Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care provides an in-depth review of the state of translational science across all stages of pharmaceutical development with a special focus on personalized health care. This book provides a complete picture of biomarker development and validation in a pharmaceutical setting while addressing the inherent challenges of targeting the appropriate indications, biomarker robustness, regulatory hurdles, commercialization and much more. It features case studies devoted to the applications of pharmacogenomics, toxicogenomics, and other genetic technologies as they support drug discovery and development.

With chapters written by international authorities in industry and academia, this work is a truly unique presentation of the thoughts and approaches that lead to the development of personalized medicine. Intended for all those involved in clinical translational research, this book is the ideal resource for scientists searching for the applications, strategies and successful approaches of translational science in pharmaceutical development.

• Provides case studies in applications of pharmacodynamic and predictive markers in drug development in oncology, autoimmunity, respiratory diseases and infectious diseases
• Shows how to identify potential new therapeutic targets in different diseases and provides examples of potential new disease indications for life cycle management of drugs
• Authored by leading international experts from industry and academia

Pharmaceutical scientists involved in biologics research and drug development, including clinical pharmacologists, toxicologists, pathologists, bioinformaticians and biostatisticians and clinical researchers.

• Preface
• About the Editors
• List of Contributors
• Chapter 1. Application of Translational Science to Clinical Development
• 1.1 Introduction
• 1.2 Two Approaches to Identify Patient Subsets that are Likely to Respond to Individual Therapeutic Interventions
• 1.3 Use of a Genomic Pharmacodynamics (PD) Marker to Aid in Dose Selection in Clinical Development
• 1.4 Safety
• 1.5 Conclusions
• References
• Chapter 2. Personalized Health Care (PHC) in Cancer
• 2.1 Introduction
• 2.2 Biomarkers
• 2.3 Companion Diagnostics
• 2.4 Conclusions
• References
• Chapter 3. Personalized Healthcare in Autoimmune Diseases
• 3.1 Introduction
• 3.2 Interferon Gamma (IFN-γ) as a Pharmacodynamic (PD) Marker for Ustekinumab (CNTO 1275) in Psoriasis
• 3.3 A Type I Interferon Signature as a PD Marker and Potential Predictive Marker for Anti-Type I Interferon Therapy in Systemic Lupus Erythematosus (SLE), Myositis and Systemic Sclerosis (SSc)
• 3.4 Biomarker for Anti-CD20 mAb Therapy in Patients with Rheumatoid Arthritis (RA)
• 3.5 A Type I Interferon Signature as a Predictive Marker of Response to Interferon-β Therapy in Patients with Multiple Sclerosis
• Acknowledgments
• References
• Chapter 4. Molecular Heterogeneity, Biomarker Discovery, and Targeted Therapy in Asthma
• 4.1 Introduction: Asthma Heterogeneity
• 4.2 Molecular Heterogeneity in Asthma
• 4.3 Biomarker-Guided Patient Selection in Therapeutic Trials
• 4.4 Companion Diagnostic Development
• 4.5 Outlook for the Future
• Acknowledgments
• References
• Chapter 5. microRNA Biomarkers as Potential Diagnostic Markers for Cancer
• 5.1 Overview of microRNAs (miRNAs)
• 5.2 Development of a miRNA-Based Clinical Test
• 5.3 Detection of miRNAs in Clinical Specimens for Cancer Diagnostics and Prognostics
• 5.4 The Challenge of miRNAs as Biomarkers
• 5.5 Conclusions
• References
• Chapter 6. Toxicogenomics – A Drug Development Perspective
• 6.1 Introduction
• 6.2 The Concept of Toxicogenomics
• 6.3 The Technology Landscape of Toxicogenomics
• 6.4 Toxicogenomics in Drug Discovery and Development
• 6.5 Efforts to Address Technical Challenges in Toxicogenomics
• 6.6 Publicly Available Toxicogenomic Databases
• 6.7 Bioinformatics Challenges in Toxicogenomics
• 6.8 Toxicogenomics in Regulatory Application
• 6.9 The Future Perspective of Toxicogenomics
• References
• Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration
• 7.1 Introduction
• 7.2 Definition of an IVD Companion Diagnostic
• 7.3 A Mini Review of FDA Guidance on Approval of the Companion Diagnostic
• 7.4 Assay Development and Validation in Drug Diagnostic Co-Development
• 7.5 Conclusions
• References
• Index