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同時開催会議
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Preclinical Development 概要
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第4回
臨床前開発
臨床安全性の予測改善方法
2008年3月26〜28日
オープニングセッション:基調講演（薬剤安全性動向との共同セッション）
- 毒性試験と予測の最新動向 （薬剤安全性動向との共同セッション）
- ケーススタディ：臨床前開発における成功と失敗（薬剤安全性動向との共同セッション）
- 毒性経路 （臨床前開発、薬剤の安全性動向、および癌の分子マーカーとの共同セッション）
- 生物医薬品の毒性試験の適切なモデル：Tegeneroからの教訓（薬剤安全性動向との共同セッション）
- 内部での意思決定と規制認可の双方に対応するための画像モダリティの選定（展開医療との共同セッション）
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Keynote Session
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Improving R&D Productivity Through Better Preclinical
Decision Making and Science
B. Michael Silber, Ph.D., Senior Vice President and Head Safety
& Technical
Sciences (Preclinical Development), Roche Pharmaceuticals, LLC
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Toxicity Testing in the 21st Century: Opportunities for
Pharmaceutical Risk Assessment
Daniel Krewski, Ph.D., MHA, Professor and Director,
McLaughlin Centre for Population Health Risk Assessment,
University of Ottawa
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Highlighted Presentations
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From Publication to Practice: Interlaboratory Validation of Microarray and QPCR-based Signatures for Predicting Carcinogenicity in the Rat
Mark Fielden, Ph.D., DABT, Discovery and Investigative Safety, Non-Clinical Drug Safety, Roche Palo Alto LLC
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Mechanistic Cardiac Modeling: Concepts and Utility in
Drug Development
Anna Georgieva, Ph.D., Associate Director, Modeling & Simulation,
and Ruben Bibas, Ph.D., Biology Modeler, Modeling &
Simulation, Novartis Inc.
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Challenges of Doxercalciferol, a Prodrug of a Potent
Vitamin D Hormone
Joyce Knutson, Ph.D., Senior Director of Research, Bone Care
International
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Defining and Finding Relevant Animal Models:
The Evolution of 迭elevant・During Development
Nancy Wehner, Ph.D., Senior Director, Non-clinical Safety
Evaluation, Elan Pharmaceuticals
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Predicting the Undesirable Pharmacodynamic Effects of
Small Molecules on Physiological Function: From the Brain to the Heart
Vivek Kadambi, Ph.D., Director of Drug Safety Evaluation,
Millennium Pharmaceuticals, Inc.
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Predicting Cardiac Toxicity with Adjuant Trastuzumab Therapy
Ellie Guardino, M.D., Ph.D., Assistant Professor of Medicine,
Breast Oncology, Stanford University
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Imaging Biomarkers in Early Clinical Development of
Novel Therapeutic Agents
Jeffrey L. Evelhoch, Ph.D., Executive Director, Medical Sciences,
Imaging, Amgen Inc.
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Session:
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Advances in Toxicity Testing and Prediction
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Case Studies: Successes and Failures in Preclinical Development
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Toxicity Pathways
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Finding the Relevant Model for Toxicity Testing
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Choosing an Imaging Modality
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Hot Topics This Year:
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Interlaboratory Validation of Signatures for Predicting
Carcinogenicity
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Mechanistic Cardiac Modeling and Utility in Drug
Development
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Defining and Finding Relevant Animal Models
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Advances in Liver Toxicity Testing
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Predicting Cytokine Storms from in Vitro Cell Based Models
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Translating Safety from Animals to FIH Studies of
Biologics
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