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Up Directory CCL 06.06.04 Applying Mechanisms of Chemical Toxicity to Predict Drug Safety, WASHINGTON, D.C
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To: chemistry-request at
Date: Wed Feb 1 09:50:19 2006
Subject: 06.06.04 Applying Mechanisms of Chemical Toxicity to Predict Drug Safety, WASHINGTON, D.C
Applying Mechanisms of Chemical Toxicity to Predict Drug Safety

Today, pharma discovery scientists have the benefit of excellent 
chemistry and often a wealth of drug candidates to choose from. 
Many, if not most drug candidates fail due to toxicology issues, 
so chairs Prof. F. Peter Guengerich, Professor of Biochemistry and t
he Director of Vanderbilts Center in Molecular Toxicology, and 
Dr. James MacDonald, EVP of Preclinical Development at the 
Schering-Plough Research Institute, specifically organized 
this conference to aid industry scientists in the early prediction 
of which candidates will prove toxic.

The conference will discuss basic and practical issues of chemical 
tox as well as newer technologies. It will also cover what systems 
have proven most useful in prediction, and how information can be best 
used in the regulatory process. The sessions are designed to encourage 
discussion and audience participation and are arranged around the 
topics of:

Mechanisms of Chemically Induced Toxicity:

    * Prof. Sidney Nelson of the University of Washington will speak 
      on structural alerts in medicinal chemistry and the science of 
      reactive metabolites
    * Prof. Timothy Macdonald of the University of Virginia will speak 
      on felbamate and other problem drugs and the roles that reactive 
      metabolites play in toxicity
    * Dr. David Evans of Johnson & Johnson will speak on the application 
      of covalent binding screening and its usefulness in decisions
    * Dr. David Thompson of Pfizer will speak on contexts of drug 
      toxicity and the extents of contribution of major mechanisms 
      including reactive metabolites, off-target toxicity, on-target 
      toxicity, and immune reaction

Celluar Responses to Chemically Induced Toxicity:

    * Prof. Christopher Bradfield of the University of Wisconsin will 
      speak on studies with the AhR receptor and genomic and informatic 
      approaches to understanding its roles
    * Prof. Thomas Kensler of Johns Hopkins University will speak on the 
      Keap1/Nrf2 system in a model of regulation of pathways by toxicant 
    * Dr. S. G. Rhee of NIH will speak on redox linked regulatory 
      systems, including the peridoxins, and their roles as mediators 
      of response to toxic injury
    * Dr. Donald Nicholson of Merck will discuss the role of apoptosis 
      in cell injury

Potential Molecular & In Vitro Approaches to the Detection of Cellular 

    * Lois Lehman-McKeeman of BMS will speak on new technologies that 
      are impacting decisions in discovery toxicology and overall 
      strategies for new technology applications.
    * Tim Ryan of Eli Lilly will present case studies illustrating the 
      application of genomic technology to safety assessment.
    * Cindy Afshari of Amgen will present case studies on combining in 
      vitro models with new technology in early safety screening, and 
      safety assessment of bioproducts.
    * Don Robertson of Pfizer will present case studies illustrating the 
      use of metabonomics as an early safety assessment tool.
    * Dr. James Stevens of Eli Lilly, a leader in the area of molecular 
      toxicology, will chair this session.

The Status of Molecular Approaches (Whats Working, Whats Yet to Be Done):

    * David Jacobsen-Kramm of the FDA Office of Pharmacology and 
      Toxicology will speak on the agencys efforts to understand how 
      to best utilize technologies to predict potential human risk
    * Bruce Carr of BMS will speak on identifying signals of potential 
      concern for human tox in drug candidates
    * Michael Cunningham of NIEHS will speak on exploring how effects 
      of chemicals on various organ systems can be detected with 
      molecular tools at doses that are not associated with frank toxicity
    * Eric Bloome of Abbott will speak on molecular/in vitro approaches 
      to assessing potential chemical induced toxicity in a drug 
      development environment.


    * Prof. Gilbert Omenn of the University of Michigan and current 
      President of the American Association for the Advancement of 
      Science (AAAS) will speak on the promise and challenge of 
      accurately predicting potential human risk.

Short Course (optional):

    * Roger Ulrich of Merck/Rosetta will give an overview of genomics 
      and small RNA interference, Prof. Daniel Liebler of Vanderbilt 
      University will give an overview on proteomics and metabolomics.  
      An FDA perspective is also planned, with the speaker TBD.
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