Mary Joe Davis is an industry leading expert in animal pharmaceutical research and development with over 25 years of experience. She has held roles in various stages of product development and product support including expertise in disciplines such as efficacy, safety, manufacturing, and regulatory affairs. She has planned research and program strategies, helped identify key decisions points, and communicated and interpreted results to the appropriate audiences. Mary Jo has extensive experience in helping companies overcome regulatory challenges, by assisting in decision making support and submission, program strategy, developmental progression, and technical writing. She has voluminous background in managing, consolidating, and building working relationships to make EPA portfolios more efficient. Throughout her career she has held numerous research jobs, including safety studies regarding pharmaceuticals in beef cattle, and research into food safety product development that would reduce bacteria in meat animals. She also has research experience in Infectious bursal disease virus (IBDV), infectious diseases, coccidiosis, parasitology, and muscle development.
Mary Jo has had extensive dealing with the EPA. During her time as a regulatory consultant with Elanco, she worked to integrate Novartis and Elanco into one company by managing their EPA portfolio. While also at Elanco she worked on a beef development team concentrated on pivotal studies that were required to register pharmaceutical products for cattle, where Mary Jo focused on data and project management. She worked closely with the FDA and CVM throughout this ongoing effectiveness and target animal safety submission, which required 15 different studies from 4 separate sites. She created tools to track study completion and progress, coordinated quality review, created submission table of contents and cover pages, and facilitated final data package compilation with publishing. She has background in dealing with regulatory pathways for products in the food safety sector. She was able to provide support to select the best pathway option for each product and then coordinate specific plans with corresponding agencies.
In addition to consulting for Scullion Strategy Group Mary Jo also owns and operates her own consulting company, Option MJD, LLC. She has also previously held various positions in regulatory and research roles with Elanco Animal Health.
Mary Jo has received the Eli Lilly and Company, 2014 Global Lean Six Sigma Award, and a Black Belt in team excellence.
Mary Jo received her M.S in Developmental Biology from University Wisconsin Madison and her B.S. in Bacteriology and Agriculture Journalism from Indiana University-Perdue University Indianapolis