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.
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
In case you cannot join us in person in Leiden, the Netherlands, you are welcome to register to receive the recording.