Adapting to a Changing Research Funding Landscape

In a recent video interview with Applied Clinical Trials, Michael Miller, chief operating officer, Quanterix, discussed how the clinical research industry is increasingly integrating biomarkers. Biomarkers are particularly beneficial in neurology, where advancements in imaging and blood tests have improved trial outcomes, and in oncology, where multiomic approaches and protein tissue imaging aid in matching therapies to mutations. Synopsis professionals should focus on the biomarker's purpose, technical requirements, and regulatory compliance. Platform trials and biomarkers are also driving accelerated drug approvals. These advancements are crucial for biopharma companies navigating the shift between private and government-funded research.

Miller: I can think of a couple areas. One is, in terms of, let's say biotechs or smaller companies, probably not so much large pharma, but participating in platform trials as a way of having a more efficient clinical trial approach. A platform trial is where a particular institution or different institutions will pull money together to be able to recruit patients within a particular disease area. Sometimes it's rare diseases because they're less available and harder to recruit, and then multiple drug companies can come and access that population and do subsets of that population, give them drugs, track their outputs, and the infrastructure is put together by the platform so each company doesn't have to do that lift. That's one example I can think of that can help people be more efficient given the times, and do things like that.

The other relates back to one of the main themes of this discussion, which is biomarkers. In the example I'll cite here is that biomarkers have allowed people to get accelerated approval for drugs that have a breakthrough designation. One example in the neurology area was a blood test for neurofilament light that was used to gain accelerated approval for an ALS drug, so that's an example. That's a technology that Quanterix was involved in, neurofilament light, making that commercializing that assay, but that's a huge gain to where now you have a rare disease, it's very difficult to track clinical outcomes, and here's a biomarker that can show efficacy by giving you a signal of lower levels of neurodegeneration that then can speed going to getting regulatory approval. Again, accelerated regulatory approval, nonetheless, it allows them to get them to market faster and advance the drug.