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. Continue reading →
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 Continue reading →
Biopharmaceutical companies both big and small have witnessed the shift toward patient-centric practices in the current healthcare landscape. As a result, many are now including or planning to incorporate the voice of the patient in their drug development strategy.
How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices? We recently spoke to Jonathan Zung, PhD, group president, clinical development and commercialization services at Covance to understand his view on the patient centricity imperative and how it impacts clinical development activities. Continue reading →
Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end.
Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading →
The introduction of vaccines against Measles, Mumps, Rubella (MMR), and Varicella (the “V” in MMRV vaccines) led to a drop in the incidence of these diseases by 89% (Varicella) and 99% (MMR). These effective vaccines are a core component in most pediatric immunization programs across the world. Hence, every time a new pediatric vaccine is added to the existing immunization schedule, clinical evidence must be provided that the newcomer does not adversely influence the immunogenic response to the MMRV-licensed vaccines. These required non-inferiority studies when vaccines are co-administered (known as concomitant vaccine testing) come with their own challenges.