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 |
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| 8:00-8:15 a.m. | Welcome and Introduction Wanda Haschek-Hock, University of Illinois at Urbana-Champaign |
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| Product Development: From Discovery to Approval | ||
| 8:15-9:15 a.m. | Overview of Product Development Colin G. Rousseaux, Colin Rousseaux and Associates |
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| 9:15-9:45 a.m. | Break | |
| 9:45-10:45 a.m. | The Pharmaceutical Industry Hugh E. Black, Hugh E. Black & Associates, Inc. |
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| 10:45-11:45 a.m. | The Biotechnology Industry Noel O. Dybdal, Genentech, Inc. |
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| 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 |
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| 2:00-3:00 p.m. | Early Preclinical Development in Support of Drug Discovery Glenn H. Cantor, Bristol-Myers Squibb Co. |
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| 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. |
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| 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. |
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| 9:00-10:00 a.m. | The Cancer Bioassay: Past, Present, and Future Robert R. Maronpot, Maronpot Consulting, LLC |
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| 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. |
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| 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. |
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| 2:00-3:00 p.m. | Clinical Pathology for Drug Safety Studies Nancy E. Everds, Amgen, Inc. |
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| 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. |
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| 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. |
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| 9:00-10:00 a.m. | Emerging Issue: Genomic Pathology Robert Cardiff, University of California, Davis |
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| 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) |
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| 11:30 a.m. | Lunch and Adjourn |