Article | September 19, 2018

4 Ways To Avoid Failure In Phase III Clinical Manufacturing

Source: Thermo Fisher Scientific

By Sylvia Tsengouras, Senior Clinical Supply Chain Manager, Fisher Clinical Services - Part of Thermo Fisher Scientific; Isabelle Lafosse, Head of Technology Transfer, Patheon; Kara Faford, VP of Commercial Finance, Patheon


More than half of the novel drugs developed in the United States and approved by the FDA have come from companies with fewer than 500 employees, making small to midsize companies the drivers of innovation in drug discovery and development.1 Yet, as with any venture, a promising molecule can only get you so far. Proper planning is vital, especially for biopharma companies facing far greater resource and financial challenges than their manufacturing counterparts in large pharma.

So, while you may be dreaming big, your budget could be limiting the control you have over your long-term plan and may lead to decisions based primarily on pricing. A lack of resources can also impede your road to success, as it takes a village to bring a drug to market. For some, the answer may be to work with a CDMO with the established processes and depth of expertise needed to mitigate the risks of drug development. However, any emerging company entering the biopharma space must understand the challenges they will face and how to prepare for them in order to plan appropriately. What you do today dictates the options you have later when the costs — and the stakes — get even higher.