Regulatory and Legislative Activities: Shaping Biomarker and Diagnostic Use and Driving Personalized Medicine

Regulatory and Legislative Activities: Shaping Biomarker and Diagnostic Use and Driving Personalized Medicine published by Decision Resources, Inc. in November, 2009. This report consists of 28 Pages and the price starts from US $ 4600.

Introduction

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
  • Safety
  • Efficacy
• 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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