Length 184 pages

Date published June 2009

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Pharmacogenomics: Delivering on the Promise Table of Contents

 

Author: Leslie A. Pray, PhD

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 Sadée, 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