Welcome to the Office of Public Engagement, College of Veterinary Medicine at the University of Illinois at Urbana-Champaign

University of Illinois at Urbana-Champaign

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Toxicology and Pathology
in Drug Discovery and Development Short Course

This course is designed for toxicologists and pathologists working in the pharmaceutical, chemical and consumer products fields with a primary emphasis on drug discovery and development. The course is also applicable to professionals responsible for design and evaluation, safety assessment and regulatory issues associated with product development in industry, government, and contract laboratories, and universities.

The objective of the course is to address current global issues in the rapidly advancing fields of toxicology and pathology; to enhance attendees’ skills in interpreting animal safety studies; to facilitate interactions with federal regulatory agencies; and to provide networking opportunities.

Course Check-In
All course sessions will be held at the Hilton Garden Inn. Course check-in and materials will be available on Monday, July 20, 2009, between 7:00 and 8:00 a.m.

Monday, July 20, 2009

 
  7:00-8:00 a.m. Course Check-In
Continental Breakfast
  8:00-8:15 a.m. Welcome and Introduction
Wanda Haschek-Hock, University of Illinois at Urbana-Champaign
Product Development: From Discovery to Approval
  8:15-9:15 a.m. Overview of Product Development
Colin G. Rousseaux, Colin Rousseaux and Associates
  9:15-9:45 a.m. Break
  9:45-10:45 a.m. The Pharmaceutical Industry
Hugh E. Black, Hugh E. Black & Associates, Inc.
  10:45-11:45 a.m. The Biotechnology Industry
Noel O. Dybdal, Genentech, Inc.
  11:45 a.m.-1:00 p.m. Lunch
Preclinical Product Development
  1:00-2:00 p.m. General Principles of Toxicology in Drug Development
Myrtle Davis, The National Cancer Institute, NIH
  2:00-3:00 p.m. Early Preclinical Development in Support of Drug Discovery
Glenn H. Cantor, Bristol-Myers Squibb Co.
  3:00-3:30 p.m. Break
  3:30-4:30 p.m. The Design and Writing of the Non-Clinical Safety Report
Hugh E. Black, Hugh E. Black & Associates, Inc.
  5:30 p.m. Reception
  6:30 p.m. Dinner at Hilton Garden Inn

Tuesday, July 21, 2009

Preclinical Product Development (continued)
  7:00-8:00 a.m. Continental Breakfast
  8:00-9:00 a.m. Pathology Issues in Study Design
Ricardo Ochoa, Pre-Clinical Safety, Inc.
  9:00-10:00 a.m. The Cancer Bioassay: Past, Present, and Future
Robert R. Maronpot, Maronpot Consulting, LLC
  10:00-10:30 a.m. Break
  10:30-11:30 a.m. Reading the Roden Bioassay: Problems, Pitfalls, and Peer Review
Jerry F. Hardisty, EPL, Inc.
  11:30 a.m.-1:00 p.m. Lunch
  1:00-2:00 p.m. Diagnostic Dilemmas in Toxicologic Pathology
Jerry F. Hardisty, EPL, Inc.
  2:00-3:00 p.m. Clinical Pathology for Drug Safety Studies
Nancy E. Everds, Amgen, Inc.
  3:00-3:30 p.m. Break
  3:30-4:30 p.m. Use of Genetically Modified Mice in Drug Development
Elizabeth Galbreath, Eli Lilly & Co.
  5:00 p.m. Depart for Dinner and Tour
  5:15 p.m. Tour of University of Illinois College of Veterinary Medicine Pathology Facilities
  6:15 p.m. Dinner and Activities at Hardy's Reindeer Ranch

Wednesday, July 22, 2009

  7:00-8:00 a.m. Continental Breakfast
  8:00-9:00 a.m. Use of Genetically Modified Mice in Drug Development (continued)
Elizabeth J. galbreath, Eli Lilly & Co.
  9:00-10:00 a.m. Emerging Issue: Genomic Pathology
Robert Cardiff, University of California, Davis
  10:00-10:30 a.m. Break
  10:30-11:30 a.m. . Integration of Pathology and Toxicology in Risk Assessment: A Regulatory Viewpoint
Elizabeth A. Hausner, Center for Drug Evaluation and Research, FDA (invited)
  11:30 a.m. Lunch and Adjourn