Accelerate drug development by embracing a 360˚ CDMO and CRO approach
As pharmaceutical companies grapple with diminishing returns on R&D and prolonged drug development timelines, the search for efficient solutions has become a strategic imperative. According to a recent Deloitte report¹, the average cost of bringing a new drug to market has surged to $2.3 billion, with the average cycle time now spanning more than seven years. The financial burden and extended timelines highlight the urgent need to streamline the complex drug development process.
In this environment, the benefits of an integrated approach that consolidates essential drug development services cannot be overstated, particularly for small and emerging biotech and biopharma companies just entering the market or in the midst of progressing a clinical trial across any molecule type.
Proof of this can be seen in companies that have adopted Accelerator™ Drug Development by Thermo Fisher Scientific. By combining multiple aspects of the drug development process into one streamlined service—including drug substance, drug product, clinical manufacturing, and supply chain management—timeline gaps are eliminated, regulatory challenges are proactively identified and risk mitigated, and the development journey from lab to market is expedited.
Relevant across all clinical phases and extending into commercial projects, Accelerator™ Drug Development projects that include drug substance and drug product manufacturing by Thermo Fisher Scientific are guided by a program manager who coordinates activities across the global Thermo Fisher network, ensuring efficient and secure supply chain management. As the centralized point of contact, the program manager serves as a customer advocate, a team integrator, and a risk mitigator across the drug development journey.
Consolidating processes under a single master service agreement and utilizing harmonized quality systems minimizes the complexities and risks associated with the traditional approach to pharmaceutical development, which outsources pieces of a program across multiple providers.
Partnering with an experienced ally and embracing an integrated approach allows pharmaceutical companies to focus more on innovation and less on operational logistics and enables them to bring treatments to patients faster and more reliably.
How Accelerator™ Drug Development enhances drug development
The road to success
The effectiveness of Accelerator™ Drug Development is highlighted through several case studies that showcase the ability to navigate complex logistical and supply chain challenges.
In one instance, a customer required support to manage the global distribution of clinical trial materials, and to address over-enrollment at multiple sites which threatened a supply shortage. Strategic adjustments in packaging solutions and the use of a new API source, facilitated by comprehensive service integration and centralized management, prevented any delays in the study timeline. Additionally, the program’s end-to-end, integrated and customizable solution featuring global experts that integrate drug development and clinical services into a single vendor solution, ensured that all regulatory requirements were met without impacting the study’s progress. The program's robust framework and proactive risk management approach were instrumental in seamlessly adapting to the challenges presented during the trial.
Another example involved the rapid development of a COVID-19 treatment. Integrated service delivery and project management capabilities enabled the scale-up of drug substance production and the subsequent manufacture of more than 200 million capsules within a 12-month period. This efficient response not only met urgent global demand but also strictly adhered to emerging regulatory approvals. The program’s ability to rapidly scale operations and its comprehensive regulatory oversight were pivotal in accelerating timelines during a critical period.
These cases illustrate the program's capacity to streamline complex processes and enhance operational efficiency and demonstrate a proven record of success in reducing time to market for critical therapies amidst intricate global drug development challenges.
A look ahead
As we reflect on the pressing challenges the pharmaceutical industry faces, moving to an integrated and streamlined drug development approach is increasingly critical. The effectiveness of the Accelerator™ Drug Development solution exemplifies how such integration not only meets the urgent needs of the industry but also sets a forward-looking standard for efficiency and effectiveness.
Bringing together diverse capabilities under one unified strategy offers a promising path forward for companies aiming to overcome the inherent complexities of getting new treatments to market swiftly and successfully. Incorporating comprehensive CRO services alongside CDMO services further enhances the value of an integrated approach. By including analytical and clinical study support, companies can achieve even greater efficiency and coordination throughout the drug development process. This integrated model addresses the immediate challenges and points to a future where innovative treatments reach those in need more quickly than ever before.
Learn more about the value Thermo Fisher Scientific’s Accelerator™ Drug Development can add to your drug development journey. (Add a CTA here: Contact us for more information.)
¹ Deloitte. Measuring the Return from Pharmaceutical Innovation: Unleash AI’s Potential. Deloitte LLP, 2024.
