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.
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.
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
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).
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
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
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.
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
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.
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.
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.”
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
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.