New CPHI Report Forecasts Global Shift in Outsourcing Strategies

Ahead of CPHI Frankfurt (November 1-3, 2022), a new CPHI Report predicts a significant shift is under way in global outsourcing strategies, with innovators now mapping a product’s full life-cycle development as early as pre-clinical.
 
A key finding is that innovators across the industry are planning ‘pharma-ready’ synthetic routes much earlier in the development process, with ‘phase appropriate development’ increasingly seen as outdated – and particularly inappropriate for accelerated pathways.
 
The report suggests that innovators will need to choose either a single end-to-end provider or take a multi-provider model. CDMOs will need to rethink their approach both to development as well as to how they market their services to innovators and biotechs.

Evolution of Outsourcing Strategy

The type of outsourcing strategy presented by CDMOs helps customers identify their most suitable potential partners. As a result, most CDMOs will focus on marketing to specific types of customers rather than the entire market. This shift reflects the different risk tolerance and collaborative capabilities of biotechs, small pharma or large pharma organizations.
 
“This report highlights that innovators need to meet contract services partners sooner, plan much earlier and far further into development. We are evolving CPHI Frankfurt to help both CDMOs and innovators adapt to this shift in approach by providing new insights and more networking opportunities for early-stage companies attending the event. Over the next few years, we anticipate many more biotechs will use CPHI to map out their potential partners long before IND. Exploring what type of outsourcing approach will best fit their products development and even commercial needs,” commented Orhan Caglayan, brand director at CPHI Frankfurt.
 
According to the report’s experts, innovators are now looking for an outsourcing approach which gets them rapidly through IND to reach phase iib and beyond as fast as possible. The impact of this trend isn’t only on development timelines, but also on investors: ‘pharma process readiness’ will have a fundamental impact on when and how investors can exit. 
 
At phase ii sale, a biotech with a clear plan and ready-to-scale manufacturing strategy will deliver a better validation than a promising target in need of ‘fine tuning’. The CPHI experts predict that early-stage investors will increasingly use CMC consultants and ‘process specialist CRO/CDMOs’ to help ensure a smooth scale up process.
 
The CPHI experts warned innovators against adopting an exclusive ‘phase appropriate’ approach, saying they risked building in severe delays to later stages of the development process.
 
Bikash Chatterjee, CEO of Pharmatech Associates commented: “There are lots of strong chemistry houses out there that can get you to IND, if that’s your goal. But an IND is where you lay the foundational CMC, quality, and clinical arguments for your ultimate submission. Developing an IND strategy with the end submission in mind is how a drug sponsor shrinks their time to market and lowers program risk. For drug sponsors relying upon their CDMO partner for program insight, an early-stage specialist may not be the best way to realize overall program acceleration.”
 
Drug sponsors will need to decide whether to use two or more CDMOs (i.e. one for drug substance and one for drug product), a larger full service provider, or to work with a specialist integrated development partner earlier before re-reviewing options in Phase I or II. However, according to Brian Scanlan, Operating Partner – Life Sciences at Edgewater Capital, “mid-sized outsource partners may be a better fit for highly nimble biotechs who are willing to accept the added complexity of working with multiple vendors as a trade-off for quality and cultural alignment”.
 
Valdas Jurkauskas, senior vice president at Pardes Biosciences advises that it’s not only synthetic routes that need to be optimized, but also data packages. He added, “the redoes are the killers of program timelines, and we see that very often in the oncology space. For example, phase i studies are short with very few subjects, allowing the company to expand into phase ii, and the quality presentation requirements, both in the United States and European Union, are much more demanding than for phase i. So it may be that quality is in place, however, the quality presentation is not ready for phase ii pivotal studies.”
 
For accelerated pathways, the report advises innovators will need both a ‘pharma ready’ process in early development, and to be fully prepared for a post approval Change Order. 
 
Stephanie Gaulding, MD at Pharmatech Associates, added: “Typically, I would say within the first year or so the majority of those that are going through accelerated pathways do see some level of change associated with the manufacturing process. In my experience, it’s hard to get the process fully optimized from the get-go. In this case, a pharma-ready formulation is still needed to get through approval, but innovators must also plan for post approval manufacturing improvements.”
 
The implications of the report’s finding will be analyzed next week in a special CPHI hosted LinkedIn Live session with the report’s authors.