AI, partnerships, and planning: Key takeaways from the Biotech Outsourcing Strategies event

A key theme across the conference was the importance of building a long-lasting partnership between the pharmaceutical company and the service provider or CMO/CDMO. Speakers, including those from Bayer, emphasized that the type of expertise a startup would need differs significantly from that of a large pharmaceutical company, so finding the right partner and then maintaining that relationship and a common long-term vision is key.  

This partnership approach benefits both parties by ensuring a collaborative approach to tackling problems, which typically arise during the development process. When seeking a reliable CMO/CDMO partner, developers should also ask what problems a vendor has encountered with other clients and how they were resolved, and request supportive use case studies. These steps should reveal how the vendor worked with other clients to address problems as a team rather than in isolation.  

One key takeaway from the conference was the importance of collaboration across developers, CDMOs, as well as with regulatory departments and consultancies to address complex development and regulatory requirements for innovative products such as specialty radiology products or novel peptide products. The ever-changing global landscape of regulatory requirements makes it more difficult to understand the exact regulatory requirements for relatively new product entities in different geographies. For example, key guidances, such as ICH M4Q (R2)ⁱ, which will require companies to restructure how quality information is presented to health authorities, are being updated and will need to be taken into consideration for products in development and products already commercialized worldwide. 

These changes put significant pressure on companies to firstly stay informed on complex scientific areas, such as radiology compounds for strategic product development and manufacturing principles, and secondly to determine the potential impact of evolving regulations or their development pipeline and registered portfolios.

It is not uncommon for developers to adopt a cost-focused, minimized, and siloed approach to development. Often financial constraints mean developers invest in a consecutive phase-by-phase approach rather than planning strategically across the development process. Experience was shared from a large Germany-based CDMO that showed the comparative cost distribution of adopting a cost-minimizing approach versus a strategic holistic approach, with the latter generally resulting in developers having to invest heavily in the final phase three development due to lack of generated data beforehand.

From their experience it was concluded that a more efficient and cost-effective approach is to have a clearly defined vision and development strategy in place from the outset. In our regulatory consultancy experience, this strategic approach applies not only to the manufacturing development strategy, but also to the regulatory strategy. Early strategic planning and mapping of data requirements help developers to ensure they sufficiently meet the data requirements for their regulatory filing with consistent data sets across phase 1, 2 and 3 of their clinical trials. 

As one speaker noted, nearly half of biopharmaceutical companies now outsource part of their biomanufacturing. To get the most from these relationships, companies need to focus on collaboration, have a strong development strategy in place and ensure a good process for managing the relationship with their outsourcing partner.

Key developments such as the growing use of AI and concerns caused by issues such as tariffs mean companies must make sure their manufacturing and development partner is right for their size and needs, is willing to share risk, and has the experience to navigate the challenges likely to be faced across the development and manufacturing lifecycle.