Application of Commercial Research-Grade Biomarker Assays in Drug Development: Is It Time to Create ‘Pharmaceutical-Grade’ Kits?

Bowsher, Ronald R.; Nowatzke, William; Sailstad, Jeffrey; Khan, Masood

doi:10.4155/bio.12.238

Cited by 9 publications

(4 citation statements)

References 22 publications

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“…Andreasson, Blennow and Zetterberg[11] provided an update and overview of ultrasensitive technologies to measure AD-related biomarkers in blood as well as CSF. While still early in the process, these novel assay technologies have the capacity to detect very low-levels of markers that may be of significant advantage when seeking to move from research-grade to “pharmaceutical-grade” kits in future attempts to take research use only (RUO) methods towards laboratory developed tests (LDTs) and in vitro diagnostics (IVDs)[12, 13]. As evident from the continued progress of the Global Biomarkers Standardization Consortium of CSF biomarkers (GBSC), the blood-based biomarker field will need to address additional methodological barriers in order to produce clinically useful and applicable biomarkers.…”

Section: Current State Of the Sciencementioning

confidence: 99%

Blood‐based biomarkers in Alzheimer disease: Current state of the science and a novel collaborative paradigm for advancing from discovery to clinic

O’Bryant

Mielke

Rissman

et al. 2016

Alzheimer's & Dementia

250

226

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The last decade has seen a substantial increase in research focused on the identification of blood-based biomarkers that have utility in Alzheimer’s disease (AD). Blood-based biomarkers have significant advantages of being time- and cost-efficient as well as reduced invasiveness and increased patient acceptance. Despite these advantages and increased research efforts, the field has been hampered by lack of reproducibility as well as an unclear path for moving basic discovery towards clinical utilization. Here we reviewed the recent literature on blood-based biomarkers in AD to provide a current state-of-the-art. Additionally, a collaborative model is proposed that leverages academic and industry strengths to facilitate the field in moving past discovery only work and towards clinical use. Key resources are provided. This new public-private partnership model is intended to circumvent the traditional hand-off model and provide a clear and useful paradigm for the advancement of biomarker science in AD and other neurodegenerative diseases.

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Section: Current State Of the Sciencementioning

confidence: 99%

Blood‐based biomarkers in Alzheimer disease: Current state of the science and a novel collaborative paradigm for advancing from discovery to clinic

O’Bryant

Mielke

Rissman

et al. 2016

Alzheimer's & Dementia

250

226

View full text Add to dashboard Cite

show abstract

“…This can be a win-win proposition for the bioanalytical community and the kit manufacturers. There have been calls in the past from the industry for kits developed specifically for drug development in the same vein as kits developed specifically for diagnostics (e.g., pharmaceutical grade) [20]. However, we believe the framework and recommendations for kit contents and assay performance presented here set the foundation for these kits for discussion of the practical considerations at future meetings.…”

Section: Intended Use Full Validation Full/partial Validation Exploramentioning

confidence: 95%

Adaptation of Commercial Biomarker Kits and Proposal for ‘Drug Development Kits’ to Support Bioanalysis: Call for Action

Islam

Kar

Islam³

et al. 2018

Bioanalysis

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There has been an increased use of commercial kits for biomarker measurement, commensurate with the increased demand for biomarkers in drug development. However, in most cases these kits do not meet the quality attributes for use in regulated environment. The process for adaptation of these kits can be frustrating, time consuming and resource intensive. In addition, a lack of harmonized guidance for the validation of biomarker poses a significant challenge in the adaptation of kits in a regulated environment. The purpose of this perspective is to propose a tiered approach to commercial drug development kits with clearly defined quality attributes and to demonstrate how these kits can be adapted to perform analytical validation in a regulated environment.

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“…There have been previous calls for commercial kits that are characterized specifically for drug development use in a regulated environment. Bowsher et al called for 'pharmaceutical grade kits' that would comply with clear criteria and documentation that are suitable for use in a regulated environment [17]. Islam et al proposed a three-tiered approach to 'drug-development kits' with clearly defined quality attributes that can be adapted to perform fit-forpurpose (FFP) analytical validation in a regulated environment [18].…”

Section: Introductionmentioning

confidence: 99%

Recommendations for Classification of Commercial LBA Kits for Biomarkers in Drug Development From the GCC for Bioanalysis

Islam

Kar

Ritzén³

et al. 2019

Bioanalysis

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Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members' opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.

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Application of Commercial Research-Grade Biomarker Assays in Drug Development: Is It Time to Create ‘Pharmaceutical-Grade’ Kits?

Abstract: We believe a mutual lack of communication has helped foster a protracted misunderstanding between manufacturers of 'research-use-only' kits and users of research-use-only kits."

Cited by 9 publications

References 22 publications

Blood‐based biomarkers in Alzheimer disease: Current state of the science and a novel collaborative paradigm for advancing from discovery to clinic

Blood‐based biomarkers in Alzheimer disease: Current state of the science and a novel collaborative paradigm for advancing from discovery to clinic

Adaptation of Commercial Biomarker Kits and Proposal for ‘Drug Development Kits’ to Support Bioanalysis: Call for Action

Recommendations for Classification of Commercial LBA Kits for Biomarkers in Drug Development From the GCC for Bioanalysis

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