Pesticide active ingredient renewal: how to negotiate the EU endocrine disruptor requirements

ED assessment of active substances in PPPs came into effect in November 2018 in the EU. Insights from EFSA’s assessment of the first 65 actives shows how guidance is applied and how waivers are being used. Read on to find out how to negotiate the ED assessment process and when to consider derogations for active substances with ED potential.

Decentralized Clinical Trials (DCT) Monthly Blog – March 2021

This month, we want to highlight the growing connections between decentralized clinical trials (DCTs) and the critical therapeutic area of oncology.

Expanding clinical trial support in Europe, the Middle East and Africa with a new automated kit production line

As part of a global growth and expansion strategy, we’re announcing the spring opening of a new kit production line at our European Operations Center (EOC). Based in Mechelen, Belgium, the EOC is a multi-use facility that handles dry ice production and distribution for the EU, as well as study and logistics support. This new automated kit production line will produce industry-leading specimen collection kits for investigator sites in Europe, the Middle East and Africa (EMEA).

Minimal Residual Disease by Flow Cytometry: Latest Insights on Validation

Despite the development of cellular and antibody-based therapeutics that eliminate malignant cells, patients who have achieved complete remission or response may experience relapse. Increasing evidence suggests that the presence of measurable/minimal residual disease (MRD) in bone marrow (BM) tissue is one, if not the strongest, prognostic factor for disease outcome in patients with hematological conditions.1 There is now much interest around early use of MRD as a surrogate marker of survival, especially given its potential to accelerate trial reporting and be accepted as a primary/secondary trial endpoint. Here, we explore how next-generation flow cytometry (‘flow’) is integral to evaluating MRD.

Overcoming challenges in the processes of characterization, assessment, and registration of your UVCB in Europe

The demand under European regulations for detailed environmental risk assessment of UCVBs is challenging both the industry and regulators alike. Read on to explore the challenges and possible ways of overcoming them.

Who is most at risk for mold allergies? New study uncovers prevalence of mold allergies in the US

A recent study analyzed allergy testing data to identify who faces the highest risk for mold allergies and which mold species are most often linked to allergic reactions.

Six Automated Clinical Alerts You Need to Increase Efficiency in your Clinical Trials

What is an automated clinical alert? Automated clinical alerts continuously monitor study data and send alerts and notifications to clinical trial project team members based on specific study, country, site or subject performance criteria to help boost clinical study monitoring and improve quality management.

Antibody Reagent Spotlight – Generating positive control antibodies for your Anti-Drug Antibody (ADA) assay

Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, hormones, cytokines, growth factors, gene therapy products are a crucial class of therapeutic agents that have transformed the treatment of various diseases. As these complex molecules are introduced into patients, it is essential to monitor potential immunogenic responses. The potential immunogenicity of biological products results in the elicitation of anti-drug antibodies (ADA).  Anti-Drug Antibodies (ADAs) are immune responses generated against the therapeutic drug itself. The assessment of ADAs is a vital component of biopharmaceutical development. To ensure the reliability and sensitivity of ADA assays, positive control antibodies are generated as key reference materials.

Recognizing National Kidney Month by Breaking Down Barriers to Improve Clinical Trials for Glomerular Diseases

To raise awareness about kidney diseases during National Kidney Month, we’d like to focus on rare renal diseases and the importance of studying not only adults but the pediatric population as well. Several rare glomerular diseases1 can impact the kidney’s important cleansing function. Tiny clusters of looping blood vessels, called glomeruli, sit within each kidney’s approximately 1 million nephrons. Similar to other kidney diseases, glomerular diseases often progress silently and remain undetected until the disease becomes more advanced. Once diagnosed, treatment options have historically been limited, but recent clinical trials and drug approvals have been encouraging.