Mike is responsible for the executive management of the business, scientific and regulatory operations of Immunologix Laboratories. His role includes executive responsibility for the organization to ensure studies and supportive functions are conducted in accordance with good business practices and applicable regulatory requirements and guidelines, as well as oversight of timelines, budgets, and assay support priorities for clients’ drug development programs.
Mike has over 12 years of experience in regulated bioanalysis, all within the CRO industry. He has extensive experience with pharmacokinetic (PK), immunogenicity and neutralizing antibody assays, having worked on hundreds of different regulated immunoassays. He has participated in numerous regulatory filings and has significant experience in consulting on assay design and development.