It is inevitable that small- and medium-sized pharmaceutical companies outsource key research and chemistry, manufacturing and control (CMC) functions to contract research organizations (CROs) when it does not make financial sense to build internal capabilities for activities that are infrequent and/or require large capital or headcount investments to establish expertise. For inhalation product development, there is additional complexity in the conduct of preclinical animal studies. Therefore, the quality of the CRO and their procedures and experiments need to be closely monitored to prevent errors. Furthermore, it is essential to establish a relationship with the CRO professionals responsible for the conduct of studies and provide training on methodology that may be novel to them. Periodic assessment and refresher training may also be necessary if the procedures are conducted infrequently.
Accelerating inhalation product development: Choosing between outsourcing and developing internal capabilities
Examples of challenges in inhalation pharmaceutical development, how they were diagnosed and steps taken to improve confidence in the execution of outsourced studies. Where a long-term workload was expected, functions were brought in-house. Other activities were outsourced, with training provided for the contract research organizations.