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

  • Shire Partners With ArmaGen On AGT-182 For Hunter Syndrome

    Shire announced in a press release that it has partnered with ArmaGen, a U.S. biotechnology company, on AGT-182 for Hunter syndrome. The investigational enzyme replacement therapy (ERT) has potential in treating the central nervous system (CNS) symptoms of the rare disease. Shire states that the new collaboration demonstrates its commitment to the Hunter syndrome community and strengthens its rare disease pipeline.

  • Aarhus University, Bionor Pharma Use Celgene’s Istodax To Lure HIV

    Researchers from Aarhus University and Bionor Pharma presented an abstract at the Aids 2014 congress in Melbourne regarding a small study that used Celgene’s Istodax (romidepsin) to lure HIV hidden in reservoirs in the body. Driving the virus into the open makes it susceptible to antiretroviral therapy. Medscape reports that Sharon Lewin, MD, co-chair of the meeting organizing committee, said the results were the first of its kind and significant; waking up the long-lived, sleeping forms of the virus and making it leave the cell is a big step. Steven Deeks, MD, from the University of California at San Francisco, said, "I think this is the single most important advance we've heard of at this meeting, and it's going to have a huge impact in the future."

  • Two Australian Patients Reported HIV-Free After Cancer Treatment

    Two male Australian patients were reported to be ostensibly free from Human Immuno-deficiency Virus (HIV) following stem cell transplants to treat cancer.

  • BCM Engineers Virus-Specific T Cells Against 5 Infections Scientists from the Baylor College of Medicine in Houston recently reported that they have identified a technique to rapidly generate virus-specific T cells (VSTs) against five infections that affect immunocompromised patients following bone marrow or stem cells transplantation.
  • Meissner’s SGT (Single-Use Gauge Tee) Allows Secure Pressure Monitoring Within A Single-Use System

    Meissner’s SGT provides high accuracy pressure monitoring functionality for pre-sterilized single-use systems.

  • Outsourced Pharma West Conference To Feature Andy Skibo of MedImmune/AstraZeneca

    Andy Skibo, EVP Operations for MedImmune, as well as RVP Supply Biologics for AstraZeneca, will be a featured panelist at the Outsourced Pharma West Conference and Exhibition, November 10-11 in San Francisco.

  • Celladon Licenses mSCF For Gene Therapy Clinical stage biotech firm Celladon Corporation announced that it has signed an exclusive, global license from Enterprise Partners Venture Capital for the membrane-bound form of the Stem Cell Factor gene (mSCF) as treatment for cardiac ischemia. The license agreement will allow Celladon to use mSCF in gene therapy applications.
  • BioMarin And Sarah Cannon Research Institute UK Partner In EMBRACA Trial

    BioMarin Pharmaceutical and Sarah Cannon Research Institute UK (SCRI UK) announced that they have partnered to recruit patients in the ongoing Phase III EMBRACA clinical trial of BioMarin’s BMN 673 for the treatment of hereditary breast cancer with a BRCA mutation. The trial was officially initiated in October 2013 when BioMarin dosed the first BMN 673 patient.

  • ABPI, BIA Release FAQ And Guide To Biosimilars As biosimilars rise to prominence in the pharmaceutical industry, the Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have jointly worked on developing materials on biological drugs including biosimilars. The documents include a guide to the medicines and a collection of frequently asked questions.
  • 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.

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