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

  • New Therapeutic Target May Help Improve Cancer Drugs’ Efficacy Researchers from the Barts Cancer Institute, associated with Queen Mary University of London, reported that targeting the molecule focal adhesion kinase (FAK) may help enhance the efficacy of cancer drugs.
  • Wyss Announces Commercialization Arrangement For Organs-On-Chips Technology The Wyss Institute for Biologically Inspired Engineering at Harvard University declared that its Organs-on-Chips technology will be marketed by a newly formed private firm, Emulate. The new company aims to speed development of the technology in pharmaceuticals, cosmetic, chemicals, and personalized medicine applications.
  • Lion Biotech Funds Moffit Cancer Trial Expansion Lion Biotech has signed into a clinical trial grant agreement with Moffitt Cancer Center to fund the expansion of an ongoing Phase I cancer study of Lion’s tumor infiltrating lymphocytes (TILs) in combination with Bristol-Myers Squibb’s ipilimumab in patients with metastatic melanoma.
  • AstraZeneca, Kyowa-Hakko-Kirin To Collaborate In Immuno-Oncology Study

    AstraZeneca announced that they will co-fund a study to be conducted by Kyowa Hakko Kirin that will test two separate combinations of three experimental compounds in the hopes of developing safe and effective immuno-oncology treatments.

  • Auckland Researchers Use Zebrafish To Screen Cancer Drugs A new study from the University of Auckland reports that zebrafish embryos helped researchers screen thousands of compounds to identify four new potential anti-cancer drugs.
  • Artes And Burnet Partner In New Malaria Vaccine Artes Biotech and Burnet Institute have entered into collaboration to work on a new kind of malaria vaccine.
  • NIH Awards $49M Grant To SRI For HIV/AIDS Drug Development SRI Biosciences announced in a press release that the National Institutes of Health (NIH) has awarded the company a seven-year grant of $49 million for HIV/AIDS drug development. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is administering the grant for preclinical development of potential therapies, including the infections prevalent in the disease. The grant also funds research for microbicides to prevent the sexual transmission of HIV.
  • Cellectis Sells Swedish Subsidiary Cellectis AB To Takara Bio Cellectis announced in a press release that it has sold its Swedish subsidiary Cellectis AB to Takara Bio, a Japanese company. The sale, to be finalized soon, allows Cellectis to refocus on oncology therapies and its Chimeric Antigen Receptor T-cell (CART) immunotherapy products. Cellectis is currently partnered with Servier, Pfizer, and Accelera, a contract research organization (CRO), on CART technology. Cellectis also recently announced an agreement with European CELLforCURE to manufacture clinical batches of Cellectis’ CART cells. The sale is part of Cellectis’ restructuring effort.
  • Otsuka, Horizon CombinatoRx Sign $835K In Vitro Cell Line Screening Deal

    Otsuka Pharmaceutical Development and Commercialization (OPDC) has inked a $846 thousand deal with Horizon CombinatoRx, a division of the UK-based business Horizon Discovery, to perform in vitro cell line screening of certain OPDC drug development candidates in 2014.

  • Harlan Provides Expertise For Biologics And Biosimilars

    Harlan Laboratories, Ltd., a privately held provider of general and specialty toxicology services through its Contract Research Services (CRS) business, is prepared to meet the global demand for development programs in novel biologics and biosimilars.

  • EMD Millipore Introduces Magna Nuclear RNA-Binding Protein Immunoprecipitation (RIP) Kits

    EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, recently introduced the Magna Nuclear RNA-binding Protein Immunoprecipitation (RIP) kits.

  • ISPE Hires Healthcare Association Exec As Ceo

    ISPE—the International Society for Pharmaceutical Engineering announced today it has hired John Bournas as President and CEO, succeeding Nancy Berg who announced plans to leave the Society last fall. 

  • Ziopharm Develops Cancer Drugs With On-Off Switch Biopharmaceutical firm Ziopharm Oncology announced that it has expanded its synthetic immuno-oncology programs with Intrexon Corp to develop cancer drugs that can be ‘switched’ on or off with an oral pill.
  • J&J And Organovo Link For 3D-Printing Drug Discovery

    Johnson & Johnson company Janssen Research and Development announced that it is has entered into collaboration with bioprinting firm Organovo to investigate 3D printing of living tissue for drug discovery and research.

  • Scientists ‘Snip’ HIV From Cultured Human Cells

    Scientists from Temple University reported that they have designed a new approach to remove HIV from human cells growing in culture through genome editing.

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