Using legal and scientific methods that he has developed over 30 years, Lance Shea handles legal matters that require development, interpretation or advocacy of scientific evidence – primarily evidence of product efficacy, safety or bioequivalence. The differentiating feature of Lance’s practice is that he develops an in-depth understanding of the relevant scientific evidence and governing law before crafting legal strategies and positions.
Lance represents clients such as drug, medical device and biotechnology companies. Matters span regulatory (e.g., FDA, FTC, EPA) and litigation forums. Additionally, he advises clients on the development of evidence needed to protect marketing exclusivity and market share for medical products – a process that spans entire product life cycles. For an overview of Lance’s methods for developing and evaluating health science evidence, see “Causal Leverage Analysis: Obtaining Product Approval and Winning Approval Litigation.” For strategies to help ensure that the FDA applies appropriate generic approval standards, see “Bioequivalence of the Active Principle and Bioavailability Mechanism Analysis.”