Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials

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.

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.

Traditional drug manufacturing and drug delivery process development requires a huge time and financial investment. Pharmaceutical and biopharmaceutical leaders are leveraging the power of in silico approaches.

Scientists are always on the hunt for new analytical approaches that will streamline the biotherapeutic characterization process and answer questions found intractable using traditional methodologies. One such technique, hydrogen deuterium exchange mass spectrometry (HDX-MS)—a biophysical tool for characterizing protein conformation and dynamics—has become an indispensable method to answer important questions concerning therapeutic protein structure, stability, and interactions. Additionally, the correlation of HDX-MS profiles for a target protein interacting with a panel of ligands has facilitated the determination of structure-function relationships, and differentiated new ligand classes based on selective binding.