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Covance Blog
As the world waits for a vaccine to protect against COVID-19, the disease caused by the novel coronavirus, it will need not only scientific excellence but also business continuity excellence to keep vital research and immunogenicity studies running. Vaccine development relies on many early, nonclinical studies; some of the earliest …
With more complex pollinator studies now demanded by regulators of crop protection products, we have an interview with Dr Michael Ramsey, Study Director for Terrestrial Ecotoxicology, about the new Covance research apiary in Huntingdon, UK and the value it brings to research and the local ecosystem.
This online whitepaper article explores the 2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug–drug interaction (DDI) assessments.
Cell therapy breakthroughs, such as chimeric antigen receptor T-cell (CAR-T) therapy, have made a significant impact on the oncology landscape, but many potential breakthrough cell-based therapies are emerging in other therapeutic areas, such as neurodegenerative diseases and macular degeneration. “What we see in the cell-based therapeutic research area today represents …
What is DART? DART stands for ‘developmental and reproductive toxicology’ and is the acronym commonly used in place of the term reproductive toxicology. DART studies assess a chemical’s effect on several aspects of reproductive capacity in laboratory animals. These include mating performance and fertility, sexual maturation, and offspring growth and …
Traditionally the pharmacovigilance (PV) function has been responsible for collecting, assessing and reporting adverse events (AEs) and related drug safety information to regulators. Because PV is so process driven, companies have had to invest in safety systems to organize data and optimize efficiency. Yet these closed systems, including home-grown systems, …
In an age where new chemical entity drug development can average 15 years to complete and only 0.1% of drugs advance from early drug discovery to approval, a different approach is needed to address a pandemic like COVID-19. “Drug repurposing” and the request of an Emergency Use Authorization (EUA) are …
The renewal process in the EU and the US for existing active substances requires advance planning and careful and attentive management. Following is practical advice to help you tackle the renewal of your plant protection active substance. 1. Form a Taskforce or Consortium A major difference between the application for …
When asked what they miss most about their time in service, military veterans often mention the unparalleled spirit of camaraderie – and some of them find ways to start recreating it in their civilian careers. We recently learned how that affinity has inspired some of our military veteran employees to …
The COVID-19 pandemic is driving a global demand for medical supplies, equipment and cleaning agents. In terms of PPE alone, the WHO estimates that there is a world-wide monthly demand for 89 million medical masks, 76 million examination gloves and 1.6 million goggles. To meet this demand, the WHO suggests …