Marc Bailie, DVM, PHD, DSP
With nearly 25 years of experience in drug discovery and development, Dr. Bailie’s expertise includes an array of models to evaluate the pharmacologic and toxicologic activity of compounds. As Director of the In Vivo Pharmacology Facility at Michigan State University, he leads a team that provides pharmacology and early safety testing to academic and private sector investigators. He concurrently serves as partner and Chief Development Officer of Integrated Nonclinical Development Solutions Inc. (INDS), a consulting group that offers strategic and tactical support for drug discovery and development projects.
Dr. Bailie spent 11 years with Parke-Davis/Pfizer developing and directing the Safety Pharmacology Group within Drug Safety Research and Development. He served on numerous discovery and development project teams, was involved in several projects that progressed to New Drug Application (NDA) with the FDA. Dr. Bailie has published over 35 papers in peer-reviewed journals, is a certified Diplomate in Safety Pharmacology (DSP) and earned both his doctor of veterinary medicine and Ph.D. from Michigan State University.
Ann R. Donoghue, DVM, MS
Dr. Donoghue is a leading expert with over 25 years of experience in the development and registration of veterinary and human pharmaceuticals and veterinary diagnostic tests. Prior to serving as an independent consultant, she held various leadership positions with Hoechst-Roussel Agri-Vet Company, Heska Corporation, PR Pharmaceuticals, Inc. and Michigan State University Animal Health Diagnostic Laboratory.
Under Dr. Donoghue’s leadership, project teams have obtained approvals for USDA licensed diagnostic test kits, New Animal Drug Applications (NADAs), and an EPA registered pesticide. Her other noteworthy experience includes FDA pre-approval inspections, GLP study site audits, GCP clinical trial activities, and FDA pre-submission conferences. She obtained an Orphan Drug Designation and completed a subsequent Investigational New Drug (IND) application resulting in a successful phase I clinical trial less than one year from project initiation. A regular reviewer for the Journal of the American Veterinary Medical Association and the American Journal of Veterinary Research, Dr. Donoghue received her doctor of veterinary medicine, Master of Science, and Bachelor of Science from Michigan State University.