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