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 programme 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.
Agenda
- 12:30 CEST Registration opens
- 13:00 CEST Introduction to Johnson & Johnson Innovation
- Tess Korthout | Early Innovation Partner, Johnson & Johnson Innovation
- 13:15 CEST Nonclinical Safety
- Ann Lampo | EU Head Nonclinical Safety Leaders and Therapeutic Area Lead, Preclinical Sciences and Translational Safety, Janssen R&D
- 13:45 CEST Drug Metabolism Pharmacokinetics
- Mario Monshouwer |
- 14:15 CEST Chemistry, Manufacturing and Controls
- Bart Vaningelgem | Scientific Director, Janssen R&D
- 15:00 CEST Break
- 15:25 CEST Clinical Pharmacology
- Erik Mannaert | Deputy Head, Janssen Clinical Pharmacology Unit, Janssen R&D
- 16:10 CEST Regulatory Affairs
- Jens Heile | Director EMEA Regulatory Affairs Immunology, Janssen R&D
- 16:55 CEST Closing remarks
- 17:00 CEST Extended Q&A
- 18:00 CEST Program close
Registration
Early innovators and first-time entrepreneurs are welcome to register here https://jji.jnj/smallmolecules. They also welcome stakeholders supporting these startups.