The Case For Connectivity

By Jim Murphy, president and managing director, Almac Clinical Technologies

How a closed-loop system can optimize the supply chain.

The very term “supply chain” implies continuity and connectivity between various stages of delivering products to patients. But, in reality, that’s not always an apt description of the clinical supply process — especially when multiple vendors are assigned to different aspects of the job. Too often, the systems, methodologies, and steps involved are not harmonized or coordinated, and the sponsor misses an opportunity to achieve efficiencies, reduce costs, and improve outcomes.

In order to improve the efficiency of clinical studies, sponsors need the support of a strategic partner who can take into account — and capitalize on — the interconnections across a broad system. A supply management vendor with a comprehensive view of the supply chain can integrate information and processes to manage all trial supply needs cohesively and take advantage of opportunities to work better, faster, and smarter.

End-to-end solutions for managing the supply chain offer sponsors:

• A holistic view of the entire supply chain, supporting full lot genealogy
• Increased agility and resilience in meeting trial goals
• Faster, more accurate demand forecasts
• Efficiencies that translate into less drug wastage, costeffective transportation solutions, and improved study timelines
• Improved compliance
• Reduced oversight of vendors (owing to fewer handoffs and disconnects).

Here, we’ll describe the elements of such a comprehensive approach and explain how the right strategy and technology can help sponsors realize substantive process improvements that translate into a competitive advantage.

Technology: The Lynchpin
Coordinating the distribution of products to trial sites and mitigating risks call for a closed-loop technology solution that gives all functions visibility to the rest of the supply chain. This can be found in interactive response technologies (IRTs), the systems used to connect clinical supplies and patients.

By providing real-time information on patients and drug-related activities throughout the life of the study, an IRT supports forecasting and all the downstream processes of manufacturing, packaging and labeling, depot allocation, and product distribution. As the trial progresses, data is gathered from each stage of the process and used to inform all activities upstream. Creating this virtuous cycle of information is perhaps the most significant step a company can take to improve supply efficiencies.

Forecasting: A Continuous Exercise
A sound supply chain plan will begin with a carefully prepared forecast of material demand and incorporate iterative forecasting throughout the life of the trial. After a baseline forecast is created, the IRT system will provide real-time updates of what is happening with patient enrollment and product inventory as the trial progresses. This information can be used to modify the forecast and to indicate how much drug should be produced, and when. Such dynamic management supports budgeting, prevents wastage from stockpiling supplies, avoids the risk of stock-outs, and reduces emergency measures to replace expiring drugs.

The key to being able to optimize both production and distribution in this way is having coordinated oversight of the entire supply chain.

Packaging And Labeling: An Early Strategy
The various options for product packaging and labeling should be evaluated while the protocol is still being developed so that the pros and cons of various formulations and kit designs can be considered. The right partner brings experience across thousands of protocols and all therapeutic areas and can advise sponsors on how to use the kit design to encourage site and patient compliance.

The right partner can also recommend methods that can save time and money, whether in creating kit designs that take advantage of automation in the production line or in using just-in-time packaging and labeling to prevent waste. The key, however, to realizing the benefits of a given packaging and labeling strategy is to align it with the IRT functionality so that every aspect of production, distribution, and drug assignment is coordinated.

Distribution: Optimized With Information
When product distribution is optimized, enough investigational product is on hand at sites to ensure continuity of care, having arrived in usable condition at minimal cost. Achieving this ideal requires careful planning and the use of a supply engine that can identify shifts in demand and inform adaptation to those shifts as the study progresses.

The distribution strategy should reflect the milestones that will affect product demand and the regulatory and logistical details that will impact delivery. With that information, it is possible to design a system that delivers product optimally. When the proper ordering, tracking, and information-sharing practices are in place within the IRT, every function along the way can monitor supply and demand, working proactively to forestall potential issues.

Traceability: Derived From A Common Technology
With the right technology in place, sponsors can access a single, comprehensive view of drug inventory across all stages of the study — from receipt of bulk product all the way through to the return and destruction of unused or damaged product. Reconciling the amount of product shipped vs. what was allocated and used by patients vs. what went unused is far less challenging when a common technology is used to track kits as they move through the process.

Being able to trace the lot genealogy of a product across the supply chain can be critical for inspection readiness, regulatory submissions, product recalls, and managing impending product expirations. It is far easier to trace a product’s lot genealogy when a single vendor is used in packaging and distributing products; vendors all assign their own tracking codes to the product, and a full lot genealogy can only be completed by piecing together information from disparate systems.

Visibility: The Key To Efficiency
Everyone in the supply chain should have visibility to the disposition of supplies and to study progress. Through ongoing reporting and analytics, supply chain managers can ensure that the supply plan is executed properly and adjusted to reflect changing trial conditions. The IRT should provide:

• Patient enrollment statistics, with trends by site and country
• Comparisons of predicted vs. actual material forecasts
• Dashboard on the disposition of supplies
• The ability to download data, manipulate it, and export it to other formats
• Alerts when conditions approach predefined thresholds.

In today’s clinical trial environment, which is globally dispersed and increasingly costand time-sensitive, the impact of an effective clinical supply strategy on the success of a trial has never been greater. Silos and static approaches to managing the supply chain undermine our ability to cope with challenges, such as unpredictable patient enrollment and the fragility of cold-chain products. It is only by managing the clinical supply chain as one highly interdependent and dynamic system that we can move beyond the status quo and achieve breakthrough progress.

The underpinning of such an holistic approach is an advanced technology platform that manages medication-related site activities and enables a single view of the drug lifecycle. This information can then be acted on in a coordinated and iterative way across the full supply chain, ultimately establishing a virtuous cycle that leads to improved control, agility, speed, and efficiency.

Jim Murphy is president of Almac’s Clinical Technologies Business Unit, a role he has held since 2006. Since joining the company in 1999, he has held several senior positions in operations, business development, and marketing. He holds a bachelor’s degree in biochemistry and a masters in molecular biology, both from the University of California at Santa Barbara, U.S.