Panel: Build, Buy, or Partner? Rethinking CDMO Strategy for Complex Biologics and CMC Success

Wed, Oct 8 | 10:15 AM - 11:00 AM
Cezanne

Session details:

As biologics and advanced modalities spanning ADCs, bispecifics, cell and gene therapies, and mRNA grow increasingly complex, the role of CDMOs has expanded from simple execution to strategic collaboration. At the same time, biotech leaders face pivotal decisions on whether to build in-house, buy capabilities, or form long-term partnerships with CDMOs. These choices, often made as early as the preclinical stage, can shape timelines, scalability, cost structures, and regulatory readiness for years to come. This panel explores how innovators are approaching the build vs. buy vs. partner dilemma while forging strategic CDMO relationships that enable both near-term CMC success and long-term commercial viability.

  • The Build-Buy-Partner Equation: How companies are weighing in-house capabilities, outsourcing, or hybrid models to drive development efficiency.
  • Early CDMO Engagement: Why involving CDMOs during preclinical stages accelerates timelines and reduces downstream risk.
  • Tech Transfer & Scale-Up: Ensuring readiness with the right data, documentation, and quality systems.
  • CMC Risk Planning: Proactively addressing challenges in stability, comparability, and analytics across development stages
  • Global Regulatory Demands: How partnerships are evolving to meet compliance requirements for novel modalities

Tracks:
Preclinical & CMC
Community:
Drug Development