Managing multiple clinical studies through various phases of development across multiple sites is a complex operation. Moreover, when each study uses its own supply of drugs and is managed in its own standalone IRT system, the complications and inefficiencies multiply – both for the Sponsor and for investigators.
To overcome this challenge, Blueprint Medicines turned to endpoint Clinical for help in creating a unified, seamless technology experience for all the company’s studies, notably to include early phase, investigator-initiated, and compassionate use studies.
THE ISSUE: INEFFICIENT, STANDALONE SYSTEMS
Blueprint Medicines, a biotech company dedicated to understanding the genetic blueprint of cancer and other diseases, sought to consolidate its study technologies and move beyond paper-based processes for those types of studies that are rarely supported with an Interactive Response Technology (IRT) system.
We were relying on our CMO’s drug ordering platform for Phase I, single-arm/ non-randomized and compassionate use trials,” says Craig Duffy, Senior Manager, Investigational Supply Chain Operations at Blueprint. “As our pipeline began to rapidly grow with the addition of more complex and later phase trials, we realized we needed a single solution to bring all of our trials under one IRT and drug ordering platform, allowing us to continue using a pooled supply strategy for multiple trials.”
The company recognized that relying on separate technologies and approaches detracted from study participation for investigators and made it challenging – if not impossible – to pool the drug inventory for use across studies.
THE ENDPOINT SOLUTION: A UNIFIED SUPPLY CHAIN MANAGEMENT SOLUTION
The endpoint team thoroughly understood Blueprint’s requirements and each of the various trial scenarios that could potentially take place in developing an oncology drug for multiple indications stemming from their years of experience creating Sponsor-level supplies solutions for their customers.
Through this exercise, endpoint identified significant overlap in the functions needed to support Blueprint’s studies, regardless of the phase, including investigator-initiated studies (IIS) and compassionate use studies. These included steps related to:
• Drug release and inventory management
• Site startup
• Shipping logistics
• Recording patient visit and kit data
• Drug returns
• CMO integration
On that basis, endpoint devised a solution that would use the same technology framework to manage the supply chain for all of Blueprint’s studies, including those not traditionally supported by an IRT system. The result? DRIVE, a sponsor-level platform for managing trial supplies.
Drug Pooling, in Brief.
When drug supplies are pooled, they are treated as interchangeable across protocols and have a single, shared inventory definition (i.e., SKU). The dispensing units are indistinguishable in content, count, and container/closure system.
Fully decentralized and hybrid trials have proven to attract, retain, and serve patients more effectively than standard trial models and reduce costs with fewer sites, fewer physical monitoring visits by CRA’s, and limited patient and clinician travel. As a result, clinical trials have finally begun to move to the next level of patient retention, efficiency, and innovation.
Pooling drug inventory at the depot offers a number of benefits:
• Decreased amount of stock at depots
• Decreased manufacturing needs
• Reduced waste and overages
• Increased visibility into transitional program supply management
• Cost savings
• Simplified logistics
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