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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

Agenda:

  • 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

 

Speakers:

  • 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

 

Register