Pharmacogenomics: Delivering on the Promise

Table of Contents

Chapter 1 PHARMACOGENOMICS TODAY: 21ST CENTURY PERSONALIZED MEDICINE

• 1.1. Introduction
  • Pharmacogenomics: The Focus of This Report
  • The Information in This Report
  • The Concept of Pharmacogenomics
  • Definition of Pharmacogenomics
  • History of the Terms "Pharmacogenetics" and "Pharmacogenomics"
• 1.2. The Promise of Pharmacogenomics
  • What Making Better Drugs Means
• 1.3. What Is Driving Pharmacogenomics?
  • Money
  • Dismal Effectiveness of Many of Today' s Common Drugs
  • The Adverse Event Story: Safety Issues and Adverse Drug Reactions
  • Public Policy
  • The Science of Human Genetics
  • Genome-Wide Association Studies and the Genetics of Human Disease
  • Genome-Wide Association Studies and Drug Response

Chapter 2 PHARMACOGENOMICS IN THE MARKETPLACE: LESSONS LEARNED, UNANSWERED QUESTIONS

• 2.1. Introduction
• 2.2. Direct-To-Consumer Genetic Testing (Optimism): Its "Fun Factor" Is Driving Interest in Pharmacogenomics
  • 23andMe: Direct-To-Consumer Genetic Testing and More
• 2.3. Warfarin: Optimism with Questions
  • The Science Behind Warfarin Dosing: Still Building the Evidence Base
  • Questions About Clinical Utility, Again
• 2.4. Herceptin: Even Successful Pharmacogenomic Products Have Generated Questions
  • The Bigger Picture: What Is Evidence? What Is Value?
• 2.5. More on Evidence, Value, Clinical Utility... And What It All Means for Regulatory Decision-Making
  • Clinical Utility Defined: It' s All About the Evidence...But What Type of Evidence?
  • Assessing the Clinical Utility of PSA Screening: Do the Benefits Outweigh the Risks?
  • The Randomized Controlled Trial Paradigm: Is It Necessary for Predictive Genetic Tests?
• 2.6. If Not Randomized Controlled Trials, Then What?
  • The Medco-Mayo Study
  • Calls From The Peer-Reviewed Literature Echo These Concerns About Randomized Controlled Trials
• 2.7. What To Do With All the Data
  • The Notion of a National Genetic Test Registry
  • Other Genetic Test Database Initiatives

Chapter 3 FROM CONCEPTUALIZING TO APPLYING PHARMACOGENOMICS: JUST DO IT

• 3.1. Introduction
• 3.2. Pharmacogenomics Is Not the Next Great Wave...It Is Already Here
  • Pharmacogenomic Information in FDA-Approved Drug Labels
• 3.3. The "Google" (i.e., "Overly Optimistic") View of Applying Pharmacogenomics During Drug Development
• 3.4. The Reality of Utilizing a Pharmacogenomics-Based Approach During Drug Development
  • Ways to Utilize Pharmacogenomics, or Pharmacogenetics, During Drug Development
  • Efficacy Pharmacogenomics: GlaxoSmithKline and Rosiglitazone
  • Safety Pharmacogenomics: GlaxoSmithKline and Abacavir
  • The Beginning of a Trend?
• 3.5. Rescuing Failed Drugs vs. Rummaging Through the Trash: A Fine Line?
• 3.6. Utilizing Pharmacogenomics to Seize Missed Opportunities: CETP Inhibitors as a Case Study
  • Pharmacogenomics and Statins

Chapter 4 THE FUTURE OF PHARMACOGENOMICS

• 4.1. Introduction
• 4.2. Economic Challenges: Is the Blockbuster Model Busting?
  • Can Pharmacogenomics Really Save Companies Money?
• 4.3. Reimbursement
• 4.4. Regulatory Oversight
• 4.5. Physician Education
• 4.6. Impact of Technology on Pharmacogenomics
  • Advances in DNA Sequencing
  • Other Technologies That Could Potentially Advance Pharmacogenomics
  • Nanotechnology and Pharmacogenomics
  • Epigenetics and Drug Response
• 4.7. From Oncology Onward
  • Pharmacogenomics in Psychiatry
  • Iloperidone: A Long Road to Success
• 4.8. Concluding Remarks

Chapter 5 EXPERT INTERVIEWS

• 5.1. Information Technology and Pharmacogenomics: Challenges and Opportunities
  • Interview with Teri E. Klein, PhD
  • Senior Scientist, Stanford University
  • Director, PharmGKB, Palo Alto, CA
• 5.2. A Perspective on Pharmacogenomics Based on Interviews With 60 Industry Executives and Key Opinion Leaders
  • Interview with Philip Ma, PhD
  • Director
  • McKinsey & Company
  • Palo Alto, CA
• 5.3. Planning Prospective Trials, Pipeline Management: Two Keys to Pharmacogenetic Success
  • Interview with Allen D. Roses, MD
  • Director, Deane Drug Discovery Institute, Duke University School of Medicine
  • Jefferson-Pilot Professor of Neurobiology and Genetics, Duke University
  • CEO, Cabernet Pharmaceuticals
  • Durham, NC
• 5.4. Thoughts From Academia: From Functional Biomarkers to Healthcare Reform
  • Interview with Wolfgang Sadee, PhD
  • Professor and Chair, Pharmacology
  • The Ohio State Medical Center
  • Columbus, OH
• 5.5. Thoughts From a Statistician: Designing Pharmacogenetic Clinical Trials
  • Interview with Richard Simon, DSc
  • Chief, Biometric Research Branch
  • Division of Cancer Treatment and Diagnosis
  • National Cancer Institute
  • Rockville, MD

Chapter 6 RESULTS OF INSIGHT PHARMA REPORTS' PHARMACOGENOMICS SURVEY - MARCH/APRIL 2009

• 6.1. Nature of Involvement With Pharmacogenomics
• 6.2. Pharmacogenomics in Drug Development
• 6.3. Views on Pharmacogenomics

References

Company Index with Web Addresses