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Got a Plan? Your Guide to Filing a Large or Small Molecule IND
September 2, 2020 @ 8:00 am - 12:00 pm
Do you have a solid plan to achieve IND acceptance? Johnson & Johnson Innovation – JLABS and Janssen R&D invite you to an in-depth look into the process of filing an IND. 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 solutions, it can be helpful to demonstrate a clear strategy for IND approval, hear the experts weigh in.
Join us for a series of short presentations exploring the basic requirements and considerations that can be helpful for preparing a biologic and small molecule IND submission.
The presentations will highlight the following:
· Janssen Research & Development – your partner of choice
· Key CMC strategies to First-in-Human aimed to help set you up for commercial success
· Non-clinical safety assessment strategies for biologics and small molecules
· Designing First-in-Human trials to explore the qualities of your molecule
· Regulatory strategy, IND requirements, and Pre-IND meetings