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.
On April 4, 2017 the first international Stem Cell Community Day will take place in Hamburg. Experts from academia and industry will discuss the status quo, perspectives, and challenges in stem cell cultivation for research and therapy, according to the event’s motto: “Bioprocessing Technologies in Stem Cell Research – Challenges and Chances for Commercialization”
Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, recently announced that it has expanded its fill-finish services to its Kalamazoo, Michigan (United States), site.
Thermo Fisher Scientific Inc. announced that its pending acquisition of Finesse Solutions, Inc., a leader in the development of scalable control automation systems and software for bioproduction, has received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Leading life science company Eppendorf introduces the BioFlo 120, their latest bench scale fermentor/bioreactor system for research and development.
Outsourced Pharma is excited to announce the agenda for its Boston event. The Summit On Modern-Day Drug Development and Manufacturing Outsourcing is scheduled for April 26 and 27 at the Boston Park Plaza. The complete agenda and list of panelists can be found here (http://outsourcedpharmaevents.com/programs/agenda).
MilliporeSigma has introduced CAN MultiFlow™ screening services to more accurately predict genotoxic and mode of action* properties of substances, ingredients and drug compounds. Offered through its BioReliance® testing facilities, MilliporeSigma will be the first company to provide this service in the United States.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has developed an innovative and fully integrated technology platform to meet the requirements of today’s upstream bioprocessing. It will allow customers to adopt a Quality by Design (QbD) approach in which they build quality into their biological products by combining the power of highthroughput mini bioreactors with data analysis and knowledge management tools so that robust and well-characterized processes can be scaled up at the first attempt.
MilliporeSigma, a leading science and technology company, recently announced the opening of a facility in Mollet des Vallès, Spain dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.
The German National Center for Tumor Diseases (NCT) Heidelberg and Protagen AG recently announced a collaboration to utilize Protagen’s SeroTag technology to identify biomarkers that predict therapy responsiveness and the detection of immune-related adverse events (irAEs) in melanoma patients treated with checkpoint inhibitors
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, opened a new validation service laboratory yesterday at its site in Shanghai Zhangjiang Hi-Tech Park. The opening event was attended by business partners from the biopharmaceutical industry and representatives of the local community.
The CPhI Worldwide expert panel predicts pharma’s biggest opportunities and threats in 2017 – the wider industry, attendees and exhibitors increasingly look to the CPhI global events as a key indicator of future trends and partnerships.
MilliporeSigma recently announced that Ying Li, from The Pennsylvania State University, has won the company’s Life Science Award in Bioseparations.
Life Science Connect, a business unit within the pioneering B2B media services company VertMarkets, announced two new appointments to the company’s Life Sciences team. Bob Marshall joins the Life Science Connect team as the Editor In Chief of Med Device Online.
Sartorius Stedim Cellca based near Ulm in southern Germany, continues on the growth track.
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, announced the launch of its new G3Lite+ SmartController for upstream cell culture and fermentation.