Looking ahead: Today’s technical trends shaping 2021 priorities
A range of new treatment and administration routes are being introduced to pharma’s pipeline, bringing new complexities and prompting demand for experienced CDMOs.
The pipeline’s trajectory is requiring new clinical manufacturing infrastructures and the need to find and engage contract partners with enough development and commercial experience to get the job done has never been higher—or more important to overall drug development strategy.
In this blog, Nicole Strauss, Pipeline Development and Innovation Lead at Pfizer CentreOne takes a look at some of the main trends that will shape the industry in 2021.
Emerging complexity requirements
Novel, orphan and emerging biologic development pathways are affecting batch scale and manufacturing economies, calling for precision-processing environments, technical flexibility and operational capabilities. Collaborating with CDMOs can allow drug developers to avoid the time and resources required to build that capability in house and leverage existing experience to bring more effective treatments to patients faster.
Strategic, value-added partnerships
While outsourcing process development and manufacturing is not new, it is becoming a more integral part of many drug strategies, with both parties collaborating earlier. It is estimated that nearly a third of pharmaceuticals are now outsourced to contract development and manufacturing organizations (CDMOs), offering both development and commercial capabilities[1].
As a strategic value-add, regulatory experience developing complex products is also in high demand as many projects require in-depth understanding of global regulatory requirements. The regulatory landscape and strategy must be considered from the very beginning of a drug development project to meet timelines, assure compliance and obtain market approval.
Broadening the offer
With the industry demanding more than ever before from their contract partners, a broader range of services from the CDMO industry will be essential. From integrated development and commercial scale capabilities, to a long-term robust supply chain, the industry will be depending upon contract pharma from beginning to end to see their breakthroughs to market.
With changing complexity and batch scale demands, CDMOs will need to invest deliberately in infrastructure from capacity to experts in key development technologies to ensure agility while providing effective and creative solutions for customers.
Ready to meet patient priorities
Experience accelerates development and time to market and this means critical medicines can reach patients faster. Whether responding to classic or emerging industry needs, the right partners with the right capabilities will help deliver advanced therapies and novel patient breakthroughs as fast and as safely as possible.