Biomarkers

Wehling, Martin

doi:10.1016/b978-0-12-820493-1.00019-2

Cited by 3 publications

(2 citation statements)

References 41 publications

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“…Regarding the professional background, clinical pharmacologists (for drug projects) with experiences in pharmaceutical industry appear to be most suitable. Most drug companies have addressed the challenges of translation by establishing specialized departments, and access to professional specialization in and teaching of translational science in medicine has become easier in recent years [ 142 ]. However, as some of the COVID-projects or other recently failed projects show, the translational crisis is not yet over and structured prospective scoring may help to further improve the outcomes.…”

Section: Discussionmentioning

confidence: 99%

Translatability scoring in prospective and retrospective COVID drug development cases

Wendler

Wehling

2023

Eur J Clin Pharmacol

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Background The ongoing pandemic of severe acute respiratory syndrome coronavirus 2 has led to an enormous surge of clinical research. So far, the speed and success rate of related drug development projects, especially of vaccines, is unprecedented. For the first time, this situation allowed for the opportunistic evaluation of a translatability score, originally proposed in 2009, in a prospective manner. Methods Several vaccines and treatments under development in clinical phase III trials were selected for translational scoring with the translatability score. Six prospective and six retrospective case studies were performed. The scores had to be determined for a fictive date before any results of the phase III trial were reported in any media. Spearman correlation analysis and a Kruskal Wallis test were performed for statistical evaluation. Results A significant correlation between the translatability scores and the clinical outcomes in translation was found, as judged on the basis of positive/intermediate/negative endpoint studies or market approval. The Spearman correlation analysis of all cases (r = 0.91, p < 0.001), the prospective cases alone (r = 0.93, p = 0.008), and the retrospective cases alone (r = 0.93, p = 0.008) showed a strong correlation between the score and outcome; R2 demonstrated a score-derived determination of outcomes by 86%. Conclusions The score detects strengths and weaknesses of a given project, resulting in the opportunity of selective amelioration of a project, as well as prospective portfolio risk balancing. Its substantial predictive value that has been demonstrated here for the first time could be of particular interest for biomedical industry (pharmaceutical and device manufacturers), funding agencies, venture capitalists, and researchers in the area. Future evaluations will have to address the generalizability of results obtained in an exceptional pandemic situation, and the potential adaptations of weighing factors/items to particular therapeutic areas.

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Section: Discussionmentioning

confidence: 99%

Translatability scoring in prospective and retrospective COVID drug development cases

Wendler

Wehling

2023

Eur J Clin Pharmacol

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“…A biomarker refers to any characteristic or measurement of a biological sample or medical condition that can be accurately and reliably measured. In other words, it is a way to describe or quantify features of a biological system [ 27 , 28 ]. On the other hand, the term “marker” is more encompassing, referring to any discernible attribute, substance, or indicator that can be employed to identify, measure, or monitor a particular condition, disease, or biological process [ 29 ].…”

Section: Introductionmentioning

confidence: 99%

Current State of Knowledge on Blood and Tissue-Based Biomarkers for Opisthorchis viverrini-induced Cholangiocarcinoma: A Review of Prognostic, Predictive, and Diagnostic Markers

Kafle,

Suttiprapa

2024

Asian Pac J Cancer Prev

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Cholangiocarcinoma (CCA) is a prevalent cancer in Southeast Asia, with Opisthorchis viverrini ( O.viverrini ) infection being the primary risk factor. Most CCA cases in this region are diagnosed at advanced stages, leading to unfavorable prognoses. The development of stage-specific biomarkers for Opisthorchis viverrini -induced cholangiocarcinoma (Ov-CCA) holds crucial significance, as it facilitates early detection and timely administration of curative interventions, effectively mitigating the high morbidity and mortality rates associated with this disease in the Great Mekong region. Biomarkers are a promising approach for early detection, prognosis, and targeted treatment of CCA. Disease-specific biomarkers facilitate early detection and enable monitoring of therapy effectiveness, allowing for any necessary corrections. This review provides an overview of the potential O. viverrini -specific molecular biomarkers and important markers for diagnosing and monitoring Ov-CCA, discussing their prognostic, predictive, and diagnostic value. Despite the limited research in this domain, several potential biomarkers have been identified, encompassing both worm-induced and host-induced factors. This review offers a thorough examination of historical and contemporary progress in identifying biomarkers through multiomics techniques, along with their potential implications for early detection and treatment.

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A Review on Machine Learning and Deep Learning Based Approaches in Detection and Grading of Alzheimer’s Disease

Bhadra,

Sengupta

2023

Communications in Computer and Information Science

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Biomarkers

Cited by 3 publications

References 41 publications

Translatability scoring in prospective and retrospective COVID drug development cases

Translatability scoring in prospective and retrospective COVID drug development cases

Current State of Knowledge on Blood and Tissue-Based Biomarkers for Opisthorchis viverrini-induced Cholangiocarcinoma: A Review of Prognostic, Predictive, and Diagnostic Markers

A Review on Machine Learning and Deep Learning Based Approaches in Detection and Grading of Alzheimer’s Disease

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