Advances in Drug-Diagnostic Co-Development

Date: May 22, 2011
Pages: 102
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: AD61D06C50CEN
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Advances in Drug-Diagnostic Co-Development
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Introduction

This report provides in depth analysis of the current and evolving regulatory framework for drugs and diagnostics in the US and EU and specific guidance for their co-development. Advances in biomarker development and validation are assessed and case studies given of regulatory approvals of drugs and companion tests. Strategies for drug-diagnostic co-development are evaluated.

Features and benefits
  • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development.
  • Understand the biomarker discovery and validation process.
  • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU.
  • Discover the various types of collaborations used by pharma and diagnostic companies.
  • Assess the impact of drug-diagnostic co-development on key stakeholders including the industry, regulators, physicians, and pharmacy benefit managers.
Highlights

The regulatory landscape for drug-diagnostic co-development projects is evolving. The FDA and EMA both have similar biomarker qualification processes in place that enable companies to obtain advice or qualification of the biomarker in question and the agenices have published their current thinking in relation to drug-diagnostic co-development.

Changes to diagnostics regulation in the EU and US are under discussion and are viewed as critical given the pivotal and game changing role of diagnostics in the future of healthcare. Both the FDA and lawmakers in the US are taking steps to address the problems with the current system and a public consulation recently completed in the EU.

The lack of clarity around regulations for drug-diagnostic co-development is only one of the hurdles facing the commercialisation of companion diagnostics. Market acess issues provide another major hurdle as clear pathways to gaining value-based reimbursement for high value molecular diagnostic tests are not available.

Your key questions answered
  • How is the regulatory landscape for drug-diagnostic co-development evolving in the US and Europe?
  • How do the FDA and EMA qualify biomarkers prior to their inclusion in a diagnostic procedure?
  • How can pharma and diagnostic companies make collaborations between them work for both parties?
  • How has the type of deal between pharma and diagnostic companies changed over the last six years?
  • How can key stakeholders including industry, regulators, and physicians benefit from the introduction of drug-diagnostic developments
Executive Summary
  Introduction
  Drug-diagnostic co-development: from concept to reality
  New pathways and regulatory change
  Strategies for drug-diagnostic co-development in pharma R&D
  Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics
About the Authors
  Sara Sleigh
  Cheryl L Barton
  Disclaimer
Introduction
  Summary
  Introduction
  Regulatory framework for drugs and diagnostics in the US
    Biomarker guidance
    Drug-diagnostic co-development guidance
    FDA organization
    Drug and biologics regulation by the FDA
    Diagnostics regulation by the FDA
  Regulatory framework for drugs and diagnostics in the EU
    EMA guidance for personalized medicine
    Drug and biologics regulation by the EMA
    Diagnostics regulation in the EU
  Comparing and contrasting regulation in the EU and US: drivers for change
  Report outline
Drug-diagnostic co-development: from concept to reality
  Summary
  Biomarkers and companion diagnostics in drug development
  Stages of drug-diagnostic co-development
    Biomarker discovery
    Analytical validation
    Clinical validation and clinical utility
  Regulatory approvals of drugs and companion diagnostic tests
    Drug-diagnostic co-development: Selzentry
    Introducing companion diagnostic tests for efficacy post-approval
    Omapro (Chemgenex): a case study
    Introducing companion diagnostics for safety reasons
  Labeling considerations
  Conclusions
New pathways and regulatory change
  Summary
  Introduction
  Biomarker qualification
    Biomarker qualification: FDA
    Biomarker qualification: EMA
  FDA guidance on drug-diagnostic co-development
    FDA-industry discussion of the drug-diagnostic co-development concept paper
    New FDA guidance documents relating to co-development
  Changes to device regulations in the US
    Changes at the FDA
    Proposed legislative changes
  EMA guidance on drug-diagnostic co-development
  Changes to device regulations in the EU
  Conclusions
Strategies for drug-diagnostic co-development in pharma R&D
  Summary
  Introduction
    Partnership for a specific drug-diagnostic co-development programs
    Broad partnership: the preferred provider route
    Licensing
    In-house diagnostics development
    The widening role of CROs
  Conclusions
Stakeholder perspectives on regulatory change: outlook for pharma and diagnostics
  Summary
  Introduction
  Regulators
  Pharma industry
  Diagnostics industry
  Patients
  Physicians
  Payers
  Emerging stakeholders
    Pharmacy benefit managers
    Next generation sequencing companies
    Health IT companies
  Conclusions and outlook
Appendix
  Research methodology
  Acknowledgements
  Abbreviations
  Glossary
  References
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