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The Road to the Clinic for Small Molecule
10. Mai 2017 @ 13:00 - 18:30
Johnson & Johnson Innovation, JLABS, and Janssen Discovery Sciences invite you to an in-depth look into the process of filing a CTA.
Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting a CTA 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 clear blueprint for CTA approval, and we want you to be ready.
Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful small molecule CTA submission. The presentations will highlight the following:
- Janssen Research & Development – a brief overview
- Preclinical Development strategies for pharmacokinetics, drug metabolism and toxicology
- Key CMC strategies to balance cost, time and quality risks
- Designing First-in-Human trials to highlight the qualities of your molecule
- Regulatory strategy, CTA requirements, and Pre-CTA meetings