Pre-Summit Workshop Day: Monday, May 21st, 2012

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9:00 AM Opening Remarks & Chairman’s Welcome

9:15 AM Role of the FDA in Validating Methodologies to Predict Human Toxicities

The role of science and research at FDA Centers and in particular the National Center for Toxicological Research
Reduction of the risk of adverse health effects from products on the market
Introduction of safe and efficacious products to the market

10:00 AM New Technology for Safety Assessment

Challenging traditional predictive toxicology trends
Increasing use of in silico tools
Evaluation of the new role of technology in toxicity testing

11:30 AM Clinical Experience on Difficult to Predict Toxicities

Detecting acute toxicity during early pre-clinical studies
Predicting long term toxicity via in vivo assays
First-hand results and techniques delivered by a toxicological expert

12:15 PM Tox 21 Phase II; Translating Screening Results to Human Relevance

National Toxicology Program’s vision for the 21st Century
Bridging high throughput screening results to human toxicology
Leveraging high throughput gene expression analysis as a high content information source

1:00 PM Lunch

2:00 PM Pre-Clinical to Clinical Translation

Paradigm of mechanisms, models and markers relevant to both safety and efficacy
Distinguishing between adaptive and toxic response
The role of biomarkers for safer translation

2:45 PM Early Assessment of Hepatotoxicity Potential of New Chemical Entities (NCEs) Using a Variety of In Vitro Approaches

An oxygen consumption assay for mitochondrial toxicity
A High Content Mechanistic Screening approach for multiple assay endpoints in the presence and absence of cytokine addition
Transporter assessment and a long term co-culture approach for repeated dosing

4:15 PM In Vivo Pig-A Gene Mutation Assay

Assessing the need for the creation of new approaches to toxicity prediction
Integration of gene mutation measurement into repeat-dose toxicology studies
Development of a new tool for the detection of gene mutation

9:00 AM Practical Workshop A: High-Content Imaging Technology for Prediction of Toxicity

Katya Tsaioun PhD , Chief Scientific Officer, Cyprotex Discovery

(Continental Breakfast served during workshop)

This workshop will highlight techniques for using high-content imaging technology for predicting toxicity in potential drug candidates. Because assistance at the drug discovery stage to help reduce attrition in the drug development process offers genuine competitive advantages, this workshop is designed to significantly accelerate and improve the cost-effectiveness of the process from “hit-to-lead” in drug discovery.

What you will learn:

Basics of HCS: principles, end points, cell models, equipment
HCS for toxicology: background and rationale, value of doing early toxicology, early validation work, and cell models available
State of the art information on cell models and validation

How You Will Benefit:

Assess your need for in-house HCS toxicity capabilities
Understand what criteria to look for when selecting equipment, cell models, and end points
Get better results from you high-content imaging technology

Katya Tsaioun PhD
Chief Scientific Officer
Cyprotex Discovery

11:30 AM Registration

12:00 PM Practical Workshop B: Toxicology & Its Practical Application for Improving Risk Methods

Michael Dourson , President, Toxicology Excellence for Risk Assessment

(Box Lunch served during workshop)

The application of a collaborative philosophy to emphasize partnership building and bring together cutting edge toxicology expertise with state of the art scientific assessments form the basis for the dev elopment of an independent and science-driven analyses for a range of risk assessment needs. This workshop will provide attendees with the tools needed for the best use of toxicity data in risk assessment.

What you will learn: