Co-development of a companion diagnostic for targeted cancer therapy

Cheng, Suzanne; Koch, Walter; Wu, Lin

doi:10.1016/j.nbt.2012.02.002

Cited by 42 publications

(24 citation statements)

References 48 publications

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“…These steps demonstrated the clinical utility of the BRAF mutation test, thus supporting the filing of the premarket approval application, and vemurafenib's risk-benefit profile simultaneously supported the new drug application to the FDA. The drug and the diagnostic were marketed at the same time to ensure access of the therapy to eligible patients (47 ).…”

Section: Patient Selection and Companion Diagnosticsmentioning

confidence: 99%

Biomarkers in Pharmaceutical Research

Zhao

Modur²,

Carayannopoulos

et al. 2015

Clinical Chemistry

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BACKGROUND:Biomarkers are important tools in drug development and are used throughout pharmaceutical research.CONTENT: This review focuses on molecular biomarkers in drug development. It contains sections on how biomarkers are used to assess target engagement, pharmacodynamics, safety, and proof-of-concept. It also covers the use of biomarkers as surrogate end points and patient selection/companion diagnostics and provides insights into clinical biomarker discovery and biomarker development/validation with regulatory implications. To survey biomarkers used in drug development-acknowledging that many pharmaceutical development biomarkers are not published-we performed a focused PubMed search employing "biomarker" and the names of the largest pharmaceutical companies as keywords and filtering on clinical trials and publications in the last 10 years. This yielded almost 500 entries, the majority of which included disease-related (approximately 60%) or prognostic/predictive (approximately 20%) biomarkers. A notable portion (approximately 8%) included HER2 (human epidermal growth factor receptor 2) testing, highlighting the utility of biomarkers for patient selection. The remaining publications included target engagement, safety, and drug metabolism biomarkers. Oncology, cardiovascular disease, and osteoporosis were the areas with the most citations, followed by diabetes and Alzheimer disease.

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Section: Patient Selection and Companion Diagnosticsmentioning

confidence: 99%

Biomarkers in Pharmaceutical Research

Zhao

Modur²,

Carayannopoulos

et al. 2015

Clinical Chemistry

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“…Developing any CDx can be enormously challenging, as seen in the development of the BRAF mutation (108) and ALK gene fusion (109, 110) tests. A primary reason is that the device development timeline does not align with the drug development timeline, as illustrated in a development timeline chart (Figure 4) (15, 108, 111).…”

Section: Strategic Challenges For Drug and Diagnostic Developersmentioning

confidence: 99%

“…A primary reason is that the device development timeline does not align with the drug development timeline, as illustrated in a development timeline chart (Figure 4) (15, 108, 111). Ideally, CDx development for the NGS assay would start with the initiation of early phase studies (Ph1/2a studies in Figure 4) to allow sufficient time for development of the Investigational Use Only (IUO) version of the device before start of the phase 3 pivotal trials.…”

Section: Strategic Challenges For Drug and Diagnostic Developersmentioning

confidence: 99%

Navigating the Rapids: The Development of Regulated Next-Generation Sequencing-Based Clinical Trial Assays and Companion Diagnostics

2014

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Over the past decade, next-generation sequencing (NGS) technology has experienced meteoric growth in the aspects of platform, technology, and supporting bioinformatics development allowing its widespread and rapid uptake in research settings. More recently, NGS-based genomic data have been exploited to better understand disease development and patient characteristics that influence response to a given therapeutic intervention. Cancer, as a disease characterized by and driven by the tumor genetic landscape, is particularly amenable to NGS-based diagnostic (Dx) approaches. NGS-based technologies are particularly well suited to studying cancer disease development, progression and emergence of resistance, all key factors in the development of next-generation cancer Dxs. Yet, to achieve the promise of NGS-based patient treatment, drug developers will need to overcome a number of operational, technical, regulatory, and strategic challenges. Here, we provide a succinct overview of the state of the clinical NGS field in terms of the available clinically targeted platforms and sequencing technologies. We discuss the various operational and practical aspects of clinical NGS testing that will facilitate or limit the uptake of such assays in routine clinical care. We examine the current strategies for analytical validation and Food and Drug Administration (FDA)-approval of NGS-based assays and ongoing efforts to standardize clinical NGS and build quality control standards for the same. The rapidly evolving companion diagnostic (CDx) landscape for NGS-based assays will be reviewed, highlighting the key areas of concern and suggesting strategies to mitigate risk. The review will conclude with a series of strategic questions that face drug developers and a discussion of the likely future course of NGS-based CDx development efforts.

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“…For the healthcare provider, the economic benefits seem clear -less money is spent on drugs that are ineffective for many patients resulting in an obvious cost saving, equally for the patient there is the clear benefit of an improved therapeutic outcome. For the drug developers the issues are less clear, stratified approaches can be seen as a disincentive as their drugs are used in reduced amounts, furthermore there may be an onus on the drug developers to provide a companion diagnostic which will absorb further development costs and likely command lower margins [9]. It is likely that in time a good part of this 'lost' revenue can be recovered as the increased certainty of a beneficial effect promotes increased uptake of the drug amongst responders and increased patient compliance.…”

Section: Economic Impacts Of Stratificationmentioning

confidence: 99%

Biopharmaceutical factory of the future

Alldread¹,

Robinson²

2015

Pharmaceutical Bioprocessing

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The growth in stratified medicine and the economic pressures to reduce capital investment, cost of development and cost of goods are forcing a change in how biopharmaceutical manufacturing plants are designed, built and operated. It is likely that future manufacturing facilities will be built on the principle of flexibility and make even greater use of single use technology, continuous manufacturing and alternative expression systems. Large scale production will in many cases be achieved by the 'scale out' of multiple smaller facilities rather than the 'scale up' to large capacity plants. Some of the core technology required to achieve this vision is already available though further development is required in many areas.There has been much recent discussion on the nature of the biopharmaceutical manufacturing factory in the future. The traditional model of large scale, stainless steel facilities with high capital costs, high requirements for purified water and other services, operated in fed batch mode has served the industry well but many factors are forcing a rethink about biopharmaceutical manufacture and the design of manufacturing facilities.The factors forcing change are both economic and technical. Economic factors include the need to reduce capital investment required for new manufacturing facilities and the need to reduce cost of goods for biopharmaceutical therapies, technical drivers of change include the move toward novel types of molecule and the rise of stratified and ultimately personalized medicines.Given these pressures, the improvements in the productivity of bioprocesses and the availability of new process technology solutions, it is likely that future biopharmaceutical manufacturing plants will look considerably different from those we have become used to. In particular there is a significant gulf between current biopharmaceutical manufacturing facilities and the needs of stratified and personalized medicines.

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Co-development of a companion diagnostic for targeted cancer therapy

Cited by 42 publications

References 48 publications

Biomarkers in Pharmaceutical Research

Biomarkers in Pharmaceutical Research

Navigating the Rapids: The Development of Regulated Next-Generation Sequencing-Based Clinical Trial Assays and Companion Diagnostics

Biopharmaceutical factory of the future

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