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The Road to the Clinic for Small Molecule

Mai 10 @ 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

Details

Datum:
Mai 10
Zeit:
13:00 - 18:30
Veranstaltungskategorie:
Webseite:
https://www.eventbrite.co.uk/e/the-road-to-the-clinic-for-small-molecule-registration-33242324688?aff=ehomecard

Veranstalter

Johnson & Johnson Innovation, JLABS
Webseite:
http://jlabs.jnjinnovation.com/?utm_source=eventbrite&utm_medium=web&utm_campaign=EuropeEB

Veranstaltungsort

Marsilius Arkaden Heidelberg