個人化醫療（2010年）：評估商業化搭配診斷與標的療法的機會與挑戰

個人化醫療（2010年）：評估商業化搭配診斷與標的療法的機會與挑戰 是由出版商Arrowhead Publishers在2010年05月所出版的。 這份英文市場調查報告書包含280 Pages 價格從美金2495起跳。

簡介

本報告對藥物基因體學進行相關個案研究，針對到2016年為止全球七大市場個人化醫療的預測，並就個人化醫療相關法律規制環境、可確保收益的行銷策略等進行整理，其概要如下所示。

第1章 實施概要

第2章 個人化醫療簡介

• 分子生物學的進步如何影響醫療業界
• 什麼是個人化醫療
• 藥物基因體學與藥物遺傳學
• 個人化醫療的歷史
• 個人化醫療時間進程
• 個人化醫療為何如此重要
• 以人口與疾病為基礎之基因庫
• 醫療費用高漲
• 高齡化
• 研究開發費用高漲
• 開發時間長
• 對藥物開發公司而言是高風險事業
• 個人化的方法與目前治療策略
• 增加效力
• 減低毒性
• 縮短住院時間
• 個人化醫療的實踐

第3章 基因體學與蛋白質體學概要

• 基因體學
• 基因體學的介紹
• 基因改造、調控與表現的機制
• 基因甲基化模式
• RNA
• 轉錄因子
• 體外核酸流通
• 人類基因體認定
• 人類基因體計畫
• 國際人類基因組單體型圖組織、其他

第4章 藥物診斷學概要

• 房診斷
• 羅氏藥廠的ampiChip P450試驗
• 預後診斷
• 藥物基因體試驗
• Tarceva
• Xeloda
• MabThera/Rituxan
• Avastin
• 組織庫的重要性
• 管理機關對於新興診斷的反應

第5章 個人化醫療中研究開發的最佳化

• 標準臨床試驗概要
• 個人化醫療臨床試驗的生物標記
• 何謂生物標記
• 反應的生物標記
• 效力與用量的生物標記
• 安全性生物標記
• 臨床前試驗安全性生物標記
• 臨床試驗安全性生物標記
• 生物標記策略的導入
• 生物標記的開發
• 作為臨床評估項目的生物標記
• 以調控因子驗證生物標記
• 藥物公司的生物標記方案、其他

第6章 個人化醫療相關法律規制

• 美國的法律規定
• 歐盟的法律規定
• 日本的法律規定

第7章 個人化醫療的道德爭議

• 告知同意書
• 電子病歷標準
• 電子病歷及醫療IT的導入
• 醫療記錄與隱私權的保護、其他

第8章 法律規制與償還問題

• 智慧財產權爭議、其他

第9章 在治療方面的應用

第10章 市場潛力

第11章 個人化醫療的策略性啟示

目錄

Abstract

Report Description

The era of Personalized Medicine is set to revolutionize the healthcare industry. As our knowledge of genetics and molecular biology rapidly expands, a personalized approach to medical care is becoming increasingly important. Not only does this paradigm promise to improve an individual' s treatment outcome and reduce healthcare expenditure, personalized medicine is set to transform the pharmaceutical/biotechnology and companion diagnostic markets. Arrowhead' s Personalized Medicine 2010 report provides an in-depth assessment of this burgeoning market, and examines the major challenges that need to be overcome to maximize success.

Key features of Arrowhead' s Personalized Medicine 2010 include:

• Case studies of leading pharmacogenomic products
• Analysis of the personalized medicine market, including seven major market sales forecasts to 2016
• Regulatory and legal issues surrounding personalized medicine
• Payer reimbursement challenges
• Marketing strategies to capitalize profits
• Survey results from key opinion leaders across the life sciences industry

Key questions answered by Arrowhead' s Personalized Medicine 2010 include:

• What are the major challenges in this market and how can these be overcome?
• How will pharmacogenomics transform clinical trials?
• What are the leading pharmacogenomic products on the market?
• Who are the key players involved in the market and what strategies are they using to enhance product performance?
• What pharmaceutical/biotechnology and diagnostic companies are seeking alliances in 2010?
• How can company alliances maximize commercial success?

Table of Contents

Chapter 1 - Executive Summary

• Scope of Personalized Medicine: Market Trends and R&D Insights
• Methodology of Personalized Medicine: Market Trends and R&D Insights
• Key challenges in the commercialization of personalized Medicine
• Overview of current therapeutic applications of personalized Medicine
• Market Potential of personalized Medicine
• Strategic Implications of personalized Medicine

Chapter 2 - Introduction to Personalized Medicine

• How bio-molecular advances have influenced changes in the healthcare industry
• What is personalized medicine?
• What are pharmacogenomics and pharmacogenetics?
• The history of personalized Medicine...the story so far
• Timeline of Personalized Medicine
• Why are personalized Medicine important?
• Population and disease-based bio-banks
• Increasing healthcare costs
• The aging population
• Rising R&D expenditure
• Long development time
• High risk venture for drug development companies
• Personalized approach versus current treatment strategy...a patient case study
• Increased efficacy
• Reduced toxicity
• Reduced hospitalization
• Putting Personalized Medicine into Practice ...a case study of CYP2D6

Chapter 3 - Overview of Genomics and Proteomics

• Genomics
• Introduction to genomics
• Mechanisms of gene modification, regulation and expression
• Methylated Gene (meDNA) Patterns
• RNA
• Transcription Factors
• Circulating Cell-free nucleic acids
• Identification of the human genome
• The Human Genome Project
• The International HapMap Consortium
• CDC and the development of the Centers for Genomics and Public Health
• Genomic Research into Genetic Polymorphisms
• Single Nucleotide Polymorphisms (SNPs)
• The SNP Consortium
• Companies and academic centers involved in the SNP Consortium
• Proteomics
• Introduction to proteomics
• Proteins
• From genes to proteins
• The human genome versus the proteome
• The relationship between the proteome and the genome
• Widespread genotyping and the creation of a genetic database
• The pharmacogenetics knowledge base (PharmaGKB)

Chapter 4 - Overview of Pharmacodiagnostics (IVDs)

• Predictive diagnostics
• Roche AmpiChip P450 Test
• Prognostic diagnostics
• Pharmacogenetic testing
• Tarceva
• Xeloda
• MabThera/Rituxan
• Avastin
• The Importance of Tissue banking...focus in oncology
• Regulators response to emerging diagnostics

Chapter 5 - Personalized Medicine R&D Optimization

• Overview of standard clinical trials
• Biomarkers for Personalized Medicine clinical trials
• What are biomarkers?
• Biomarkers of response
• Biomarkers of Efficacy and dose
• Safety biomarkers
• Preclinical safety biomarkers
• Clinical safety biomarkers
• Implementing a biomarker strategy
• Development of biomarkers
• Biomarkers as clinical end points
• Validating biomarkers with regulators
• Biomarker Programs Created by Pharma
• J&J
• Novartis
• Pfizer
• Roche
• GSK
• Merck
• Personalized Medicine and the Optimization of R&D
• Identify patients to give maximum efficacy (responders versus non-responders)
• Predict Adverse Drug Reactions and Identify genotypes correlating to Adverse Drug Reactions
• Develop targeted drugs for specific genetic disorders
• Identify patients at different stages of a disease
• Monitor clinical responders in novel and comparator drugs to allow potential strategic alliances
• Identify patients with drug resistance
• Alter clinical trial paradigms
• Intro of Phase 0
• End of Phase I and IIA
• Adaptive Phase IIB and Phase III
• Phase IV
• Cheaper drug development

Chapter 6 - Personalized Medicine Regulatory Issues

• US Regulation
• FDA Pharmacogenomic submissions
• FDA Labeling and recommendations
• FDA Voluntary Genomic Submissions Program
• Critical Path by FDA
• NIH Research Tools Policy
• NIDDK model
• FDA Pharmacogenetic approval for marketed drugs
• EU Regulation
• EMEA Pharmacogenomic submissions
• EMEA Labeling and recommendations
• EMEA Pharmacogenetic approval for marketed drugs
• Japan Regulation
• Global Personalized Medicine Harmonization: ICH
• The Interdisciplinary Pharmacogenomic Review Group (IPRC)

Chapter 7 - Personalized Medicine Ethical Issues

• Informed consent
• Electronic medical record standards
• Adoption of electronic health records and healthcare IT (HIT)
• Protection of medical records and privacy
• Nuffield Council on Bioethics
• Equitable distribution of benefits
• Prevention of discrimination
• Administration of personalized Medicine
• Limited to wealthy individuals/markets
• Race issues BiDiL
• Lack of Asian and African Research
• Cost of genotyping
• Guidelines for genetic screening
• National Society of Genetic Counselors Guidelines for genetic testing
• NSGC Recommendations for protocols relating to predisposition genetic testing

Chapter 8 - Personalized Medicine Legal and Reimbursement Issues

• Intellectual Property Issues
• US Patent and Trade Office (USPTO)
• SNP Consortium
• Payer reimbursement
• Medicare
• Medicaid
• NICE

Chapter 9 - Personalized Medicine Therapeutic Applications

• Drug Metabolism: The Cytochrome System
• CYP2D6
• CYP2D6 polymorphic variations
• Ultra rapid metabolizers
• CYP2C19
• CYP3A
• CYP2C9
• Oncology
• 9.2.1 Breast cancer
• Introduction to breast cancer
• Epidemiology of breast cancer
• Breast cancer Biomarkers
• Prognostic tests
• MammaPrint 42
• Oncotype DX
• Predictive Tests
• Hormonal therapies
• Taxanes/anthracyclines
• Biologicals
• Herceptin
• Triple Negative breast cancer
• Colorectal cancer
• Introduction to Colorectal cancer
• Epidemiology of Colorectal cancer
• Colorectal Cancer Biomarkers
• Prognostic tests
• Predictive tests
• Erbitux
• Panitumumab
• Lung cancer
• Introduction to Lung Cancer
• Epidemiology of Lung cancer
• Lung Cancer Biomarkers
• EGFR
• Avastin
• Tarceva
• Iressa
• Erbitux
• CVS
• CVD
• Asthma
• COPD
• Indoctoral P2 Norvartis
• Beta adrenergic receptor
• RAS polymorphisms
• Pgp
• Thiazides
• 825T allele
• Statins
• CNS
• Improved diagnosis and follow up tools
• Alzheimer' s disease
• Introduction to Alzheimer' s disease
• Epidemiology of Alzheimer' s
• Alzheimer' s Biomarkers
• APOE4
• Parkinson' s disease
• Intro to Parkinson' s disease
• Epidemiology of Parkinson' s disease
• Parkinson' s Biomarkers
• Depression
• Introduction to Depression
• Epidemiology of Depression
• Pristiq Wyeth
• Schizophrenia
• Intro to Schizophrenia
• Epidemiology of Schizophrenia
• Schizophrenia Biomarkers
• DAAO D-amino acid oxidase
• Atomoxetine Strattera Eli Lilly ADHD

Chapter 10 - Market Potential of Personalized Medicine

• The end of the blockbuster? ...Niche/ Orphan drug status markets and its benefits
• Minimize failures of late-stage candidates
• Cheaper drug development
• Reviving Failed Drug Candidates
• Expanding Indications for Launched Drugs
• Arrowhead' s Personalized Drug Revenue Forecast 2004-2019

Chapter 11 - Personalized Medicine Strategic Implications

• An Interdisciplinary challenge...The Personalized Medicine Coalition Recommendations
• Pharma Strategies
• Biotech Strategies
• Pharmacodiagnostic strategies
• Company Alliances are fundamental
• Independent biotech companies are driving the personalized medicine revolution
• Successful Alliances

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