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.

More featured articles...

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

More white papers and case studies...

VIDEOS

More videos...
Newsletter Signup
Newsletter Signup
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

NEWS

  • Researchers Develop Faster Cancer Drug Discovery Platform

    University of Michigan researchers have developed a new method for identifying potential cancer therapeutics that speeds up the traditionally slow drug discovery process. Using this new platform, the researchers were able to identify a novel antibody which is currently being evaluated as a potential treatment for breast, ovarian, and other cancers.

  • Puma Biotech Posts Positive Phase 2 Data For NSCLC Drug

    Development stage biopharmaceutical firm Puma Biotechnology reported positive early results from its Phase 2 trial investigating PB272 (neratinib) for the treatment of patients with HER2-mutated non-small cell lung cancer (NSCLC).

  • Pfizer And Kyowa Hakko Kirin To Combine Immuno-Oncology Drugs

    Pfizer announced that it has entered an agreement with Kyowa Hakko Kirin to explore the potential of the immuno-oncology combination of Kyowa’s mogamulizumab and Pfizer’s antibody PF-05082566 in patients with solid tumors.

  • Atara Biotherapeutics, MSK Enter Into New Immunotherapy Alliance

    California based biotech company, Atara Biotherapeutics, has entered into an exclusive option agreement with Memorial Sloan Kettering Cancer Center (MSK) for the development and commercialization of allogeneic T-cell therapies, which are currently being investigated in human clinical trials for the treatment of certain cancers and persistent viral infections.

  • Glialogix Receives National Multiple Sclerosis Society Funding For Treatment Development

    Glialogix announced that it had signed a research agreement with the non-profit Fast Forward, a part of the National Multiple Sclerosis Society (NMSS), which would fund continued development of GLX1112, a neuroprotective oral therapy with the potential to treat progressive MS. 

  • Meissner To Exhibit At ISPE’s Annual Product Show At Gillette Stadium

    Meissner will be hosting attendees in booth #2164 at the ISPE Boston Chapter’s 23rd Annual Product Show. The event will run from 12:00 pm – 7:30 pm on Wednesday, October 1, 2014, at Gillette Stadium, Foxborough, MA.

  • Rare Antibodies May Be Key To Future HIV Vaccine

    A team of researchers from The Scripps Research Institute (TSRI) reported their findings about a single family of antibodies that could adapt to fight the elusive HIV virus and its different strains. Their discovery may one day provide the key to designing an effective HIV vaccine in the future.

  • Researchers Identify Potential Treatment For Deadly Kidney Disease

    Biochemists at UCLA have uncovered a potential treatment for PH1, a rare and potentially deadly genetic kidney disease in children.

  • U.K. Researchers On Track To Develop Enzyme-Blocking Cancer, Alzheimer’s “Wonder Drug”

    Scientists at the Imperial College London have discovered a molecule with the potential to block the activity of an enzyme that is responsible for the progression of disease. Further investigation and development could yield a revolutionary and potent treatment for serious diseases, such as cancer, Alzheimer’s disease, and diabetes.

  • Novo Nordisk To Focus On Obesity With New Seattle Research Unit

    Novo Nordisk is focusing efforts on obesity treatments and is building a new obesity research unit in Seattle, WA. The company announced the initiative in a press release. The Novo Nordisk Obesity Research Unit will initially employ 10 people, reaching 60 by the end of 2016. The new center will concentrate on basic research and treatments for obesity. Mads Krogsgaard Thomsen, EVP and CSO at Novo Nordisk, said, “Our ambition is to drive scientific progress in the obesity disease area and through this, identify and develop new treatment options for people with obesity.”

  • Novel Compound Shows Promise In Fighting Multiple Myeloma

    Scientists at the Dana-Farber Cancer Institute have shown that a novel compound prevents metastasis of multiple myeloma in mouse models, and it is this discovery that will form the basis of the company’s future plans to progress the compound into human trials.

  • MIT Team Hacks Anthrax To Deliver Cancer Drugs

    A team of chemists from the Massachusetts Institute of Technology (MIT) reported that they have turned to bacillus anthracis bacteria, the culprit behind anthrax infection, in order to deliver cancer drugs more effectively.

  • FDA Grants Orphan Status To MabVax’s Neuroblastoma Vaccine

    Clinical stage oncology drug development firm MabVax Therapeutics announced that it has received the coveted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its vaccine targeting childhood cancer neuroblastoma.

  • NIH Funds Phase 2 Of ‘Tissue Chip For Drug Screening’ Program

    The National Institutes of Health (NIH) announced that it will award funds to support the next phase of the Tissue Chip for Drug Screening program, which will attempt to a build a human-like system to test drugs’ safety and efficacy.

  • Researchers Develop New Anticancer Peptide Vaccines and Inhibitors

    Two new anticancer peptide vaccines and two peptide inhibitors have been developed by researchers at The Ohio State University Comprehensive Cancer Center as part of a larger peptide immunotherapy project.

More news...