How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays while achieving proof-of-concept (POC)?

• 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?
• Integrating pharmaceutical sciences and clinical testing to de-risk and accelerate drug product development

Kieran Crowley, Executive Director and Head of Drug Development Solutions North America, Quotient Sciences