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    Join BIOCYTOGEN at PBSS Nonclinical Safety Assessments of Biologics

    September 20, 2024
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    We're excited to share that we will be attending the PBSS Nonclinical Safety Assessments of Biologics event on September 20, 2024, at the Crowne Plaza in Foster City, CA, in the San Francisco Bay Area. This event is an excellent opportunity to connect with experts focused on the safety assessments of biologics. Join us as we delve into the latest insights and innovations in the field!

     

    What are Nonclinical Safety Assessments of Biologics?

     

    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 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.

     

    Event Overview  

    Venue: Crowne Plaza, Foster City, CA (San Francisco Bay Area)

    Dates: 2024-09-20

    Event Schedule

    Time PSTTopic
    8:45-9:00 amPBSS Welcome
    9:00-9:10 amWorkshop Introduction
    9:10-9:50 amSetting the Stage: an Overview of Biotherapeutics
    9:50-10:30 amCD3 bispecific: An Important Modality in Cancer Immunotherapies – Considerations for Nonclinical Development
    10:30-11:10 amNonclinical Safety Assessment Strategies for Peptide-MHC Targeting Therapeutics
    11:10-11:20 amMajor Sponsor Presentation
    11:20-11:40 amBreak and Vendor Show
    11:40 am-12:40 pmLunch
    12:40-1:15 pmUsing a Platform Approach to Assess Nonclinical Safety of ADCs
    1:15-1:50 pmEvolution of Peptide Therapeutics - Nonclinical Considerations for Drug Development
    1:50-2:30 pmA Sticky Situation: Current Safety Considerations for Developing Molecular Glues and Other Targeted Protein Degraders
    2:30-2:40 pmMajor Sponsor Presentation
    2:40:3:00 pmBreak and Vendor Show
    3:00-3:25 pmManaging Immunogenicity of Biologics During Nonclinical Safety Assessment Studies
    3:25-3:50 pmOverview of in-vitro Cytokine Releases Assays in the Context of Preclinical Safety Assessments
    3:50-4:30 pmRegulatory perspectives
    4:30-5:00 pmAll Speakers
    5:00-6:00 pmHappy Hour

     

    About BIOCYTOGEN

    Biocytogen is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® platforms for fully human monoclonal antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA(Boston, San Francisco), and Germany (Heidelberg).

    We look forward to seeing you at PBSS Nonclinical Safety Assessments of Biologics in San Francisco Bay Area!