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In the 30 years Dr. Donoghue has been in the drug development field, she has been involved in all aspects of new drug and diagnostic test development. She has led project teams in the successful approval of USDA licensed diagnostic test kits, an EPA registered pesticide and New Animal Drug Applications. 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. She was part of the team that obtained conditional approval and then full approval for the first approved drug for the treatment of lymphoma in dogs. 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.
Dr. Donoghue received Bachelor of Science (animal science), Doctor of Veterinary Medicine and Master of Science (large animal clinical sciences – parasitology) degrees from Michigan State University. She served as the chief of the parasitology section of the MSU Animal Health Diagnostic Laboratory. Her employment has been with Hoechst-Roussel Agri-Vet Company, Heska Corporation and PR Pharmaceuticals, Inc., VetDC, Inc. and now as the principle of Donoghue Consulting, LLC. She is a regular reviewer for the Journal of the American Veterinary Medical Association and the American Journal of Veterinary Research and has been an invited continuing education speaker at state and national veterinary conferences.