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 big pharma and Venture Capital firms competing for the most promising compounds, startups are expected to demonstrate a clear blueprint for their CTA approach, and need to get ready.
Johnson & Johnson Innovation -- JLABS invites you to an in-depth look into two aspects of filing a large molecule CTA.
- Chemistry, Manufacturing & Controls (CMC) Strategies
- Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- Drug product formulations for First-in-Human
- Clinical Trial Design
- Designing First-in-Human trials
- Operational aspects for this phase
- 9 AM | Introduction by JLABS
- 9:05 AM | CMC Strategies
- 9:50 AM | Audience Q&A
- 10 AM | Break
- 10:05 AM | Clinical Trial Design
- 10:50 AM | Audience Q&A
- 11 AM | Program Close
- Ben Bulthuis | Director Early CMC Development, Janssen R&D, LLC
- Veronique Mathijssen | Associate Director, Global Trial Leader Early Development Oncology, Portfolio Delivery Operations, Janssen-Cilag B.V.
- Subinay Ganguly | Senior Director, BioTherapeutic Development, Janssen R&D, LLC