Johnson & Johnson Innovation (JLABS) event - Road to the Clinic for Biologic Therapeutics
JLABS, 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 Clinical Trial Authorisation (CTA) 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 CTAs 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 CTA acceptance.
Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic CTA 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 and requirements for a CTA submission package
Partners:
This event is presented in partnership with Janssen, and the University of Toronto
The event is free for the U of T community.