PBSS Workshop——Nonclinical Safety Assessments of Biologics and Other Novel Modalities for IND/NDA/BLA Filings

With the advent of complex biologics and the increasing use of novel modalities over traditional antibodies during drug development, it has become critical to develop our understanding on their unique safety assessments and challenges. Pharmaceutical companies are challenging the dogma of traditional safety packages and providing evidence with more robust in-vitro packages demonstrating specificity and challenging use of in-vivo studies where pharmacologically relevant nonclinical species are not available. This workshop will focus on fostering deeper understanding of the participant on the inclusion of in-vitro and in-vivo safety packages and various unique first in human dose determination strategies for biologics and their unique modalities. Workshop will be initiated with an overview of biologics followed by presentations that will cover non-clinical safety assessment strategies with case study examples of a wide range of biologics including CD3 bispecific, peptide MHC, Antibody-drug conjugates and novel modalities like peptides and protein degraders. Common risk assessment like immunogenicity assays and cytokine assays will also be provided in shorter talks. The intent of this workshop is to enlighten to develop an understanding of toxicity risk assessments and share latest progress in the field of biologics to activate discussions that will lead to more successful IND/BLA submissions. Medicilon team will be present throughout the event.  

Agenda

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Subject丨PBSS Workshop September 20

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