Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.
The events of recent years have accelerated the pharmaceutical’s industry’s dedication to speed—more than ever, we’re striving for “innovation at pace.” With the rapid adoption of new technologies, adapted ways of working, and increased expectations for better, more personalized care, as an industry we are focused on delivering breakthrough treatments much faster for patients who are waiting.
“Innovation at pace” could transform the lives of millions of patients facing life-limiting disease but, along with the inherent challenges of drug discovery, development, and delivery, inevitably there will be unexpected hurdles.
Quality is pivotal to addressing these challenges. Not just “quality as a discipline” but as a collective culture of quality across an organization, helping to create the right environment for accelerated innovation. Building confidence and trust, protecting people and data integrity, and overcoming barriers early are fundamentals.
At Astellas, we are evolving operational frameworks that can help to accelerate innovation to deliver at speed without compromising on quality.
We encourage curiosity and diversity of thought because we know that brave ideas will lead to the best health outcomes. But brave ideas require an element of intelligent risk-taking, which must be underpinned by ethical decision-making and solid risk-management principles to truly realize life-changing potential for patients.
A robust quality framework with defined principles gives confidence and empowers rapid decision-making. It’s a model that allows teams to not only identify the biggest risks, but to implement control strategies, such as monitoring systems, and ensure the necessary cross-functional collaboration and communication to recognize and address challenges early. Through our experience, we know issues can and do arise, but our framework allows us to be agile in our response, helping to find problems fast and fix them faster. In our partnership with regulatory agencies, too, our model can inspire confidence and trust in our risk and quality management systems to limit the time-consuming cycles of submission, review, and approval, and ensure rapid access to innovative medicines.
The industry’s response to COVID-19 is a great example of what can be achieved at pace within a quality framework. With unparalleled intent, game-changing COVID vaccines were developed quickly to address the large-scale pandemic challenges. This was only possible through brave decision-making and intelligent risk-taking. If we had relied on our traditional, more conservative approaches, we no doubt would have seen even more devastating illness and loss of life, or we might still be waiting for a path out of lockdowns.
Although it was a unique scenario, we can take valuable lessons from the pandemic—in terms of exceptional risk management, communication, and collaboration, especially between industry and regulatory agencies, establishing how decisions could be made rapidly. The unprecedented speed of development was made possible due to an acute focus on a collective threat, with all eyes and hopes pinned on a solution, but without compromising the expectation of safety and data integrity. Quality standards didn’t change, just the process and speed at which the industry was able to reach our goal.
Quality as a function is quickly adapting to this new reality and expectations for accelerated innovation. Historically, quality was considered “complying with the rules”—an end-stage tick-box exercise. Now, with a much broader scope of responsibility, we are increasingly living the “quality by design” concept, which considers how we control risk in a much more sophisticated way, underpinned by a culture of quality “owned by all.”
At Astellas, we’ve adopted a quality maturity model to assess and improve our quality practices and identify better ways of achieving quality. For example, shifting the emphasis from compliance with memorized rules and procedures, to, instead, leveraging competencies. We’re also looking at the best way to utilize technologies and digitizing transactional work to move our organization to a more mature quality level. This includes investment in an electronic quality management system (eQMS) platform to leverage advanced digital technologies and unlock capabilities in artificial intelligence, including automation and natural language processing, allowing the system to not only process basic work, but also to identify trends. This enables our team to shift away from some of the more routine tasks, freeing up capacity for critical thinking on resolving issues and driving continuous improvement activities.
As with many organizations, the quality maturity model is well established at Astellas—particularly in good manufacturing practice (GMP)—but we are also now implementing it with success across other functions, such as drug development and pharmacovigilance. Although created with manufacturing in mind, by adjusting the language but not the foundational concepts of the quality maturity model, we have been able to identify where meaningful action can be taken by other areas of our organization, to help them advance along the quality maturity continuum. The process has sparked interesting conversation within our functions, helping business partners to consider more deeply what constitutes quality and inspire new ideas to further embed a culture of quality across our organization.
To deliver the complex innovations of the future and allow quality management systems to realize their true potential, we must always ensure we do the basics brilliantly. We need robust quality systems focusing on the fundamentals of risk management and strong knowledge management and documentation. That is key to understanding or reconstructing events, enhancing insight, and preventing issues from recurring in the future. At Astellas, we strategically look at our development programs and map the quality pathway to approval, anticipating risks and tailoring our approaches to address scenarios should they arise. The learning is then shared across our programs and built into the new quality strategic plans. Success comes from open dialogue and our collaborative approach ensuring individual programs don’t operate in silos. Instead, teams have visibility of what drives quality success throughout our organization.
Building on our commitment to expand “quality competencies,” however, we’re transitioning away from a typical compliance model, where individuals are trained to follow processes and procedures or focus on fixing what has already occurred. Our Astellas quality competencies emphasize analysis and the ability to influence and interpret data and draw conclusions to help accelerate the new ideas and innovation that will have the greatest impact for patients. Training and procedures remain crucial but as highlighted, new digital tools are increasingly supporting this aspect of our work, allowing our quality experts to focus their energy and skills on critical thinking.
We’re also working to build new quality capabilities through cross-training within our organization, helping to expand team expertise in new modalities or different areas of compliance, and by giving individuals broader opportunities, roles, and visibility in the workplace.
We should all be viewing quality differently, shifting perceptions of the quality function away from the “rule enforcers” and “the people who say no.” Quality is no longer on the sidelines, independent and auditing, pointing out problems and then removing itself from the solution.
Quality is key to the solution and should be considered a core enabler of accelerated innovation—achieved through greater collaboration and partnership across functions; earlier involvement in planning; the sharing of risk-management expertise; and independent perspectives to inspire trust in the work we’re doing.
Instilling confidence, with all stakeholders assured of patient safety and data integrity, really is the pinnacle, and that’s what we’re moving toward. With this, quality will be integral to delivering the life-changing therapies of the future.
David Fryrear, Executive Vice President and Head of Quality Assurance, Astellas Pharma Inc.