Program - Society of Toxicology

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44 th Annual Meeting and ToxExpo Continuing Education SOMETHING OLD, SOMETHING NEW; TRADITIONAL AND NOVEL BIOMARKERS OF RENAL INJURY PM 11 BASIC Chairperson(s): Susan Emeigh Hart, AstraZeneca Pharmaceuticals, Wilmington, DE and Syril Pettit, ILSI Health and Environmental Sciences Institute (HESI), Washington, DC. Endorsed by: Risk Assessment SS Toxicologic & Exploratory Pathology SS* Because the kidney is an important target organ of toxicity, there is a need for sensitive, specific and non-invasive assays that can be used to detect low-level, potentially reversible renal injury in both animal toxicology studies and the clinical setting. Most of the available techniques do not allow identification of the segment(s) of the kidney affected by a toxicant. Better understanding of the pathophysiology of nephrotoxic processes, combined with information arising from genomic, proteomic and molecular biologic assessment of the effects of nephrotoxic chemicals has led to the identification of several promising new candidates that might serve as sensitive, segment-selective biomarkers of nephrotoxicity that can be applied readily in both the preclinical and clinical settings with adequate testing and validation. This basic CE course will provide an overview of renal structure and function, discuss the appropriate use and limitations of traditional clinical pathology assessment of renal injury, and describe the processes necessary for appropriate validation and subsequent regulatory acceptance of a novel biomarker. The final two speakers will describe the novel biomarker candidates under consideration by the Nephrotoxicity Working Group of the ILSI-HESI Technical Committee on the Development and Application of Biomarkers of Toxicity. The first of these will provide an overview of novel biomarkers for proximal tubular injury while the second will discuss the pathophysiology of renal papillary necrosis and how it relates to the identification of novel biomarkers of papillary injury. • Technical and Regulatory Issues in Biomarker Selection and Validation, James T. MacGregor, Toxicology Consulting Services, Arnold, MD. • Classical Clinical Pathology Approaches to the Assessment of Renal Structure and Function, Denise Bounous, Bristol-Meyers Squibb Company, Princeton, NJ. • Emerging Biomarkers of Renal Proximal Tubular Injury, Ernie Harpur, Sanofi-Synthelabo Research, Malvern, PA. • Emerging Biomarkers of Renal Papillary Necrosis, Susan Emeigh Hart, AstraZeneca Pharmaceuticals, Wilmington, DE. EVALUATION OF CARDIAC DRUG TOXICITY IN PHARMACEUTICAL DISCOVERY AND DEVELOPMENT PM 12 (REPEATS AS AM 06) BASIC Chairperson(s): Brian Short, Allergan, Irvine, CA and Y. J. Kang, University of Louisville, Louisville, KY. Endorsed by: Comparative and Veterinary SS HESI Biomarkers Technical Committee Mechanisms SS Regulatory and Safety Evaluation SS Student Advisory Committee The heart is an important potential target organ to evaluate in nonclinical and clinical studies during drug development as well as a therapeutic site of action for many cardiovascular diseases. There are examples in almost every therapeutic class of drugs that produced unanticipated cardiotoxicity leading to market withdrawal or cessation of development. Toxicologists are an integral part of an interdisciplinary group, including physiologists, pharmacologists, pathologists, clinicians, and regulators, which assess cardiac safety. As such, toxicologists play a critical role in the screening of pharmaceutical agents for cardiotoxicity as well as in establishing an adequate margin of safety and working basis for monitoring therapeutic endpoints and clinical safety of trial participants. The goal of this continuing education course is to illustrate the integration of physiology, pharmacology, toxicology, and pathology of the heart addressing both recent scientific advances and practical knowledge in pharmaceutical company setting. This course will cover in vitro and in vivo models of drug-induced cardiac injury and recent advances in biomarkers of cardiac injury to improve the strategy for detection and nonclinical and clinical monitoring of drug-related cardiotoxicity. This CE course will provide current understanding of the physiology of the heart with a focus on normal and drug-induced disturbances in cardiac electrophysiology and cardiac function, as well as testing strategies for assessing potential cardioactive drug candidates prior to entry into clinical trials. It will also cover basic and advanced knowledge of pathology of the heart, including a review of cardiac pathological evaluation, and provide case examples of the integration of physiological and pathological parameters and risk assessment to humans. Biochemical, cellular and molecular mechanisms of cardiac toxicity, including recent work in experimental animal studies and novel approaches directed toward understanding mechanisms of druginduced cardiac injury, cardiomyopathy and cardiac hypertrophy will be presented. Finally, biomarkers of drug-induced cardiac injury will be discussed. This will include a review of the findings of the Expert Working Group on Biomarkers of Drug-Induced Cardiac Toxicity, an in-depth look at serum troponins, and related work currently in progress under the ILSI-sponsored Subcommittee on the Development and Application of Biomarkers of Toxicity. • Physiological Basis for Cardiac Drug Toxicity and Evaluation, Robyn L. Phelps, Allergan, Irvine, CA. • Integrating Cardiac Pathology into Drug Discovery and Development, Calvert Louden, AstraZeneca Pharmaceuticals, Wilmington, DE. • Mechanisms of Drug-Induced Cardiotoxicity, University of Louisville, Louisville, KY. • Biomarkers of Drug-Induced Cardiac Toxicity, Malcolm J. York, GlaxoSmithKline, Ware, Hertfordshire, United Kingdom. CE 44 SOT’s 44 th Annual Meeting
INTERNATIONAL HARMONIZATION OF TECHNICAL REQUIREMENTS FOR CONDUCTING NON-CLINICAL SAFETY STUDIES OF HUMAN PHARMACEUTICALS: GUIDELINES, CASE STUDIES, AND CHALLENGES PM 13 (REPEATS AS AM 07) 44 th Annual Meeting and ToxExpo Continuing Education BASIC Chairperson(s): Rakesh Dixit, Merck Research Laboratories, West Point, PA. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 to standardize and harmonize technical requirements for the world-wide marketing approval of human pharmaceuticals. The six party ICH comprises the regulatory agencies and research-based pharmaceutical industrial organizations from three major geographical areas, the United States, the European Union and the Japan. The major goals of the ICH process are to minimize unique regional requirements, reduce the duplication of non-clinical toxicology and clinical testing requirements, and to accelerate the global development, registration and marketing of human pharmaceuticals in a cost-effective manner. Under Safety topics (non-clinical safety), 15 major guidelines have been harmonized and implemented through three major global regulatory agencies. These include guidelines on technical requirements for genotoxicity, toxicity, carcinogenicity, reproductive and development toxicity, biotechnology safety, toxicokinetics, safety pharmacology and joint safety and efficacy. This course is designed to provide a thorough understanding of the rationale behind ICH guidelines and the utility of the ICH guidelines in accelerating and global harmonization of safety evaluation of pharmaceuticals. The presentations will also highlight case studies with detailed examples, and experience in conducting non-clinical ICH safety studies. The presentations will also discuss the challenges, and problems encountered due to the differences in the interpretation, and the acceptance of the ICH Guidelines by the practicing regulatory organizations, reviewers and the traditional practices of specific geographical areas. • Guidelines on Genotoxicity Testing: Case Studies, Study Interpretation and Challenges, Sheila Galloway, Merck Research Laboratories, West Point, PA. • Developmental and Reproductive Toxicology Testing: Case Studies Study Interpretation and Challenges, Maureen Fesuton, Sanofi- Synthelabo, PA. • Chronic Toxicity, Carcinogenicity and Toxicokinetics Guidelines: Case Studies and Challenges, Rakesh Dixit, Merck Research Laboratories, West Point, PA. • U.S. FDA’s Experience and Guidance Related to ICH Safety Guidelines, David Jacobson-Kram, U.S. FDA, Rockville, MD. CE up-to-date information at www.toxicology.org 45
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Program - Society of Toxicology

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