Post by Dr. Stella K. Vnook

I recently joined @Kevin Budorf of CDMO world at CPHI Americas for a conversation about the rapidly changing relationship between biotechnology companies, investors, and their manufacturing partners. Using Kaida BioPharma and our work in ovarian cancer as a real-world example, we discussed why manufacturing strategy can no longer be treated as a downstream operational decision. It must be considered early—alongside clinical development, financing, regulatory strategy, commercialization, and potential M&A. Why watch this conversation? We explore: • Why ovarian cancer remains one of the most consequential areas of unmet need in women’s health • How manufacturing yield directly affects clinical-development costs and the future commercial price of a biologic • Why biotech companies need #CDMOs to become true development partners—not simply order takers • How Biosecure considerations, onshoring, technology transfer, capacity, and geographic risk are changing CDMO selection • Why investors now routinely evaluate where a product is manufactured, whether the process can scale, and whether the CMC package can withstand diligence • How an inadequate manufacturing strategy can delay—or even stop—a clinical program • Why companies must begin thinking about Phase II, Phase III, commercialization, and M&A readiness while they are still in preclinical development • How AI can improve process development, manufacturing efficiency, product characterization, and scalability One of the most important points from our discussion: A #biotech company may be developing one or two products. An experienced #CDMO has seen dozens—sometimes hundreds. That institutional knowledge should be actively applied to improve the process, reduce risk, and create a more commercially viable product. The CDMO industry is at an inflection point. The strongest partners will not merely execute a transferred process. They will help companies identify what can be optimized before inefficiencies become expensive clinical, regulatory, or transaction liabilities. 🎥 Watch the full conversation here: https://lnkd.in/e9DixrSA #Biotechnology #Biopharma #CMC #CDMO #DrugDevelopment #Manufacturing #OvarianCancer #WomensHealth #Oncology #ArtificialIntelligence #LifeSciences #CPHI https://lnkd.in/e9DixrSA