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JLabs: The Road to the Biologic IND

Join JLabs for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following:

  • Janssen BioTherapeutics - overview of biologics
  • Key CMC strategies to balance cost, time and comparability risks
  • Non-Clinical safety assessment strategies for biologics
  • Determining and understanding PK/PD and immunogenicity
  • Regulatory strategy, IND and CTA requirements, and Pre-IND meetings

Information and registration here