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

  • Merck And Advaxis Partner In Prostate Immunotherapy Trial

    Clinical stage biotech firm Advaxis announced that it has partnered with Merck to conduct a clinical trial investigating its cancer immunotherapy ADXS-PSA with Merck's investigational anti PD-1 antibody pembrolizumab. The combination therapy will be evaluated in a Phase I/II study involving patients who have undergone treatment for metastatic, castration-resistant prostate cancer.

  • EC Designates Innate’s CTCL Antibody As Orphan Drug

    Innate Pharma, a biopharmaceutical company developing innate immunity drug candidates, announced that the European Commission has awarded Orphan Medicinal Product Designation to its antibody IPH4102 for the treatment of cutaneous T-cell lymphoma (CTCL).

  • New Animal Resource Facility India’s Latest R&D Move

    India’s department of health research announced that the country plans to build its first ever National Animal Resource facility for biomedical research that will only accept animals of a “defined quality.” This will empower researchers to obtain more reliable results for vaccine development.

  • Researchers: Proteins That Promote HIV/Ebola Virus Also Inhibit Release

    In an unexpected discovery, scientists at Missouri University have found that proteins that promote the entry of viruses like HIV and Ebola into host cells also possess the ability to block the release of these diseases. Scientists feel this discovery helps to better the understanding of these viruses and could lead to new therapies for stopping their progression.

  • AB SCIEX, Dalton To Develop New ADC Analysis Methods

    AB SCIEX and Dalton Pharma announced they will collaborate on the development of a new comprehensive method for analyzing Antibody-Drug Conjugates (ADC) with hopes of bringing more biological oncology therapies to market.

  • C4XD Lends Its NMR Technology To Takeda For 3D Drug Molecule Structures

    C4X Discovery (C4XD) announced in a press release that it will lend its Nuclear Magnetic Resonance (NMR) technology to Takeda Cambridge Limited (TCB). The new partners seek to use the technology to make 3D identifications of TCB’s drug molecules. Piers Morgan, CEO of C4XD, said, "We are delighted to partner with TCB, a leading pharma company with world class target identification and validation capabilities. This collaboration will provide increased visibility of the potential advantages and benefits of C4XD's technology."

  • Antitope To Partner With UCL In Antibody Project

    Antitope, an Abzena firm focused on biopharmaceutical development, announced its collaboration with the University College London (UCL) to humanize an anti-LRG1 antibody in order to inhibit cancer growth and spread.

  • Alexion Launches Eculizumab Trial In Kidney Transplant DGF

    Alexion announced that it has started dosing in its clinical trial evaluating eculizumab for the prevention of delayed graft function (DGF). The trial involves adult patients who have undergone kidney transplantation and who are at increased risk of DGF.

  • Alkermes Submits NDA For New Schizophrenia Drug

    Alkermes yesterday announced its submission of a New Drug Application (NDA) to the U.S. FDA for its much awaited schizophrenia drug, aripiprazole lauroxil. The drug is a long-acting injectable atypical antipsychotic, which if approved, will be a novel once-monthly treatment for schizophrenia.

  • DPx Holdings B.V. Reaches Definitive Agreement To Acquire Gallus BioPharmaceuticals

    DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, is pleased to announce that it has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a leading contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners. Following the transaction, Patheon’s biologic drug substance business, a unit of DPx Holdings, will span four facilities in Europe, Australia and North America and include 550 employees globally.

  • Modality Solutions And DeltaTrak Partner To Provide Life Science Cold Chain Monitoring Solutions

    Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce its approved business partnership with DeltaTrak.

  • American Airlines Cargo Begins Work On State-Of-The-Art Pharmaceutical Facility In Philadelphia

    American Airlines Cargo has started construction of a dedicated pharmaceutical handling facility in Philadelphia, PA.

  • Scientists Turn To Pomegranate To Develop Dementia Drugs

    Scientists from the University of Huddersfield reported that dementia and neuro-inflammation may be curbed by a natural compound found in pomegranate.

  • Emergent And MorphoSys To Co-Develop Prostate Cancer Drug

    Emergent BioSolutions announced that it has signed an agreement with therapeutic antibody specialist firm MorphoSys to co-develop and commercialize its preclinical bi-specific antibody ES414 as treatment for prostate cancer.

  • Insys Therapeutics’ Cannabidiol Granted Another Orphan Drug Designation

    Insys Therapeutics announced that the FDA has granted another orphan drug designation (ODD) for its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM), a common and aggressive form of malignant brain tumor. This is the second such designation for Insys’ CBD and the third for cannabis-based pharmaceuticals.

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