BIOMARKERS
(eg companion diagnostic versus early detection tool).
Early-phase discovery and validation can take two to five years, during which biomarkers are identified, analytically validated, and correlated with disease states across multiple cohorts. From there, promising candidates enter the translational research and clinical validation stage, requiring another three to five years for large-scale studies, reproducibility checks, and regulatory guidance alignment.
If the biomarker is intended for diagnostic use, regulatory clearance (such as FDA approval or CE marking) adds two to four years depending on whether it’s classified as a Laboratory Developed Test (LDT), IVD, or part of a companion diagnostic. For biomarkers integrated into therapeutic trials, timelines align with drug development phases – spanning seven to 10-plus years – as the biomarker may serve as a patient selection tool, response marker, or safety endpoint.
How have funding requirements for research changed? With a competitive research landscape demanding funding to accelerate innovations and breakthrough therapies, the pressure to demonstrate flexibility and real-world impact is reshaping how researchers design their programmes. Research sponsors want to ensure their funds are supporting programmes with the highest likelihood of delivering meaningful, data-backed results. This means that researchers need to place a greater emphasis on demonstrating impact and measurable results. Given the complexity involved, researchers must also define clear timelines while maintaining the flexibility to adapt to changes as needed. To investigate the most pressing questions in disease research, increasingly sophisticated tools are required, whether nucleic acid, protein, small molecule or multi-omic. Additionally, highly characterised biospecimens or unique biological model systems need to be used to unlock insights. When funding is tight, researchers do not have the ability to employ the latest tools or get the
Advancing research into clinical breakthroughs demands integration of many dynamic components, for pharmaceutical companies this means having a broad network, resources and relevant partnerships.
specimens they need, putting pressure on funding sources to either increase funds or pursue collaborations to pool resources.
What are the pros and cons of government/institution-funded versus privately funded research? As the demand for research funding for innovative therapies increases, we’re seeing a teetering balance between government/institution and private funding as they play a critical role in shaping the direction, pace and impact of scientific research. Often, government/institutionally
funded research involves a lengthy process where findings are peer-reviewed frequently ensuring quality, consistency and reproducibility. Public funding often allows for more exploratory research as it isn’t necessarily tied to a commercial launch; this means researchers have more freedom to advance broader knowledge. As the findings from these research programmes are public, it promotes collaboration and transparency that drives further research into new areas.
Additionally, these programmes will often be focused on initiatives that drive better health outcomes for broader public health applications.
Privately funded research has fewer budget constraints and a more streamlined timeline as it is often associated with a commercial launch. While these initiatives have a more localised focus, they bring together significant resources, align to meet market needs and drive innovation. However, the research direction is typically determined by the sponsor, and findings are often kept confidential. While government/institutionally
funded research supports broader research initiatives, privately funded research enables a more targeted approach centred on advancing innovations in diseases once considered incurable and untreatable.
With a competitive research landscape demanding funding to accelerate innovations and breakthrough therapies, the pressure to demonstrate flexibility and real-world impact is reshaping how researchers design their programmes
66
Good examples of collaborations involving both public and private funding are programmes that curate large cohorts of well-characterised biospecimen from various diseases. Initiating these projects requires the foresight to recognise the long-term value these cohorts offer to biomarker researchers and test developers. Spanning years or even decades, such cohorts enable faster validation of new biomarker tests in a retrospective setting, providing critical evidence before advancing to prospective studies.
What are the implications of reduced funding from public bodies towards biomarker research?
AUGUST 2025
WWW.PATHOLOGYINPRACTICE.COM
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72
