FDA FSMA Preventive Controls: Cross Contact and Contact Contamination

Autoimmune diseases such as ulcerative colitis require chronic treatment that often causes systemic immunosuppression, increasing long term cancer and infection risk. Reducing systemic side effects with localized treatment would greatly benefit patients. This webinar will explore the spatial characterization of oral gut-selective versus systemically available JAK inhibitors in the mouse oxazolone model of ulcerative colitis using the GeoMx™ Digital Spatial Profiler (DSP) from NanoString®.

It is increasingly appreciated that crosstalk at the nexus of the nervous and immune systems mediates a delicate balance between dysregulation and homeostasis across many important biological processes. In this Cell Press webinar, three speakers will explore emerging developments in our understanding of mediators and mechanisms of neuro-immune interplay.

This presentation will summarize the state-of-the-art in transporters in drug development based on four recent ITC3 whitepapers (Clin Pharmacol Ther 104, October 2018). Practical overview of emerging transporters of clinical relevance will be provided (e.g., OCT1, OATP2B1, etc.). Best practice in design of clinical DDI studies will be illustrated with recent advances in the study of OCT1, P-gp, and BCRP. Considerations for optimal selection of clinical probe drugs, including future potential utility of transporter biomarkers, also will be discussed.

Toxicity failures caused by off-target or unintended on-target liabilities are a leading cause of attrition in clinical and preclinical programs. Given the effort, cost, and technical limitations of traditional biopharmaceutical de-risking strategies, there is a need for a robust and scalable approach that can be rapidly applied to the discovery phases of therapeutic programs. Join us for this exciting new GEN Webinar, where our panel of experts will discuss new approaches to de-risking lead selection of antibodies and other biotherapeutics.