In today’s pharmaceutical R&D pipeline there are more molecules in development than ever before, but the attrition rates of drug candidates reaching Phase II remains high and an increasing number of molecules have challenging drug properties.
To keep costs under control, biotech and pharma companies need to transition molecules through early development as quickly as possible, to reach Proof-of-Concept (POC) and select the "winners" for late stage development. To achieve this, there is a need to better understand drug properties and the developability of a molecule, while exploring novel and integrated approaches to early drug development. This, in turn, will enable molecules to reach patients faster by shortening development times.
This webinar highlights how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
Key Learning Objectives:
- Discover how you could potentially shorten your time to POC by over 12 months, with industry case studies
- Understand how it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules in a single clinical protocol
- Hear how it is possible to bridge from 'fit-for-purpose' FIH formulations to 'patient ready' dosage forms without losing time in the development program.
- Explore strategies for managing CMC investments and creating time savings, including the use of pharmacy preparations and real-time GMP manufacturing
- Assess the value of streamlining your outsourcing partners and the importance of end-to-end project management.