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Session 3 - Prediction and Prevention of Serious Drug-Induced Skin Injury
Session Chair(s)
E. Stewart Geary, MD
Senior Vice President
Eisai Co., Ltd., Japan
Serious skin reactions are rare but can be life-threatening and leave patients with lasting disabilities. Reports of these reactions tend to cluster around certain drugs or drug classes. Biomarkers of risk for Stevens Johnson Syndrome or Toxic Epidermal Necrolysis (SJS/TEN) based on HLA subtype have shown some usefulness in identifying patients at risk of these reactions but the utility of the biomarker tested varies by ethnic group. This session will discuss what is currently known about biomarkers for risk of serious skin reactions, identification of patients or drugs at greatest risk for these reactions and what can be imputed about the mechanisms of these reactions.
Speaker(s)
What Do We Know About Serious Skin Reactions and Causality?
Manfred Hauben, MD, MPH
Pfizer , United States
Senior Director Product Safety Surveillance and Reporting
Biomarkers for Risk of SJS/TEN in Japanese Compared to Other Populations
Ryosuke Nakamura, PhD
National Institute of Health Sciences, Japan
Chief, Division of Medicinal Safety Science
Practical Issues in Applying Biomarkers for Significant Skin Reactions During Clinical Development and Post-Marketing
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
Senior Vice President
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