Immunogenicity studies for the coronavirus vaccines: How to stay on track and build testing capacity even during COVID-19

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 …

Cell Therapy

Advancing the next generation of pluripotent and multipotent stem cell candidates

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 …

pharmacovigilance

Transforming pharmacovigilance operations through automation and cognitive technologies

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, …