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
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
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.Continue reading
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.1Continue reading
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).Continue reading
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.Continue reading
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
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.Continue reading
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.”Continue reading
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.Continue reading