This presentation, delivered by Nikki Whitfield VP, CDMO Services, at Drug Delivery & Formulation Summit (DDF) explains how to quickly develop first-in-human (FIH) dosage forms and bridge to drug products for proof-of-concept (POC).
Watch the presentation and learn about:
- Choosing the appropriate dosage form for first-in-human/Phase I trials
- 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?
About Nikki Whitfield
Nikki possesses 25 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase spray-dried inhaled and topical products intended for both European and U.S. markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki’s responsibilities at Quotient Sciences involve building the global formulation and manufacturing services business.