In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.
We have recently launched a novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM). This is one of the most cutting-edge personalised therapy clinical trials in the world for several reasons including
Single nucleotide polymorphisms (SNPs) are responsible for more than 80% of the variations between individuals, and are present throughout most genes and other important sequences in the human body, which makes them ideal for tracking down correlations between genotype and phenotype.
Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.
Change is a part of life which some fear whilst others thrive. In the commercial world, a fundamental aspect of good management is to apply strategic insight to react to change in order to survive and grow. The pharmaceutical industry, as with every industry, is constantly exposed to new threats. Companies are all too painfully aware that the external threats that it currently faces, as well as the threat of their own drying pipelines, are forcing it to adapt and to stay on the lookout for new opportunities - now more than ever.
Person-specific cell therapy could potentially offer a cure as opposed to ongoing treatment, but it is also a disruptive technology that doesn't currently fit into traditional therapeutic manufacturing processes.
Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.