Electronic Health Reporter

By Dimitar Karaivanov, CEO and co-founder, Kanbanize.

As many know, the pharmaceutical industry is heavily regulated and specialized, with slow drug-development timelines, strict processes and quality requirements, and rigid silos. Without a direct relationship with patients, the industry also struggles to understand customer desires and expectations beyond what clinical data reveals. These constraints might sound utterly incompatible with Agile methods, frameworks and principles, however, Agile in pharma is on the rise.

In short, agility means quickly adapting to changes in the market. This includes external demands such as new regulations that impact drug development, or internal shifts such as new leadership or changes in processes.  In the context of a business, an Agile organization is one that has a strong foundation of established core practices and capabilities, with a high degree of flexibility and ability to make timely course adjustments to address change.

In response to seismic shifts in the industry and digital technological advancements, many pharmaceutical companies are reassessing traditional operating models as the need to drive efficiencies, bring new innovation to market and fuel strategic growth initiatives is paramount. Pharmaceutical companies are responding to this shift and using it as an opportunity to establish cost-competitive, outcomes-focused operating models, centered around Agile principles, to drive profitable growth and competitiveness.

There are several frameworks for “going agile,” but one method in particular that has increased in popularity in the pharmaceutical industry is Kanban. As companies embark on their Agile journeys, one of the main principles that makes Kanban appealing is that it can be layered onto pre-existing processes and operations and does not require companies to reinvent what they are already doing.

Moreover, the focus is on incremental, evolutionary change to foster long-term flexibility and continuous improvements. For an industry that has been historically reluctant to change, Kanban is the perfect method for pharmaceutical companies to become agile and adopt a flexible architecture that allows it to scale across the enterprise in a natural and human-centric way.

Benefits of Agile Adoption

The biggest advantage that the Agile philosophy provides to pharmaceutical companies is the flexibility in delivering value in multiple contexts. This industry involves a lot of communication, daily R&D work, and an innovation-oriented mindset. To accelerate innovation, shorten time-to-market and increase operational efficiency, pharmaceutical companies are adopting Agile practices, leading to significant changes in the way they operate.

Reshaped R&D Departments

Disrupting the traditional waterfall-oriented operation model that is hierarchical and organized by siloed teams that are separated by specific areas of expertise, Agile organizations have smaller, integrated teams that include relevant subject experts and different levels of hierarchy.

Creating a team that is “fit for purpose” starts with strategically identifying who must be on the team and defining clear responsibilities and goals. With an Agile method like Kanban, organizations break the rigid silos and form cross-functional working groups to increase organizational agility, transparency and employee engagement.

Further on, the smaller groups are more flexible, so they can iterate faster and accelerate overall operational efficiency.

Faster Decision-Making

Doing away with unneeded hierarchy, and being informed about where projects stand using a visual workflow representation like a Kanban board, teams are empowered to make decisions within their defined scope, helping to remove bottlenecks, avoid miscommunication and improve flow of work.

To accelerate their development times, some pharmaceutical companies introduce daily progress discussions. Others transfer a big part of the decision making to the team meetings, to shorten approval chains and eliminate progress blockers.

As a proof point, by combining these approaches and extending Agile workflow to more than a dozen different departments, in one year, a pharmaceutical company was able to double its R&D capacity without adding new resources.

Increased Collaboration

Moving away from blindly relying on clinical data, companies are gathering new insights and launching continuous improvement initiatives for their products to meet the needs of all stakeholders. In the pharmaceutical industry, Agile encourages a shift toward decentralized innovation across organizational borders, involving a high level of collaboration between external parties and the in-house R&D department in an agile organization. New R&D models, like “Virtualized R&D,” are also on the rise. With virtualized R&D, pharmaceutical companies can access specific expertise while also minimizing the buildup of infrastructure through collaboration with external partners.

Achieving Agile Transformation

Implementing Agile practices in pharmaceutical companies comes with some challenges. Being a research-intensive industry, a lot of the staff tends to be highly specialized and used to sequential and rigid ways of working. Also, the overall company culture leans towards a focus on stability, pre-defined work and strong process orientation.

When introducing Agile methodologies, there are automated software tools that help companies create a stable workflow, enhance communication and visualize different workflows for initial implementation and for long-term success.

In Agile, a widespread method and tool for work visualization is Kanban. Kanban is focused on continuous, small incremental and evolutionary changes to the current process, without disrupting what is already successfully being done. The teams visualize their project workflow and work items on Kanban boards to ensure a high level of transparency and alignment.

By segmenting the boards to match their specific workflow, teams also unhide bottlenecks and easily discover weak spots in the work process. Optimizing those allows them to increase their efficiency and operational capacity.