Link to the CDMO News Analysis download:
“CMC topics are often taken a bit late in development. The biggest pitfall is not only it’s going to cost you more, but it’s going to cause delays to your programme. The more you push it, the bigger are the costs and potentially the delays.”
Marine Joly-Battaglini, CMC consultant and founder of PharmDev, specialises in CMC regulatory strategy for pharmaceutical companies at all stages of development. With a decade of experience in CMC development at Galderma and a master’s degree in regulatory affairs, she has built her career around preventing the costly mistakes that derail pharmaceutical development programmes.
In the latest PharmaSource podcast episode, Marine reveals the strategic framework that successful biotechs use to navigate manufacturing partnerships, avoid development pitfalls, and position their products for commercial success. Her approach challenges conventional wisdom about when to engage with CMC planning and demonstrates how early strategic thinking prevents expensive delays down the development pathway.