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Wednesday, May 16:
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Discovery Workshop
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Thursday, May 17:
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Discovery Ends, Development Workshop Begins
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Friday, May 18:
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Development Workshop
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*Sessions, talks and speakers are subject to change
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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Registration
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Conference Introduction
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Oliver Flint
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Bristol-Myers Squibb
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Plenary
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What do Physicochemistry and Pharmacokinetics add to Toxicology?
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 Dennis Smith
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Consultant
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SESSION I - SESSION I - Applying Physicochemical and PK Attributes to Safety Lead Optimization
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The Role of Lipophilicity in Toxicity
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Steve Swallow
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AstraZeneca
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Optimization of pKa to Attenuate Small Molecule Toxicity
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Dylan Hartley
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Array BioPharma
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Lipophilicity and LUMO Modeling
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Kevin Ford
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Genentech
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SESSION II - Covalent Binding and Reactive Metabolites: The Good, The Bad, and he Ugly
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Covalent Binding and Reactive Metabolites: The Good
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Jus Singh
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Avila Pharmaceuticals
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Covalent Binding and Reactive Metabolites: The Bad
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Richard Thompson
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AstraZeneca (Sweden)
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Covalent Binding and Reactive Metabolites: The Ugly
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EVENING RECEPTION
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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SESSION III - Novel Models for Predictive Toxicology
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Human Hepatocytes Derived from Stem Cells, Characterization and Utility
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Oliver Flint
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Bristol-Myers Squibb
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Stem Cell Debate - Protagonist
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Ian Cotgreave
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AstraZeneca
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Stem Cell Debate - Antagonist
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Organs on a Chip
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Geraldine Hamilton
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WYSS Institute at Harvard
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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SESSION IV: Reduction of Animal Usage - Creative Study Designs
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Applying 3Rs Principles to Improve Efficiency and Success of Toxicology Programs
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Lauren Black
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Charles River Laboratories
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Case Studies
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Patricia Ryan
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Medimmune
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Appropriate Use of Recovery Groups in Toxicity Studies
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Michael Leach
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Pfizer
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Mapping Pathways of Toxicity - A perspective on the future of toxicity testing
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Thomas Hartung
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Johns Hopkins Bloomberg School of Public Health
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Ending Plenary
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Implementing the Biologics Price Competition and Innovation Act of 2009
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Leah Christl
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FDA
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EVENING RECEPTION
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SESSION
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TOPIC
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SPEAKER
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COMPANY
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TIME
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SESSION V: Changing Landscapes in Oncology Safety Assessment
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Nonclinical Safety Assessment for Anticancer Drugs: View of the Division of Hematology Oncology Toxicology
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John Leighton |
FDA |
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Editorial on ICH S9
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Rafael Ponce
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Amgen
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Strategies on ICH S9
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David Hutto
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Eisai
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Round Table Discussion
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All Speakers
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SESSION VI: Hot Topics in Neurotoxicology
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FDA Guideance an Requirements on Abuse Testing
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Tom Hudzik
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Abbott
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Neurological Safety Concerns Associated with Biotherapuetics
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Keri Cannon
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Pfizer
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How do we Incorporate into General Tox Studies?
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Abuse Liability - Methodologies and Study Design
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