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.
Anyone involved in clinical work knows investigator engagement is not an easy task. Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.
Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.
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.
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.
The NextDocs Compliance Cloud is a state-of-the-art delivery platform for the NextDocs compliance suite and was built from the ground up for the Life Sciences industry.
IPS-Integrated Project Services, LLC (IPS), a leading global provider of engineering, architecture, project controls, construction management, commissioning and qualification services, and G-CON Manufacturing, Inc. the leading provider of prefabricated cleanrooms, today announced the unveiling of the iCON™ brand which represents the collective facility design and build capabilities of the two companies.
Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization of biologic-based drug substances, has opened its 10,000-square foot, cell-culture process development laboratories in Wilton Center, Teesside, England.
Brammer Bio ("Brammer"), a cell and gene therapy contract development and manufacturing organization (CDMO), today announced completion of its clinical capacity expansion in Alachua, Florida.
Pfizer Inc. (NYSE:PFE) today announced positive findings from REFLECTIONS B327-02 (n=707), a pivotal Phase 3 randomized, double-blind comparative safety and efficacy study of the company’s investigational trastuzumab biosimilar (PF-05280014) versus Herceptin 1(trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid. Positive data from a supplemental study, REFLECTIONS B327-04 (n=226), were also presented at the meeting. PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin.
Bayer’s North American Crop Science Division Headquarters required a modernization to be reflective of a modern brand, accommodate increased staff levels and attract professionals to Bayer. CRB provided mechanical, electrical and plumbing services to help create an efficient, modern facility within the existing building envelope on Bayer’s growing campus.
Outsourced Pharma San Francisco will feature Achaogen as its Spotlight Leadership Company at its conference for professionals of biotech, pharma, and contract development and manufacturing organizations (October 17 - 18 at the Hyatt Regency San Francisco Airport). The session is titled: Spotlight Leadership Company: Achaogen.
BioPhorum Operations Group (BPOG) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) are pleased to announce they have entered into a collaboration agreement to develop a US-specific roadmap for the biopharmaceutical manufacturing industry to complement the existing BPOG global roadmap.
Beckman Coulter Life Sciences has opened up the possibilities for cancer researchers with the launch of the first flow cytometer to offer excitation sources across the visible spectrum in a standard configuration.
Coherus BioSciences today reported topline results from the first of three ongoing pharmacokinetic bioequivalence ("PK/BE") studies comparing CHS-1420, a proposed adalimumab ("Humira") biosimilar candidate versus European marketed Humira.
Samsung Bioepis Co., Ltd. announced today that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas. The two companies will immediately begin working on the program’s first therapeutic candidate, TAK-671, which is intended to treat severe acute pancreatitis.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has announced the ambr 15 automated micro bioreactor system combined with a Nova Biomedical (Nova) BioProfile FLEX2 automated cell culture analyzer.
Amgen and Allergan today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Celltrion and Teva today announced that the U.S. FDA has accepted for review the BLA for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin (INN:trastuzumab) which is used for the treatment of Human Epidermal growth factor Receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer.
The BioPhorum Operations Group (BPOG), a cross-industry collaboration, has recently published the first edition of The Technology Roadmap for the Biopharmaceutical Manufacturing Industry.
Tunnell Consulting has been solving the most complex problems faced by life sciences companies for over 50 years.