藥物基因體學 是由出版商Insight Pharma Reports在2009年06月所出版的。
這份英文市場調查報告書包含184 pages 價格從美金3195起跳。
本報告書內容包括：藥物基因體學藥物開發的應用動向、產業表現及經驗、面臨的課題等。內容網要摘記如下：
第1章 藥物基因體學現況：21世紀的個別化醫療
- 介紹
- 藥物基因體學的發展潛力
- 藥物基因體學的促進因素
第2章 市場中的藥物基因體學：經驗及未解決的問題
- 介紹
- 基因測試
- Warfarin（可脈丁）
- Herceptin（賀癌平）
- 更進一步證據、價値、臨床的利用度
- 不採用隨機臨床實驗的情況
- 所有資料的活用方法
第3章 從概念化到應用
- 介紹
- 藥物基因體學不是新一代的東西，早就存在
- 藥物基因體學在新藥開發上的應応用
- 利用藥物基因體學的新藥開發對策實際的利用程度
- 拯救失敗的藥物就是自毀前程
第4章 未來的藥物基因體學
- 介紹
- 經濟課題
- 補貼
- 法規限制
- 醫師教育
- 技術影響
- 腫瘤學
- 結論
第5章 專家訪談
第6章 結論
Abstract
Pharmacogenomics (PGx) is often considered "the great new wave" in medicine,
promising better, safer, and more affordable healthcare. Yet its adoption and
widespread use in the clinic is up against some tremendous challenges. This
report considers:
- Drivers of PGx
- Applications of PGx in drug development
- Industry experiences with PGx and lessons learned
- Type of evidence needed to establish clinical utility
- Challenges to moving PGx forward
- Survey results and expert views on utilization of PGx
Pharmacogenomics: Delivering on the Promise explores the pharmacogenomic (PGx)
realm of personalized medicine, analyzing current R&D and market trends
related to the use of genetic information to predict how well patients will
respond to certain drugs. Pharmacogenomics is an extremely difficult business,
one for which there are no easy answers. Even companies manufacturing and
marketing already successful pharmacogenomic drug-test combinations continue
to face difficulties. This report examines how these and other companies have
(or are) navigating through the scientific, statistical/experimental design,
and "clinical utility" landscape of PGx.
Not the least of the challenges facing pharmacogenomics is scientific.
Separating a consistent, predictive association between a SNP or other genetic
marker and a drug response phenotype from all the other variables that play
into drug response can be next to impossible. Once candidate associations are
identified, knowing how to design clinical trials capable of teasing out these
associations in the clinic and aligning those trials in preparation for
regulatory review create another set of challenges. Pharmacogenomics:
Delivering on the Promise considers prospective versus retrospective clinical
trial design and when, if ever, the FDA might allow the latter for regulatory
decision-making purposes.
Moreover, validating an association in a carefully controlled clinical setting
is different than knowing whether or not that association is truly clinically
useful. The risk of a product not being adopted as the standard of care
(either by prescribers, payers, or patients) because of insufficient evidence
regarding its "clinical utility" is clearly a disincentive. Varying opinions
raise questions about the nature of the evidence necessary for establishing
the clinical utility of PGx tests. We consider the growing skepticism about
the universal nature of the randomized controlled trial (RCT) gold standard
and the usefulness of non-RCT experimental designs with respect to genetic
testing.
Challenges examined include economic, reimbursement, regulatory,
technological, and those related to a lack of physician education and
awareness of pharmacogenetic testing. Overcoming these challenges could enable
physicians to engage in smart PGx prescribing, leading to increased efficacy
and reduced adverse drug reactions. PGx also has important applications in
drug development, both with new drugs or new indications and as a way to
"rescue" failed drugs; these various uses of PGx are explored in detail.
Pharmacogenomics: Delivering on the Promise also includes comprehensive
interviews with experts in the field and results from a qualitative survey of
individuals involved with pharmacogenomics.
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
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