From the global COVID-19 pandemic to recent concerns over monkeypox, the pharma industry has been operating in a climate of persistent health care crisis. This has both spurred newfound speed and agility and emphasized the need for greater emergency preparedness. Unfortunately, prior to these recent disruptions, progress on adopting technology to streamline production had been slow. Nineteen years ago the pharma industry was deemed to have “…manufacturing techniques [that] lag far behind those of potato-chip and laundry-soap makers...”1. Progress since then has continued to lag, despite encouragement from regulators.
To be fair to the industry, there are several challenges that have impeded innovation beyond the notion of an innately risk-averse culture. For example, while regulatory oversight will rightfully remain a strong part of both development and manufacturing operations, the evolving interpretations and questions of clarity around regulations have contributed to risk-averse policies over the years. Furthermore, the industry has been keenly aware that modernizing operations is not a risk-free endeavor: failure to fully address risks associated with data integrity, change management and system security can lead to a “modern-yet-non-compliant” solution needing significant subsequent improvements to meet regulatory requirements.
Despite these challenges, the industry continues to grow in its ability to deliver positive outcomes when the needs are great. Technology, public policy, field logistics, community outreach, and geopolitical dynamics have all played key roles. In terms of the technology component, there are at least five digitally mature capabilities that can readily be deployed to better prepare the industry for future crises. Additionally, the challenges surrounding COVID-19 have catalyzed a new openness in pharma to embrace such technologies with a sense of urgency.
Although transition from manual to digital operations has compelling benefits, manual pen-on-paper workflows persist in many areas, risking clerical errors and data integrity violations. Digital batch execution management, electronic lab notebooks and factory dashboards, can greatly alleviate these error-prone processes and facilitate collaboration along the product lifecycle by enabling data-driven decision making and improving inspection readiness. This certainly could come into play during times of accelerated process design and scale-up as in the COVID-19 case2, and for inspection readiness to reduce compliance-related delays as in the recent monkeypox case3.
With this in mind, converting remaining operations workflows from manual to secure digital would go far towards enhancing crisis readiness, as demonstrated by GSK.
Mechanistic Process Models
One common characteristic of a crisis environment is the need to develop and scale-up new processes in a timely manner with limited material resources. This was the case for all recent crises, but particularly for the COVID and Ebola crises where clinically proven therapies needed to be scaled up rapidly. This is where first-principles, mechanistic and hybrid models of key process operations can play a pivotal role by leveraging subject matter expertise in engineering, biology and chemistry to streamline development and scale-up, without compromising quality. For example, a Japanese company reported how they were able to use mechanistic modeling to quickly design a new process with superior performance on quality and productivity.
Data Stream Enrichment
What good is taking operations digital if the existing data streams present limited value? Today’s operating units generate a richness of process data, but this data is not always deemed sufficient for critical monitoring, control and release workflows, especially in the case of legacy operating lines such as those that were repurposed to support COVID vaccine demand.
This was one of the main drivers for the FDA’s Process Analytical Technology (PAT) guidance back in 20044— to enrich the process data streams with timely, frequent and relevant information to both streamline development and ensure quality in full-scale production. The effectiveness and reliability of PAT measurement technology has improved greatly in the past several years, and intuitive compliance-ready PAT platforms have reduced barriers to effective deployment. Taking advantage of these to enrich operations’ data streams will put you in a much better position to respond to the next crisis, as demonstrated by Ferring Pharmaceuticals.
Predictive and Prescriptive Maintenance
During an emergency, there is a tendency to lean heavily on the physical assets that support all development, manufacturing, and distribution operations. In many cases legacy assets will need to be repurposed to support these operations, as was done for the COVID-19 crisis. This underscores the importance of asset management and maintenance to ensure operational readiness and agility. Asset Performance Management (APM) solutions, which utilize live asset system measurements acquired during operations, combined with machine learning models, can be particularly effective for both predictive and prescriptive maintenance of this equipment. Intuitive agent-building solutions tailored to the asset expert, as well as more flexible “bring your own model” solutions to exploit existing asset models, can be put into service to help keep you one step ahead of unplanned equipment shutdowns and potential supply disruptions during the next high-visibility crisis. GSK have demonstrated significant benefits deploying such technology at scale.
Supply Chain Management
The COVID crisis, and its various impacts, have brought the term “Supply Chain” to the forefront of our lexicon. Of course, those working in Supply Chain Management (SCM) and Scheduling in pharma have long appreciated the challenges of reliably producing and distributing medicines on a global scale and were already wary of the complexity and fragility of many of the supply chains.
Fortunately, increased digitalization of operations in recent years has opened the door to digital solutions supporting scheduling, SCM and supply chain optimization workflows. Regarding the latter case, imagine being able to simulate the effects of specific disruptions (e.g., closed political borders, loss of operations personnel to illness, lost access to raw material suppliers, etc.) on delivering your life-saving treatments or vaccines. In a recent interview, our in-house expert on planning and scheduling for pharma, Cade VanRooyen, delves into these issues in greater depth.
No one is scrambling to say it, but it’s likely that the next health crisis is just around the corner. Contrary to history, the industry has demonstrated the ability to respond to such crises, and there are several solutions available today to help prepare.
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1. “New Prescription For Drug Makers: Update the Plants - After Years of Neglect, Industry Focuses On Manufacturing; FDA Acts as a Catalyst”, Leila Abboud and Scott Hensley, Wall Street Journal, Sept. 2003.
2. Detour: Reminiscing 2017, from legacy Camo website
3. Ebola outbreak of 2014–16 | Description, Stages, Experimental Treatments, & Challenges | Britannica (archive.org)
4. FDA PAT Guidance citation (2004) COVID-19 Vaccine Manufacturing: Challenges, Solutions and Implications for the Pharma Industry | L.E.K. Consulting (lek.com)
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