Companion diagnostics: emerging strategies and issues in pharmaceutical development

Thomas, Janette; Stratton, Elyse; Keppens, Mieke

doi:10.1586/erm.12.49

Cited by 5 publications

(5 citation statements)

References 5 publications

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“…There are four areas where this assay could be used: (1) to identify patients who are most likely to benefit from a drug, (2) to identify patients likely to be at increased risk of serious adverse reactions as a result of treatment with a drug, (3) to monitor the drug response for the purpose of adjusting treatment (e.g., schedule, dose, and discontinuation) to achieve improved safety or effectiveness in clinical settings, and (4) to identify patient populations for which a new drug will be the most effective in the drug development pipeline. 87,88 While a CDx can improve patient outcomes in the clinic and reduce the failure of a new drug compound in the development pipeline, manipulating limited patient samples and choosing corresponding readouts remain challenging, 6 and it is clear that we need additional approaches to develop a robust CDx platform for hematologic cancer research. Recent advances in biomicrofluidic and microfabrication technologies have demonstrated the capability of manipulating minute patient-derived samples in microfluidic cellbased platforms to test different anticancer drugs with quantitative readouts in hematologic cancer research, which shows the promising application of this platform to developing a personalized diagnostic model to select therapy in the clinic.…”

Section: Companion Diagnosticsmentioning

confidence: 99%

“…Hence, more reliable, accurate, and personalized diagnostic models are needed for obtaining information that is essential for the safe and effective use of a therapeutic agent on a specific patient in the early phase of a clinical trial. 6,86,87…”

Section: Challenges In Drug Development and Treatment Selectionmentioning

confidence: 99%

“…2,3 Furthermore, the unresolved issue of drug resistance and the lack of sufficient biological information from patient-derived heterogeneous tumor samples upon which appropriate therapies can be selected for each individual are two major shortcomings of current clinical practice. 4,5 Such unsatisfactory clinical translation in hematologic cancer drug development can largely be attributed to poor clinical efficacy, adverse side effects and toxicity issues, and a high rate of morbidity at different phases of clinical trials, 6,7 which influence the decision-making process in the drug development pipeline. In clinical settings, a variety of techniques are used for hematologic cancer diagnosis, classification, prognostication, and therapeutic decision-making, including those based on immunohistochemistry (IHC), enzyme linked-immunosorbent assay (ELISA), electrophoretic mobility shift assays (EMSAs), fluorescent in situ hybridization (FISH), flow cytometry immunophenotyping, chromosome analysis, molecular testing, and microbiology testing.…”

Section: Introductionmentioning

confidence: 99%

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Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications

et al. 2019

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A persistent challenge in developing personalized treatments for hematologic cancers is the lack of patient specific, physiologically relevant disease models to test investigational drugs in clinical trials and to select therapies in a clinical setting. Biomicrofluidic systems and organ-on-a-chip technologies have the potential to change how researchers approach the fundamental study of hematologic cancers and select clinical treatment for individual patient. Here, we review microfluidics cell-based technology with application toward studying hematologic tumor microenvironments (TMEs) for the purpose of drug discovery and clinical treatment selection. We provide an overview of state-of-the-art microfluidic systems designed to address questions related to hematologic TMEs and drug development. Given the need to develop personalized treatment platforms involving this technology, we review pharmaceutical drugs and different modes of immunotherapy for hematologic cancers, followed by key considerations for developing a physiologically relevant microfluidic companion diagnostic tool for mimicking different hematologic TMEs for testing with different drugs in clinical trials. Opportunities lie ahead for engineers to revolutionize conventional drug discovery strategies of hematologic cancers, including integrating cell-based microfluidics technology with machine learning and automation techniques, which may stimulate pharma and regulatory bodies to promote research and applications of microfluidics technology for drug development.

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Section: Companion Diagnosticsmentioning

confidence: 99%

Section: Challenges In Drug Development and Treatment Selectionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications

et al. 2019

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“…Development of a biomarker might actually be more difficult than that of the drug it is linked to [39,40]. It should have proven clinical utility, robust analytics, reproducibility, standardization, and reliable systems [41].…”

Section: The Challengesmentioning

confidence: 99%

Personalized Medicine in Oncology and Companion Diagnostics:Development and Challenges

Cheng²,

Pan

2013

Transl Med

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The core of the whole concept of personalized medicine is to tailor medical practice, from prevention, diagnosis, treatment to prognosis, based on the underlying pathophysiological changes of the disease and the patient. More specifically, this approach may include new diagnostic tools to determine genetic alterations and expression, including the noncoding genetic elements, in order to more precisely screen and diagnose diseases and their subtypes, select the most effective and/or the least toxic therapeutic agents including dosage personalization, and stratify patients into different prognostic groups. This review will focus on the molecular biomarkers in medical oncology that help achieve the above mentioned applications, the selected molecular companion diagnostics, as well as the challenges around the aspects of development of these tests.

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“…However, a substantial increase in this number is expected in the years to come. It has been estimated that around 80 targeted cancer drugs could be introduced before 2018 and many of these will likely have a CDx linked to their use [8,9]. This article will discuss issues related to the development and use of tissue-based companion diagnostics within oncology, including the regulatory aspects.…”

Section: Introductionmentioning

confidence: 99%

Companion Diagnostics in Oncology - Current Status and Future Aspects

Jørgensen¹

2013

Oncology

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A large number of targeted anticancer drugs are currently under development and most of them will have a companion diagnostic linked to their use. If a diagnostic assay is developed in conjunction with a targeted anticancer drug, such an assay will later end up determining the conditions for the use of the drug after its approval. The assay then becomes a kind of ‘gatekeeper' in relation to which patients should be treated with the drug in question. This ‘gatekeeper' role implies that companion diagnostic assays must live up to the same regulatory standards and requirements known from drug development. The assays must have proven to be analytically robust and reliable and to have demonstrated clinical utility before they are routinely used in the clinic. In the drug-diagnostic codevelopment model, several ‘traditional' study designs have been used to demonstrate clinical utility. However, if we are to benefit from the increasing knowledge provided by molecular oncology, new ways should be developed to demonstrate the clinical utility of drug-diagnostic combinations. The development of such an approach will require a rethinking at different levels and is likely to include a number of ethical, regulatory and practical challenges.

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Companion diagnostics: emerging strategies and issues in pharmaceutical development

Cited by 5 publications

References 5 publications

Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications

Biomicrofluidic Systems for Hematologic Cancer Research and Clinical Applications

Personalized Medicine in Oncology and Companion Diagnostics:Development and Challenges

Companion Diagnostics in Oncology - Current Status and Future Aspects

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