Bridging science and care: Advancing biomedical innovation
Behind every breakthrough therapy and every promising clinical trial result is a foundation forged in laboratories – where diagnostic science, assay development, and biomarker validation are quietly powering the pipeline of modern medicine. As professionals working in labs and clinical services, we support innovation by operationalising it.
Today, that role is more critical than ever. Historically, the National Institutes of Health (NIH) and other public institutions have funded and coordinated much of the early-stage research that drives drug development; however, recent political and regulatory decisions have cast doubt on the stability of this support. In the meantime, demand for new treatments has continued to grow, placing enormous pressure on the private sector to fill the gap.
But research alone doesn’t deliver outcomes. The path from biomarker discovery to regulatory approval and clinical use is long and complex, and the clinical lab is where a significant amount of that critical translational work happens. As public funding becomes more uncertain, lab and clinical services professionals are increasingly being called on to help pharma, biotech, and diagnostics companies maintain, and accelerate, momentum.
The expanding role of labs in private-sector research
For decades, the NIH has been the bedrock of US biomedical innovation, funding the kind of exploratory research that eventually becomes the basis for new diagnostics and therapies. Earlier this year, that support all but ceased completely. Even as study section meetings, grant reviews, and regulatory rollouts resume, private-sector organisations like pharmaceutical companies are being pushed to take the lead in early discovery areas once driven mainly by public funding.
This shift isn’t theoretical. It’s something we see every day in clinical and research labs across the country. Pharma companies are increasingly turning to contract labs not just for testing support, but also for collaborative development of new strategies, faster clinical validation, and robust assay design that can meet regulatory standards.
Lab services have become a critical accelerator for transforming scientific hypotheses into validated tools that can be deployed in clinical trials or integrated into care pathways.
Biomarkers: More than just measurement
Biomarkers are no longer just indicators of disease; they are becoming increasingly central to how we monitor disease progression, predict treatment response, and personalise patient care. As scientists, we see firsthand how biomarkers influence trial design, patient stratification, and regulatory decision-making.
Take p-tau217, a key biomarker in Alzheimer’s disease research. In developing and validating assays for neurodegenerative diseases, the effectiveness of measuring p-tau alongside other markers like p-tau181, NfL, GFAP, and total tau helps researchers form a clearer picture of disease onset and progression. A recent study published in Nature expanded on this concept, profiling these biomarkers in patients without dementia at baseline. This kind of work is only possible when pharmaceutical researchers partner directly with specialty labs that can develop and validate reliable, high-throughput assays to measure these complex biological signals.
And that’s just one example. Across oncology, neurology, cardiology, and infectious diseases, biomarker panels are transforming how we approach clinical trials and personalised medicine. But, without strong partnerships, those biomarkers often remain stuck at the discovery stage, never reaching the patients who need them most.
Custom assays and clinical validation
Developing new biomarker assays is highly specialised work. It requires careful screening of antibody pairs, sensitivity and specificity testing, and performance validation across different sample types and platforms. It also requires relentless quality control and the ability to adapt quickly as trial protocols evolve.
Labs that specialise in custom assay development are now essential to how pharmaceutical and biotech companies advance their therapies. From early feasibility testing through late-stage clinical trial support, lab teams help ensure that biomarkers are not only scientifically valid, but also clinically actionable.
This work is time-intensive and resource-heavy, and it’s an area where contract labs bring unmatched expertise, guiding pharma partners through the regulatory and technical hurdles that often delay or derail drug pipelines.
Collaboration as the catalyst for progress
If there’s one lesson most people in the industry are familiar with, it’s that science moves most efficiently and effectively when stakeholders collaborate early and often. That’s why many pharmaceutical companies are no longer treating outsourced labs as transactional vendors, but as strategic partners embedded in the innovation process. Through these partnerships, pharma organisations are accelerating development timelines, increasing test accuracy, and reducing the risks associated with assay development and validation. The result: better data, faster trials and, ultimately, faster access to life-changing therapies for patients.
As federal funding uncertainty persists, these collaborations will be even more critical in allowing research to move forward without interruption. The future of drug development depends on our ability to turn promising scientific discoveries into validated, clinically useful tools. That work doesn’t happen in isolation. It happens in labs and clinical settings where science meets patient care.
As a leader on the lab side of these partnerships, I know our role is not only technical; it’s strategic. By building strong partnerships, investing in assay innovation, and maintaining the highest standards of quality, we can help the pharmaceutical industry continue to deliver on its promises.
Sources
Insights into the use of biomarkers in clinical trials in Alzheimer's disease. eBioMedicine. October 2024. https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00358-X/fulltext
Diagnosis of Alzheimer’s disease using plasma biomarkers adjusted to clinical probability. Nature aging. November 12, 2024. https://www.nature.com/articles/s43587-024-00731-y
About the author
Jorge Marques Signes, PhD, is VP of accelerator lab & clinical services at Quanterix, where he leads assay development, validation, and clinical trial support. He brings over 15 years of experience in analytical development, next-generation sequencing, and GMP operations. Prior to joining Quanterix, he held scientific leadership roles across biotech and pharmaceutical companies, guiding programmes from discovery through commercialisation and bridging assay innovation with regulatory and clinical strategy.
