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Christine Gathers, RAC

Senior Consultant
À propos Regulatory Consulting Services

With over 35 years of industry experience spanning the entire pharmaceutical value chain, today Christine is engaged in regulatory consulting. She has spent nearly a third of her career in regulatory as a scientist, policy shaper and as a leader, and has spent more than 15 years focused on personalized medicine, working with clients to address their companion diagnostic issues and to pave new pathways for personalized medicine with the goal of improving patient lives. She worked at Eli Lilly and Company for 28 years and had a multitude of experiences spanning the pharmaceutical value chain (e.g. manufacturing, development, marketing, sales, business development, corporate strategy, medical and regulatory). Biomarkers have been a focus for her since working in Diagnostic and Experimental Medicine where she was responsible for clinical biomarker operations at Lilly. In her nearly ten years within Regulatory, she provided support for numerous drug efforts in clinical development across multiple therapeutic areas (e.g. diabetes, cardiovascular, autoimmune, musculoskeletal, oncology). As a Senior Director in Regulatory, she was responsible for regulatory support across Lilly’s portfolio of companion diagnostics including collaboration with diagnostic manufacturers to integrate the development and registration of the diagnostic with that of the drug product. For the last 9.5 years, Christine has been working as an independent consultant (Apropos Regulatory Consulting Services, LLC) advising biotech and pharma companies with a focus on companion diagnostic co-development programs and biomarker qualification but also consulting on regulatory strategies and FDA communications for drugs in various therapeutic areas. Christine holds a BS in Chemical Engineering from Case Western Reserve University, a MSc in Pharmacology with thesis from Butler University, a MSc in Biology from Purdue University as well as a Regulatory Affairs Certification (RAC).

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