From Structure to Function: Combining the Power of Cryo Electron Microscopy and Mass Spectrometry for Deeper Insights

Poor drug solubility is one of the most challenging issues in drug development. Up to 90 % of all newly discovered drugs show insufficient aqueous solubility in their crystalline form,

The revolutionary potential of real-world evidence (RWE) has been much discussed this last decade. From more advanced safety insights and fairer market access, to complimenting clinical trials and providing real-time care insights – the opportunity of understanding real-world effectiveness is undoubtedly worth the hype. However, up until now the progress of RWE has been limited – with frustration in some communities rising due to lack of cross-industry understanding, investment, and regulatory ambition – all needed to drive the real change needed. Within the field of respiratory allergy, exploring the long-term and sustained effectiveness of allergy immunotherapy is of great clinical relevance, as allergy immunotherapy is the only causal treatment option.

The webinar will focus on the relationship between analytics of biotherapeutic products and the interpretation of data to build and support a solid regulatory Chemistry, Manufacturing and Control (CMC) strategy. The importance of data interpretation is illustrated in the development of biosimilars and new biological entities, as well as in regulatory specifications regarding biotherapeutic products.

The dynamics of tumor and immune responses associated with immune checkpoint blockade are unique and complex. Despite the initial successes of immunotherapy, a low objective response rate due to resistance is still the main challenge in solid tumors, particularly advanced-stage lung cancer.