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MISHRA: Clinical trial supply chains are complex and operate in a dynamic environment where the stakeholders are loosely connected, both internal to a drug development organization and external. At an elevated level, how does N-SIDE address the overall formidable challenge?
COPPE: The Supply Chain is one of the last cogs of a large machine, where stakeholders in different departments make decisions without always understanding the impact ( they have downstream. N-SIDE’s mission is to tackle this specific issue by connecting stakeholders with data. Decisions taken by clinical operations in the protocol design, by the CRO in the country selection, by the IRT in its site resupply algorithm, all end up having an impact on the supply chain. What N-SIDE’s solutions do, is connect all pieces of information around a clinical trial, and optimize decisions for a global best-case scenario, where all patients are supplied their drug in time, while drug supply is never again a bottleneck to ambitious timelines.
MISHRA: What tools do you provide for Planning and dynamically updating the plan based on realities of actual enrollment, IRT feedback, manufacturing lead times, quality failures, etc.?
COPPE: Planning and adapting to the supply chain is already quite a challenge. Promising 20-60% waste reduction on top of it, and actually being able to deliver it by the end of the trial requires even stronger algorithms than simple forecasting or data aggregation.
First, anticipating uncertainties in recruitments and demands is a must to have a robust supply chain, as it gives supply managers the flexibility to adapt to real-time events. This is delivered through N-SIDE’s proprietary simulations algorithm. Second, adapting to real-time events is a matter of both efficient monitoring and quick decision-making. N-SIDE provides a monitoring application with an alerting system so that, if there are any deviation in the expected recruitment or demand, the user is alerted immediately, saving up to 3 months in reactiveness. Finally, if there is a discrepancy, a release delay, a protocol amendment, or any other challenging event, N-SIDE’s system uses machine learning to adapt to real-time events and re-optimize future decisions in order to prevent risky situations, and keep waste as low as possible.
MISHRA: Fundamentally, how does your overall service reduce time-to-market which is the most critical objective for majority of the drug developers?
COPPE: The biggest trend in the industry is now aiming at reducing global clinical development timelines. The pandemic has shown it was possible to speed up the whole development process and bring solutions to COVID in record-breaking times. Still, when planning to reduce timelines, we quickly realize that the Supply Chain might be a bottleneck in the critical path forward. We are hearing that many trials are delayed due to drug availability and that a shortage of manufacturers is hitting the industry. Being able to streamline the end-to-end Supply chain (i.e. maximizing the drug allocation to patients and minimizing waste on the global process) is the key step in making trials feasible despite low drug availability. The next strategic step, after reducing drug needs at a trial level, is to have global visibility on manufacturing and global drug availability, to either anticipate any supply chain bottleneck or re-allocate remaining drugs to accelerate trial timelines. N-SIDE’s experience on hundreds of programs has allowed the acceleration of programs by 2-6 months by enabling the increase in the number of recruiting sites, the initiation of new indications earlier or, overall, enabling a trial to be feasible at all.
MISHRA: I believe that Visibility in the supply chain may provide the greatest benefit in terms of shorter lead times, reduced drug waste and mitigation of risk. If you agree, how does your systematic solution achieve an outcome we all want?
COPPE: One big challenge for Biopharma companies is to have accurate visibility on actual and future stocks and allocations, as well as on demands. An important cause of waste comes from a lack of visibility on clinical trial demands. Indeed, overestimating patient demand is a common solution to account for uncertainties, and these are often complemented by an even larger overage that is manually calculated. Giving visibility on accurate demands, and simulating the future allows for N-SIDE’s system to understand the real impact of uncertainties and account for an optimized overage, provided as an output, that complements an accurate demand forecast.
This was the first critical step. Upstream manufacturing (DS, DP, Devices, …) can also be quite complex, and buffers are often taken at every step of the process. Having visibility on demands, while knowing that uncertainties are also taken into consideration, allows for lean manufacturing planning where buffers in quantities can be replaced by time buffers. Meaning that, instead of having additional waste to cover uncertain events, we are able to assess how much time we have to react to said events and whether it is safe.
MISHRA: Considering that BSMA primarily caters to small and medium-sized companies who cannot afford an ERP system, what is the nature of your SaaS platform and what capabilities must a customer have to utilize it?
COPPE: ERP systems can be expensive, but the most important constraint is the amount of time it takes to implement them. The same is true for inventory management solutions. Our SaaS platform allows for a quick implementation (2 weeks) and an even faster ROI. Small & medium-sized pharma can choose to use it by themselves in-house, or to use N-SIDE’s consultants in case the size of their team does not allow for efficient resource management. The other point is that cost and waste savings from our solution are reported, tracked and challenged by real-time events, not only a promise. And I am happy to say that N-SIDE’s cost is generally below 1% of the value that is brought to our partners. The other advantage of a supply chain planning and decision-making solution is that it does not need to be GxP, therefore making its selection and implementation a lot easier.
MISHRA: How can clinical trials be successfully migrated to commercial operations?
COPPE: Commercializing a new drug is a bumpy road on the regulatory side of things but planning for commercial manufacturing and supply chain is also important to prepare for in advance. Scaling up the manufacturing, designing the commercial network of distributors and suppliers is quite a challenge and a lot of money and time can be lost with the wrong decisions. Another challenge we often encounter is that commercial and clinical trials demands are generally handled through different systems and teams. In the early years of commercialization, there will likely still be ongoing clinical trials on the newly available drug, meaning that there is a need for jointly planned manufacturing. N-SIDE solutions helped with both.
Our optimization algorithm in the Production App allows for strategic decision making (network design, vendor selection, scale-up strategy optimization) along with combined planning for both commercial and clinical demands.
MISHRA: Can you highlight of the economic benefits realized in the areas of waste reduction, timely completion of studies, cost reduction in sourcing of comparators and reduction of stress in the network?
COPPE: N-SIDE’s experience on thousands of trials has allowed us to draw conclusions on the benefits brought to the industry. For our partners that have implemented the N-SIDE Suite along with efficient processes, we were able to reduce their drug waste from an industry average of 70% to 20-25%, across all indications. This represents an approximate 20-40% cost reduction in clinical supply, manufacturing and sourcing. TO On the other hand, we are often called to solve drug shortages in ongoing trials or help make trials feasible with extremely limited drugs. In these cases, we have been able to ensure supply continuity without slowing down recruitment at all by assessing the impact of risk-mitigation solutions.
Overall, when optimizing a whole program and recommending efficient re-allocation of drugs, we have accelerated our partners’ trial timelines by 2-6 months
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