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

  • Novo Nordisk To Focus On Obesity With New Seattle Research Unit

    Novo Nordisk is focusing efforts on obesity treatments and is building a new obesity research unit in Seattle, WA. The company announced the initiative in a press release. The Novo Nordisk Obesity Research Unit will initially employ 10 people, reaching 60 by the end of 2016. The new center will concentrate on basic research and treatments for obesity. Mads Krogsgaard Thomsen, EVP and CSO at Novo Nordisk, said, “Our ambition is to drive scientific progress in the obesity disease area and through this, identify and develop new treatment options for people with obesity.”

  • Novel Compound Shows Promise In Fighting Multiple Myeloma

    Scientists at the Dana-Farber Cancer Institute have shown that a novel compound prevents metastasis of multiple myeloma in mouse models, and it is this discovery that will form the basis of the company’s future plans to progress the compound into human trials.

  • MIT Team Hacks Anthrax To Deliver Cancer Drugs

    A team of chemists from the Massachusetts Institute of Technology (MIT) reported that they have turned to bacillus anthracis bacteria, the culprit behind anthrax infection, in order to deliver cancer drugs more effectively.

  • FDA Grants Orphan Status To MabVax’s Neuroblastoma Vaccine

    Clinical stage oncology drug development firm MabVax Therapeutics announced that it has received the coveted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its vaccine targeting childhood cancer neuroblastoma.

  • NIH Funds Phase 2 Of ‘Tissue Chip For Drug Screening’ Program

    The National Institutes of Health (NIH) announced that it will award funds to support the next phase of the Tissue Chip for Drug Screening program, which will attempt to a build a human-like system to test drugs’ safety and efficacy.

  • Researchers Develop New Anticancer Peptide Vaccines and Inhibitors

    Two new anticancer peptide vaccines and two peptide inhibitors have been developed by researchers at The Ohio State University Comprehensive Cancer Center as part of a larger peptide immunotherapy project.

  • Scripps Researchers Create New Classes Of Antibiotics

    In two recent developments, researchers at The Scripps Research Institute, La Jolla, CA have reported work on new classes of antibiotics to fight drug-resistant bacteria.

  • MIT Researchers Develop New Strategies To Fight Drug-Resistant Bacteria

    Engineers at MIT have developed two different technologies that could help combat drug-resistant bacteria.

  • Tropical Disease Treatment At Heart Of New Research Collaboration

    Celgene Global Health (CGH), a division of Celgene Corporation, and the Drugs for Neglected Diseases initiative (DNDi) inked a four-year research collaboration agreement Wednesday. The organizations will expand on the parties’ ongoing collaboration in order to discover and produce new treatment options for neglected tropical diseases (NTDs).

  • Genzyme Links With Universities In Gene Therapy Research

    Sanofi company Genzyme announced that it has signed a research partnership with the University of Pennsylvania and the University of Florida for the development of a gene therapy that addresses the rare genetic disease Leber congenital amaurosis type 1 (LCA-1).

  • Researchers Develop Vaccine To Prevent Catheter-Associated UTIs

    Researchers at Washington University School of Medicine in St. Louis have developed an experimental vaccine which may prevent the most common type of infections patients pick up in hospitals. In their study in mice models, this vaccine effectively prevented urinary tract infections that are caused by catheters. 

  • Researchers Uncover Key Pathway Contributing To Alzheimer’s Disease

    Researchers at Mayo Clinic, Jacksonville, have identified a defect in a key cell-signaling pathway which might be responsible for the development of Alzheimer's disease. They found that this defect caused overproduction of toxic protein in the brains of Alzheimer's disease patients and loss of communication between neurons, which are both processes known to contribute to the development of the disease.

  • Achaogen Begins Phase 3 Trial For New Antibiotic Plazomicin

    Achaogen has begun enrolling patients in the Phase 3 clinical trial of its novel aminoglycoside antibiotic, plazomicin, to treat infections caused by carbapenem-resistant enterobacteriaceae (CRE).

  • Gilead’s HIV Regimen Pulls Weight In Phase 3 Studies

    Gilead Sciences plans U.S. and EU regulatory filings in Q4 2014 for HIV drug tenofovir alafenamide (TAF) following good news from two Phase 3 studies. The announcement in a press release revealed that TAF showed non-inferiority to the company’s other treatment for HIV, Stribild, and demonstrated more favorable renal and bone safety.

  • Published Scientific Data Shows Plasticell’s Massively Parallel Approach Is Set To Transform The Regenerative Medicine Research Landscape

    UK stem cell biotech pioneer Plasticell Limited announced recently the publication of scientific research which demonstrates how the company’s innovative high throughput 'Combinatorial Cell Culture' (CombiCult) technology allows a single scientist to carry out 10,000 stem cell biology experiments in parallel.

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