Lessons Learned in Developing & Scaling Novel Platforms
Time: 3:30 pm
day: Day Two
Details:
- A high-level overview of the early phase clinical development of one of our core platforms, including not only the challenges to the early phase and transfer from concept to clinic but indications about the challenges to commercialization as well
- As part of this review will explore how the use of platform technologies can streamline development and provide savings in time and resources; they must be approached with a full understanding of their limitations as well as their benefits. This applies not only to development but to production planning, scale-up, method development, and phase-appropriate validation
- Outlining how recent changes in the global supply chain and global regulatory and legal frameworks continue to offer challenges in translating concepts to clinical material. Examples of challenges and possible solutions include alternate suppliers to backfill supply chain shortfalls, developing multiple lines of regulatory options to deal with the constantly changing global environment
