Litigation And Technology Scientific Advisor
CurrentTrusted advisor with technical insight and direction at times of risk. From early discovery through the lifespan of a product, communicated clear strategies rooted in compelling yet complex scientific facts. Coordinated priorities with global and external partners for a track record of successful outcomes. Registered patent agent.-- Aligned IP strategy for Actemra© across global partnerships based on the development history. In depth analysis of the regulatory submissions ensured a robust protection of both the clinical, production, and quality aspects of the licenses while remaining sensitive to regulatory, political, and supply concerns during the pandemic.-- Limited the litigation exposure of two blockbuster drugs by over $300 million with an in-depth analysis of CMC and commercial lot documentation characterizing a small subset limited by production and sale dates. -- Identified critical patent protection for biosimilar manufacture of three blockbuster drugs with over $5 Billion in sales per year. Analyzing the manufacture of Genentech biologics, comparing quality regulatory documents, and evaluating common practices across the field. This protection softened market loss, beating analyst estimated earnings during critical years.-- Took a holistic approach to support a successful defense of labeling and promotional practices. Ensured strategies accounted for the interplay of: the label history, regulatory communications, promotional materials, internal teaching materials, ISTs, the various phase trials, the history of compendium listings, collaborations, discussions with medical liaisons, discussions with thought leaders and ad campaigns, as well as implications to our IP protection. -- Coordinated in-house evaluation and supported successful response to various government inquiries related to commercial practices, health agency approved commercial materials, pricing, reporting, and supplying the market.
