The Road to the Biologic IND
JLABS, the Johnson & Johnson Innovation Centers and Janssen BioTherapeutics 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 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 requirements, and Pre-IND meetings