Following the rebrand and restructure of the Chinese regulatory body, the China Food and Drug Administration (CFDA), in 2013, the regulation process now includes inspections for all multi-national and local pharmaceutical companies with drug filings in China.
As a continued commitment to meet clients’ needs and conform to local Chinese regulations, the Covance Central Laboratory Services Shanghai team (Covance CLS Shanghai) provides guidance to our clients to navigate CFDA inspections. Backed by more than 10 years of experience in China, the Covance CLS Shanghai team delivers a deeper understanding of CFDA regulatory and operational requirements and helps clients with a standardized process and corresponding documentation.
What issues do patients cite as barriers to clinical study participation? How far are they willing to travel to participate in a study and how much more willing are they to participate knowing that their physician is aware of the study?
We asked these questions – and more – to group of 135,000 people who opted in to the LabCorp database to receive more information about Covance clinical studies. More than 2,500 responded to our survey, providing our team with unique insights to better understand the patient mindset and design more effective recruitment strategies.
Next, to see if our colleagues in the drug development industry could surmise our participants’ aggregate answers from this survey, we delivered a short pop quiz. Any attendees who stopped by our booth at the 2017 Drug Information Association annual meeting (DIA), had a chance to take the quiz and see how they fared. Continue reading
Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. We also discuss the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading
Natural killer (NK) cells first earned their title as “killers” nearly 40 years ago when researchers observed the rapid immune response of these lymphocytes as they destroyed host cells infected with a virus or tumor cells. It seemed that NK cells could attach spontaneously without prior activation. Over time, researchers have learned more about the molecular mechanisms that regulate their activation and function.
Today, the NK cell assay is used to support specialty immunotoxicology studies for safety assessment. At Covance, we work with clients that often ask us about performing a NK cell functional analysis and the role of standard immunophenotyping to enumerate cells. This article addresses these questions by providing a brief background on the innate immunity of NK cell biology and comparing assay methods. Continue reading
In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading
No single blood test or physical finding alone can confirm the diagnosis of rheumatoid arthritis (RA). However, two tests that detect markers of inflammation are often ordered when RA is suspected: erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Other common tests include rheumatoid factor and anti-CCP antibodies.
RA patients in the United States
While the test results are clearly valuable to the requesting physician to inform diagnostic decisions, sponsors can also leverage this information to support patient recruitment in an increasingly competitive space. We recently evaluated how de-identified patient data from these common tests run by LabCorp can support sponsors’ clinical trials in rheumatoid arthritis. Continue reading
When it comes to novel drug discovery and development, flow cytometry is known for being both a powerful and versatile technology. It can deliver valuable information to advance early biomarker development, tolerability, clinical studies and even companion diagnostics. But leveraging flow cytometry technologies to answer analytical questions and empower decision making from the research lab to the clinic requires a deep knowledge of cutting-edge approaches.
Virginia Litwin, PhD, principal scientist, hematology/flow cytometry at Covance and her team are examining current trends in rare event analyses assays to ensure that performance is well characterized and fit-for-purpose – particularly in regulated environments. They are also addressing the various hurdles associated with analyzing cellular biomarkers for immunotherapy and adoptive cell therapy. Continue reading
Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today’s regulatory environment. Continue reading
Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the mechanisms of immune response to various antigens, thereby aiding them in the development of novel approaches to treat immune-system-related diseases and better design vaccines to combat infectious agents and cancer.
Currently, one of the most sensitive techniques available for the detection, measurement, and functional analysis of immune cells is the enzyme-linked immunospot (ELISPOT) assay. Covance uses the ELISPOT technique in applications such as evaluation of vaccine efficacy and immunogenicity of biological products.
A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but actually refer less than 0.2% of their patients into clinical trials.1 In conjunction, more than 80% of patients say they are willing to participate in clinical research studies, but only around 10% actually do so.2 It is further reported that while 85% of patients are generally comfortable presenting any clinical research information they find to their doctor, only 17% have actually done so.3 And what of those patients that are interested in participating in a clinical study only to find they are ineligible? When queried on next steps after finding out he/she did not qualify, 36% stopped looking for a clinical research study to participate in.3 This latter fact is a staggering waste of potential when you consider that there are currently >130 planned or ongoing industry-sponsored Phase II-III rheumatoid arthritis (RA) studies to choose from (>210 when you consider any type of study sponsor).4