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Covance Blog
Chimeric Antigen Receptor T Cells, In Vitro and In Vivo Preclinical Models, plus regulatory and safety considerations In a recent webinar, we presented on and discussed the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.
As COVID-19 was declared a pandemic, Covance Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
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 …
BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and manage the information required. Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful …
Introduction 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 …
The Brexit1 deadline has been extended once again – now to January 31, 2020 – and a withdrawal deal seems likely given the result of the December 12 general election. However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product …
The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers. It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs. As such, this Draft Guidance supports the Qualification of Drug Development Tools …
The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …
Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.
Pharmaceutical companies are increasingly relying on biomarkers to deliver precision medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests …