[gdlr_text_align class=”justify”]The field of companion diagnostics is picking up a lot of interest in the pharmaceutical and healthcare industry. Its ability to test the safety of drugs and therapeutic products before their use and identify potential harms due to side effects has led to a wider use in the earlier stages of drug development.
The World CDx Boston 2014 5th annual summit taking place from Sept 23-15, 2014 provides a platform for companion diagnostic strategy for reaching a higher level of success in tackling the biggest opportunities and challenges in the field of precision medicine. The summit will benefit all those interested in new advances in drug-companion diagnostics and enable the formation extensive network with opinion leaders within the field.
An interesting WorldCDx survey2012 in the field of personalized medicine provides an insightful look into the market trends. More than a third of the participants in the survey were drug developers. Other participants included diagnostic developers and academic institutions.
Among the main factors that ensure success in the companion diagnostics/ personalized medicine approach, participants identified the following to be the most important:
- Return on Investment: How does the use of diagnostics considerable reduce the cost of healthcare?
- Accuracy: How accurately does the CDx predict the therapeutic potential of the drug?
- A collaborative business model: Selection of appropriate diagnostic combinations that benefit to both pharma and diagnostic companies.
- High involvement of diagnosticians: Since they understand patient value of the CDx approach and the heterogeneity of diseases.
- Deep understanding of regulatory requirements: For both diagnostics and commercialization.
- A validated biomarker: This point was highly emphasized. Early and systematic investigation and validation of a candidate biomarker.
- Clinical trial design: Address the clinical practice hurdles like sample access, test access as well as allow for a clinical trial design to incorporate biomarker proof of concept.
Some changes we can expect in the field of CDx over the coming years:
- Greater stringency by the FDA as testing moves towards multi-biomarkers
- More clarity from the regulatory aspect.
- Development of standardized panels for NGS sequencing in areas where several biomarkers have already been identified like lung cancer, breast cancer, etc.
Some expected changes in the field of personalized medicine:
- Fractionation of patients to guide further advanced drug development: personalized medicine will be driven by diagnostics, both in vitro and in vivo, with targeted therapies in smaller subsets of patients.
- Increasing use of databases for sharing of clinical data: information on patient disease, treatment and outcome through an extensive profiling database. This database can then be shared to guide treatment and further drug development.
- Bioinformatics: Assimilation and comparison of genomic data with gene expression, RNA and clinical trial data.
- Collaboration between pharma, academia and IT: to shorten and quicken the development phase.
- Decreasing costs of genomic sequencers: leading to personalized whole genome sequencing.
- Ethical concerns: liability and consequences in cases of false negative testing and false positive testing.
- Targeting the right biomarkers: through systematic assay investigations.
For more information on the World CDx Boston Summit, please visit their official website at http://world-cdx.com/