Kevin Kane, PhD, CMC Strategy Director, shares insight on AI-assisted development, phase-appropriate supply strategies and coordinated clinical, CMC and manufacturing decision-making.
AI-Assisted Development
AI is being applied to formulation screening, process optimization, analytical method development and submission preparation, accelerating timelines while improving robustness.
Phase-Appropriate Supply Strategies
Not every stage needs the same CMC investment. Phase-appropriate strategies balance speed and cost early while building the foundation for late-stage success.
Coordinated Decision-Making
Integrated project teams that bring together clinical, CMC and manufacturing expertise make better decisions faster and avoid downstream surprises.
About This White Paper
This white paper is published by Thermo Fisher Scientific Pharma Services and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.