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Sunday, AM

Study Director Training

This course is intended to provide an introduction to a Study Director’s responsibilities.

Go with the Flow! Cytometry Applications in Toxicology —

Flow cytometry provides a powerful, high throughput tool for analyzing multiple characteristics of individual cells in a complex mixture of cell types without having to physically separate the cells.

Toxicology Testing for Preventive Vaccine Development —

The development of preventive vaccines presents unique challenges and complex issues related to toxicity assessments

Sunday, PM

Contd.

Study Director Training —

The afternoon session will focus on the types of data typically collected for standard toxicology studies.

Target Organ Toxicity —

This course will serve as a general overview of the Liver, Kidney and Heart as target organs of toxicity.

ICH Harmonization Process —

Although bilateral discussions regarding harmonization of requirements for registration of new drugs have occurred in the past, they did not result in significant progress, and the global marketing of medicinal products remained a long, repetitive and expensive project. The International Conference on Harmonization (ICH) process evolved out of a desire to enhance drug development through consensus on technical requirements for approval across the three major pharmaceutical regions of the world, Japan, Europe, and the United States. Beginning in 1991, four ICH meetings were held, and a fifth is planned. As the result of these meetings, consensus has been achieved across a wide range of issues affecting the conduct of studies and the format and organization of submission documents. Numerous ICH guidelines have been published, and the Common Technical Document (CTD) is becoming a global standard. This mini-course is intended to bring toxicologists up to date with the ICH process.

Monday - November 3, 2003

The following Symposia will be offered:

I - The Human Genome and Toxicology - KEYNOTE SPEAKER

FRANCIS S. COLLINS, M.D., PH.D.

Director

National Institutes of Health

Recent advances in the study of the human, and other, genomes will have a dramatic effect on both basic research in Toxicology and upon the practical application of Toxicology in the processes safety evaluation and regulatory affairs. The Keynote Speaker for this symposium will be Dr. Francis Collins, Director of the National Human Genome Research Institute.

II - Impact of Genomics on Regulation of Chemicals and Drugs —

Toxicogenomics is an emerging scientific field that combines studies of genetics, genetic susceptibility, gene expression, and bioinformatics to understand the roles of gene-environment interactions in disease. Toxicogenomic data increasingly are having an impact on risk assessments, toxic tort litigation, environmental regulation, and workplace protection standards.

III - Alternatives to Carcinogenicity Testing Using Genetically Altered Rodent Models for Carcinogen Identification and Mechanism of Action

Genetically altered mouse models (GAMM) for human cancers have been critical for investigation of gene expression and function and characterization of the associated phenotype. To identify potential human carcinogens and mechanisms of carcinogen-gene interactions and tumorigenesis, several laboratories have developed and used genetically altered rodent models for carcinogen identification.

TUESDAY - November 4, 2003

PLENARY SPEAKER

GEORGE LAMBERT, M.D.

Director, Center for Childhood Neurotoxicology

Associate Professor of Pediatrics

Robert Wood Johnson Medical School

“AUTISM AND THE ENVIRONMENT: IS THERE A LINKAGE?”

Autism has devastating effects on children and their families. The apparent increase in the prevalence of autism, the links to the environment, and why studying the interaction between the environment and autism is a public health mandate.

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IV - Molecular Epidemiology & Biomarkers —

Assessing the human health effects of environmental agents is the common goal of both epidemiologists and toxicologists.

V - A Multidisciplinary Approach to Assess Nasal Injury Caused by the Inhalation of Complex Mixtures in the Rodent —

Although rats and mice are obligated nose breathers, unlike oronasal breathing humans, these laboratory animals are commonly used in toxicology studies to estimate the risk of various inhaled chemicals to human health. The rodent nasal cavity is often a target site for toxicant-induced injury.

VI - Hormonal Issues in Carcinogenesis —

Several cancers are directly related to hormonal status. In the clinical setting the three cancers most closely related to hormonal action are thyroid cancer, breast cancer and prostate cancer. Animal models for these human cancers have elucidated several pathways that may lead to primary or secondary prevention of these tumors.

WEDNESDAY - November 5, 2003

CURRENT ISSUES LECTURE

LONE SIMONSEN, PH.D.

Office of Global Affairs

National Institute of Allergy and Infectious Diseases

National Institutes of Health/NIH

“THE EMERGENCE OF SARS 2003: A GLOBAL OUTBREAK OF A NEW DISEASE WITH PANDEMIC POTENTIAL”

VII - Current Issues in Cardiotoxicity —

Proper cardiac function is essential to the health of mammals, and injury to the heart is an important consideration in safety assessment.

VIII - Practical Application of Genomic and Proteomic Technologies to Drug Safety Evaluation

High expectations abound that emerging genomic technologies (RNA expression profiling, protein profiling, pathway analysis, and metabonomics) and accompanying informatics will revolutionize toxicology and drug safety evaluation.

This year we will have our GREAT DEBATE on Tuesday afternoon, November 4, 2003.

Do the Benefits of Statins as Currently Used Outweigh the Risks?

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