In this issue’s cover story, “CDMO Trends: New Wave Technologies,” James Park, senior vice president and chief business officer at Samsung Biologics, explores the challenges that contract development and manufacturing organizations (CDMOs) have faced as they welcome a new era of mRNA-based technologies and also discuss the opportunities that have arisen for companies supporting mRNA manufacturing in exciting new development areas. He says with the onset of the COVID-19 pandemic, an array of new and novel modalities were placed center stage by the biopharmaceutical industry and as a result, biopharma companies have started to further explore more unfamiliar technologies, including mRNA-based drugs.

At the same time, in today’s competitive drug development market, investing precious resources in moving a drug candidate from the lab to a first-in-human, phase I clinical trial can represent a significant gamble for sponsors, according to Caitlyn Clauss, supply chain solutions manager at Almac Clinical Services. In her, “Early Phase Clinical Supply Trends,” she says building integrated clinical supply chains, designed for speed, agility and performance, helps to facilitate improved visibility, better management of risk and effective contingency planning as programs evolve. To achieve this, “early planning, clear communication and a willingness to break with clinical supply convention must reign supreme.”

While the global supply chain has undergone huge changes and struggles recently due to a range of factors including the COVID-19 pandemic, it has not stopped the pharmaceutical industry from launching new products, according to the experts at Cardinal Health Third Party Logistics Services.

In “Prepping for a Cold Chain Launch,” Cardinal’s Joel Wayment, vice president of operations, and Shantese Marchbanks, director of client relations and business implementations, say the FDA is approving more drugs and therapies than ever before, making the success of a drug launch even more important—and one of the fastest-growing categories of new products is temperature-controlled products, including many vaccines, biologics and cell and gene therapies. The authors say, “Understanding how to effectively launch a cold chain product, while also minimizing risk and roadblocks, is becoming an increasingly vital part of healthcare logistics.”

On the regulatory front, as more companies modernize their approach to quality management, regulators are emphasizing the need for companies to bring real-world quality metrics into their day-to-day operations and find ways to build a culture of quality within their organizations, according to Veeva Systems’ director of vault quality, Ashley Wentworth. In “Advancing Quality Transformation,” she says “more pharmaceutical manufacturers are reducing variability in their processes and taking a proactive approach to quality as an enabler of operational excellence rather than a cost center. In the process, they are saving millions of dollars per year.”

Tim Wright, Editor
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