市場調査レポート

個別化医療(2010年):コンパニオン診断と標的療法の製品化における機会と課題の評価

Personalized Medicine 2010 - Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies

発行 Arrowhead Publishers 商品コード 117128
出版日 ページ情報 英文 280 Pages
納期: 即日から翌営業日
価格
こちらの商品の販売は終了いたしました。
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個別化医療(2010年):コンパニオン診断と標的療法の製品化における機会と課題の評価 Personalized Medicine 2010 - Assessing the Opportunities and Challenges in Commercializing Companion Diagnostics and Targeted Therapies
出版日: 2010年05月01日 ページ情報: 英文 280 Pages

当商品の販売は、2016年07月01日を持ちまして終了しました。

概要

当レポートでは、ファーマコゲノミクスに関するケーススタディ、世界7大市場の個別化医療に関する2016年までの予測、個別化医療を取り巻く法規制環境、収益確保のためのマーケティング戦略などについてまとめ、概略下記の構成でお届けいたします。

第1章 エグゼクティブサマリー

第2章 個別化医療のイントロダクション

  • 生物分子の進歩は医療業界にどのような影響を及ぼしたか
  • 個別化医療とは
  • ファーマコゲノミクスとファーマコジェネティクス
  • 個別化医療の歴史
  • 個別化医療スケジュール
  • なぜ個別化医療がそれほど重要なのか
  • 人口と疾患に基づくバイオバンク
  • 医療費高騰
  • 高齢化
  • 高騰する研究開発費
  • 長期の開発時間
  • 薬剤開発企業にとっての高いリスクベンチャー
  • 個別的アプローチと現在の治療戦略
  • 効能向上
  • 毒性低減
  • 入院期間の短縮
  • 個別化医療の実践

第3章 ゲノミクスとプロテオミクスの概要

  • ゲノミクス
  • ゲノミクスのイントロダクション
  • 遺伝子修飾・法規制・発現のメカニズム
  • メチル化遺伝子パターン
  • RNA
  • 転写因子
  • 無細胞核酸
  • ヒトゲノムの特定
  • ヒトゲノムプロジェクト
  • 国際的HapMapコンソーシアム 他

第4章 ファーマコダイアグノスティクスの概要

  • 予防診断
  • RocheのampiChip P450試験
  • 予後診断
  • ファーマコジェネティック試験
  • Tarceva
  • Xeloda
  • MabThera/Rituxan
  • Avastin
  • 組織バンキングの重要性
  • 新興診断への規制当局の反応

第5章 個別化医療における研究開発の最適化

  • 標準的治験の概要
  • 個別化医療治験のためのバイオマーカー
  • バイオマーカーとは
  • 反応のバイオマーカー
  • 効能と用量のバイオマーカー
  • 安全性バイオマーカー
  • 前治験安全性バイオマーカー
  • 治験安全性バイオマーカー
  • バイオマーカー戦略の導入
  • バイオマーカーの開発
  • 臨床評価項目としてのバイオマーカー
  • 規制当局とのバイオマーカーの評価
  • 製薬会社によるバイオマーカープログラム 他

第6章 個別化医療関連の法規制

  • 米国の法規制
  • EUの法規制
  • 日本の法規制

第7章 倫理的問題

  • インフォームドコンセント
  • 電子カルテの標準化
  • 電子カルテおよび医療ITの導入
  • 医療記録とプライバシーの保護 他

第8章 法規制および償還問題

  • 知的財産問題 他

第9章 治療への応用

第10章 市場の潜在性

第11章 個別化医療の戦略的影響

目次

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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