Simulation Best Practices for the Pharmaceutical Industry

The Drug Supply Chain Security Act (DSCSA) has its final deadline approaching in November 2023. To confirm that only trusted entities are involved in the exchange of prescription drugs, one of the lesser thought-about elements mandates that the required data exchange through the supply chain is only done with authorized and registered trading partners.

Intratumor heterogeneity (ITH) is a major underlying cause of therapy resistance and disease recurrence and is a read-out of how a tumor has grown. Current methods to analyze genetic ITH rely on the sequencing of ‘bulk’ or flow-sorted populations, in which the spatial context of tumor subclones is not preserved, and rare subclones may not be detected. These shortfalls can be addressed with BaseScope™ ISH–a unique mutation-specific RNA in situ hybridization assay. The BaseScope assay represents a significant technical advance for in situ mutation detection and provides new insight into the mechanisms of tumor evolution with potential ramifications for selecting patients for treatment. Join us to learn more about this new approach to ITH analysis.

In the last 20 years Hot Melt Extrusion (HME) has seized the attention of pharmaceutical industry for the development of pharmaceutical solid dispersions. It is a versatile processing technology, which can effectively increase the solubility/dissolution of water insoluble active pharmaceutical ingredients (APIs).

Incorporation of patient-focused drug design principles is increasingly becoming essential to ensure that a new drug is commercially successful and delivers the best patient outcomes. Often, patient factors and insights are not considered or discovered until the later phases of drug development when dose form, dose strength, and route of administration are already decided. There is tremendous potential benefit of equipping formulators and other scientists with patient insights earlier in the development process so that the drug product can be designed to address the specific needs of target patient populations.