Dose #23: Scaling Biologics CDMOs, Capacity, and Digitalization with Kevin Sharp (Samsung Biologics)

In this episode of SCW for Pharma, Evren Ozkaya welcomes Kevin Sharp, Executive Vice President and Head of Sales and Operations at Samsung Biologics. Kevin shares his more than 20 years of experience in the pharmaceutical industry, spanning procurement, manufacturing, supply chain, and business development roles across companies such as GSK, Contract Pharmacal Corp, and Samsung Biologics. With the last decade focused on biologics, he offers a broad and practical perspective on how the industry has evolved.The conversation begins with an overview of Samsung Biologics and its position in the CDMO market. Founded in 2011, Samsung Biologics has rapidly become a leader in biologics manufacturing capacity, leveraging Samsung’s deep engineering expertise and manufacturing DNA. Kevin explains how the company’s end-to-end CDMO model addresses one of the biggest pain points for biopharma companies: the cost, risk, and time associated with tech transfers across multiple suppliers.Evren and Kevin then dive into the unique complexity of biologics supply chains. Kevin highlights how longer planning horizons, strict quality requirements, and capacity slot management make timing and end-to-end coordination critical. As molecules become more complex and new drug modalities emerge, even small disruptions in sequencing or release timing can have significant consequences for quality and supply reliability.The discussion expands to broader biopharma trends, including the growing share of combination therapies and novel modalities. Kevin notes that a significant portion of products expected to be approved in the coming years will fall outside traditional standards, putting pressure on CDMOs to invest in modern facilities, scalable platforms, and standardized yet flexible production processes. He emphasizes that while there is room in the market for CDMOs of all sizes, larger players differentiate themselves through integrated, one-stop-shop capabilities and scalable capacity.Digitalization is another key theme of the episode. Kevin explains how Samsung Biologics applies its technology-driven heritage to biologics manufacturing, drawing parallels between semiconductor production and biopharma in terms of precision and environmental control. He discusses the use of MES, supply chain visibility tools, AI, and digital twins, and how real-time data transparency creates value for clients while improving consistency and operational performance.Finally, Evren and Kevin explore why digital transformation remains slow across much of the pharma CDMO landscape. Kevin points to investment requirements, long implementation timelines, sunk costs, and concerns about technology obsolescence as major barriers. He also shares advice for younger professionals in the industry, encouraging early exposure to different functions and the importance of building strong, long-term relationships.They conclude by reflecting on how capacity, technology, and adaptability will continue to shape the future of biologics manufacturing, and why companies that commit early to scalable platforms and digital foundations are likely to widen the gap in the years ahead.