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市場調查報告書
法制規章行動：生物標記與診斷上使用・個人化醫學的促進
Regulatory and Legislative Activities: Shaping Biomarker and Diagnostic Use and Driving Personalized Medicine
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法制規章行動：生物標記與診斷上使用・個人化醫學的促進 是由出版商Decision Resources, Inc.在2009年11月所出版的。
這份英文市場調查報告書包含28 Pages 價格從美金4600起跳。
為了促進個人化醫學，對使用生物標和診斷藥物的企業來說，做好符合法制規章的萬全準備已成為一個前提條件。美國、歐洲、日本的法規當局了解其重要性，透過提出各種方針和見解來與業界有所接觸。即便如此，法制規章上存在著特有的問題和其解釋等各種課題，而業界相關人冀望藉由各種方式來克服這些課題。
本報告，彙整了PMA•510(k)•CE標記•CLIA認證等的法制規章程序和當局的概要、美國•歐洲•日本的市場動向等，由下列摘要形式闡述。
報告摘要
簡介
個人化醫學上的生物標記的使用
法制規章的展望與支援
- 美國的個人化醫學相關的法制規章課題
- 法制規章
- Genetic Information Nondiscrimination Act
- Genomics and Personalized Medicine Act
- 課題
- 智慧財產權與基因專利
- 個人基因組學與消費者導向的基因數據收集
今後展望
Abstract
Introduction
Successful navigation of the regulatory maze is a prerequisite for companies
using biomarkers and diagnostics to advance personalized medicine. U.S.,
European, and Japanese regulators recognize the critical role they play and
are reaching out to the industry by publishing guidance and requesting
commentary. Additionally, recent legislation, such as GINA, is giving
companies new opportunities to further their efforts in personalized medicine.
However, plenty of barriers still exist: some are intrinsic to regulatory
processes, while others relate to the interpretation of regulations. Industry
players are exploring a variety of approaches to overcome these challenges.
Questions Answered in This Report
- A host of regulatory decisions and deadlines are occurring right now.
How will GINA (signed into law in May 2008) influence clinical trial
enrollment and purchasing of personal genetics products once it fully takes
effect in November 2009? What impact will the imminent final report on gene
patents by the SACGHS have on licensing practices and patient access to
genetic tests? What will the results of the Navigenics/Mayo Clinic study on
predictive genetic risk assessments reveal when the study completes in
December 2009? What will be the outcome of the August 2009 announcement by the
EMEA to clarify criteria used to evaluate in vivo diagnostic tests, taking
effect on February 1, 2010? How will Japan' s PMDA adhere to the action plan it
set forth in April 2009 to enable shorter review times of diagnostics?
- The ACLU has filed a suit against Myriad Genetics regarding Myriad' s BRCA
gene patents. How is Myriad responding to the lawsuit? What are the
implications of this litigation? Why is there so much controversy surrounding
gene patenting?
- In July 2009, the FDA amended the drug labels for Amgen' s Vectibix
(panitumumab) and ImClone/ Bristol-Myers Squibb/Merck KGaA' s Erbitux
(cetuximab) to incorporate KRAS testing prior to determining treatment for
colorectal cancer. What value do regulators place on genetic data? What
other moves has the FDA made recently related to biomarker requirements and
recommendations? What regulations has the EMEA instituted on this front?
- Debate surrounding the use, regulation, and marketability of personal
genetic tests is heating up. Who is benefiting from personal genetic tests?
How should these tests be regulated? Which agency currently has oversight of
these tests? What are the different ways in which these tests marketed?
- Europe has identified more pharmacogenomic markers than the United States
or Japan. For how many drugs does the EMEA support pharmacogenomic testing?
What is Japan' s position on pharmacogenomic testing and on reviewing these
data?
Scope
- Regulatory processes: PMA, 510(k), CE marking, CLIA certification.
- Agencies: FDA, EMEA, PDMA, AdvaMed, CDER, CBER, CDRH, PMC, CDC,
USPTO, and ACLU.
- Markets: United States, Europe, and Japan.
- Relevant issues and key legislations to watch: gene patenting,
comparative effectiveness research, DTC genetic profiling services, CLIA,
GINA, Genomics and Personalized Medicine Act.
Mentioned in This Spectrum Report
- 23andMe
- Allergan
- Amgen
- AstraZeneca
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Celgene
- Cephalon
- Chugai
- deCode
- Eli Lilly
- Genentech
- GlaxoSmithKline
- ImClone
- Knome
- Medicis Pharmaceutical
- Merck KGaA
- Myriad Genetics
- Navigenics
- Novartis
- Otsuka Pharmaceutical
- Pathway Genomics
- Pfizer
- PricewaterhouseCoopers
- Roche
- Sanofi-Aventis
- Takeda
- Teva
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Uses of Biomarkers in Personalized Medicine
- Regulatory Perspectives and Support
- United States
- Europe
- Japan
- U.S. Legislation and Regulatory Issues Related to Personalized Medicine
- Legislation
- Genetic Information Nondiscrimination Act
- Genomics and Personalized Medicine Act
- Regulatory Issues
- Intellectual Property and Gene Patents
- Personal Genomics and Direct-to-Consumer Genetic Profiling
- Outlook
Sidebar
- Regulatory Processes for Diagnostics: United States and Europe
Tables
- 1. Key Uses of Biomarkers in Biopharmaceutical R&D
- 2. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for
Required and Recommended Tests
- 3. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for
Information Only
- 4. FDA In Vitro Diagnostic Classes
- 5. Limitations of the Genetic Information Nondiscrimination Act
- 6. Preliminary Conclusions on Gene Patents by SACGHS
- 7. Select Personal Genomics Companies Offering Genome Scans
- 8. Select Public Comments from Industry on the International Conference on
Harmonization' s Draft of Guidance on E16 Genomic Biomarkers
Figures
- 1. Timeline of Key Regulatory Events Contributing to the Advance of
Personalized Medicine
- 2. Genomic Biomarker Testing Requirements/Recommendations by the FDA
- 3. Permissibility of Direct-to-Consumer Advertisement of Personal Genomics
Services, by State
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