Development of novel custom active pharmaceutical ingredients (APIs) is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. With hundreds of potential partners that drug owners can choose from to develop and manufacture custom API, choosing the best partner can be a challenging task.
In this white paper, we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy. We also review how increasing development of novel drugs are also impacting the industry’s go-to-market efforts, driving new demand for expert custom API suppliers. Finally, we consider how custom API development projects can be executed by leveraging the experience of embedded contract development and manufacturing (CDMO) partners.