Christine Gathers, MS

Christine Gathers, MS

Senior Consultant, Apropos Regulatory Consulting, LLC

Christine Gathers worked at Eli Lilly and Company for nearly 29 years with a multitude of experiences spanning the pharmaceutical value chain (e.g. product development, medical, strategy, marketing and sales, biomarker operations and regulatory).  

In Regulatory for 8.5 years at Lilly, Christine provided support for numerous drug development efforts across multiple therapeutic areas as a regulatory scientist. While in Regulatory, Christine spearheaded Lilly’s regulatory efforts for companion diagnostics and biomarker qualification which included:  external policy work, FDA interactions, and collaborating with diagnostic manufacturers to integrate the diagnostic with that of the drug product for many Lilly teams.  

For the last 9.5 years, Christine has been working as an independent consultant (Apropos Regulatory Consulting Services, LLC) for biotech, pharma and device companies with a focus on companion diagnostic co-development programs and biomarker qualification by advising on strategies and spearheading FDA device communications (pre-submission documents, study risk determinations, IDEs and premarket applications). Additionally, she consults on regulatory strategies for drug programs in various therapeutic areas (e.g., metabolic disorders, neuroscience, oncology, genetic disorders, and cardiovascular) which includes advising and leading FDA communications (e.g., IND submissions, end-of-phase and pre-IND FDA meetings, NDA submissions).

Christine has a BS in Chemical Engineering and a MSc in both Pharmacology and Molecular Biology, as well as Regulatory Affairs Certification (RAC) and is a member of the ADDF Scientific Advisory Board.