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

  • Sun Pharma Licenses Merck’s Psoriasis Drug For $80M

    Merck announced that it has entered into a licensing agreement with Indian generics company Sun Pharmaceuticals for Merck’s therapeutic antibody candidate tildrakizumab as treatment for chronic plaque psoriasis.

  • Mylan, Gilead Partner To Bring Cheaper Hepatitis C Treatment To Developing Countries

    In a new collaboration with Gilead Sciences, Mylan has won the nonexclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Gilead currently markets Sovaldi, the brand-name version of sofosbuvir, indicated for those with hepatitis C.

  • Biogen Idec Announces Strides In Clinical Studies For MS Treatments

    Biogen Idec announced clinical study results for three of its Multiple Sclerosis (MS) treatments at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston last week.

  • EMD Serono, Sutro Biopharma Form ADC Partnership

    EMD Serono, a subsidiary of Merck, and Sutro Biopharma in San Francisco announced a new partnership to collaborate on the production of antibody drug conjugates (ADCs) for undisclosed cancerous targets.

  • Avanir’s Drug Combination Reduces Agitation in Alzheimer’s Disease Patients

    Avanir Pharmaceuticals this week announced the positive results from its phase 2 clinical trial for its combination drug therapy AVP-923, which was successful in lowering agitation in patients with Alzheimer's disease.

  • NIH Awards Grants In Cell Pathway Research For New Therapies

    The National Institutes of Health (NIH) announced that it has awarded more than $64 million in grants to six research institutions to advance understanding of cellular pathways and help in the development of new treatments.

  • Akashi Acquires Global Rights To Tarantula Venom DMD Therapy

    Akashi announced that it had acquired global rights to GsMTx-4, an amino acid peptide toxin isolated from Grammostola rosea (Chilean rose) tarantula venom, in development with Tonus as a potential therapy for Duchenne Muscular Dystrophy (DMD).

  • More Vaccines Needed For Tropical Diseases, Study Reveals

    There has been quite a clamor recently about the record-setting outbreak of the deadly Ebola virus in West Africa, which has killed over 2,200 people to date and spurred numerous strategies in an effort to control it, including a new vaccine and other experimental drugs.

  • SELLAS Collaborates With MSK For New WT1 Cancer Vaccine

    Swiss-based biopharmaceutical company, SELLAS Life Sciences, announced that it has signed a global collaboration and license agreement with the Memorial Sloan Kettering Cancer Center (MSK) to develop, market, and commercialize MSK's new proprietary WT1 cancer vaccine.

  • Researchers Discover Gene Targets In Emery-Dreifuss Muscular Dystrophy

    An international team of researchers has just discovered new genetic targets responsible for an incurable muscle-wasting disease, Emery-Dreifuss muscular dystrophy (EDMD).

  • Novartis, University Of Pennsylvania To Build Center For CAR Research

    Novartis and the University of Pennsylvania announced their plans to build the Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

  • Asterias Biotherapeutics, Cancer Research UK To Conduct Clinical Trial Of Lung Cancer Immunotherapy Vaccine

    BioTime and its subsidiary Asterias Biotherapeutics announced in a press release that they have agreed to conduct an immunotherapy vaccine trial for lung cancer with Cancer Research UK. The charity’s development and commercialization arm, Cancer Research Technology (CRT), will also participate in the trial of AST-VAC2 in subjects with non-small cell lung cancer. The trial will evaluate toxicity, safety, feasibility, immune response, and clinical outcomes.

  • New Immunotherapy Vaccine Developed For HER2 Positive Breast Cancer

    Researchers at the University of Texas MD Anderson Cancer Center have developed a new and promising immunotherapy breast cancer vaccine candidate, GP2, which prevents disease recurrence in high-risk patients, especially in combination with a powerful immunotherapy drug.

  • EMD Serono Collaborates With Accelerated Cure Project For MS Research Study

    EMD Serono last week announced that it has entered an agreement with the Accelerated Cure Project for Multiple Sclerosis (ACP) to help launch a new MS research program called the Optimizing Treatment—Understanding Progression (OPT-UP) study. The collaborative research study will help advance the understanding of and treatment options for MS, which is a disabling neurological disease affecting more than two million people worldwide.

  • FUJIFILM Diosynth Biotechnologies Chooses ambr250 System For Optimising Microbial Fermentation

    TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, is pleased to announce that its ambr250 automated mini bioreactor system is being successfully used at leading Contract Development and Manufacturing Organisation, FUJIFILM Diosynth Biotechnologies, for optimising their microbial fermentations to accelerate scale-up production of protein-based therapeutics.

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