Pacific Pharma Group, LLC, is a niche consulting company focused on increasing the efficiency of global product development, especially through the early development phases.
AREAS OF PARTICULAR INTEREST INCLUDE:
- First Time In Humans studies, including biologics
- Early development strategies, from IND through proof of concept
- The role of an exploratory IND and microdose studies
- “Bridging” studies for registration in Japan
- Healthy elderly, pediatrics, and special patient populations
- Global development strategies, especially involving Asian jurisdictions