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With uncertainty surrounding the future of government funding, the onus is being placed on the private sector to continue driving new discoveries.
Michael Miller, PhD
Chief operating officer
Quanterix
For almost 140 years, the National Institutes of Health (NIH) has provided support through grant funding and other resources to help drive biomedical research forward and improve the lives of patients. Recently, regulatory actions and political shifts have created uncertainty regarding the continuation of that support, leading to concerns about the future of government-funded research initiatives.
As the largest public funder of biomedical research in the United States, the NIH has historically played a crucial role in advancing new drug innovations and breakthroughs. While the NIH is slowly resuming its study section meetings and grant reviews, operations are still far from fully returning to normal––with new changes continuing to roll out weekly. With uncertainty surrounding the future of government funding, the onus is being placed on the private sector (particularly pharmaceutical companies) to continue driving new discoveries that will power future therapies for the patients who need them.
One critical area where the private sector is stepping up to meet this moment is biomarker research. Biomarkers, which provide valuable insights into new drug safety, efficacy, and progression, are becoming increasingly important in advancing biomedical innovation. Collaborative efforts are driving progress in biomarker discovery and development, and the pharmaceutical industry is adapting to the challenges of advancing research and development posed by regulatory uncertainty.
Improving patient health outcomes depends on continuous scientific advancements and medical innovation to develop novel therapies. Pharma companies are now taking on greater responsibility in driving forward research that might have previously relied on public funding and may now be hindered by regulatory or funding delays. Pharmaceutical companies must have the necessary networks, resources, and partnerships to advance critical innovations.
Collaborative programs provide clinical researchers with the resources to accelerate biomarker discovery and development through direct partnerships with pharma and life science companies. These programs not only enhance the pace of scientific progress but also provide a practical framework for moving therapies through the pipeline from early-stage research to clinical applications, ensuring that breakthroughs reach patients in a timely manner.
Biomarkers are playing an increasingly important role1 in today’s clinical trials. Initially used to indicate the presence of a disease, biomarkers have evolved into essential tools in pharmaceutical research, used to monitor disease progression and assess therapeutic efficacy. In this context, biomarkers are no longer just tools for diagnosis but are critical to determining the effectiveness of treatments and therapies.
While biomarkers’ value to both diagnosis and treatment is well-known within our industry, there is still immense opportunity to expand their role in understanding comorbidities and disease progression, in addition to further streamlining diagnostic pathways. Biomarkers like p-tau 217 have been established as essential to the study of neurodegenerative diseases like Alzheimer's and new research is highlighting the value of measuring multiple biomarkers to develop a more complete picture of these diseases.
A study published in Nature2 earlier this year examined p-tau 181, p-tau 217, total tau (t-tau), NfL and GFAP and established an understanding of these biomarkers for patients without dementia at baseline. These findings will help researchers better identify treatments that are most effective in treating neurodegenerative diseases, track their progress through clinical trials and enable more efficient drug development.
Conducting cutting-edge research to drive breakthrough developments often requires developing custom assays to test novel biomarkers. This is a complex, time-intensive process, requiring expertise and resources for extensive testing of antibody pair combinations. Unfortunately, success isn’t guaranteed, and often advanced skills with biomarkers and assay platforms is needed to navigate the path to a functional assay. Even when assays are developed, it can be a challenge to ensure quality control and performance.
Instead of navigating this journey alone, many pharmaceutical companies are instead choosing to partner with specialized research facilities and labs to improve their odds of success.
Through partnerships with private sector labs, pharmaceutical companies can accelerate their research timelines and increase the accuracy and reliability of their findings.
The shifting balance between government-funded and private research has placed the future of drug development and biomarker research at a crossroads, and I expect to see the pharmaceutical industry taking a more prominent role in supporting research and advancing novel discoveries. These organizations are positioned to drive significant innovation through collaboration in drug discovery, biomarker testing and pathology studies.
The role of biomarkers in drug development and clinical trials will only continue to grow, and the private sector must be at the forefront of driving these advancements to ensure that patients receive the best possible care and that new treatments are brought to market. By fostering collaboration and investing in research, pharma companies can play a vital role in shaping the future of medical innovation and improving patient outcomes in the years to come.
Michael Miller, PhD., is chief operating officer at Quanterix.
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