The Production App has already saved one biopharma firm €10.5 ($12.8) million by optimizing manufacturing planning within the uncertainty of the R&D process, says N-SIDE.

N-SIDE has a suite of software aimed at optimizing the entire clinical trial supply chain management process from production planning through to protocol design and delivery of supplies to patients.

The latest offering, known as ‘The Production App,’ focuses on helping biopharma firms manage the complexities and uncertainties of manufacturing clinical material and according to the firm can save end-users millions.

Image: iStock/LeoWolfert

Sébastien Coppe, director of Life Sciences at software consulting company N-SIDE spoke to this publication about how the tech works and the benefits it brings.

In simple terms, how does this app work?

Sébastien Coppe (SC): The Production App is leveraging an advanced optimization algorithm, allowing to optimize all decisions made on the upstream part of the clinical supply chain. It empowers the CMC/project leaders in optimizing their production planning for Drug Substance, Drug Product, including any other production step or component (devices, sourcing, placebo, etc…), and react to the uncertainties of clinical trials. The ability to challenge multiple critical decisions, like lot sizing, stability plan, network, scale-up strategy, lot-to-lot allocation, is another important strength of this App.

How does it work with the current N-SIDE app, and is it necessary to use them together?

(SC): The N-SIDE Suite with the Supply and Production Apps is offering a true risk-based, end-to-end optimization of the clinical supply chain. Both Apps can be used as a standalone, with a clear focus on study planning and management for the Supply App and a project/program planning for the Production App. If one App is used as a standalone, thanks to the advanced optimization algorithms, it will offer trial or program-specific benefits. But when both Apps are used together, we have in our hands the full potential end-to-end planning and monitoring, with very important budget and drug savings while allowing straightforward and immediate data exchange between trial supply and project/CMC teams.

With every drug candidate being different, how is this technology capable of supporting different clinical programs?

N-SIDE’s Life Sciences Director, Sébastien Coppe

(SC): The N-SIDE Suite was built with that specific challenge in mind. It allows to accurately model any clinical trial and project, with all its specificities and constraints, while making it possible to run the system with very limited early data (protocol outlines). When studies go live, the built-in machine learning capabilities leverage actual data and refine the accuracy of all forecasts, therefore reducing the uncertainty inherent to any clinical development project. This consistently improves the quality of the optimized decisions, enabling further drug waste and budget reductions. But the most important aspect of accurate modelling is the risk coverage, allowing to keep safety margins to handle changes without having to firefight or compromise the patient service level.

I understand you can’t say who your clients are specifically, but can you speak about the general demand you are seeing from the pharma market?

(SC): The Production App was successfully implemented by two of the Top 10 pharmaceutical companies as well as by multiple small and mid-size biopharma companies. Really, we have worked on over 10,000 trials in the past years, and have therefore worked on all types of molecules, biologics and trial types and sizes you can imagine.

Whatever the context, we know that when facing increasingly ambitious clinical development plans, an optimal supply chain is what enables recruitment accelerations and additional trials and indications to be tested much earlier.

For several of our clinical-stage partners, we have observed significantly reduced timelines towards commercialization by anticipating and removing bottlenecks in the end-to-end supply chain.

Are there any plans to make this available for commercial supply?

(SC): As opposed to typical commercial supply chain solutions, the Production App is designed to handle all of the R&D’s supply chain specificities, like long lead times, lot sizing and lot allocation constraints, stability plans, process improvements or scale up to late phases.

Nonetheless, it also helps biopharma companies plan for a commercial launch while managing all the clinical trials and other kinds of demands (e.g. technical) that share this newly commercialized product. We believe that, due to the complexities of clinical development production planning, it is important to have a system that gives you the flexibility to manage these, while efficiently planning shared resources with commercial supply chain. Therefore, many of our pharma partners are exploring the opportunity to optimize the global supply chain in a single system.