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Accelerating Drug Development with Strategic CDMO and CRO Partnerships
October 21, 2024 by Staff writer (12 minute read)
Insights from CPHI 2024: Accelerating drug development through strategic CDMO and CRO partnerships
As pharmaceutical and biotech companies face increasing pressures, from regulatory challenges to rising costs, finding the right outsourcing partner has become a strategic necessity. At CPHI Milan 2024, Jennifer Cannon, President of Commercial Operations at Thermo Fisher Scientific, shared insights on how strategic partnerships can help companies thrive in this complex landscape.
“The pressures on today’s drug developers are immense,” Cannon explained. “To stay competitive, companies need partners who provide not only expertise but also the agility to navigate this environment and accelerate every stage of development.”
The expanding need for outsourcing
Cannon outlined several key factors driving the growing need for outsourcing, noting both external and internal pressures. Externally, companies are grappling with rising competition, stricter global regulations, and supply chain disruptions. Internally, financial pressures—such as increasing R&D costs—are pushing organizations to rethink traditional models and optimize resources.
“New outsourcing models are becoming more crucial than ever,” Cannon emphasized. She explained the necessity of forming partnerships with CDMOs and CROs that offer flexibility, reliability, and the expertise required to keep pace with market demands and regulatory frameworks.
Tailoring outsourcing to meet therapeutic challenges
Cannon also touched on the importance of tailoring outsourcing strategies to address the unique challenges of different therapeutic areas.
For small molecules, outsourcing helps manage cost pressures, intellectual property protection, and regulatory compliance, with CDMOs offering scalable manufacturing and secure systems. In biologics, more complex manufacturing processes and cold chain logistics require advanced facilities and expertise to ensure regulatory compliance. Cell and gene therapies, meanwhile, demand flexible, scalable platforms to accommodate patient-specific treatments and evolving regulations.
“Tailoring outsourcing solutions to specific modalities is essential for success,” Cannon explained, highlighting that a one-size-fits-all approach doesn’t work in such a complex landscape.
The value of comprehensive partnerships
Cannon highlighted the trend of consolidating outsourcing services under a single provider to reduce complexity and improve development speed. She pointed to Thermo Fisher’s Accelerator™ Drug Development model as an example of how consolidating services for drug substance, drug product, and clinical trials can streamline the process.
“Managing multiple relationships across different service providers can add unnecessary time and cost to development programs,” she explained.
Insights from real-world case studies
To illustrate the benefits of strategic outsourcing, Cannon shared several case studies. In one example, a customer faced variability in assay transfer that threatened to delay a First-in-Human (FIH) trial and could have resulted in significant financial losses. Thermo Fisher’s regulatory and CMC consultants streamlined the process, allowing the trial to begin 12 months ahead of schedule and avoiding costly delays.
In another case, a biopharma company experienced delays due to poor communication across siloed teams. Thermo Fisher’s integrated program governance and improved communication helped the company meet its milestones on time, while also reducing costs.
“These case studies highlight how effective outsourcing partnerships can have a measurable impact on the speed and cost of drug development,” Cannon said.
Preliminary findings from new research
Cannon also referenced preliminary findings from a recent study conducted by the Tufts Center for the Study of Drug Development, showing financial benefits and faster timelines for projects developed under the Accelerator™ Drug Development model. The full results, set to be released later this year, emphasize the value of working with a single partner offering comprehensive services and expertise across the development continuum.
Looking forward
Cannon concluded by emphasizing that outsourcing will continue to play a key role in pharmaceutical and biotech success. As companies face increasing challenges, forming long-term, strategic partnerships will be crucial to ensuring that therapies reach the market efficiently and cost-effectively.
“Success will depend on partnerships that provide not only expertise but also the operational flexibility needed to adapt to changing regulatory demands and market conditions,” she said.
Thermo Fisher’s presence at CPHI Milan, including the launch of its Accelerator™ Drug Development model, reflects the company's commitment to supporting its partners with comprehensive CDMO, CRO, and clinical supply services.