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.
Our “Meet Me in 5” series covers 5 people, topics or
questions to illustrate how our business nurtures exceptional people, provides
an energizing purpose and enables extraordinary potential in its employees’
In this article, we spoke to Ilse Mathieu, Site Lead
European Operations Center – Associate Director, EMEA Distribution, based in Mechelen,
Belgium. She discussed how the Covance Mechelen site is ramping up to become a major
kit production facility to supply clinical trial kits across Europe, the Middle
East and Africa – and what this high-profile project means for career growth
opportunities in Mechelen.
On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.
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.
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.
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