Addressing
Scientific Challenges Associated with Emerging
Regulatory Genetic Toxicology Guidance, Standard
Testing Approaches and Genotoxic Impurities
Invited Speakers Presentations
Robert
Daniel ("Dan") Benz, Ph.D.
Food and Drug Administration, CDER
Joel
P. Bercu, M.P.H.
Eli Lilly and Company
Managing Genotoxic Impurities
Throughout Development of a Pharmaceutical:
Control Strategies and Case Studies
Laura
L. Custer, Ph.D.
Bristol-Myers Squibb
Aneugen
Detection in the Rat Peripheral Blood Micronucleus
Assay
Krista L. Dobo Ph.D.
Pfizer Global Research and Development
Application
of the Staged TTC to a High Dose Drug Intended
for Short Term Use
Paurene Duramad, Ph.D., M.P.H.
Genentech, Inc.
Flow
Cytometry, High-throughput Drug Screening, and
Biomarkers of Immunotoxicity
Kathleen L. Gabrielson, D.V.M.,
Ph.D., D.A.C.V.P.
Johns Hopkins University School of Medicine
Overview-
Introduction -Applicability/Feasibility of Rodent
Imaging
Sheila M. Galloway, Ph.D.
Merck Research Laboratories
Towards Developing an Integrated Approach to Safety Assessment of Potentially Genotoxic Impurities, Degradates and Metabolites of Pharmaceuticals
Collaborative Study on 15
Compounds in the In Vivo Liver Comet
Assay Integrated into 2- and 4-Week Studies
Jim
Harvey, Ph.D.
GlaxoSmithKline
Genotoxic
Impurities That Are Also Metabolites: What's
Next?
Michael
L. Homiski
Pfizer Global Research and Development
Different Approaches to Automation
of the In Vitro Micronucleus Assay Using
Image Analysis
Timothy
E. Johnson, Ph.D.
Merck Research Laboratories
Assessing
the Potential Risk of a Positive In Vivo
Micronucleus Result
Peter
Kasper, Ph.D.
Federal Institute for Drugs and Medical Devices
(BfArM)
Genotoxic
Impurities and Risk: Managing the Unknown
Nagu
Keshava, Ph.D.
US-EPA
Introduction
to Genotoxic Mode of Action and Its Use in Cancer
Risk Assessment
Prof.
David Kirkland, B.Sc., CBiol, Ph.D.
Genetic Toxicology Consultant
The OECD In Vitro MN Guideline: Cytotoxicity Issues
Summary
of Conclusion from 2009 (Basel) IWGT
Hans-Joerg
Martus, Ph.D.
Novartis Institutes for BioMedical Research
>Follow-up of In Vivo
Positive Genotoxicity Results: Novartis Experience
Anu
Mudipalli, Ph.D.
US-EPA
In
Vitro Genotoxicity Tests: Concerns and Considerations
for Sound Science
Sashi
Nadanaciva, D.Phil.
Pfizer Global Research and Development
Strategies
to Reduce NCE Attrition Due to Mitochondrial
Toxicity - Novel Screening Methods
M.
Vijay Reddy, Ph.D.
Merck Research Laboratories
Synthetic
Intermediate That is Also a Metabolite, Impurity
and Degradate: What Are the Appropriate Risk
Evaluation Options?
Maik
Schuler, Ph.D.
Pfizer Global Research and Development
Strategies for Better Understanding
In Vivo Micronucleus Positives With Kinase
Inhibitors
Kevin
S. Sweder, Ph.D.
Bristol-Myers Squibb Company
Kinase Inhibitors and In
Vitro Genetic Toxicology Assays
Michael
D. Waters, Ph.D.
Integrated Laboratory Systems (ILS), Inc.
Understanding
and Differentiating the Genotoxic Mode of Action
Using Toxicogenomics Data