As CDMO and sponsor relationships have evolved, the definition of what constitutes a good partner has changed, along with how value is defined. A decade ago, clients viewed service providers through a transactional lens. Now, it has become increasingly important to have a CDMO as a strategic partner that has a significant amount of expertise to ensure client success, thus changing the value propositions of the CDMO.
In an interview with BioSpace, Jeff Mocny, vice president for Scientific Leadership at Rose BioSolutions, discussed why the CDMO-client connection has transitioned and what steps CDMOs should take to ensure they are true collaborators rather than just suppliers. He discussed how Rose BioSolutions anticipates potential manufacturing hurdles before they arise and the importance of a CDMO to challenge customer assumptions rather than simply execute against a scope of work.
Mocny also considered the key areas that sponsors underestimate in terms of potential roadblocks and how they should be addressed.
Evolving CDMO-sponsor relationships
The deeper collaboration and partnership among participants along the product development value chain, as well as commercial supply chain, is driven by value recognition, Mocny said. And those values need to align. As industry experience with cell and gene therapy has grown, sponsors have recognized the expertise in CDMOs for successful deliverables, but also how those values reflect relationships.
“As programs mature, the shared needs change, but the values must remain consistent. Like any relationship, with time, we look for different things from our partners, but ultimately, the goal of CDMOs is to protect our clients from unacceptable risk and serve their needs to achieve the objective,” said Mocny. “Our success is directly related to the success of the partner.”
In addition, the enhanced partnership has been fostered by a greater drive towards efficiency, BioSpace reported in its CDMOs At a Crossroads white paper.
This can mean cost efficiency: rising costs, driven by increased prices for raw materials and transportation, lead to the compression of margins, especially as pharmaceutical companies face limits on their ability to pass costs on to customers. However, efficiency is not just about capital spending. In this new environment, CDMOs must act adeptly as innovation collaborators, allowing pharma companies to stay nimble and attuned to political and regulatory headwinds.
Recently, these headwinds have meant a move toward increasing U.S. manufacturing capacity. This may include nearshoring, or shifting manufacturing, IT or operational processes to nearby or bordering countries rather than distant ones, and retaining diverse manufacturing sites to account for political instability while also considering global scope. On the regulatory front, FDA inspections rose sharply in 2025, with 694 more than in 2024. Untitled letters jumped to 58 from five, and Form 483 observations exceeded 600.
In this environment, outsourcing partners are being asked to support a sharpened focus that delivers rapid data, specialized expertise and landscape knowledge to ensure product and manufacturing success.
Strategic partnership success
For the CDMO partnership to be truly collaborative, it is key for the service provider to understand how the product is defined so that the CDMO and sponsor align on the correct regulatory stipulations, Mocny said. “Strategy and execution are not the same, but they complement one another.,” he added. “The strategy points in one direction and the execution enables identification of landmarks along the way necessary to achieve to reach the goal laid out by the strategy.”
The correct product definition enables the CDMO to predict where problem areas may lie and to anticipate potential challenges before they occur. Leveraging the experience of a CDMO partner, coupled with a clear understanding of the path forward, allows companies to foresee challenges that can be more readily solved together, Mocny said.
Consequently, it’s key that regulatory understanding is baked into the program at the outset, he said. The introspective questions that collectively should be asked are simple and a little bit philosophical: “What is it you think you need to do, how do you execute it effectively, do you need to do that to stay aligned with the plan and why do you need to do it?”
This approach can provide clarity, direction and communicate intent with the team for alignment. Communication builds trust, Mocny emphasized. “It is crucial that trust is established with the client to address these matters, to share information and move forward collectively to satisfy mutual business goals,” he said.
In collaboration with a sponsor, a partner CDMO should contest customer assumptions if warranted, Mocny said. “A true partner will be politely critical, inquisitive and thoughtful with their support,” he noted. In customer proposals, Rose BioSolutions sets out a development/CMC strategy that encompasses the manufacturing approach and expected output at specific points in the therapeutic development life cycle.
Attention is given to program-specific risks as understood by Rose based on what a sponsor presents, as well as to recommendations to address them.
Developers consistently underestimate compliance when selecting and working with a CDMO partner. That said, a good partner employs the product definition and regulatory strategy to resolve potential issues, Mocny said.
For example, with complicated product types that don’t fall neatly into any one category, there are multiple elements that need to be considered in the final composition during product development. In turn, the CDMO and sponsor need to consider each element individually and collectively to apply across these product types. This is why product definition is key at the outset.
“Sometimes sponsors struggle with understanding how to interpret the compliance landscape,” Mocny noted. This is where the real value proposition of a CDMO can be seen, contextualizing and bridging the gap between compliance/scientific justification and regulated body guidance. An ideal CDMO partner will have an in-depth understanding of the regulatory frameworks and guide clients to success.
