Enabling flexibility and scientific innovation in oral solid dose (OSD) development

Many biotech companies assume that once they have a promising compound, clinical progress is just a matter of execution. But early-stage formulation and process development are where timelines stall—and where strategic decisions can make or break a program.  Poor solubility, unpredictable stability, and the need for scalable manufacturing processes to support changing clinical needs can create delays and put pressure on limited resources. At the same time, evolving pipeline priorities require a CDMO partner that is as agile as it is technically capable.

Cerevance, a Boston-based clinical-stage biotech, faced these exact risks while advancing cell-type-specific treatments for central nervous system disorders. With complex formulation needs and evolving clinical data, they required a CDMO partner with both deep technical expertise and the flexibility to adapt. They knew that the wrong partnership could cost them time—and momentum. They found that partnership in Thermo Fisher Scientific. Working closely with experts at Thermo Fisher’s Center of Excellence for Solubility Enhancement, Advanced Drug Delivery, and Early-Phase Development in Bend, Oregon, they overcame formulation hurdles and developed a scalable strategy to supply their rapidly approaching clinical trial.

At the outset, Cerevance had multiple programs running in parallel, each with unique technical and resource demands. The Bend team supported these efforts, helping the company prioritize development activities and align resources to advance their pipeline efficiently. "Everybody contributes—not only responsibly, but proactively," said Brett Truitt, VP of Technical Operations at Cerevance. "You start realizing the team’s really thinking about this. It’s not just a set of activities—it’s a passion. And you can see that in the team."

In a recent conversation, Truitt and Thomas Yonker, VP of Project/Quality Management at Ceravance, reflected on the broader impact of the collaboration and highlighted the qualities that made the Bend team an effective partner. The critical factors that influenced their drug development efforts included:

• The ability to pivot quickly in response to changing priorities
• Use of digital and in silico modeling to guide formulation strategies
• Integrated development and manufacturing expertise 

Flexibility that keeps clinical progress on track

In early-stage drug development, shifting timelines and evolving demands can create challenges that threaten progress. Maintaining momentum requires a partner that can adapt quickly without disrupting key milestones.

For Cerevance, the ability to navigate evolving project demands was crucial, according to Yonker. "We had a lot of shifting priorities, and [Thermo Fisher] matched this move for move. That flexibility was incredibly helpful." By adjusting timelines and resources dynamically, the team ensured that development activities remained on schedule. 

Overcoming complex oral solid dosage formulation challenges

Formulation complexity is a persistent challenge in early drug development, particularly as new therapeutic modalities push the boundaries of traditional drug design. As emerging therapies become more sophisticated, the need for solubility and bioavailability solutions has grown, requiring innovative approaches to formulation design.

For Cerevance, poor solubility became a significant roadblock in advancing one of their lead compounds. Unexpected degradation during formulation testing underscored the need for a tailored approach to enhance stability and bioavailability. Finding a formulation solution that optimized bioavailability while maintaining stability was essential to advancing their program.

Thermo Fisher worked closely with the team to refine the formulation strategy, leveraging advanced technologies to accelerate problem-solving and ensure the compound’s viability for clinical trials. "What I really appreciated about the [Thermo Fisher] team is that they looked at the data with us and also recommended that we don’t continue to pursue [the initial formulation]. It wasn’t just about moving forward with a plan, but making sure it was the right plan," Truitt explained. Ultimately, they identified a technology that produced a 30-fold improvement in solubility without compromising stability of the drug molecule.

Delivering real value through integration and collaboration

Integrated expertise across development and manufacturing played a key role in ensuring efficiency and scalability. By working with a team that combined formulation scientists, process engineers, and manufacturing specialists, Cerevance was able to align technical problem-solving with production considerations. This approach ensured that formulation decisions aligned with manufacturing scalability, reducing risk as the program advanced.

"We’ve had our clinical packaging and labeling at [Thermo Fisher sites in] Allentown, IND writing in Canada, and QP release in Germany. We didn’t have to chase resources—it was all seamlessly connected," Yonker noted.

Additionally, proactive collaboration helped the team anticipate challenges before they became roadblocks. "One of the biggest advantages was having a fully integrated team that anticipated our needs before we even had to ask," Yonker said. "It meant fewer delays, faster decision-making, and a much smoother path forward."

Looking beyond the immediate challenge

Beyond solving immediate development hurdles, the collaboration helped shape Cerevance’s overall development strategy. The proactive approach taken by Thermo Fisher ensured that challenges were not just resolved but anticipated, allowing the company to make informed, strategic decisions at each stage of development.

"I’ve really loved working with the team in Bend,” Truitt said. “It’s been a true collaboration—people thinking ahead, proactively reaching out, and genuinely invested in the success of the program. It’s not just a project; it’s a partnership that builds trust over time.”