FEATURED ARTICLES

  • Quantitative Measurements Of p95 Protein Expression In Tumors From Patients With Metastatic Breast Cancer Treated With Trastuzumab
    Quantitative Measurements Of p95 Protein Expression In Tumors From Patients With Metastatic Breast Cancer Treated With Trastuzumab

    Background: Expression of p95 in HER2-positive breast cancer is potentially a major determinant of trastuzumab resistance because p95 lacks the trastuzumab binding site while retaining kinase activity. Previously, an optimal clinical cutoff for a continuous measurement of p95 expression was defined in a training set of trastuzumabtreated MBC patients (Clin Cancer Res, 16:4226, 2010).

  • Clinical And Analytical Performance Of Non-Small Cell Lung Cancer Biomarkers
    Clinical And Analytical Performance Of Non-Small Cell Lung Cancer Biomarkers

    A variety of biomarkers are currently used to help guide treatment decisions for patients with non-small cell lung cancer (NSCLC). These include mutation analysis for the EGFR and KRAS genes, along with gene rearrangement analysis for the ALK and ROS1 loci. In this study we have evaluated the clinical and analytical performance features of these assays in a series of formalin-fixed paraffin-embedded (FFPE) tissue samples.

  • Flow Cytometry For The Pharmaceutical Industry In A Central Lab – Clinical Trials Setting: Specific Challenges And Solutions
    Flow Cytometry For The Pharmaceutical Industry In A Central Lab – Clinical Trials Setting: Specific Challenges And Solutions

    With the exception of some simple generic assays (such as lymphocyte T/B/NK Immunophenotyping, CD4 counting or progenitor counting) the implementation of pharma-client tailored flow cytometry assays within a multisite, multiplatform environment (central lab / clinical trials setting) in global longitudinal studies involves specific challenges that necessitate special processes and quality control procedures. We already addressed these well before flow cytometric assays became generally adopted in the clinical trials field.

  • Analysis Of Gene Expression Profiling Of Formalin-Fixed And Paraffin-Embedded Tumor Tissues From Preclinical Models And Patient Samples In Early Phase Clinical Trials
    Analysis Of Gene Expression Profiling Of Formalin-Fixed And Paraffin-Embedded Tumor Tissues From Preclinical Models And Patient Samples In Early Phase Clinical Trials

    The objective of this study was to identify gene expression biomarkers that are potentially predictive for birinapant response. Birinapant is a novel small molecule that mimics endogenous Smac (Second mitochondrial-derived activator of caspases), by activating the programmed cell death pathways that are dysregulated in cancer cells.

  • Acquisition Expands Phase I Capabilities
    Acquisition Expands Phase I Capabilities

    Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

    With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States. 

  • Covance Reduces The Regulatory Uncertainty In External Testing
    Covance Reduces The Regulatory Uncertainty In External Testing

    Bringing a novel therapy to market has never been an easy task, but new pressures introduced by increasing clinical trial complexity—combined with more stringent regulatory oversight—are forcing the industry as a whole to re-think long-held standards and practices.

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CLINICAL TRIALS WHITE PAPERS & CASE STUDIES

  • Expediting Companion Diagnostic Development Through Collaboration
    Expediting Companion Diagnostic Development Through Collaboration

    August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

  • Examining Tau Phosphorylation As A Potential Alzheimer’s Disease Biomarker
    Examining Tau Phosphorylation As A Potential Alzheimer’s Disease Biomarker

    Covance scientists are always on the lookout to apply the latest research to their work and contribute additional findings to the scientific community. They will present a poster studying the regulation of Tau phosphorylation at the upcoming 2013 Society for Neuroscience conference in San Diego. By Jordan Jensen and Robert Martone, Covance

  • DATATRAK ONE™ Delivers Over $1.3M In Cost Savings For Phase III Clinical Trial Supply Management & Shipping Procedures
    DATATRAK ONE™ Delivers Over $1.3M In Cost Savings For Phase III Clinical Trial Supply Management & Shipping Procedures

    Technology advancements for the clinical trials industry have created cost savings in all areas of the trial process. Web-based systems drive efficiency in trial design, randomization, clinical supply management, and more. 

  • Harvard Clinical Research Institute (HCRI) Realizes Efficiencies And Savings On Clinical Trials With BioClinica® OnPoint CTMS
    Harvard Clinical Research Institute (HCRI) Realizes Efficiencies And Savings On Clinical Trials With BioClinica® OnPoint CTMS

    Having grown to a premier research organization with 400 clinical trials to its credit, HCRI’s clinical trial management needs had surpassed the conventional processes it had been using to manage and monitor information and documents related to its clinical studies. The Institute’s 140 users relied on Excel spreadsheets and other manual processes that proved labor-intensive, inefficient, and a barrier to team communication.

  • Applications For Circulating Tumor Cells To Support Clinical Trials In Asia
    Applications For Circulating Tumor Cells To Support Clinical Trials In Asia

    Advances in our understanding of cancer have accelerated the development of new diagnostics over the past decade. Now, when assessing the efficacy of an experimental drug, clinical trial teams can supplement traditional markers from tissue biopsies with assessments on circulating tumor cells (CTC). The rollout of such tests has, to date, largely been limited to Western markets, but this is changing. By Ken Pennline, Ph.D., Vice President and, Global Head, Cytometry Services, LabCorp Clinical Trials

  • Risk-Based Monitoring For Late-Phase Research: Strategies For Real-World Post-Approval Studies
    Risk-Based Monitoring For Late-Phase Research: Strategies For Real-World Post-Approval Studies

    The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality, and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV). By Maria Harrison, Vice President Late Phase Services, PRA

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NEWS

  • Scientists Report Discovery Of Biomarker For HIV Vaccine Scientists from the University of London, St. George’s, and Bionor Pharma published the results of an exploratory analysis of a Phase II study investigating an HIV vaccine that revealed a possible biomarker for patients receiving the vaccine.
  • Regulus Receives FDA Orphan Status For Rare Kidney Disease Drug

    Biopharmaceutical company Regulus Therapeutics announced that the U.S. Food and Drug Administration (FDA) have issued Orphan Drug designation to its RG-012 for the treatment of rare kidney disease Alport syndrome.

  • aTyr And Partner Universities Publish Human Protein Discovery

    aTyr Pharma and its Hong Kong subsidiary Pangu Biopharma announced the discovery of a new class of human proteins called physiocrines which are believed to have potential therapeutic value in a broad range of diseases.

  • Teva Acquires Labrys, Expands CNS Portfolio Teva Pharmaceutical announced that it has successfully completed its acquisition of Labrys Biologics.
  • Researchers Present Alzheimer’s R&D At AAIC 2014

    Researchers from pharmaceutical companies and universities presented their latest data on Alzheimer’s R&D at the Alzheimer’s Association International Conference 2014 (AAIC) that took place last week in Copenhagen, Denmark.

  • Alkermes Starts Phase I Study Of Potential MS Treatment

    Dublin drug manufacturer Alkermes has initiated a phase I clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule intended for the treatment of multiple sclerosis (MS). The launch of this trial could hopefully lead to some good news for those 400,000 individuals in the U.S. and 2.5 million people worldwide affected by MS.

  • AbbVie Acquires Shire To Reincorporate In U.K. AbbVie and Shire announced in a cooperation agreement that AbbVie has agreed to acquire Shire in a $54 billion takeover deal. The acquisition of the U.K. pharmaceutical company will allow AbbVie to reincorporate in the U.K. and lower its tax bill from 23 percent in the U.S. to 13 percent in the U.K., according to The New York Times. The deal follows a recent trend of U.S. firms reincorporating in the U.K. to lower taxes, although top executives including AbbVie’s CEO Richard A. Gonzalez, have denied that the primary reason is financial. Rather, he says the Shire acquisition was a strategic fit.
  • Salix Gets FDA OK For Rare Genetic Disease Drug The U.S. Food and Drug Administration (FDA) announced that it has approved Salix Pharmaceuticals and Pharming Group’s Ruconest as the first recombinant C1-Esterase Inhibitor for the treatment of acute attacks in patients with hereditary angioedema (HAE).
  • French Drugmaker Ipsen Starts Operation In Cambridge, MA

    The French pharmaceutical company Ipsen joins the growing number of pharmaceutical companies that has planted roots in Cambridge, Massachusetts with the launch of Ipsen Bioscience.

  • Life Science Leader Chief Editor To Co-Chair BIO International Program Committee

    Life Science Leader magazine’s Chief Editor, Rob Wright, has been invited to serve as educational program planning committee co-chair for the 2015 BIO International Convention,  

  • Scientists Design Immunosignatures As Early Cancer Diagnostic A team of scientists from Arizona State University’s Biodesign Institute, under the leadership of Phillip Stafford, has designed an innovative technique called immunosignaturing for early cancer detection. Much of the research and funds in the recent years have been directed at the discovery of biomarkers, which serve as pre-symptomatic cancer indicators. According to a previous study, predictive molecular assays can also help increase specificity and efficacy of drugs in treating diseases such as cancer. However, identifying cancer biomarkers requires overcoming a number of hurdles.
  • Welsh Gov Launches Life Sciences Hub In Wales The Life Sciences Hub Wales has been set up by the Welsh government as a national and international center for the Life Sciences and Healthcare sectors in Wales.
  • Immunocore And Lilly Ink Immunotherapy Partnership Eli Lilly announced that it has signed into a $45 million collaboration deal with privately held clinical stage biotech firm Immunocore. Together, the companies aim to discover and develop novel cancer immunotherapies called ImmTACs.
  • Lilly Study Suggests Cognitive-Function Impairment Link In AD Eli Lilly and Co. reported findings from its analyses of five datasets investigating the relationship between cognitive and functional impairment in the progress of mild Alzheimer’s disease. According to the company’s analyses, cognitive decline both precedes and predicts later impairment in function observed in patients with AD. The data were presented at the Alzheimer's Association International Conference 2014 (AAIC 2014) in Copenhagen, Denmark.
  • Ipsen And Galderma Enter Exclusive Partnership In Neurotoxins Specialty pharmaceutical company Ipsen and global healthcare firm Galderma announced that they have entered into an exclusive partnership to develop and market new neurotoxins, including their liquid formulations. The partners have also extended the scope of their distribution partnership for Dysport/Azzalure in the U.S. and Canada.
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