’s work with innovation and product development teams throughout the product lifecycle has also included elements of medical materials science (polymers, elastomers, metals), product sustainability/recycling, sterilization modalities, and post-market support. He has supported hundreds of successful device and combination product 510(k), IDE, and PMA submissions, EU MDR CE submissions, China NMPA registrations, IND, NDA, and ANDA programs, inclusive of additional materials regulations (e.g., REACH, California Prop 65).
Dr. Eaker has also served as an Institutional Official (IO) under the US Federal Animal Welfare Act, overseeing responsible use of laboratory animals and AAALAC-accredited facilities.