N-SIDE, a clinical trial supply optimization expert, launches the N-SIDE Production App. The new app is the latest addition to the N-SIDE Suite and will further enhance end-to-end clinical trial supply chain management by optimizing the manufacturing process. The Production App has already saved a large pharmaceutical company 10.5M€ and is the only solution that can truly optimize manufacturing planning for the entire clinical program, from drug substance, to drug product, to investigational medicinal product.
Clinical trial supply chains are notoriously difficult to manage. It is a very dynamic world with constantly changing information, large uncertainty in clinical trial demand, multiple teams and siloed data, which leads to inconsistencies and substantial, often hidden, buffers. With ever changing supply needs and long manufacturing lead times, it is extremely difficult for clinical managers to plan manufacturing to meet these highly variable needs while also minimizing waste, controlling costs and reducing the risk of disrupted drug supply. At a program level, this is particularly challenging as multiple trials need to be considered in different global locations, often with a lack of standardization in ways of working and out of date or unreliable data to base decisions on.
In order to support decision making, optimize clinical manufacturing and accelerate time to market, N-SIDE has launched the Production App. The app is based on 20 years’ experience in clinical trial supply optimization and provides an innovative software solution to solve these manufacturing challenges. What-if scenario planning allows teams to understand how individual changes might impact the overall situation and proactively model different scenarios to design the optimal plan. With readily available, accurate data, managers can make informed decisions and rapidly adapt to ever-changing clinical plans. The app automatically optimizes the usage of production assets and resources to reduce waste, budget and timelines and then facilitates communication of any changes to all stakeholders, worldwide.
The Production App has been tested by a large pharmaceutical company to optimize the clinical trials manufacturing plan for a key biological compound. The optimized manufacturing plan resulted in an 11% decrease in manufacturing costs, which translated into 10.5M€ savings for that program. This is in-line with savings observed by other N-SIDE clients currently using the N-SIDE Supply app to optimize their clinical trial supply chain. The Production App adds to this existing capability, optimizing clinical trial manufacturing at the program level, including lot sizing, lot allocation and stability planning. The Production App also accounts for non-clinical demand such as ancillaries and technical demand. It can be used alone or as part of the N-SIDE Suite in conjunction with the Supply App which optimizes at the individual clinical trial level.
Sébastien Coppe, Life Sciences Director of N-SIDE, commented: “We’re proud to launch the N-SIDE Production App to provide a much needed solution to optimize clinical manufacturing. This is the only solution that accurately models and optimizes production planning based on all of the specificities and constraints in the biopharma R&D manufacturing process. It connects strategic vision and operational decisions, not only giving a global view but also providing traceability on decisions, such as for lot allocation. This will support clinical program and CMC managers to proactively handle risk and optimize end-to-end clinical supply chain efficiency, bringing medicines to market to treat patients in need more quickly.”
Jacques Parlongue, CEO and Sébastien Coppe, Life Sciences Director at N-SIDE, announce the launch of the Production App in the N-SIDE Suite in this video. You can also discover how the N-SIDE Production App delivers not just a feasible plan but the optimal plan for a clinical program, taking specific constraints and changes into account, in this animation.