Pharmacogenomics

Pharmacogenomics

Challenges and Opportunities in Therapeutic Implementation

1st Edition - February 12, 2013

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  • Editors: Yui-Wing Francis Lam, Larisa Cavallari
  • Hardcover ISBN: 9780123919182
  • eBook ISBN: 9780123983039

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Description

Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation includes discussions and viewpoints from the academic, regulatory, pharmaceutical, clinical, socio-ethical and economic perspectives. Each chapter presents an overview of the potential or opportunity within the areas discussed and also outlines foreseeable challenges and limitations in moving pharmacogenomics into drug development and direct therapeutic applications. This edited book contains review questions for a more in-depth analysis of the implications of pharmacogenomics and discussion points to generate ideas on best to move the field forward. Clinical pearls and case studies are used to illustrate real-life experiences and both successful and unsuccessful applications. Tables, figures, and annotations are included throughout the book to facilitate understanding and further reference.

Key Features

  • Multi-contributed book and chapters are written by contributors who are experts in their field
  • Provides perspectives from those involved in all aspects of pharmacogenomics—including academic, regulatory, economic, industry and medical—to illustrate how all of the pieces fit together and where the challenges may be
  • Includes case studies of both successful and unsuccessful applications so readers can consider the potential and challenges in moving the science into drug development and direct therapeutic applications
  • Chapters contain discussion questions and clinical pearls and enable readers to reflect on how to move pharmacogenomics forward and apply these observations and useful tips to their own work and research

Readership

This book is intended for scientists and clinicians interested in pharmacogenomics implementation in academic, research, medical and pharmaceutical industry settings. Relevant fields include pharmacology, pharmaceutical sciences, genetics, molecular biology and medicine. This book may also be used as a recommended textbook for pharmacy students and graduate-level students in health and pharmaceutical science programs. 

Table of Contents

  • Dedication

    List of Contributors

    Preface

    Chapter 1. Principles of Pharmacogenomics: Pharmacokinetic, Pharmacodynamic, and Clinical Implications

    Objectives

    Introduction

    Cytochrome P-450 Enzymes

    Non-CYP-450 Drug Metabolizing Enzymes

    Polymorphisms in Drug Transporter Genes

    Drug Target Genes

    Conclusion

    Questions for Discussion

    References

    Chapter 2. Translating Pharmacogenomic Research to Therapeutic Potentials

    Objectives

    Introduction

    Implementation of Biomarkers in Clinical Practice

    Incorporating Pharmacogenomics into Drug Development

    Conclusion

    Questions for Discussion

    References

    Chapter 3. Governmental and Academic Efforts to Advance the Field of Pharmacogenomics

    Objectives

    Introduction

    The Role of the National Institutes of Health

    The Role of the Food and Drug Administration and Other International Government Agencies

    Activities of Non-U.S. Agencies

    Conclusion

    Questions for Discussion

    References

    Chapter 4. Pharmacogenomics in Cancer Therapeutics

    Objectives

    Introduction

    Role of Oncology Biomarkers

    Concepts in Targeted Cancer Therapy

    Oncology in the Postgenomic Era

    Challenges in Drug Development and Cancer Trials

    Seeking Pharmacogenomic Value

    Questions for Discussion

    References

    Chapter 4A. A Look to the Future: Cancer Epigenetics

    Learning Objectives

    Introduction

    Histone Modification

    DNA Methylation

    Noncoding RNA (ncRNA)

    Conclusion

    Questions for Discussion

    References

    Chapter 5. Pharmacogenetics in Cardiovascular Diseases

    Objectives

    Introduction

    Pharmacogenomics of Antiplatelet Agents

    Warfarin Pharmacogenomics

    Other Genetic Contributions to Warfarin Dose Variability and Response

    Trials and Tribulations of Pharmacogenomics of Agents Used to Treat Dyslipidemia

    Pharmacogenomic Potential in Heart Failure

    Genetic Influences of Drug-Induced Arrhythmia

    Conclusion

    Discussion Points

    Discussion Questions

    References

    Chapter 5A. A Look to the Future: Cardiovascular Pharmacoepigenetics

    Learning objectives

    Introduction

    Opportunities

    Challenges

    Conclusion

    Questions for Discussion

    References

    Chapter 6. Pharmacogenomics in Psychiatric Disorders

    Objectives

    Introduction

    Polymorphisms in Proteins that Affect Drug Concentrations

    Polymorphisms in Proteins that Mediate Drug Response

    Application of Pharmacogenomics in Psychiatry

    Conclusion

    Questions for Discussion

    References

    Chapter 6A. A Look to the Future: Epigenetics in Psychiatric Disorders and Treatment

    Objectives

    Nature and Nurture Both Contribute to the Etiologies of Psychiatric Disorders

    Epigenetic Processes Are Likely to Contribute to the Biochemical Basis of “Nurture”

    Epigenetic Dysfunction Has Been Linked to Psychiatric and Neurological Disorders

    Epigenetic Processes May Be Critical to Treatment Response in Psychiatric Disorders

    Epigenetic Variation of Genes Regulating Pharmacokinetic Processes Is Likely to Influence Treatment Response

    Epigenetic Modifications of Drug Transporters

    Epigenetics and Adverse Drug Reactions

    Limitations of Epigenetic Biomarkers in Psychiatry

    Conclusion

    Questions for Discussion

    References

    Chapter 7. The Role of Pharmacogenomics in Diabetes, HIV Infection, and Pain Management

    Objectives

    Introduction

    Diabetes Overview

    Type 2 Diabetes Pharmacogenomics

    Challenges and Opportunities of Pharmacogenomics in Diabetes

    Pharmacogenomics and HIV

    Pharmacogenomics and Pain Control

    Conclusion

    Questions for Discussion

    References

    Chapter 8. Molecular Approaches, Models, and Techniques in Pharmacogenomic Research and Development

    Objectives

    Introduction

    Human Genetic Variation

    Strategies in Pharmacogenomic Research and Development

    Bioinformatic Resources for Pharmacogenomic Research and Development

    Conclusion and Outlook

    Acknowledgement

    Questions for Discussion

    References

    Chapter 8A. Modeling the Pharmacogenetic Architecture of Drug Response

    Objectives

    Introduction

    Genetic Mapping

    Functional Genome-Wide Association Study

    Discussion

    Questions for Discussion

    Acknowledgements

    References

    Chapter 9. Study Designs in Clinical Pharmacogenetic and Pharmacogenomic Research

    Objectives

    Introduction

    Clinical Study Designs to Discover and Confirm the Impact of Human Pharmacogenetic Variation

    Conclusion and Perspectives

    Questions for Discussion

    References

    Chapter 9A. Incorporating Pharmacogenomics in Drug Development: A Perspective from Industry

    Objectives

    Introduction

    Pharmacogenomics in Different Phases of Drug Development

    Drug Target Screening and Identification

    Preclinical Animal Toxicology Studies

    Phase I Studies

    Phase II and III Studies

    Phase IV Studies

    Challenges in Applying Pharmacogenomics in Drug Development

    Future Perspective

    Discussion Questions

    References

    Chapter 10. The Importance of Ethnicity Definitions and Pharmacogenomics in Ethnobridging

    Objectives

    Introduction

    Ethnicity

    Ethnic Factors Affecting Drug Response

    Acceptability of Foreign Clinical Data

    Conclusion

    Discussion Questions

    References

    Chapter 11. Beyond ELSIs: Where to from Here? From “Regulating” to Anticipating and Shaping the Innovation Trajectory in Personalized Medicine

    Objectives

    Pharmacogenetics: An Old Science that Stood the Test of Time

    Pharmacogenomics: An Old Science Becomes Large-Scale and Global

    Rethinking Bioethics in the Twenty-First Century

    Beyond Classic ELSIs

    An Invitation to Reflexive and Global Bioethics

    Conclusion

    Discussion Questions

    Acknowledgments

    References

    Chapter 12. Pharmacoeconomics of Pharmacogenetics within the Context of General Health Technology Assessments

    Objectives

    Introduction

    Criteria for Decision Making

    Pharmacoeconomics/Health Economics within the HTA Context

    Process

    Conclusion

    Questions for Discussion

    References

    Appendix: Case Study in the Netherlands

    Appendix 1 References

    Chapter 13. Integrating Genomics into Pharmacy Education and Practice: Pharmacogenomics Is Not Enough

    Objectives

    Introduction: The Case for Genomics

    Technology as the Driver of Genomic Science

    The Critical Gap in Pharmacy Education

    Educational Competencies

    Conclusion

    Questions for Discussion

    References

    Color Plates

    Index

Product details

  • No. of pages: 510
  • Language: English
  • Copyright: © Academic Press 2013
  • Published: February 12, 2013
  • Imprint: Academic Press
  • Hardcover ISBN: 9780123919182
  • eBook ISBN: 9780123983039

About the Editors

Yui-Wing Francis Lam

Dr. Lam is Professor of Pharmacology at the University of Texas Health Science Center San Antonio (UTHSCSA). His editing experience included the first edition of Pharmacogenomics as well as being the lead editor of another published book entitled “Herbal Supplements – Drug Interactions. Scientific and Regulatory Perspectives”. He is also a co-author for a book chapter on pharmacogenetics in six consecutive editions of the textbook “Pharmacotherapy: A Pathophysiologic Approach”. Dr. Lam designed and continues to direct a graduate course “Molecular and Pharmacological Basis of Therapeutics” since 2002 for the UTHSCSA and the College of Pharmacy at the University of Texas at Austin. He has organized and participated in international and national symposia on topics related to personalized and molecular medicine, and is a scientific councilor for the Pacific Rim Association for Clinical Pharmacogenetics.

Affiliations and Expertise

Professor of Pharmacology, Minnie Stevens Piper Professor (2018), James O’Burke Endowed Centennial, Fellow in Pharmacy, University of Texas Health Science Center, San Antonio, TX, USA

Larisa Cavallari

Affiliations and Expertise

PharmD, Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago

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