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

  • Human ADME & Studies With Radiolabeled Compounds
    Human ADME & Studies With Radiolabeled Compounds

    During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences

  • 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

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NEWS

  • AbbVie Acquires Shire To Reincorporate In U.K. AbbVie and Shire announced in a cooperation agreement that AbbVie has agreed to acquire Shire in a $54 billion takeover deal. The acquisition of the U.K. pharmaceutical company will allow AbbVie to reincorporate in the U.K. and lower its tax bill from 23 percent in the U.S. to 13 percent in the U.K., according to The New York Times. The deal follows a recent trend of U.S. firms reincorporating in the U.K. to lower taxes, although top executives including AbbVie’s CEO Richard A. Gonzalez, have denied that the primary reason is financial. Rather, he says the Shire acquisition was a strategic fit.
  • Salix Gets FDA OK For Rare Genetic Disease Drug The U.S. Food and Drug Administration (FDA) announced that it has approved Salix Pharmaceuticals and Pharming Group’s Ruconest as the first recombinant C1-Esterase Inhibitor for the treatment of acute attacks in patients with hereditary angioedema (HAE).
  • French Drugmaker Ipsen Starts Operation In Cambridge, MA

    The French pharmaceutical company Ipsen joins the growing number of pharmaceutical companies that has planted roots in Cambridge, Massachusetts with the launch of Ipsen Bioscience.

  • Life Science Leader Chief Editor To Co-Chair BIO International Program Committee

    Life Science Leader magazine’s Chief Editor, Rob Wright, has been invited to serve as educational program planning committee co-chair for the 2015 BIO International Convention,  

  • Scientists Design Immunosignatures As Early Cancer Diagnostic A team of scientists from Arizona State University’s Biodesign Institute, under the leadership of Phillip Stafford, has designed an innovative technique called immunosignaturing for early cancer detection. Much of the research and funds in the recent years have been directed at the discovery of biomarkers, which serve as pre-symptomatic cancer indicators. According to a previous study, predictive molecular assays can also help increase specificity and efficacy of drugs in treating diseases such as cancer. However, identifying cancer biomarkers requires overcoming a number of hurdles.
  • Welsh Gov Launches Life Sciences Hub In Wales The Life Sciences Hub Wales has been set up by the Welsh government as a national and international center for the Life Sciences and Healthcare sectors in Wales.
  • Immunocore And Lilly Ink Immunotherapy Partnership Eli Lilly announced that it has signed into a $45 million collaboration deal with privately held clinical stage biotech firm Immunocore. Together, the companies aim to discover and develop novel cancer immunotherapies called ImmTACs.
  • Lilly Study Suggests Cognitive-Function Impairment Link In AD Eli Lilly and Co. reported findings from its analyses of five datasets investigating the relationship between cognitive and functional impairment in the progress of mild Alzheimer’s disease. According to the company’s analyses, cognitive decline both precedes and predicts later impairment in function observed in patients with AD. The data were presented at the Alzheimer's Association International Conference 2014 (AAIC 2014) in Copenhagen, Denmark.
  • Ipsen And Galderma Enter Exclusive Partnership In Neurotoxins Specialty pharmaceutical company Ipsen and global healthcare firm Galderma announced that they have entered into an exclusive partnership to develop and market new neurotoxins, including their liquid formulations. The partners have also extended the scope of their distribution partnership for Dysport/Azzalure in the U.S. and Canada.
  • EMA Continues Review Of Ariad’s Iclusig In EU Ariad Pharmaceuticals announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is continuing its review of cancer drug Iclusig and has issued a request for limited additional information under the Article 20 referral procedure.
  • Stainless Steel Vial Filling System Developed For Use In Vaccine Facilities

    TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, recently announced the development of a stainless steel version of the fill-it system, designed for safely dispensing biohazardous materials such as vaccine stocks.

  • Roche And A*STAR Ink Drug Discovery Deal A*STAR's Bioprocessing Technology Institute (BTI) announced that it has signed into agreement with pharma giant Roche to identify new drug candidates for the treatment and early detection of cancer.
  • Research Shows Nanoparticle Drug Delivery May Harm Brain While nanoparticles are being designed with the hopes of delivering drugs to target locations, new research suggests that drugs delivered to the brain through nanoparticles called micelles might be more harmful than good.
  • FDA Accepts For Review Teva’s NDA For SABA Inhaler Israeli firm Teva Pharmaceuticals announced that its New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) has been accepted for review by the U.S. Food and Drug Administration (FDA).
  • CPhI Panel To Analyse New Industry Perspectives And Innovations Ahead Of Predictive 2014 Annual Report

    CPhI Worldwide, organised by UBM Live, has announced its full line up of confirmed expert industry panel members for 2014, building on the huge success of the CPhI annual report launched at CPhI Worldwide in October 2013.

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