A new report from CPHI (released ahead of the group’s conference in Frankfurt, Germany (November 1-3) reveals a notable shift is underway in global outsourcing strategy, with many leaders looking to plot out a product’s entire development lifecycle beginning in the preclinical stages.
According to the study, innovators in various corners of the industry are planning ‘pharma-ready’ synthetic routes much earlier in the development process. Further, perceptions appear to be shifting to view ‘phase-appropriate development’ as outdated, especially when accelerated pathways are involved.
The predictions shared in the report suggest that industry innovators would be well advised to choose one of two routes:
- Single end-to-end providers
- Multi-provider models.
Further, the report suggests contract development and manufacturing organizations (CDMOs) rethink current approaches to development as well as the marketing of services.
The outsourcing strategy exhibited by CDMOs is geared toward helping potential clients identify their most suitable partners. For that reason, the report points out, CDMOs are likely to focus on marketing to specific types of customers, rather than the entire market; this shift is likely reflective of the varying risk tolerance and collective capabilities of biotech companies, and small and large pharma organizations.
“This report highlights that innovators need to meet contract services partners sooner, plan much earlier and far further into development,” said CPHI brand director Orhan Caglayan. “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.”
This evolution, Caglayan added, is likely to continue and change in the near future.
“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,” he said.
According to experts cited in the report, industry innovators are exploring an outsourcing approach that aids them in getting rapidly through IND to reach Phase IIb and beyond as fast as possible. This trend is seen in development timelines as well as investment behavior, with ‘pharma process readiness’ having a fundamental impact on when and how investors can exit.
Further, the experts in the report advised innovators against adopting an exclusive ‘phase-appropriate’ approach, indicating this risks building in significant delays in later stages of development.
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,” Chatterjee added. “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.”
Sponsors must decide whether to engage the services of two or more CDMOs (i.e. one for drug substance and one for drug product), a larger full-service provider or work with a specialist integrated development partner earlier before re-reviewing options in Phase I or II. However, according to Brian Scanlan (operating partner of 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, advised that data packages need to be optimized in addition to synthetic routes.
“The redoes are the killers of program timelines, and we see that very often in the oncology space,” Jurkauskas said. “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 US and EU, 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 II5 pivotal studies.”
The CPHI report advises that for accelerated pathways, 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.”
With all the concerns about new partner sourcing and increased supply chain resilience, CPHI Frankfurt organizers report they expect interest in the event to achieve or exceed pre-pandemic levels. Caglayan said, “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 specialized partners. Our goal is to act as the catalyst for the industry to connect.”
Experts will be presenting a LinkedIn Live session Friday, August 26; to learn more or check the specific time, visit the event page. The report can be downloaded online, and CPHI Frankfurt registration and additional information are available on the event site.
