The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications 

Program Overview: 
Do you have a solid plan to achieve IND acceptance? Filing a biologic Investigational New Drug (IND) application might be the next step in advancing your company\’s early-stage drug development program. Janssen Labs, the Johnson & Johnson Innovation Centers and the Janssen Biotechnology Center of Excellence invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company\’s early-stage drug development program. Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving IND acceptance. 

Join us 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 Biotech, Inc. – your partner of choice
    – 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 requirements, and Pre-IND meetings