Speaker Profile
Kenneth L. Hastings

Kenneth L. Hastings DrPH, DABT, ATS

Toxicology, Clinical Pharmacology
Mount Airy, Maryland, United States of America

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Kenneth L. Hastings, Dr.P.H., D.A.B.T., Fellow A.T.S. received his Doctor of Public Health degree from the School of Public Health, the University of North Carolina at Chapel Hill, in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology under the direction of Dr. Jack Dean. Dr. Hastings then served as a US Peace Corps Volunteer in Fiji under the Permanent Secretary for Health. From 1988–to 1991 Dr. Hastings completed a postdoctoral fellowship and was then appointed Research Associate in the Pharmacology/Toxicology Research Laboratory, Department of Anesthesiology, College of Medicine, University of Arizona, under the direction of Dr. A. Jay Gandolfi. From 1991–to 2007 Dr. Hastings worked in the Center for Drug Evaluation and Research, US Food and Drug Administration, in various positions: pharmacology/toxicology reviewer in the Division of Antiviral Drug Products (1991–1997), pharmacology/toxicology supervisor in the Division of Special Pathogen and Immunologic Drug Products (1997–2003), and as an Associate Director in the Office of New Drugs (2003–2007).

Dr. Kenneth L. Hastings, Dr.P.H., D.A.B.T., Fellow A.T.S. served on numerous committees and working groups while at FDA, including a lead representative for CDER/FDA on the ICCVAM validation of the murine local lymph node assay and as lead negotiator on ICH S8 (Immunotoxicology Evaluation of New Drugs). From 2007–to 2014 Dr. Hastings was Associate Vice President for Regulatory Policy, Sanofi US, serving as corporate representative on numerous industry working groups dealing with regulatory science and policy. Dr. Hastings has served in many professional societies (President, Society of Toxicology Immunotoxicology Specialty Section; President, American College of Toxicology; President, SOT Regulatory and Safety Evaluation SS). Dr. Hastings served as President of the American Board of Toxicology and has numerous publications, including editor of books on the use of mini-pigs in biomedical research and international standards for nonclinical safety evaluation of medical products. Dr. Hastings is currently an independent consultant specializing in toxicology studies in drug development.

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