癌基因體:癌症治療的未來 是由出版商Insight Pharma Reports在2006年01月所出版的。
這份英文市場調查報告書包含166 pages 價格從美金2750起跳。
利用癌基因體所研發的Herceptin等少數第一代治療藥,已經成功地打入臨床與消費者市場上。鎖定特定病患的更安全且有效的治療法不僅為癌症治療開啟新的里程碑,也提高將癌症轉為可控制慢性疾病的可能性。
在調查基因領域上,素有高度評價的 Insight Pharma Reports(總公司:美國麻州),詳盡地調查與分析在癌症治療上有潛力的癌基因體,並出版綜合報告書 "Oncogenomics: The Future of Cancer Care" 。
此報告書在下面的內容裡,除了說明尚未研發成功的癌症目標藥劑所擁有的潛在醫學性/獲利性優點的評價、針對特定病患的目標治療藥的初期成功例與研發中目標藥劑概要,也探討特定病患的臨床開發的科學爭論、個別醫療的阻礙要素與課題、特定病患的臨床實驗的經濟性。另外也分析癌症基因體變異與基因體發現模式的相關技術、人體基因體計畫對發現過程的貢獻、in vitro技術與使用動物模型的技術等。
第1章 基因疾病的癌症
- 癌的遺傳基礎
- 癌的統計:死亡率降低,但新病例數增加。
- 分子目標藥劑的概要
- 目標的選擇與病患的選擇
- 癌治療的未來
- 人體免疫不全病毒/後天性免疫不全症候群與癌治療的比較
- 適合藥物研發的目標診斷可能性
第2章 目標治療:初期的成功案例與有潛力的替代藥
- 小分子藥
- Gleevec (Imatinib):2001年的許可
- Iressa (Gefitinib):2003年5月的許可
- Tarceva (Erlotinib):2004年11月的許可
- 開發中的有潛力小分子藥
- 低甲基化劑
- Azacitidine
- Decitabine與Zebularine
- 免疫療法:抗體與疫苗
- 治療用單株抗體
- Rituxan (Rituximab)
- Herceptin (Trastuzumab)
- 免疫接合體
- Avastin (Bevacizumab)
- 癌疫苗
第3章 目標治療:臨床前的發現技術
- 癌基因體的檢測:發現技術
- 比較性基因體雜合分析 (CGH)
- Array CGH
- 人體基因體計畫
- 癌基因體學的診斷檢查:基因發現技術
- Transcription Profiling技術
- 癌基因體學的正常組織資料庫
- 蛋白質體與癌治療
- 臨床前的驗證:癌基因體的篩除
第4章 特定臨床病患的目標藥劑:機會與課題
- Gleevec的實例:從懷疑論至Iressa
- 病患選擇的重要性:科學性爭論
- 小規模病患特定實驗的優點
- 病患特定實驗的設計方法
- 成為醫療研究阻礙的樣本收集
- 從過去癌化學療法的嘗試學習樣本收集方式
- 病患、醫師、付費者的病患選擇:阻礙要素
第5章 癌基因體產業:課題與機會
- 變化研究的公家/學術參與
- 特定病患階層市場的經濟報酬預估
- 分子診斷產業
第6章 專家的訪談
第7章 主要企業檔案
Abstract
Oncogenomics: The Future of Cancer Care analyzes the key advances and
challenges associated with translating research efforts into successful,
clinically meaningful therapeutic products. The emergence of oncogenomics
promises a new era of cancer care. Over the next decade or so, biomedical
researchers hope to have fully catalogued all genetic alterations associated
with cancer, greatly expanding the number of "druggable" anticancer molecular
targets.
Oncogenomics has already seen clinical and market success with a handful of
"first-generation" oncogenomic therapeutics such as Herceptin, raising hope
and expectations that safer and more effective patient-selected targeted
therapeutics will revolutionize cancer therapy and transform cancer into a
manageable chronic disease. While patient-selected genomic-based therapy has
only recently emerged as a viable clinical practice, many experts argue that
it will become crucial not just in clinical practice but as an integral
component of targeted drug development.
However, despite the early success stories of Herceptin and Gleevec, many
leaders in the field are cautious about the extent to which genomics will
truly impact cancer care over the next 10 to 15 years. Employing the right
tools, technologies, and strategies will be crucial to realizing the clinical
and marketplace opportunities stemming from the burgeoning growth of
oncogenomics. Oncogenomics: The Future of Cancer Care offers insightful
evaluation of the following key challenges to achieving this goal and examines
current approaches to addressing these issues:
- Preclinical drug candidate screening needs to be more predictive in order
to increase the chance that a targeted drug entering clinical trials will
succeed.
- Patient selection needs to be integrated into targeted drug development
and clinical practice.
- Many pharmaceutical companies remain resistant to the patient-selected
targeted drug model.
- Not all of the targets yielded by the Human Genome Project are "druggable"
and it is extremely difficult to determine which genes associated with cancer
are consequences, not causes, of cancer.
- Most tumors involve multiple mutations, which could translate into
multiple pathways.
This report also:
- Evaluates important questions about the potential medical and revenue
benefits of targeted cancer drugs that are not being realized.
- Provides an overview of the early success stories of patient-selected
targeted therapeutics and highlights promising targeted therapeutics in
development.
- Explores the scientific arguments for patient-selected clinical
development, discusses the disincentives and challenges to patient-selected
therapy, and examines the economics of patient-selected trials.
- Highlights key technologies used to discover cancer-associated genetic
variation and gene expression patterns, and discusses the way in which the
tools and technologies advanced by the HGP have improved this discovery
process. Some of the key in vitro and animal model technologies being used to
functionally test and "validate" (i.e., preclinically) these discoveries are
summarized.
Table of Contents
Chapter 1. Cancer as a Genetic Disease
- 1.1. The Genetic Basis of Cancer
- 1.2. Cancer Statistics: Mortality Has Decreased, but the Number of New
Cases Is Increasing Cancer Survivor Care
- 1.3. What Are Molecularly Targeted Drugs?
- 1.4. Target Selection versus Patient Selection
- 1.5. The Future of Cancer Care
- Parallels between Human Immunodeficiency Virus/Acquired Immunodeficiency
Syndrome and Cancer Care
- 1.6. The Diagnostic Potential of Druggable Targets
Chapter 2. Targeted Therapies: Early Success Stories and Promising
Candidates
- 2.1. Small Molecule Drugs
- Gleevec (Imatinib): Approved 2001
- Iressa (Gefitinib): Approved May 2003
- Tarceva (Erlotinib): Approved November 2004
- Promising Small Molecule Drugs in Development
- 2.2. Hypomethylating Agents
- Azacitidine
- Decitabine and Zebularine
- 2.3. Immunotherapeutic Intervention: Antibodies and Vaccines
- Therapeutic Monoclonal Antibodies
- Rituxan (Rituximab)
- Herceptin (Trastuzumab)
- Immunoconjugates
- Avastin (Bevacizumab)
- Cancer Vaccines
Chapter 3. Toward Targeted Therapies: Preclinical Discovery Technology
- 3.1. Finding the Cancer Gene: Discovery Technology
- Comparative Genomic Hybridization (CGH)
- Array CGH
- 3.2. The Human Genome Project
- Advances in Sequencing Technology: Digital Karyotyping as an Example
- Accelerated Drug Discovery
- 3.3. Oncogenomic Diagnostic Testing: Gene Expression Technology
- Transcription Profiling Technology
- Oncogenomics Normal Tissue Database
- 3.4. Proteomics and Cancer Care
- 3.5. Preclinical Validation: Screening Cancer Genes
Chapter 4. Patient-Selected Targeted Drugs in the Clinic: Opportunities and
Challenges
- 4.1. The Gleevec Paradigm: From Skepticism to Iressa
- 4.2. The Importance of Patient Selection: A Scientific Argument
- 4.3. The Small-Size Advantage of Patient-Selected Trials
- 4.4. How to Design Patient-Selected Clinical Trials
- 4.5. Sample Acquisition as a Major Barrier to Patient-Selected Research
- 4.6. Lessons about Sample Acquisition from Past Attempts to Individualize
Cancer Chemotherapy
- 4.7. Patient Selection from the Patient, Physician, and Payer Perspective:
Disincentives
Chapter 5. The Business of Oncogenomics: Challenges and Opportunities
- 5.1. Public and Academic Involvement in Translational Research
- 5.2. The Potential Financial Rewards of a Patient-Selected Tiered Market
- Expanding Indications for Targeted Drugs
- Drug Safety
- The Scientific Counterargument
- 5.3. The Molecular Diagnostics Industry
- Patient-Selected Molecular Diagnostics
Chapter 6. Expert Interviews
- Charles Brenner, PhD, Dartmouth Medical School; Coeditor (with David
Duggan), Oncogenomics: Molecular Approaches to Cancer
- Walter P. Carney, PhD, Oncogene Science (part of Bayer HealthCare)
- Nicholas C. Dracopoli, PhD, Vice President of Clinical Discovery
Technology, Pharmaceutical Research Institute, Bristol-Myers Squibb
- Geoffrey Duyk, MD, PhD, Managing Director, Texas Pacific Group Ventures
- Michael L. Salgaller, PhD, Toucan Capital Corporation
- Herman Spolders, PhD, Chief Executive Officer, OncoMethylome Sciences
Chapter 7. Company Profiles
- Abgenix, Inc.
- ArtisOptimus, Inc.
- Dendreon Corporation
- Genomic Health, Inc.
- ImClone Systems, Inc.
- Medarex, Inc.
- OncoMethylome Sciences, Inc.
- Onyx Pharmaceuticals, Inc.
- OSI Pharmaceuticals, Inc.
- Spectral Genomics, Inc.
- Vivo Biosciences, Inc.
Notes
Glossary
Index
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