Tag: Biomarker

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Protein Biomarkers in Practice: Strategies to Reduce Drug Development Risk

Drug development demands scientific rigor, sustained investment, and confident decision-making under uncertainty. As programs move from early discovery into clinical development, teams must balance biological complexity, timelines, and capital allocation— often without sufficient translational insight. Selecting the wrong target or patient population can result in costly delays and increased clinical risk.

Protein biomarkers are becoming central to how pharmaceutical leaders reduce that risk and guide strategy. Unlike static genomic associations, proteins provide dynamic, functional insights into disease biology, reflecting pathway activity, target engagement, and treatment response in real-time. Advances in high-throughput proteomic technologies have transformed protein biomarkers from exploratory tools into strategic assets applied across the drug development lifecycle.

When integrated early, biomarker-driven approaches can strengthen target validation, support proof-of-mechanism studies, enable more precise patient segmentation, and provide measurable indicators of efficacy and safety. The result is more informed decision-making, improved trial design, and greater confidence as programs advance.

This eBook is designed to deliver both strategic insight and practical guidance. It opens with a White Paper informed by expert perspectives from senior translational leaders at leading pharmaceutical organizations. These experts explore how protein biomarkers mitigate risk across the drug development continuum, from early target validation to clinical trial design, by strengthening biological confidence and enhancing decision quality.

Building on these strategic insights, the eBook presents seven real-world application examples that illustrate how these approaches are implemented in practice. Together, these perspectives provide readers with actionable frameworks and concrete use cases to help reduce uncertainty, optimize patient selection, improve trial efficiency, and make more confident, data-driven decisions earlier in development.

The post Protein Biomarkers in Practice: Strategies to Reduce Drug Development Risk appeared first on GEN – Genetic Engineering and Biotechnology News.

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Markers of neuroinflammation in the CSF of patients with difficult to treat psychiatric disease

IntroductionThe immune system is recognized as participating in the pathophysiology of psychiatric disease and there is renewed interest in identifying biomarkers of this immune activation. MethodsWe measured serum and cerebral spinal fluid (CSF) autoantibodies with other routine and novel markers of neuroinflammation, including CSF cytokines in patients with atypical psychiatric presentations of both psychotic and mood disorders (n=35). Their markers were compared with cohorts of non-inflammatory neurological disease (NIND) controls (n=18), patients with central nervous system (CNS) viral infection (n=22) and autoimmune encephalitis (AE; n=40). ResultsThe most common autoantibody detected in the serum of patients with psychiatric disease were anti-nuclear antibodies followed by thyroid autoantibodies. Few atypical psychiatric patients had abnormal conventional CSF markers of neuroinflammation (pleocytosis, oligoclonal bands, abnormal CSF IgG: albumin ratio). Further analysis of CSF revealed elevation of ITAC/CXCL11 in the psychiatric cohort. TARC/CCL17 was lower in the psychiatric cohort compared to other groups in a random-effects multinomial model, despite no significant differences on univariate analysis. When the values of CSF cytokines were examined in individual patients, six patients (17%) had at least one CSF cytokine greater than four standard deviations above the mean of the NIND cohort group. Extensive serological evaluation revised the diagnoses of six (17%) of our psychiatric group, and these patients’ showed improvement with immunosuppression. ConclusionOur results suggest a subset of people with atypical psychiatric disease may have a predominant immune contribution. This highlights the need for reevaluation and further consideration of differential diagnosis where patient presentations are not clinically typical, do not respond to conventional psychotropic treatment, or if other risk factors for autoimmunity are present.
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Research trends and knowledge mapping of transcranial direct current stimulation in depression: a bibliometric study based on web of science, Scopus, and PubMed (2000-2025)

BackgroundDepressive disorders are clinically heterogeneous and mechanistically complex psychiatric conditions. Transcranial direct current stimulation (tDCS), a key non-invasive neuromodulation technique, has expanded rapidly in both therapeutic application and mechanistic research. However, the field is marked by rapid publication growth, thematic diversity, and variability in evidence quality. A systematic quantitative synthesis is therefore needed to map the research landscape, identify hotspots, and inform future directions.MethodsA systematic search was conducted for English-language publications in the Web of Science Core Collection (WoSCC), Scopus, and PubMed using the terms (“Transcranial direct current stimulation” OR “tDCS”) AND (“depression” OR “major depressive disorder” OR “depressive disorder” OR “MDD”). Only articles and reviews were included. Records from 2026 and non-research publications, including conference abstracts, editorials, letters, news items, and errata, were excluded. Deduplication was performed using DOI-based matching followed by title-assisted matching. Bibliometrix (R), VOSviewer, and CiteSpace were used to analyze publication trends, contributions by countries/regions, institutions, authors, and journals, collaboration networks, keyword co-occurrence, thematic clustering, and burst terms. Citation analysis was based on WoSCC data only.ResultsResearch on tDCS for depression showed sustained growth, with marked acceleration after 2020 and a peak in 2024. The United States, Germany, and Brazil occupied central positions in both productivity and international collaboration, with the United States ranking first in publication volume. Major research hubs included the Universidade de São Paulo, the University of Toronto, and Harvard University, while Brain Stimulation, Journal of Affective Disorders, and Frontiers in Psychiatry were the leading publication venues. Highly cited studies mainly focused on neurophysiological mechanisms, pivotal randomized controlled trials, and evidence-based guidelines. Keyword analyses indicated a shift from early attention to cortical excitability, safety, and short-term efficacy toward a more integrated framework involving prefrontal-targeted stimulation, cognitive function, functional connectivity, treatment outcomes, and cross-disorder applications.ConclusiontDCS research in depression is entering a multidimensional and interdisciplinary phase, with increasing emphasis on network-level mechanisms and precision intervention. Functional connectivity is emerging as a potential biomarker for patient stratification and outcome prediction. Further progress depends on multicenter standardization, reproducible analytic pipelines, and high-quality comparative effectiveness research.
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<![CDATA[DSM-6 forces psychiatry to choose: sharper science or softer labels. Explore why validity, biomarkers, and hierarchy matter for credibility.]]>
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Clinical application of 1H MRS in the human brain at 7T

Proton magnetic resonance spectroscopy (1H MRS) enables non-invasive biochemical sampling of tissues, potentially aiding diagnosis, prognosis and monitoring of various pathologies, while providing novel imaging biomarkers. Ultra-high-field (UHF) imaging at 7 tesla (7T) benefits from improved spectral dispersion due to an increase in chemical shift differences between metabolites, and a higher signal-to-noise ratio (SNR), making 1H MRS at 7T a particularly promising diagnostic tool for identifying and separating metabolites not clearly resolved at lower field strengths. However, 1H MRS at UHF presents technical challenges related to the short RF wavelength at 7T, resulting in B1 transmit field inhomogeneity, and the increased magnetic susceptibility gradients leading to B0 field inhomogeneity. Appropriate MRS methods are required to address these issues. In this article, we describe the technical aspects and challenges of 1H MRS at 7T, based on the experience in our centre, where single voxel 1H MRS has featured prominently in clinical 7T research applications for several years. We present data from six patients with glial tumours, including three who were post-operative, in whom post-surgical metalware affects the specific absorption rate (SAR), along with two patients with neuroinflammatory conditions and two with neurodegenerative diseases. The potential clinical use of 1H MRS for these pathologies and its possible integration as a promising biomarker into advanced imaging pathways are discussed.
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First Atlas of Female Reproductive System Maps Uncharted Menopause Biology

The first large-scale study across all major female reproductive organs has uncovered how aging processes impact each organ and tissue in unique ways. Published today in Nature Aging, the study has identified novel blood biomarkers that could help physicians anticipate health risks associated with menopause, such as pelvic floor prolapse. 

“Until now, we tended to consider menopause mainly as the end of the ovary’s reproductive function,” says Marta Melé, PhD, leader of the transcriptomics and functional genomics group at the Barcelona Supercomputing Center (BSC) and director of the study. “However, our results show that it acts as a turning point that profoundly reorganizes other organs and tissues of the reproductive system, and allow us to identify the genes and molecular processes that could be behind these changes.”

Menopause is a complex biological process with significant implications for overall health, which is estimated to be actively affecting 6% of the world’s population at any given time. However, the cellular and molecular processes driving it across reproductive organs and tissues have historically remained understudied. 

To map the complex biology of menopause, Melé’s team analyzed 1,112 tissue images and 659 RNA sequencing samples from 304 women between the ages of 20 and 70. This allowed the researchers to reconstruct aging trajectories of the uterus, ovary, vagina, cervix, breast, and Fallopian tubes. Using deep learning algorithms, they were able to identify key changes associated with aging in each organ, both at the molecular and tissue levels. 

Results showed that not all organs age uniformly across the female reproductive system. For instance, the ovary and vagina were shown to age gradually in a process starting years before menopause. Meanwhile, the uterus undergoes a very abrupt transition during menopause. 

Even within the same organ, different tissues were shown to age in distinct ways. In particular, the muscle tissue of the uterine wall and the vaginal epithelium were observed to be the most affected during menopause, undergoing sharp changes. 

The study also analyzed blood plasma samples from 21,441 women, which led to the identification of molecular signals of aging that can be detected in the blood. These biomarkers could offer non-invasive monitoring of female reproductive organs during menopause and enable more accessible, less invasive follow-up tests for women at risk of complications associated with menopause, such as pelvic floor prolapse. 

“We not only identified the molecular changes underlying the aging of these organs, but we also saw that they can be detected in blood, which opens the door to new clinical tools,” says Oleksandra Soldatkina, PhD, lead author of the study and researcher at BSC.

This study marks a step toward better understanding a key biological process that has historically been left behind, leading to better prevention, diagnosis and treatment of multiple diseases linked to menopause. The researchers highlighted that their findings “position menopause as a key inflection point in female aging and provide insights with tissue-specific focus to support healthier menopausal transitions and reduce age-related disease risk.”

The post First Atlas of Female Reproductive System Maps Uncharted Menopause Biology appeared first on Inside Precision Medicine.

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Plasma Biomarker Patterns Distinguish Early-Onset Dementia

Plasma biomarker levels change in differing ways for different types of early-onset dementia, with unique clinical associations that could help stratify risk in patients, research suggests.

The findings may help improve detection and prognosis of these neurodegenerative diseases, which manifest before the age of 65 years and are often challenging to treat due to atypical symptoms and clinical heterogeneity.

The report, in JAMA Network Open, revealed differences in both the concentrations of biomarkers over time and their association with clinical outcomes in early-onset Alzheimer disease (EOAD) and frontotemporal dementia (FTD).

“Our results highlight disease-specific plasma biomarker dynamics and their potential utility in monitoring disease progression in early-onset dementia,” reported Eun-Joo Kim, PhD, from Pusan National University Hospital in Korea, and colleagues.

Recent developments with plasma biomarkers have changed the landscape of dementia diagnosis.

Phosphorylated tau 217 (p-tau217), a marker specific of Alzheimer’s disease, has been found to be highly accurate in detecting its pathology.

Meanwhile, glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) are emerging as astrocytic activation and neurodegeneration markers, respectively, with NfL particularly relevant for FTD.

Combining p-tau217 and NfL could therefore enable Alzheimer’s disease and FTD, two leading causes of dementia at an early age, to be distinguished.

To investigate further, Kim and team compared biomarker trajectories and clinical outcomes in 322 patients with EOAD and FTD, of whom 245 had EOAD and 77 FTD.

Around two thirds of each group was female, and the mean age was in the early to mid 60s.

High baseline levels of p-tau217, GFAP, and NfL were significantly associated with all clinical outcomes in the EOAD group, assessed using scores on the Mini-Mental State Examination (MMSE) and Clinical Dementia Rating–Sum of Boxes (CDR-SB).

However, among patients with FTD, only baseline GFAP and NfL were associated with decreases in MMSE scores.

The association of p-tau217 and GFAP levels with clinical outcomes was greater at earlier stages of EOAD, with the former biomarker showing no association at later stages of disease.

The plasma biomarkers followed distinct longitudinal trajectories in the two forms of early-onset dementia. In the EOAD group, the levels of all three biomarkers increased significantly over time, but with FTD only NfL increased.

Annualized changes in levels of all three biomarkers showed outcome-specific associations with clinical decline in EOAD. GFAP and NfL changes were associated with declines in MMSE score and p-tau217 levels with worsening CDR-SB score in this group. No such associations were observed for patients with FTD.

“In this multicenter, prospective cohort study of patients with EOAD and FTD, the clinical relevance of plasma biomarker levels and longitudinal changes may vary between EOAD and FTD,” the authors summarized.

“These findings may inform future clinical practice and trial design regarding stratifying patient populations and monitoring clinical progression, particularly in EOAD.”

The post Plasma Biomarker Patterns Distinguish Early-Onset Dementia appeared first on Inside Precision Medicine.

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<![CDATA[New US patent backs Denovo’s ANK3 biomarker guiding DB104 for treatment‑resistant depression, highlighting promising efficacy in selected patients.]]>