• Douglas Ball

    Research Fellow

    Drug Safety R&D, Pfizer Global R&D, Groton, CT

    Doug obtained his BS and MS in Biology from St. John’s University, Jamaica, NY in 1977 and 1980, respectively and became board certified in general toxicology (DABT) in 2003. Doug is a full member of the American College of Toxicology (ACT), Society of Toxicology (SOT) and has served as President, Vice President and Secretary/Treasurer for the Northeast Chapter of SOT (NESOT). Doug began his career at Pfizer in 2000 as a Technical Advisor in Drug Safety Evaluation. Over the years, Doug has assumed various project and regulatory strategy roles and was promoted to Research Fellow in 2005. Currently, Doug serves as both Drug Safety and Regulatory Strategy Leads for candidates in early and late stages of drug development. Doug is a recognized expert in the evaluation of leachables and extractables (L&E) in drug products and recently co-chaired a Product Quality Research Institute (PQRI) L&E work group and co-authored the PQRI Best Practices Recommendations for Evaluation of L&E in Orally Inhaled and Nasal Drug Products (2006). In addition, Doug serves as a co-chair for the PQRI work team for L&E evaluation in parenteral and ophthalmic drug products and is chairman of the Extractables and Leachables Safety Information Exchange (ELSIE).

    Key Areas of Research

    Toxicology

    Projects

    Regulatory Strategy and Compliance; PQRI Parenteral and Ophthalmic Leachables & Extractables Workteam; Extractables and Leachables Safety Information Exchange (ELSIE)

    Professional Affiliations

    Society of Toxicology; Northeast Chapter of the Society of Toxicology; American College of Toxicology; Diplomate, American Board of Toxicology

    Education

    BS/MS, Biology - St John's University

    Favorite Quote

    Shoot for the moon. Even if you miss, you'll land among the stars. ~Les Brown