Industry perspectives on biomarker qualification

Lavezzari, Gabriela; Womack, AW

doi:10.1002/cpt.264

Cited by 27 publications

(17 citation statements)

References 27 publications

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“…Since its emergence, biomarker is increasingly perceived to be an essential tool in drug development, regulation and clinical research 18 , 19 . It is believed that judicious biomarker use can improve many of the key steps in pharmaceutical development, including target identification, lead optimization, toxicology and clinical practice.…”

Section: Introductionmentioning

confidence: 99%

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

et al. 2017

Sci Rep

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Quality control is critical for ensuring the safety and effectiveness of drugs. Current quality control method for botanical drugs is mainly based on chemical testing. However, chemical testing alone may not be sufficient as it may not capture all constituents of botanical drugs. Therefore, it is necessary to establish a bioassay correlating with the drug’s known mechanism of action to ensure its potency and activity. Herein we developed a multiple biomarker assay to assess the quality of botanicals using microfluidics, where enzyme inhibition was employed to indicate the drug’s activity and thereby evaluate biological consistency. This approach was exemplified on QiShenYiQi Pills using thrombin and angiotensin converting enzyme as “quality biomarkers”. Our results demonstrated that there existed variations in potency across different batches of the intermediates and preparations. Compared with chromatographic fingerprinting, the bioassay provided better discrimination ability for some abnormal samples. Moreover, the chip could function as “affinity chromatography” to identify bioactive phytochemicals bound to the enzymes. This work proposed a multiple-biomarker strategy for quality assessment of botanical drugs, while demonstrating for the first time the feasibility of microfluidics in this field.

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Section: Introductionmentioning

confidence: 99%

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

et al. 2017

Sci Rep

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“…Considering the guidelines proposed by the FDA for the submission of pharmacogenomic data (described above), this organization has also created the Biomarker Qualification Program that facilitates the interaction between the Center for Drug Evaluation and Research (CDER) with stakeholders to support the drug development process [122]. Biomarkers are used in research, drug development, and now, in pharmacogenetic testing [11,122,123]. Identifying genes that encode variants as biomarkers are the goal of genetics [11,122,123].…”

Section: Pharmacogenetics In Clinical Trialsmentioning

confidence: 99%

“…Biomarkers are used in research, drug development, and now, in pharmacogenetic testing [11,122,123]. Identifying genes that encode variants as biomarkers are the goal of genetics [11,122,123]. These variants could 1) affect how the drug is activated, transported, or metabolized, 2) act in alternative pathways to those affected by the drug, 3) lead to the development of adverse effects or toxicity once the drug is used, or 4) be directly involved in disease acquisition and progression.…”

Section: Pharmacogenetics In Clinical Trialsmentioning

confidence: 99%

Pharmacogenetics: An Important Part of Drug Development with A Focus on Its Application

Oates¹,

Lopez²

2018

Int J Biomed Investig

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Since the human genome project in 2003, the view of personalized medicine to improve diagnosis and cure diseases at the molecular level became more real. Sequencing the human genome brought some benefits in medicine such as early detection of diseases with a genetic predisposition, treating patients with rare diseases, the design of gene therapy and the understanding of pharmacogenetics in the metabolism of drugs. This review explains the concepts of pharmacogenetics, polymorphisms, mutations, variations, and alleles, and how this information has helped us better understand the metabolism of drugs. Multiple resources are presented to promote reducing the gap between scientists, physicians, and patients in understanding the use and benefits of pharmacogenetics. Some of the most common clinical examples of genetic variants and how pharmacogenetics was used to determine treatment options for patients having these variants were discussed. Finally, we evaluated some of the challenges of implementing pharmacogenetics in a clinical setting and proposed actions to be taken to make pharmacogenetics a standard diagnostic tool in personalized medicine.

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“…Notably, Lavezzari and Womack point out there are differences in the trends between therapeutic areas and how biomarker qualification has been focused [69]. Unfortunately, neurology lags behind other therapeutics areas such as oncology in terms of biomarker qualification.…”

Section: Comparison Of Biomarker Acceptance Paths and Their Use In Drmentioning

confidence: 99%

Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

Arnerić

Batrla-Utermann

Beckett

et al. 2016

JAD

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Alzheimer’s disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options. Amyloid deposition and tau in the brain, which are most commonly assessed either in cerebrospinal fluid (CSF) or by molecular imaging, are consistently and widely accepted. Nonetheless, a clear gap still exists in the accurate identification of subjects that truly have the hallmarks of AD. The Coalition Against Major Diseases (CAMD), one of 12 consortia of the Critical Path Institute (C-Path), aims to streamline drug development for AD and related dementias by advancing regulatory approved drug development tools for clinical trials through precompetitive data sharing and adoption of consensus clinical data standards. This report focuses on the regulatory process for biomarker qualification, briefly comments on how it contrasts with approval or clearance of companion diagnostics, details the qualifications currently available to the field of AD, and highlights the current challenges facing the landscape of CSF biomarkers qualified as hallmarks of AD. Finally, it recommends actions to accelerate regulatory qualification of CSF biomarkers that would, in turn, improve the efficiency of AD therapeutic development.

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Industry perspectives on biomarker qualification

Cited by 27 publications

References 27 publications

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip

Pharmacogenetics: An Important Part of Drug Development with A Focus on Its Application

Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

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