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

  • ZZ Biotech Announces NIH-Funded Phase II Trial For Stroke Drug

    ZZ Biotech announced that the National Institutes of Health and Broadview Ventures will support a multi-center Phase II clinical trial of its experimental drug 3K3A-APC in patients suffering from acute ischemic stroke.

  • The Lancet Publishes Phase III Trial Of Nevaxar For Thyroid Cancer

    Bayer HealthCare and Onyx Pharmaceuticals, an Amgen subsidiary, announced that The Lancet published online results from its Phase III DECISION trial. Trial results showed that Nevaxar (sorafenib) tablets significantly extended the time patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment lived without their disease worsening (progression-free survival (PFS)).

  • Lpath And WRAIR Partner To Study Brain Injury Drug

    Lpath, an antibody-platform company focusing on bioactive lipid-targeted therapeutics, and scientists from the Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research (WRAIR) announced the start of a collaborative research agreement study for brain injury drug Lpathomab.

  • AbbVie Files NDA For All-Oral Hep C Regimen

    AbbVie announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

  • Aastrom Biosciences Acquires Sanofi Cell Therapy And Regenerative Medicine Business

    Aastrom Biosciences announced that it has signed a definitive agreement to acquire Sanofi’s Cell Therapy and Regenerative Medicine (CTRM) business for $6.5 million.

  • Researchers Identify Astrocytes’ New Role In Neuronal Communication

    Scientists from the University of California, Los Angeles, found that brain cells called astrocytes might play a part in neuronal communication only during bursts of neuron activity.

  • Biomarker Leads To Cancer Drug Resistance And Tumor Formation

    Researchers from the University of California, San Diego School of Medicine have identified CD61, a biomarker present on the surface of drug-resistant tumors, which they believe could shed light on why many drugs used in the treatment of lung, breast, and pancreatic cancer also encourage drug resistance and eventually lead to tumor formation in patients.

  • NSTDA Discovers New Anti-Malaria Drug

    Thailand’s state run National Science and Technology Development Agency, or NSTDA, has developed a new medication for malaria that will soon be tested in clinical trials. The medication, a chemical called P218, was designed to target the malarial enzyme and stop the disease’s DNA from replicating. Researchers have said that the drug can completely destroy malaria parasites, and it won’t be expensive for the country to manufacture.

  • Pilgrim Software's 10th Global Customer Conference Lauds 'Success Through Quality'

    Pilgrim Software, Inc., a leading provider of cloud and on-premise enterprise quality management solutions, hosted its tenth worldwide customer conference this month.

  • Sarepta Therapeutics To File NDA For Muscular Dystrophy Drug

    Sarepta Therapeutics, a company focused on developing RNA-based treatments, announced its intent to file a New Drug Application for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) by the end of 2014.

  • Researchers To Test Drugs On Micro-Organs Instead Of Mice

    Researchers from the Vanderbilt University Medical Center in Nashville, Tennessee, are developing miniaturized living copies of human organs to advance research in drug testing.

     

  • Genoa’s Inhaled Pirfenidone Shows Potential in Lung Fibrosis

    Genoa Pharmaceuticals and collaborators Martin Kolb and Kjetil Ask at McMaster University announced additional measured advantages of inhaled GP-101 (aerosol pirfenidone) in the treatment of idiopathic pulmonary fibrosis (IPF).

  • Emergent BioSolution’s BioThrax Receives FDA Orphan Drug Designation

    Emergent BioSolutions announced in a press release that the Food and Drug Administration (FDA) has granted BioThrax an Orphan Drug Designation.

  • Beckman Coulter Life Sciences To Acquire Cytometer Maker Xitogen

    Beckman Coulter Life Sciences has entered into an agreement to acquire Xitogen Technologies Inc. together with Cytojene Corporation. Xitogen, a flow cytometer developer based in Suzhou and Dalian, China, will provide Beckman Coulter Life Sciences with both a strong operational base in the growing China market and a high quality research instrument to round out their world-class cytometry offering.

  • TB Drug May Fight Other Diseases Yet Avoid Resistance

    Chemists from the University of Illinois are studying a new multi-targeted tuberculosis drug that could treat other diseases and yet avoid resistance.

     

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