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.
Outsourced Pharma’s final program in 2016 was recently concluded in San Francisco. For the first time, technology companies, venture capital firms and others from Silicon Valley and elsewhere were invited to join the Outsourced Pharma community to focus on the topic of “Drug Development and Manufacturing Outsourcing in an Era of Technology.”
A leading UK-based biotechnology company has been awarded a grant to develop packaging cell lines for virus bioproduction.
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, is pleased to announce the dates and topics for CellWorld 2017, a Finesse-sponsored event designed for innovators, visionaries and senior executives in bioprocessing.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, opened a new bioanalytical and biosafety testing laboratory yesterday in the major biotech hub of Boston, Massachusetts.
World Courier, the global leader in specialty logistics and a part of AmerisourceBergen, unveiled a new packaging solution for pallet-sized shipments that will reduce transport costs and maintain temperature up to 40 percent longer than comparable products.
In 2015, more than 20 million counterfeit pills and other medications were confiscated in one covert operation.
GE Healthcare’s Life Sciences business and Valneva SE, a fully integrated vaccine biotech company, are sharing the results of a successful collaboration to optimize virus productivity in Valneva’s EB66 cell-line, a proprietary technology for the production of a wide variety of vaccines, including human and animal health vaccines.
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, announced the launch of SmartVessel, a single-use 3-liter bioreactor vessel.
GE Healthcare’s Life Sciences business, a global provider of expertise, tools and technologies to the biotech industry, announced recently a USD 7 million expansion project at its single-use technology manufacturing facility in Westborough, MA, US.
Phillips-Medisize Corporation, is once again a sponsor and will present during a panel discussion at the upcoming Partnership Opportunities in Drug Delivery (PODD) conference in Boston, MA.
Phillips-Medisize Corporation, along with Medicom Innovation Partner (“Medicom”) will showcase their capabilities at next week’s PDA Universe of Pre-filled Syringes and Injection Devices conference in Huntington Beach, CA. This conference brings together industry and regulatory experts to share their experiences with the benefits, convenience and innovations pre-filled syringes and injection devices.
Billerica, MA — MilliporeSigma today announced that CEO Udit Batra was named “CEO of the Year” for 2016 by CPhI Pharma for his commitment to furthering life science innovation globally.
CPhI Worldwide, organised by UBM EMEA, recently announces the findings of part iii of the 2016 CPhI Annual Report, which focuses on growth opportunities over the next 5-years – specifically generics consumption and approval process, the use of big data in pharma and the potential of 3D printed formulations.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, recently announced its polyethersulfone membrane (PESU) is now integrated into two new, sterile Sartocon benchtop and production scale filtration assemblies.
Meissner is pleased to announce its participation in the ISPE’s 25th Anniversary Annual Product Show (Boston Chapter), on October 4th, 2016. Meissner will be hosting ISPE guests in booth W153 (West Hall), on October 5th, at Gillette Stadium, in Foxborough, MA, where the event is being held.