Dr. Doug Keller is a Senior Consultant in ToxStrategies’ Biopharmaceuticals/Pharmaceuticals Practice. He has more than three decades of experience in the pharmaceutical and laboratory sectors, serving as a researcher, study director, senior advisor, director, and global head in a leading pharmaceutical development/manufacturing firm. Most recently, he led a global team of 20 toxicologists conducting projects for development and marketing within the pharmaceutical industry. In this role, his responsibilities included approving project strategy and reviewing and approving regulatory compliance documents. He also represented the company on trade organization scientific committees and collaborative consortia.
Dr. Keller has also managed a team of scientific advisors and advisory groups in areas of nonclinical safety evaluation and supported preclinical safety scientists charged with implementing the science and standards on pharmaceutical development projects. In this role, he directly handled agency presentations and addressed critical issues as needed, managing innovation and implementation of new predictive assays in preclinical safety. He has been involved at a senior management level in the development of best possible scientific practices and standards in the area of drug safety, providing scientific and regulatory advice on non-clinical strategy, data interpretation, and study design to small-molecule and biotherapeutic development projects in all therapeutic areas. He has reviewed and approved regulatory submissions and served on committees (hepatotoxicity, structure-activity relationships) internally and within the greater industry (PhRMA, IQ, HESI, ECVAM) to study safety assessment issues. Several of his publications outline best practices for development and use of microphysiological systems, safety biomarkers, and animal models of disease.
Dr. Keller has been a Diplomate of the American College of Toxicology (DABT) since 1990 and a member of the Society of Toxicology since 1986. He is widely published in the scientific literature, has two book chapters to his credit, and regularly attends and presents at scientific conferences and symposia.