Beyond Outsourcing: Building Better CDMO Partnerships

For years, outsourcing in the biopharma industry followed a straightforward pattern: a sponsor created a process, handed it off to a contract manufacturer, and expected the work to be done according to specifications. David Enloe, CEO of Rose BioSolutions, contends that this model is becoming outdated, particularly when dealing with complex cell and gene therapies.

Enloe, now leading Rose BioSolutions, is advocating for a new approach in which contract development and manufacturing organizations (CDMOs) act more like an extension of the sponsor's team. "We're in the promise-making business," he explained, emphasizing commitments that extend beyond the client to the patients and their families.

This shift changes the role a CDMO must play. While manufacturing capacity remains important, scientific leadership, expertise in regulatory matters, quality assurance, and program management are becoming crucial in determining whether a program can progress smoothly toward clinical trials. Enloe views this as part of a broader change in outsourcing, where development and manufacturing are becoming more closely aligned.

This is especially true for advanced therapies, where each program can differ significantly from the next. In contrast to a previous era where manufacturers were primarily expected to execute a sponsor's established process, today's sponsors and CDMOs need to work together to assess risks, question assumptions, and make decisions considering the entire development path.

Investing in scientific, regulatory, quality, and project-management expertise at the beginning of client programs can provide significant benefits. As a CDMO works on multiple projects, it can share lessons from both successes and failures with a sponsor focusing on a single critical asset. David Enloe believes that seeing an innovator make a process change that requires substantial rework is painful, and investing more time—and sometimes money—early to identify manufacturing and regulatory risks can prevent costly delays and rework later.

This early involvement also reflects a change in how drug developers consider manufacturability. Enloe notes that while scientists designing a new therapy focus on its potential to improve patients' lives, developers increasingly need assurance that the therapy can be made reliably and at scale. To achieve this, manufacturing challenges cannot be deferred.

For Rose BioSolutions, this means giving clients direct access to technical leaders and promoting open and frequent communication. Enloe describes the ideal relationship with a simple image: "We're just 872 miles down the hallway." He believes that distance should not dictate the closeness of team interactions. Trust is essential for this model to work, and sponsors today are more open to sharing their concerns, constraints, and objectives than they were in the past.

This transparency allows both parties to hold each other accountable for decisions and timelines, improving the chances of solving problems before they jeopardize a program. Enloe brings personal experience to this argument, having spent about 15 years on the sponsor side before transitioning into CDMO leadership. He finds empathy for developers' pressures and emphasizes that manufacturing is not just an operational service but part of the path from idea to patient.

Strong partnerships are built around ensuring this path is navigated effectively together. For more information, visit www.rosebiosolutions.com.