Identification of new medicines for kidney disease remains an ongoing challenge in drug development. This challenge includes establishing new biochemical measurements (biomarkers) which can sensitively and accurately reflect the status of renal health and any associated changes in renal function. Sponsors are exploring many options to improve the application of biomarkers in preclinical use in order to better inform early phase safety studies and downstream clinical trials.
Katherine Landschulz, PhD, associate director of the translational biomarker solutions laboratory, and veterinarian pathologist Laura Boone, DVM, PhD, recently shared their experiences working on renal disease studies at Covance. They discussed their insights on how biomarkers are being used in preclinical studies to predict safety and advance translational medicine in drug development.
Of the 422 million people in the world with type 1 and 2 diabetes, 20-30% will develop diabetic nephropathy, also called diabetic kidney disease (DKD) – the leading cause of renal failure in the western world1.
From the perspective of drug developers, testing new therapies to prevent, treat or reverse this serious complication relies on biomarkers for timely and accurate patient identification and efficacy or safety monitoring.
Jennifer Ennis, MD, medical director at LabCorp and D. Walt Chandler, PhD, executive director at LabCorp, recently shared their thoughts on today’s biomarkers to detect and monitor DKD.
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 →
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Going Virtual: Evolving Real World Evidence Study Design for Speed, Flexibility and Lower Cost
Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.
Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:
The implications of electronic informed consent by the FDA
What is required to conduct a prospective virtual RWE study
How to use electronic data for a retrospective virtual RWE study
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading →
The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.
Covance and Global Specimen Solutions, Inc. (GSS) have announced a five-year strategic alliance that gives Covance clients access to a comprehensive and integrated solution that includes GlobalCODE®, snapTRACKTM and GSS wraparound services. This will enable near real-time data cleaning across clinical trial data sources which allow interventions to be made during the clinical trial, impacting overall trial execution and data validity. This also allows cross-protocol, cross-program analytics which provide context for data results, assuring robust clinical trial design and operational excellence. Continue reading →
Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical procedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical and costly.
The ultimate goal is to find noninvasive biomarkers that clearly show if the patient has steatohepatitis or liver fibrosis associated with nonalcoholic fatty liver disease (NAFLD). Recent studies suggest that nuclear magnetic resonance (NMR) spectroscopy, microRNA tests and genotyping may prove to be useful tools. Incorporating additional biomarkers into clinical trials can give biopharmaceutical companies an early indication of whether a compound is efficacious — and provide the confidence to move forward to the next phase of clinical testing. Continue reading →
Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.
An emerging focus on biomarkers
“Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted,” explained Anderson. “That’s why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit.”
The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is increasing world-wide in parallel to the increase of the obesity epidemic. Insulin resistance (IR) and the accumulation of triglyceride-derived toxic lipid metabolites play a key role in its pathogenesis. Multiple biomarkers are being evaluated for the non-invasive diagnosis of NASH. However, a percutaneous liver biopsy is still the gold standard method; the minimal diagnostic criteria include the presence of >5% macrovesicular steatosis, inflammation, and liver cell ballooning. Several pharmaceutical agents have been evaluated for the treatment of NASH; however, no single therapy has been approved so far. Due to the increasing prevalence and the health burden, there is a high need to develop therapeutic strategies for patients with NASH targeting both those with early-stage disease as well as those with advanced liver fibrosis. Continue reading →
In the effort to reduce attrition rates and improve approval rates of new molecular entities by regulatory agencies, there’s no doubt that biomarkers can make a big impact. But it’s not as simple as tacking on additional studies. Biomarker development requires an insightful strategy and consideration of specific opportunities and needs throughout the drug development pipeline.
A quality biomarker starts at the source—the sample itself. Sample collection and handling protocols must be standardized to specify the minimum volume requirement in the proper container along with the most optimal temperature during transportation and storage. These requirements should be backed and driven by validated processes. To further ensure biomarker stability, it’s equally critical to include the maximum allowed time in transportation. Continue reading →