How the use of manufacturing software is enabling pharma companies like BioNTech to accelerate development and production

Many parameters, both internal and external, influence the behavior of pharmaceutical powders. Understanding why and how is the first step in optimizing your process for developing novel pharmaceutical powders.

Nanomaterial continues to be a hot topic among regulatory agencies globally. The recent ban on TiO2 (E171) as a food additive in Europe has highlighted the need to have a comprehensive understanding of the global regulatory environment related to the presence of nanoparticles in food additives and excipients.

Not all eClinical applications are the same. For one thing, an eTMF, an EDC, and a CTMS all fulfill different functions. Perhaps more importantly, they are all built with varying degrees of complexity. The eTMF and EDC are both relatively simple applications in the IT world. Either can be introduced for a specific study or for a number of studies. If you’re unhappy with your eTMF or EDC applications, you can switch without too much fuss. The CTMS, on the other hand, is highly complex. It is the nerve center of the eClinical suite and is highly integrated with other software. It can be expensive to introduce, and its normal lifespan is more than 13 years. Therefore, once you install a CTMS, you will be committed for well over a decade. That’s why it is so important to choose your CTMS carefully and be armed with the best knowledge in order to do so. Which CTMS concept will be most functional: one where the entire eClinical suite comes from the same vendor or one where individual components are sourced from different vendors?

Heritable disorders can often be linked back to a specific gene or genetic variant which transmits the risk of disease across generations. In most cases, the penetrance, or risk of being affected by the disease, for a pathogenic variant carrier is less than 100%. For an increasing number of disorders, the penetrance is even lower (20-50%), which begins to confound our ability to understand the relationship between disease risk and a specific genetic variant. At this level, classical tools, including family and functional studies, for assessment of variant pathogenicity loose power. This webinar will address the utility of the different lines of evidence in the classification of variants in moderate penetrance disease and recommended modifications to multivariate analysis in this setting.