may, 2014

06may8:00 am11:00 amThe Road to the Biologic Investigational New Drug


Event Details

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

Program Overview: 
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: 

    – Key components of the Chemistry/Manufacturing/Controls section
    – Expression, Purification, Analytics, Formulation, Fill/Finish
    – Preclinical study design, species selection, material requirements, and timelines
    – Regulatory requirements, strategies to minimize costs & timelines while balancing risk


(Tuesday) 8:00 am - 11:00 am


Janssen Labs