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

  • Researchers Show Involvement Of DNA Modifications in Alzheimer's Disease

    In a couple of recent breakthrough research reports, scientists have revealed how modifications to DNA are involved in Alzheimer's disease

  • Expression Therapeutics, ABL Enter Collaboration For Hemophilia A Factor VIII Infusion Therapy Cell Line Development

    Expression Therapeutics, a biotechnology company which is developing therapies for hemophilia A, has just selected the Maryland-based biomedical contract research and manufacturing organization, ABL to support the cell line development studies for its novel Factor VIII infusion therapy for Hemophilia A.

  • Pharming Group Acquires Rare Disease Candidates in TRM SASU Liquidation

    Dutch biotech company, Pharming Group announced a half million euro deal ($667,000), acquiring assets from the French company, Transgenic Rabbit Models (TRM) SASU, liquidation. This deal gives Pharming Group access to five recombinant human product candidates for the treatment of rare genetic disorders: Pompe’s disease, Fabry’s disease, Gaucher’s disease, and Hemophilia A and B.

  • Glenmark Enters Oncology With Discovery of New Molecule

    Indian Pharma company, Glenmark has entered oncology with the discovery of GBR 1302, a potential antibody-based therapy for ovarian and breast cancers.

  • BMS And Celgene Collaborate For Combination Cancer Treatment Study

    Bristol-Myers Squibb Company (BMS) and Celgene Corporation announced Wednesday that they are collaborating on a Phase I clinical study, which will determine the efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab) and Celgene’s nab technology-based chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). The collaborating parties will study multiple types of tumors, including HER-2 negative metastatic breast cancer, pancreatic cancer, and nonsmall cell lung cancer (NSCLC).

  • Pfizer Files NDA For Palbociclib In Breast Cancer With FDA

    Pfizer announced that it has completed the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its investigational drug palbociclib for the treatment of postmenopausal, treatment-naive women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

  • Lilly, Boehringer Ingelheim Get Tentative FDA OK For Basaglar

    Eli Lilly together with its partner Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to Basaglar (insulin glargine injection) indicated for the improvement of glycemic control in adult patients with Type 2 diabetes.

  • Novartis Signs Investment And Option Agreement With Gamida Cell

    Gamida Cell, a company focused on stem cell expansion technologies and therapeutics, announced that it has entered into an investment and option agreement with pharmaceutical giant Novartis.

  • Southwest Airlines Cargo Earns Highest Honors For Performance

    Southwest Airlines Cargo is celebrating winning the Quest for Quality Award, awarded by Logistics Management Magazine, for 18 consecutive years. 

  • Stem Cell Research ‘Holy Grail’ Uncovered, Thanks to Zebrafish

    With help from the zebrafish, a team of Australian researchers has uncovered how hematopoietic stem cells (HSC) renew themselves, considered by many to be the ‘holy grail’ of stem cell research.

  • Jell-O-Like Biomaterial Could Hold Key To Cancer Cell Destruction

    Scientists from Penn State University reported that a biomaterial made of tiny molecules was able to attract and destroy cancer cells.

  • MicroVAX Begins Phase I Clinical Trial For New Cancer Vaccine

    MicroVAX, a biotech company in Virginia, will begin a phase I clinical trial for its unique and proprietary vaccine platform for patients with breast, prostate, colon, ovary and lung cancers that have relapsed after initial therapy. The trial is sponsored by the Singapore Clinical Research Institute (SCRI) and will be conducted by Dr. Toh Han Chong, Senior Consultant and Deputy Director at the National Cancer Center Singapore (NCCS).

  • Scientists Use Soil Bacteria To Kill, Shrink Tumors

    Scientists from the Johns Hopkins Kimmel Cancer Center reported that a modified version of common soil bacteria injected into solid cancers attacked and shrank many of the tumors.

  • New Treatments For Multiple Sclerosis Show Promising Results Researchers at the Victoria University of Wellington are developing several new and promising treatments for multiple sclerosis (MS), including some common anti-psychotic agents.
  • HDAC Inhibitors Identified As Possible Treatment For Kidney Stones

    Researchers at the Washington University School of Medicine in St. Louis discovered that a class of drugs already approved to treat leukemia and epilepsyare also effective against kidney stones in a new mouse study. The study is published online in the Journal of the American Society of Nephrology.

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