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Manufacture Vaccines, Technology and Equipment, Business Practice

Lessons Learned: Leveraging Pandemic Pandemonium for a Better Future

Though challenging, the pandemic provided the pharma industry with many opportunities for growth and continued learning. No example illustrates this as well as the development and distribution of mRNA vaccines. The production of these drugs showed how quickly the pharma value chain could be mobilized and the power of collaboration. But as the pandemic moves into a new, (arguably) less threatening phase, what lessons will we take with us?

 

Parables from a pandemic: neither gone nor forgotten
 

The sudden need for COVID-19 vaccines showed the world that mRNA vaccines might be one of the most successful tools we have for fighting viral diseases. It wasn’t just the efficacy of the vaccines that made them so impressive; it was also the speed at which we saw vaccines go from discovery to commercial availability, with Pfizer’s COVID-19 vaccine receiving the FDA’s fastest vaccine approval to date (1). 

The vaccine milestone isn’t lost on business leaders or investors. The venture capitalist industry’s investment in life sciences propelled 2021 funding to a record US $43.3 billion (2). During the same timeframe, dozens of mRNA biotechnology companies reached an aggressive growth trajectory – leveraging a primary advantage of the technology: its ability to be rapidly manufactured for inclusion in vaccines. Since mRNA vaccines teach cells how to make a protein that triggers an internal immune response, a company with a facility dedicated to mRNA production can manufacture multiple vaccines in just weeks. 

Although several leading pharmaceutical companies were able to bring their vaccines to market quickly, it took an extraordinary number of resources and huge expenditures. Going forward, mRNA companies will need to carefully evaluate processes and adopt modern techniques and methods for designing, operating, and controlling costs. The drive to bring the next generation of mRNA products to market quickly, coupled with the need to enable a remote workforce, is necessitating the adoption of new systems. This new attitude is accelerating technology transformation across the entire industry. As such, companies need to re-evaluate systems to reduce the time and effort it takes to move therapies from discovery through development. Simply put, adopting an Industry 4.0 approach is the only way to keep pace.

When it comes to data, manage what you measure, measure what you manage
 

To accelerate discovery, vaccine manufacturers are leveraging a data-centric approach, consistent processes, and a quality-first mindset. Together with a cloud-based approach, vaccine manufacturers are demonstrating an ability to reduce costs, improve access, and leverage remote technologies to keep clinical trials on track. 

Building a data-centric culture requires change management that starts with a transition from a documentation approach to a data-driven mindset. Most organizations are predisposed to documenting everything, often multiple times in different departments. Alternatively, companies can leverage a 4.0 approach that holds managers accountable for the data they create and gives them the ability to share that data across teams, business units, and senior management. With a new level of visibility and automation, business leaders can mine data for greater value. Plus, when team members understand the data behind the systems, they have a greater understanding of how their role impacts other areas of the business.

Modern platforms, tools, and applications comprise a technology stack that enables vaccine manufacturers to extract data and make better, informed decisions. This applies to all areas of the business from lab-based informatics tools to decentralized clinical trials. These tools aggregate patient data and provide the ability to extract and scan critical information.  

With higher levels of automation and collaboration, key performance indicators and quality performance measurement becomes more granular.  Organizations can measure milestones such as the time it takes to prepare for regulatory filings and commercialization, achieving clinical endpoints, and creating agile delivery models – creating a more agile and functional pharmaceutical ecosystem.

But for any of these efficiency gains to be seen, companies must also consider the regulatory and compliance requirements necessary to create next-gen products. 

Compliance and quality at the speed of mRNA vaccines
 

A compliance-driven quality management strategy today is vastly different from the pre-COVID era. Now more than ever before, it is vital to have a quality management strategy that supports the rapid influx of data. A digital, quality approach encompasses all technology, methodologies, and processes from the lab to the end-user. All technology must be able to withstand rigorous internal and regulatory scrutiny including when patient data moves through an organization. 

Quality also spans the entire validation process and is quickly transitioning from an afterthought to a forethought. With this new mindset, companies are actively transitioning from time-intensive and inefficient Computer System Validation (CSV), which forces companies to generate plentiful amounts of documentation to support audits, to FDA-supported Computer Software Assurance (CSA). 

According to a Deloitte report, CSA will likely shift quality management toward a less burdensome validation approach and also may confirm a high degree of confidence – reassuring companies that the system is fit for its intended use (3). Additionally, the new approach will likely also help to uncover risks (direct and indirect) around patient safety, product quality, and data integrity.

Cloud-based CSA is a risk-based approach that is focused on quality, data integrity, and patient safety. Critical thinking and an in-depth understanding in five key areas will ensure success: 

  1. Process: Understand your computer system life cycle management, vendors, risk assessment, and change control procedures 
  2. Vendors: Understand the vendors’ software release cycle, maturity, product specifications, limitations, and workarounds
  3. Requirements: Consider risks to patient safety, product quality, and data integrity so managers can appropriately focus key resources
  4. Execution: Consider how you maintain objectivity in the scope and risks 
  5. Attitude: Deploy a three-phase behavioral change management process that focuses on timing, transparency and collaboration.

The right solution will ensure that leaders can succinctly defend quality management decisions while making sure that new technologies are brought in responsibly, set up correctly, and leveraged throughout the organization. 

The importance of consistent processes
 

Time-consuming, manual, and repetitive tasks are a great starting point for creating new, consistent processes and deploying purpose-built automation solutions such as business intelligence, reporting, and automated process management.

But consistent processes rely on teams – both on and off-site – as well as external resources that can input, review, update and share information across an organization. Leaders have a role to play here, too. They must be able to effectively monitor and tune processes and workflows to meet the specific needs of their businesses. If they also can establish good working relationships with software partners, they may find that process management is much easier. A good software provider should be able to seamlessly provide intelligence on how processes are working across the enterprise, for example, cloud-based systems offer process or workflow automation, and capabilities that support business operations.

The key to success is ensuring that new technologies and processes leverage a framework for applications to scale and progress quickly. Solutions exist today that provide integrated process and testing automation to eliminate multi-sourced documents, software, and disparate processes. Companies should aim to invest in them to see their operations truly transform.

The take-home: use past experience to inform the future
 

Now that the industry has proven it can accelerate innovation during a pandemic, it is time to apply key learnings. Record investment, new expectations, cloud-based technologies, and the ability to pivot quickly have raised the bar. A modern digital architecture framework that is interconnected through applications and integrations is available to every life sciences company. 

From faster, decentralized clinical trials to the transition from CSV to CSA, we can and should maintain the current innovation cycle. Digitizing processes, applying a quality-first strategy, and holding everyone accountable in a new, data-driven culture, empowers an entire industry to regularly bring new life-saving treatments safely and quickly to patients worldwide.

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  1. FDA, “FDA Approves First COVID-19 Vaccine.” (2021). Available at: https://bit.ly/3GRXGoR
  2. NMRK, “2021 Year-End Life Science Overview & Market Clusters.” (2021). Available at https://bit.ly/3Q0ta09
  3. Deloitte, “Accelerating Computer Software Assurance (CSA) readiness.” (2021). Available at https://bit.ly/3Q2OsKE.
About the Author
Bryan Ennis

Chief Executive Officer at Boston Technology Research

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