Bringing a new therapy into the clinic requires far more than a promising molecule. In this webinar, Dr. Stephen Houldsworth explores the key development, manufacturing, regulatory, and supply chain challenges that can impact clinical timelines and program success. He discusses how early CMC decisions can influence a program’s future scalability, regulatory readiness, and overall development costs, while highlighting common risks that emerging biotech companies face as they advance from Phase I through commercialization.
The webinar also outlines practical strategies for securing clinical supply, minimizing development and manufacturing risks, and building a long-term pathway to commercial success. Drawing on CordenPharma’s extensive experience supporting clinical and commercial programs worldwide, Dr. Houldsworth explains how integrated development, technical expertise, scalable manufacturing capacity, and proactive planning can help sponsors accelerate development while reducing complexity.
Through real-world examples and industry insights, viewers will gain a better understanding of how the right CDMO partner can help navigate technical, regulatory, and supply chain challenges to keep development programs on track from early clinical development through commercial launch.
Key topics include:
- Common CMC challenges facing emerging biotech companies
- Identifying and mitigating clinical supply risks
- Planning development with future scale-up and commercialization in mind
- Regulatory and analytical considerations across development phases
- Strategies for building resilient and scalable manufacturing and supply chains
- How integrated CDMO partnerships can support long-term program success
Dr. Stephen Houldsworth
Sr. VP, Global Commercial Head - Innovative Synthesis Business Unit, CPI
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