Field Trials for Crop Residue Analysis – What Are the 7 Secrets to Success?

Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).

MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?

Continue reading

Brexit: Leveraging the Mutual Recognition Agreement to Mitigate Potential Risk With Commercial Drug Product Release Testing

The Brexit1 deadline has been extended once again, now to January 31, 2020, and the status of the Brexit deal will depend on the outcome of an upcoming election scheduled for December 12. Regardless of the outcome, drug manufacturers and contract test laboratories need to be proactive and understand the potential regulatory considerations relating to commercial drug product release testing and Brexit.

This article provides a brief overview of the EU-U.S. Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, U.K. and U.S. drug product releases if and when Brexit moves ahead.

Continue reading

Closing the Knowledge Gap with Real-World Evidence (RWE) Studies: The Importance of Starting Early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.

This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.

Continue reading

5 Different Kinds of Cytokine Release Assays: Weathering the Storm | CRA Post II

In our previous post, we outlined the dangers of Cytokine Release Syndrome (CRS) and the importance of preclinical Cytokine Release Assays (CRAs) when developing monoclonal antibodies (mAbs) that interact with the patient’s immune system. In this second post, we describe the different kinds of assays in use and how these may fit into your drug development program. An alternative type of CRA, peripheral blood mononuclear cell (PBMC) blood outgrowth endothelial cell (BOEC) co-culture, will be discussed in more detail in our next blog post.

Continue reading

In Vitro Cytokine Release Assays: Is There Calm After the Storm? | CRA Post I

What is a cytokine storm? 

Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines into the general circulatory system, leading to severe multi-organ damage, failure or potentially death. This is an extremely unwanted immunotoxicological side effect in drug development.

Continue reading

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction

RA Biosimilar Recruitment

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

Continue reading

Covance Shanghai Strengthens Safety Pharmacology Capabilities for In-House IND Packages to Serve Asia Clients

Covance Shanghai is pleased to announce an expansion of its general toxicology capabilities to include safety pharmacology studies, allowing our Asia-Pacific clients to more easily complete their IND requirements for CFDA regulations.

What are the new safety pharmacology offerings?

The general tox team in Shanghai is now capable of running cardiovascular safety studies with dogs, using DSI PhysioTel Digital L11 telemeters to monitor drug elicited effects on electrocardiograms and hemodynamic parameters, heart rate and blood pressure. They are also able to run neurological and respiratory studies in rat models.

Team members from Shanghai were trained in these experimental procedures by experienced safety pharm specialists from the Covance Madison site. After several months of personnel training, beginning in June 2018, validation studies at the Shanghai site were completed in early  2019.

Continue reading

Listening To – and Learning From – the Voice of the Patient

Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials.  

Patient recruitment and retention continue to be the biggest challenge in clinical studies. Designing protocols with patient needs in mind will lead to higher levels of better clinical research recruitment, drive up participation rates and save both time and money.

Continue reading

Real-World Evidence Applied in Real-Life Case Studies

Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.

Clinical Trial Data Xcellerate Informatics Covance Blog

Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.

Continue reading

Customizing Real-World Evidence (RWE) Study Designs: A New Framework Tool That Incorporates Elements of Virtual Study Design

While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range of alternative options for evidence generation that enable faster, less resource intensive and more patient-centric, study execution.

In this second article in our series of three, learn how we collaborated with RWE professionals to create a unique RWE framework tool that can help your teams with study planning in today’s rapidly evolving environment.

Continue reading