Beyond the Tufts study: Real-world application of CDMO–CRO integration

Key takeaways

• A study from the Tufts CSDD found that integrated CDMO–CRO partnerships can reduce development timelines by an average of 14 months compared to multi-vendor models.
• Time savings are achieved by eliminating handoffs, gray space, and operational silos across development stages.
• Thermo Fisher Scientific’s Accelerator™ Drug Development program applies this integrated model in real-world drug development programs.
• Case examples show how integrated planning can accelerate clinical milestones without increasing risk.

Benchmarks are often touted in the pharma industry. For example, when we look at the data from from the Tufts Center for the Study of Drug Development (CSDD) study, there's a clear takeaway: compared to the traditional multi-vendor solution, an average of 14 months can be saved through an integrated CDMO–CRO partnership. But as anyone in the trenches of drug development knows, a benchmark is just a number until you can replicate it in your own pipeline.

During a recent webinar, Joseph A. DiMasi, PhD, Director of Economic Analysis and Research from the Tufts CSDD, and Doug Ahrens, VP of Commercial Strategy and Development at Thermo Fisher Scientific, presented the primary results from a research study on the financial value of integrating CDMO and CRO services. The webinar discussed case studies that highlighted the benefits of integrated CDMO–CRO partnership. The results highlighted major time savings and cost reduction from partnering with an integrated CDMO–CRO program over traditional multi-vendor systems. But what does this really mean for a drug developer?

The truth is that the 14-month saving isn't found in a single step. It is found in the multiple handoffs, the elimination of gray space, and the breaking of silos that traditionally defined our industry.
 

How an integrated CDMO–CRO model helps reduce gray space and handoffs

In a typical multi-vendor solution, sponsors leverage different vendors for specific activities. However, when you move a product from a manufacturing site to a clinical site, time is added to every handoff. There is always a delay when responsibility ends at one deliverable and begins at the next. In an integrated model like the Accelerator™ Drug Development, we prioritize finding and eliminating of this gray space. We stop looking at drug development as a series of baton passes and start looking at it as a single, continuous sprint.
 

What is the value of an integrated CDMO–CRO partnership?

Another practical benefit of an integrated CDMO–CRO partnership is risk mitigation. In a fragmented model with multiple vendors, every handoff is an inherent risk, where no single provider has an incentive to look beyond their own task or assume responsibility beyond their subsequent stage. As a sponsor, you end up spending significant time managing the handoffs and filling the communication gaps for effective risk mitigation.

Integration changes that. By having a single partner that is unified, you have a single risk register. This allows both the sponsor and the CDMO–CRO provider to see what is happening in real time and ensures when something does happen, the integrated model allows for a rapid response because the provider understands the downstream impacts immediately.

Real-world application: Accelerating the transition from Phase I to Phase II

In one example, a sponsor was transitioning a small molecule candidate from Phase I to Phase II. They were under intense pressure to get ahead of competitors, which meant manufacturing and study startup had to be perfectly synchronized.

An integrated CDMO–CRO partnership enabled a much deeper, end-to-end review of the project plan, uncovering time-saving opportunities that a fragmented model would likely miss. The team identified that a Phase I resupply batch was already available and representative of the Phase II formulation. By aligning the material requirements of the first countries coming online with this existing Phase I supply, clinical packaging activities were able to begin significantly earlier than originally planned.

The result: By optimizing logistics along the critical path and eliminating the traditional wait for new Phase II batches, the sponsor accelerated first patient in (FPI) by four months.

Conclusion: Breaking down silos in your drug development journey

The Tufts study proves that a partnership with an integrated CDMO–CRO is financially worthwhile.

If you are looking to squeeze time out of your critical path and move your therapy to patients faster, I encourage you to watch the full webinar. In the webinar, we go much deeper into:

• Key findings from the Tufts CSDD study
• Case-driven examples illustrating the value of this model in real-world application
   

Frequently asked questions (FAQs)