Mike Ringenberg Email & Phone Number

Over 20 years of applied preclinical research experience, supporting all facets of drug development by routinely providing:• Input on study design(s) supporting in vivo experiments from discovery through drug filing.• Discovery and early development pathology support via macroscopic and microscopic tissue examination for animal model evaluation and/or efficacy endpoints, drug candidate screening and compound lead optimization for advancement into development.• Target validation and mechanistic biology understanding on archived patient samples using primarily immunohistochemistry and/or in situ hybridization.• Primary or peer-review pathology for drug/vaccine support for the purpose of risk assessment characterization, with data interpretation authored into comprehensive narrative reports for regulatory filing(s).• Collaboration on multi-disciplinary project teams to enable strategic drug development decisions. • Integration of supplementary data (clinical pathology/transcription data, immunohistochemistry results, ultrastructural morphology etc.) used principally to establish mechanisms of toxicity.• Supervisory responsibilities for laboratory operations in necropsy and histology, conducted in accordance with applicable local and/or global regulatory standards.• Due diligence input on potential in-license candidates or drug alliance deals.• Input and response preparation(s) for regulatory queries on drug candidate filings.

Listed skills include Drug Discovery, Drug Development, Toxicology, Glp, and 15 others.