Current guidance on rheumatoid arthritis (RA) stresses the importance of considering comorbidity when assessing disease activity and making clinical decisions.1 Comorbidities commonly associated with RA include cardiovascular disease (CVD), lung disease and malignancy.2
The complex relationship between RA and CVD comorbidities
The presence of CVD itself has been shown to increase the risk of death in RA patients by approximately 50%,3 and there is an emerging relationship between RA, CVD and the therapies used to treat them. Continue reading
Pharmacokinetic (PK) data guide the safe and effective management of a drug treatment; however, with diabetic patients, PK studies can be especially challenging. Varying degrees of kidney disease in patients can affect the PK characteristics of the drug and the reliability of the study results.
From screening patients to determining doses, testing a drug for diabetic patients involves several important considerations.
The importance of early work
Even before a drug reaches the clinical stages, early work can help set the stage. Preclinical research is very important in identifying agents with activity in the diabetic spectrum, while studies in early toxicology provide valuable direction as to whether the risks are acceptable in the diabetic population.
Given that most diabetic drugs affect the kidneys, performing an early renal study on a model can determine if the drug has a future in the diabetic space and may help guide earlier go/no-go decisions ‒ before allocating additional resources to the efforts. Continue reading
Welcome to a series of informational blogs where I will describe, decode and demystify the FDA “Control of Listeria monocytogenes (Lm) in Ready-to-Eat Foods: Guidance for Industry Draft Guidance” (henceforth, The Guidance). These blogs will offer translations of The Guidance for minimizing Listeria incidence in your ready-to-eat (RTE) production environment and products. In this series, I will provide a section-by-section analysis translating the FDA recommendations into usable English and offering techniques to go above and beyond for those that are so inclined. Continue reading
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