How do I Quickly Develop First-in-Human (FIH) Dosage Forms and Bridge to Drug Products for Proof-of-Concept (POC)?

14:40 - 15:15

  • Choosing the appropriate dosage form for first-in-human/Phase I trials – fit for purpose, fit for phase?
  • Compounding or GMP manufacturing – how to balance cost, time and dose flexibility?
  • Challenges with poorly soluble molecules in early development – what technologies can we deploy?
  • Bridging to robust and scalable Phase II drug products – how to avoid losing time in development?
  • Highly flexible and adaptive clinical manufacturing strategies for patient trials – how can real-time manufacturing be used?

Nikki Whitfield, Vice-President, CDMO Services, Quotient Sciences