NASH Clinical Trials: Use of Laboratory Biomarkers
Non-alcoholic fatty liver disease (NAFLD) is one of the most prevalent chronic liver diseases globally. The complex pathophysiology of the disease and invasive diagnostic requirements lead to difficulties in defining the correct patient population and monitoring the progress of the disease. This webinar aims to give an overview of NASH and NAFLD pathophysiology, with particular focus on current drug development efforts and biomarkers that can provide additional insight into patient status while reducing the burden of invasive diagnostic methods on patient care.
A Roadmap to Biomarkers in Alzheimer’s Disease Clinical Trials
Without clinical trials, there can be no better treatments, no prevention and no cure for Alzheimer’s disease.
This webinar delivers an overview of neurodegenerative diseases, with particular focus on Alzheimer’s Disease pathophysiology, current drug development and available biomarkers.
Eurofins’ full range of neurology testing options will be explored detailing case studies for recent commercial kit verification and bespoke assay development.
Streamline Your Sars-Cov-2 Antibody Testing with a svnt Nab Solution
This webinar provides some new data comparing the neutralizing antibody versus total IgG binding antibody responses to vaccination in a well-controlled participant group of about 200 health care workers will be presented.
Overcoming Effects of Interfering Factors in Cell-based Nab Methods
Strategies that mitigate interference such as positional effect and matrix effect are critical to improve assay sensitivity and effectively characterizing samples for the presence of neutralizing antibodies (NAb). Eurofins has had success in overcoming these challenges by evaluating plate/signal characteristics and applying a normalization approach. The differences observed between ‘Positive’ and ‘Negative’ samples as determined by NAb assays are oftentimes small and may be unduly influenced by these interfering components within the sample. Such interference may potentially result in a relatively high number of sample characterizations as falsely positive or falsely negative.
A case study from the development of a cell-based method to detect NAb against a therapeutic that functions as an agonist will be presented. In addition, the use of flow cytometry platform on cell-based Nab methods will be discussed.
Accelerate Your COVID-19 Bioanalytical Therapeutic and Vaccine Research While Saving Time and Reducing Costs
The pharmaceutical industry is in a race to treat and prevent COVID-19 from impacting more human lives. This has led to many alternative approaches, but regulated Bioanalytical is not an area where short cuts should be taken. We will discuss current approaches available for therapeutic and vaccine Bioanalytical assessments and regulatory requirements in clinical research.
As an alternative to the current gold standard of conventional virus neutralization tests, we will highlight a simple and rapid validated SARS-CoV-2 surrogate virus neutralization test (sVNT) that is amenable to high-throughput testing and/or fully automated by detecting total immunodominant neutralizing antibodies that can be rapidly conducted without requiring a biosafety level 3 containment.
PBMC Harmonization in Multi-Site Global Clinical Trials: Challenges & Solutions
PBMCs have many applications in clinical development allowing centralized, large batch cell-based analysis. The method used to isolate PBMCs can have significant impacts on downstream analysis. Because of this relationship, great care must be taken to handle samples in a uniform and high-quality manner to avoid bias in downstream testing, especially when multiple sites are required. This webinar will provide an insight into the current best practices in PBMC isolation in the drug development process and examine new technologies for the future.
Roadmap to Successful Drug Partnerships
Complex innovative clinical trial designs require an integrated synergetic approach to assess novel drug compounds for safety and effectiveness which often span esoteric, regulated and safety outcomes in all phases of the drug development life cycle. The companies of Eurofins Bioanalytical Services, the Eurofins Central Laboratory global network, Eurofins Viracor BioPharma Services, and Eurofins Clinical Trial Supplies are building a stronger connection to provide a seamless solutions-based approach to our client needs. Eurofins Clinical Trial Solutions provides seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. Our integrated solutions deliver the most comprehensive range of state-of-the-art analytical technologies with an expansive geographic reach in order to support our clients’ specialized testing needs and stringent quality and safety requirements around the world.
