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 test and drug for the simultaneous submission to FDA, has led to a major alteration in the way that drugs are being developed, with traditionally separate entities—pharmaceutical and diagnostic companies—now working in close collaboration.
Table of Contents
|2 Regulatory Perspectives||7-18|
|3 Perspectives from Patients, Providers, and Laboratory Representatives||19-28|
|4 Perspectives of Diagnostic Test and Pharmaceutical Developers||29-40|
|5 Perspectives of Payers and Regulators||41-48|
|6 Concluding Observations||49-54|
|Appendix A: Workshop Agenda||57-62|
|Appendix B: Speaker Biographical Sketches||63-74|
|Appendix C: Statement of Task||75-76|
|Appendix D: Registered Attendees||77-82|
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