Ann R. Donoghue

Dr. Ann Donoghue has over 20 years of drug development experience and has been involved in all aspects of new drug and diagnostic test development. She has led project teams to approval of USDA licensed diagnostic test kits, an EPA registered pesticide and New Animal Drug Applications. Her most recent role has provided her with experience in human health pharmaceuticals, from project initiation through scale up to commercial GMP manufacturing. She co-led a successful FDA pre-approval inspection of a new GMP manufacturing facility; she has conducted GLP study site audits and has been the Sponsor Monitor for several GCP clinical trials. Her teams achieved an Orphan Drug Designation and completed a subsequent Investigational New Drug Application resulting in a successful Phase I clinical trial in less than one year from project initiation. Ann has participated in product development regulatory strategy and in face-to-face predevelopment conferences with the FDA and EPA. She has developed, written and instituted controlled document systems for GLP, GCP and GMP compliance. These experiences have provided broad project management knowledge spanning early research to finished product marketing.