Refining Processes for the Co-Development of Genome-Based Therapeutics and

National Academies Press

Many drug developers have examined new strategies for creating efficiencies in their development processes, including the adoption of genomics-based approaches. Genomic data can identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and has the potential to significantly reduce the cost of clinical trials by reducing the number of patients that must be enrolled in order to demonstrate safety and efficacy. A key component of the approval of targeted therapeutics is the ability to identify the population of patients who will benefit from treatment, and this has largely hinged on the co-development and co-submission to the FDA of a companion diagnostic test.The co-development process, or the development of the\n\nRefining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests\nWorkshop Summary\nFree UK delivery on this item.\n\nThis brand new item is available with free ;