Ahead of CPHI Frankfurt (November 1-3, 2022) – the world’s largest pharma event – 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synthetic routes much earlier in the development process, with ‘phase appropriate development’ increasingly seen as outdated – and particularly inappropriate for accelerated pathways.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’s predictions suggest 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.

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 customer rather than the entire market.  This shift reflects the different risk tolerance and collaborative capabilities of biotechs, small pharma or large pharma organisations.

“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 programme risk. For drug sponsors relying upon their CDMO partner for programme insight, an early-stage specialist may not be the best way to realize overall programme 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 optimised, 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 optimised 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.”

Emphasising the market-wide surge in new partner sourcing and the need for increased supply resilience globally, CPHI Frankfurt is reporting the event is on course to ‘achieve or exceed its pre-pandemic attendees’. The event’s Brand Director Orhan Caglayan, added: “our events now form part of a wider 365 days a year sourcing approach, so we anticipate audiences engaging with CPHI Frankfurt at ‘the heart of Pharma’, but also, using our data and digital tools year-round to reduce the time it takes to source and connect. This is the crucial challenge faced by pharma supply chains today, as more clinical pathways are accelerated, and more products need specialised partners. Our goal is to act as the catalyst for the industry to connect.”

The implications of the report’s finding will be analysed next week in a special CPHI hosted LinkedIn Live session with the report’s authors. To register for the round table or to learn more, please visit CPHI’s LinkedIn page here.

To get a downloadable copy of the full report please click here. To register for CPHI Frankfurt 2022 (November 1-3) or for Connect to Frankfurt on September 28th, please visit here.