A number of recently publications have heralded the advent of Precision Medicine in Oncology, where next generation sequencing technology, other ’omics technologies, serial biopsies, sophisticated treatment algorithms and access to databases detailing response to therapy by molecular subtype can be applied to an individual cancer patient’s genomic profile to generate a specific “matching” cancer treatment. This matching treatment can subsequently be modified, with the help of additional biopsies and further analysis, to continue to match the cancer’s specific genomic characteristics upon disease progression.
Many cancers with poor prognoses are characterized by high genomic heterogeneity and rapid escape from therapy. Outcomes improvements in patients suffering from these and other similar cancers will likely continue to be very difficult to achieve unless Precision Medicine approaches are applied. However, in order for the practice of Precision Medicine in Oncology to advance several major challenges must be overcome:
- Development of detailed standards for the identification and reporting of actionable somatic genomic variants in cancer patient samples
- Establishment of data repositories, adhering to actionable somatic genomic variant calling standards, for recording cancer patient responses to therapy and matching the responses to their genomic profiles
- Clinical validation of the algorithm generation approach
- Development of frameworks to allow companies to collaborate and to give treating oncologists access to a broad range of experimental medicines, allowing them to treat patients with optimal combinations
- Clinical programs and regulatory frameworks supporting these approaches, allowing successful approaches to be commercialized
Many of these challenges require broad collaborations across company and specialization boundaries to involve academics, treating clinicians, pathologists, regulators and diagnostic, pharma and IT companies. My presentation will focus on the drug development challenges which will likely follow the application of precision medicine approaches in the field of oncology.
1. Understanding the impact that Next Gen. Sequencing will have on Oncology Drug Development
2. Understanding the opportunities and challenges which are likely to arise as consequence of the implementation of Precision Medicine approaches in Oncology.