John Ayres MD Pharma Safety Solutions, LLC

Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts. For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions. Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.