Date

Tuesday, October 18th 2022 (13:00 - 18:00)

Location

Rapenburg 73, 2311 GJ Leiden, Netherlands

Price

€0 for non-members

€0 for members

Language

English

Organised by

Janssen Pharmaceutica

Categories

Tags

Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting a Clinical Trial Application (CTA) is a critical early milestone for every biotech company. With large healthcare companies and Venture Capital 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.

You can register here: https://jji.jnj/smallmolecules

Johnson & Johnson Innovation – JLABS (JLABS) and the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) invite you to an in-depth look into different aspects in the journey towards filing a CTA for small molecules including also Antisense Oligonucleotides (ASOs), siRNA and small peptides. This program targets early innovators and first-time entrepreneurs, but we also welcome stakeholders supporting these startups.

Join us for a series of short presentations exploring the basic requirements and considerations necessary for small molecule CTA submission. The presentations will highlight the following:

  • Preclinical development strategies for pharmacokinetics, drug metabolism and toxicology

  • Key chemistry, manufacturing & controls 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

You can register here: https://jji.jnj/smallmolecules