By Amy Trotch, Business Development Director, Societal CDMO
The global pharma industry is challenging and unpredictable and sourcing materials, securing domestic capacity, and navigating the complex regulatory landscape can leave sponsors vulnerable to risks. Leveraging the expertise and advanced technical capabilities of a CDMO is becoming increasingly important for sponsors aiming to accelerate their novel drug to market. Executing a successful technical transfer is a key element of partnering with a CDMO and can impact your ability to meet project milestones on time.
Successful technical transfer programs will depend heavily on the executive sponsor’s (ES) level of engagement with the program. They play a critical role in communicating the organization’s culture from the beginning of vendor selection activities and reiterate the strategic vision of the program as it progresses.
Building and maintaining a strong relationship with your ES is crucial as it will serve as the foundation for long-term commercial success. Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical and analytical capabilities, regulatory support, quality system, and audit inspection history as well as its executive sponsorship model.