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 access 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?
Contains 102 pages
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