Biologics CMC Project Management Best Practices

Gautam Pangu of Incyte and Rebecca Watson of Johnson & Johnson Innovative Medicine co-lead an intensive workshop on biologics CMC (Chemistry, Manufacturing, and Controls) project management best practices. CMC programs for biologics are among the most technically complex and resource-intensive undertakings in pharmaceutical development, requiring tight coordination across process development, analytical methods, manufacturing scale-up, and regulatory submissions.

Workshop participants will work through case studies addressing common CMC challenges including tech transfer management, process validation sequencing, supply chain coordination for clinical and commercial supply, and managing the interdependencies between CMC and clinical development timelines. Gautam and Rebecca will share templates and frameworks refined through their collective experience at Incyte and J&J.

This hands-on session is ideal for project managers, CMC leads, and program directors who manage biologics development programs and want to sharpen their skills in this specialized domain.