What the New EU Endocrine Disruptor Assessment Means for Renewal of Your Active Ingredients

Introduction

The new EU requirements for endocrine disruptor identification will impact any active ingredient (AI) renewals with expected decisions from November 2018 onwards. Learn more about these requirements and key strategies to meet them, below[CS1] [CS2].

The European Commission has adopted new criteria for identifying endocrine disruptors (EDs) – these criteria apply to new active ingredients (AIs) and those going through renewal (). So, if the AIs in your plant protection products (PPPs) are due for renewal you need to understand the new requirements and how you can meet them.

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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.

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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.

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What You Need to Know About Neonicotinoids and The EU

Photo of a bee

Introduction

Neonicotinoids were developed to find safer, more effective alternatives to chlorinated hydrocarbons, organophosphates, carbamates, and pyrethroids, so, ironically, some neonicotinoids are now banned in the EU because of their toxicity to bees and other pollinators, as well as to a wider group of species.

The agricultural and environmental consequences of neonicotinoid use and the recent EU regulatory restriction have made neonicotinoids one of the most controversial areas of science and policy.

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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

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