A key focus at this year’s AMP conference is Next Generation Sequencing (NGS), transformative first for diagnostics but increasingly for biopharma development and patient care. Rapid progress in NGS is essential for development of many oncology drugs. You also see ample evidence at AMP that NGS will drive remarkable advances across the therapeutic spectrum. NGS technologies are migrating to screening of newborns, diagnosing multigenic disorders, diagnosing immune deficiencies and on and on. But for now, oncology remains at center stage for NGS.
Oncology trials are complex enough when companion diagnostics are involved. There are projects that evaluate multiple drug regimens, multiple genomic biomarkers for identifying responsive patients and the effectiveness of multiple tests to identify subjects with each biomarker. The good news is that when all goes well, a multiarm adaptive trial can identify an effective biomarker and appropriate subjects for a targeted therapy, resulting in stronger efficacy results for those subjects. This points the way to higher success rates in future clinical trials – you’re bound to get better results when you can identify the right patients and treat them with the right drug.
If development involving companion diagnostics is complex, the growing use of tumor genomics in oncology trials takes complexity to another level. The posters and corporate workshops at AMP convince me that NGS developers are up to the challenge of targeting the mutations responsible for the invasive characteristics of a tumor.
Some researchers have pointed out that in most failed trials of targeted therapies, what failed was the targeting, not the drug. The AMP meeting showed that our molecular diagnostics colleagues will enable biopharma companies to target the right subjects with increasing frequency. This foreshadows higher success rates despite the increasing complexity of clinical trials.
NGS development is challenge enough without recent Medicare pricing guidelines for molecular diagnostics that increase pressure for developers to run lean and fast. That’s not easy when you’re working at the frontiers of science. Successful clinical development requires systems and processes that effectively manage complex trials while reducing timelines, risk and cost. Developing such capabilities has been Health Decisions’ mission for almost 25 years.
Guest blogger: John Worden, Health Decisions Director of Strategic Business Development. John follows the biopharma and medical device industries closely and has a strong interest in molecular diagnostics. We asked him to share his takeaways from the Association for Molecular Pathology Annual Conference this week in Phoenix.