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