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市場調查報告書
藥劑及診斷藥的研究開發加速化：明確的生物標記影響
Driving Drug and Diagnostic R&D: The Undeniable Influence of Biomarkers
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藥劑及診斷藥的研究開發加速化：明確的生物標記影響 是由出版商Decision Resources, Inc.在2010年05月所出版的。
這份英文市場調查報告書價格從美金4600起跳。
本報告書內容包括:2004∼2015年的Herceptin、Vectibix、Erbitux等銷售趨勢的分析、生物標記的概要和治驗環境、附帶診斷的趨勢、合併及制約公司的生物標記及個別化醫療之關心趨勢等彙整、內容綱要摘記如下:
實施摘要
介紹
概要
個別化醫療的Herceptin角色重新認識
藥劑開發所帶來的影響之其他生物標記
生物標記資料的重新檢證
- 生物標記所使用的適應型治驗
- 生物標記資料的儲存庫
- 癌症基因地圖集
- Genetic Alliance的生物銀行
生物標記策略的合併和其他投資活動
醫藥品業界的生物標記之今後展望
Abstract
Introduction:
Pharmaceutical companies can either take action that will ensure their
position as knowledgeable and infl uential partners in drug prescribing or
watch as others help doctors determine which drugs are best for which patients.
The pharma industry has typically lacked an aggressive biomarker strategy for
their R&D efforts. Biomarkers were considered as an afterthought, pursued when
regulatory agencies demanded them. However, with the focus on safety (by
regulators and physicians) and cost-cutting (by patients and payers) inspiring
an emphasis on personalized medicine, pharmaceutical companies are starting to
realize the benefits of utilizing biomarkers and are becoming more open to the
idea of actively searching for markers of drug response.
Questions Answered in This Report:
- We are in the midst of a paradigm shift in the way pharmaceutical
companies view biomarkers. While a reluctance to proactively pursue
drug-diagnostic combinations was the norm five to ten years ago, the pairing
is becoming more common. Increased investment in biomarkers and diagnostics by
venture capitalists is but one contributing factor. What factors
contributed to the once-negative outlook on biomarkers by the pharma industry?
What are some of the main events attributed to the positive shift in strategic
thinking?
- Proponents of personalized medicine often describe the success of
Roche/Genentech/Chugai' s Herceptin to illustrate the value of biomarker-based
drug-diagnostic development. Other notable examples include Amgen' s Vectibix,
AstraZeneca' s Iressa, Bristol-Myers Squibb' s Erbitux, and possibly Novartis' s
Prexige. Why is Herceptin a prime case study? How do the other examples
compare with Herceptin in biomarker-related discovery, development, and
regulatory approval? Will Novartis' s Prexige and its associated diagnostics
join the success stories?
- Biomarker validation is one of the greatest challenges constraining proper
use of biomarkers in drug development. Use of clinical repositories of
biological samples and innovative drug trials that use biomarkers are bringing
renewed optimism toward meeting this challenge. How do these solutions
affect the availability of biomarkers and their use in drug development? What
regulatory impact on drug development is anticipated as a result of these
trends?
Scope:
- Market forecast features: Global sales over 2004-2015 for
Herceptin, Vectibix, and Erbitux from Decision Resources' Pharmaview.
- Biomarkers, repositories, and landmark clinical trials: Insight
into key markers that continue to shape drug development: HER2, KRAS, EGFR,
and BRAF; innovative ways to rethink validation of
- biomarker data: The Cancer Genome Atlas for gene expression and
Genetic Alliance for rare diseases; drug trials that showcase study designs
incorporating biomarker data: ToGA, SATURN, IPASS, I-SPY, I-SPY 2, BATTLE.
- Dealmaking assessment: Biomarker and diagnostic deals from 2005
through February 2010; select companion diagnostics deals from 2007-2010.
- Investing in biomarker-based strategies: VC and pharmaceutical
company interest in biomarkers and personalized medicine, focusing on select
next-generation diagnostics companies that highlight the importance of this
strategy.
Mentioned in This Report:
- 23&Me
- Abbott
- Almac Diagnostics
- Amgen
- AstraZeneca
- Asuragen
- Biogen Idec
- Biotage
- Boehringer Ingelheim
- Bristol-Myers Squibb
- CBT Advisors
- Chugai
- CVS Caremark
- Dako
- DiaSorin/Dana Farber-Brigham and Women' s Cancer Center
- DNA Direct
- DxS
- Elan
- Eli Lilly
- Foundation Medicine
- GeneOhm
- Genentech
- Generation Health
- Genetic Alliance
- Genomic Health
- HandyLab
- LabCorp
- M.D. Anderson Cancer Center
- Medco
- Navigenics
- Novartis
- On-Q-ity
- OSI Pharmaceuticals
- Pfizer
- Predictive Biosciences
- PricewaterhouseCoopers
- Psynova Neurotech
- Roche
- T2 Biosystems
- Tethys Bioscience
- The Biomarker Consortium
- The Cancer Genome Atlas
- Third Rock Ventures
- Third Wave Technologies
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Tipping Point
- Codevelopment of Drugs and Diagnostics
- Investment-Backed Focus
- Revisiting Herceptin' s Role in Personalized Medicine
- Use Beyond Breast Cancer
- Lessons from Herceptin
- Beyond Herceptin
- Challenges in Testing Instruments and Implementation
- Other Notable Biomarkers That Infl uence Drug Development
- Reinventing Biomarker Data
- Adaptive Trials Using Biomarkers
- The BATTLE Study
- The I-SPY Trials
- Biomarker Data Repositories
- The Cancer Genome Atlas
- Genetic Alliance' s Biobank
- VC and Other Investing in Biomarker-Based Strategies
- Agendia
- On-Q-ity
- Predictive Biosciences
- Prospects for Biomarkers in Pharma
Tables
- 1. Select Companion Diagnostics Deals, 2007-2010
- 2. Select KRAS Companion Diagnostic Tests
- 3. The I-SPY Trial, at a Glance
- 4. Emerging Value in Biomarker-Based Diagnostics
Figures
- 1. Herceptin Sales Forecast, 2004-2015
- 2. Erbitux and Vectibix Sales Forecast, 2004-2015
- 3. Number of Biomarker and Diagnostic Deals, 2005-2010
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