Market fragmentation, rapid innovation, and the ongoing call for increased efficiency in the biopharmaceutical industry are creating unique challenges when it comes to accurately forecasting and planning for demand from clinical to commercial scale. Manufacturers must be able to anticipate and respond quickly to fluctuations, all while managing production at an optimal level. Inaccurately forecasting demand could not only be devastating to the future success of a product in its targeted patient population but also put a company at risk of losing out on vital opportunities for growth.

The solution is to incorporate a flexible operations strategy that can accommodate changing volume needs throughout the drug development journey. This calls on access to capacity, advanced solutions and technology, and expertise that can help guide the way. Therefore, while moving from early to late-phase clinical trials is a critical milestone to celebrate on the way to commercialization, many face the same daunting question once the confetti settles ― now what?

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