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. 

  • Innovative Big Data Research With Big Recognition
    Innovative Big Data Research With Big Recognition

    Technological advancements in the healthcare sector are bringing about fast-growing volumes of complex, multi-dimensional digital data.  Data in this format encompass the 3 v's which define what is now commonly known as 'Big Data' - volume, velocity and variety. As an example, large and complex datasets of medical images continue to arise from global multisite clinical trials conducted to test the efficacy and safety of novel therapies. By Colin Miller

More featured articles...

CLINICAL TRIALS WHITE PAPERS & CASE STUDIES

  • Integrating Electronic Systems In The Clinical Trial Process
    Integrating Electronic Systems In The Clinical Trial Process

    What exactly is an integrated electronic system for clinical trials? Though the term means different things to different people, there are some basic similarities on which the industry can agree

  • 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.

  • Over $1.3M In Cost Savings For Phase III Clinical Trial
    Over $1.3M In Cost Savings For Phase III Clinical Trial

    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

  • Managing The Complete Drug Development Program With The Right eClinical Partner

    Bellicum Pharmaceuticals, Inc., is a biotherapeutics company that develops clinical applications of chemical induction of dimerization (CID), a drug-based remote control technology that extends the physician’s reach beyond the point that a treatment has been administered. Bellicum’s mission is to deliver a new class of controlled cellular immunotherapy products for the treatment of cancer and other serious, life-threatening diseases. With a staff dedicated to this mission, the Houston-based company brings a wealth of experience to conducting clinical trials.

More white papers and case studies...

VIDEOS

More videos...

NEWS

  • Marken The Preferred Partner To Fight Zika Virus

    Marken announced recently they are working with key pharma partners in the race to find a vaccine and treatment for the Zika virus, declared as a public health emergency by the World Health Organization (WHO) earlier this week.

  • Ametek Announces Two Acquisitions

    Brookfield Engineering Broadens AMETEK’s Laboratory Instrumentation Platform ESP/SurgeX Expands AMETEK’s Power Protection Platform

  • Biosimilars Forum Issues Statement Regarding House Energy & Commerce, Subcommittee on Health Biosimilars Hearing, Launch of New Biosimilars Education Initiative

    The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States – issued the following statement about the Biosimilars hearing before the House Energy and Commerce, Subcommittee on Health and the launch of a new biosimilars education initiative.

  • Beike Biotechnology To Supply 11 Hospitals With Cell Therapy

    Beike Biotechnology, the Shenzhen local government, and various medical institutions attended a ceremony in late 2015 to mark their successful combined efforts to provide integrative, personalized cell therapy in 2016.

  • Phase 3 Study Of BLINCYTO Met Primary Endpoint Of Increased Survival

    Amgen (NASDAQ: AMGN) today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study.

  • Amgen Announces Positive Results From Phase 3 GAUSS-3 Trial Of Repatha

    Amgen (NASDAQ: AMGN) today announced that the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24.

  • FDA Acknowledges Receipt Of Resubmission Of Shire's New Drug App

    Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

  • Invetech And Celyad To Collaborate On C-Cure Production

    Invetech, a global leader in instrument development, custom automation and contract manufacturing, and Celyad SA, (CYAD.BR) ("Celyad"), a biopharmaceutical company focused on identification and development of specialized cell-based therapies with product candidates in oncology and cardiology, today announced that they have entered into an agreement under which Invetech will develop and supply manufacturing systems to support production needs for C-Cure®, Celyad's most advanced product candidate based on the cardiopoiesis technology platform.

  • Experts To Meet In Boston To Discuss Biggest Challenges In The Analytical And Clinical Phases Of Biosimilar Drug Development

    IQPC has made several recent additions to the speaking faculty of the Biosimilars Clinical Studies & Analytical Similarity Summit.

  • Morphotek Announces Collaboration With Mayo Clinic On Phase II Trial

    Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it is collaborating with researchers Keith L. Knutson, Ph.D. in the Department of Immunology and Edith A. Perez, M.D. in the Department of Hematology and Oncology at Mayo Clinic in Jacksonville, Florida in a clinical study in patients with folate receptor alpha (FRA) positive, triple-negative breast cancer (TNBC).

  • Epigenetics Market Growth Forecast At 13.64% CAGR To 2020

    Global epigenetics market is expected to reach USD 890.0 million by 2020 growing at a CAGR of 13.64% between 2015 and 2020 with market growth majorly driven by the high prevalence of cancer, increasing R & D funding and increasing intensity of genomic research activities.

  • Telesta Therapeutics Receives Complete Response Letter From FDA

    Telesta Therapeutics Inc. (TSX:TST) (PNK:BNHLF) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Telesta's Biologics License Application (BLA) for MCNA1. In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety.

  • Nimbus Therapeutics Granted Fast Track Designation For NASH Treatment

    Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthrough drugs for serious, underserved human diseases, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NDI-010976, Nimbus’ liver-targeted allosteric inhibitor of acetyl-CoA carboxylase (ACC), for the treatment of NASH (non-alcoholic steatohepatitis).

  • Teva And AbCellera Enter Into Agreement To Discover Rare mAbs

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (TASE:TEVA) and AbCellera have entered into a collaborative research agreement whereby AbCellera will apply its high-throughput single cell antibody platform for the discovery of rare monoclonal antibodies.

  • Oricula Therapeutics Secures $2M NIH Grant

    Oricula Therapeutics, LLC, a biotech company uniquely positioned to introduce medicines to preserve hearing and balance, announced that it has received a Phase 2 Grant of $2.06 million through the Small Business Innovation Research (SBIR) Program by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

More news...