Challenge:

Our client was a biotechnology company focused on use of a proprietary nanotechnology invented to allow different combinations of drugs to be encapsulated in a single nanomedicine and delivered selectively to the tumor microenvironment, thus potentially minimizing systemic sideeffects. The client requested the Alacrita team to hold a one-day discussion on the data and subsequently to develop a regulatory plan in collaboration with internal staff members.

Solution: 

The points discussed in the workshop with the client team included:

• Understanding regulatory requirements along the development pathway
• Determine where the client had immediate needs for regulatory feedback and optimal ways to obtain feedback
• Specific activities/data to be gathered by the client for FDA feedback
• Data check: CMC, product characterization, preclinical data, data collected to support dosing and therapeutic indication, safety data, clinical indication(s) considerations, unmet need, exploratory trials
• Based on the workshop, a regulatory roadmap was developed with key actions and timings set out clearly.