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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Understanding Annexes VII-X

Avoiding obstacles with REACH Annexes VII-X

Posted by Dr. David Howes, Expert Consultant in Chemical Legislation and Chemistry, Covance

In the EU, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. The registration dossier outlines the standard information requirements for a substance and minimum data required that describe the physicochemical, toxicological, environmental fate and ecotoxicological properties of the substance.

With this information, the European Chemicals Agency (ECHA) can make a decision regarding the safety of the substance. However, data requirements vary with the amount of substance used. Often, more complex information is required to manufacture or import a substance into the EU and the European Economic Area (EEA).

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Step Inside Mechelen: A Day in the Life of a Regional Study Coordinator’s Project Management Role

Elien is a Senior Regional Study Coordinator (RSC), which is an associate project manager role, housed in our growing Mechelen, Belgium office for Covance Central Laboratory Services (CLS). She shared a glimpse inside a typical day as a Regional Study Coordinator, a role that manages local laboratory operations within our global project management department.

8:30-9:30 | I start each day by going through my inbox and calendar and making my to-do list.

Because we are working with a global team, we receive many emails overnight. My first task of the day is to clean out emails from previous days and organize others by priority so only action items are left – that way I can easily view my top priorities. Then I review my calendar and prepare for meetings.

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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.

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Preserving Lifecycles: Renewing Established Pesticides

The regulation that governs the marketing, sale, and use of pesticides is just a fact of life, but the standards imposed are constantly evolving as our scientific insight and knowledge increases. This series of informational blogs is designed to examine how existing active substances (ASs) are managed through the current regulatory renewal systems in the EU and USA.

We have been using chemicals to protect plants from pests and diseases since 2,500 BC, when, as records show, ancient Sumerians used sulfur to control mites/insects. However, it was really towards the end of the 19th century that the industrial usage of inorganic products and those derived naturally, such as pyrethrum, became common and widespread.

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#CovancePotential: A DREAMer’s Journey to Improve Health and Lives

Earning doctorate degrees in veterinary medicine and veterinary pathology are significant accomplishments, but they are underscored by the seemingly insurmountable challenges Dr. Alejandro Larios Mora has faced in his journey to date.

Alejandro wasn’t the student anyone pegged to be a doctor. In fact, he failed kindergarten – and by fifth grade the self-proclaimed troublemaker was only allowed to attend class with a parent escort.

“As a child, it’s very difficult to see past your surroundings if you live in a bad area. You think that’s as good as it gets,” Alejandro said. “That’s why it is important to have mentors – to show you something different, something better.” 

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From PhD to Clinical Trials Project Management: Ana’s Career Shift Quickly Delivers Results

Ana’s passion for biomedical sciences brought her to Covance as a Regional Study Coordinator (RSC) earlier this year. She said after working in R&D and chemistry, shifting to a project management role presented an opportunity to develop different skills and realize an immediate impact on patients’ lives. The opportunity to transform healthcare and change lives around the world – what we call Energizing Purpose – is the common thread that unites Covance employees like Ana to push new boundaries.

As she establishes her career in technical project management at our Central Laboratory Services (CLS) site in Mechelen, Belgium, Ana maintains a personal and professional balance with time at home and in the office. She has completed a rigorous training program and continues to develop her project management skills with her mentor.

Find out more about Ana’s role in project management and the potential she sees with a career at Covance.

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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.

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