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).
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.
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.
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.
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.
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
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
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.
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.
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.
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
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.
Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, announces the launch of SARTOFLOW Smart, the smart and easy benchtop crossflow system for optimized ultra- and diafiltration applications.
Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).
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.
Brookfield Engineering Broadens AMETEK’s Laboratory Instrumentation Platform ESP/SurgeX Expands AMETEK’s Power Protection Platform
ATCC, the premier global biological materials resource and standards organization, is poised to assist the medical and life science researchers that are working to address the evolving concerns around Zika Virus infection.
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF.
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, 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.
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 (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.
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, 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.
IQPC has made several recent additions to the speaking faculty of the Biosimilars Clinical Studies & Analytical Similarity Summit.
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).
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.