Can Drug Development be AGILE? – Part II

drug development

Agile Methodology is not new – except in the realm of clinical drug development.  As you will see, there are ways to use this old IT technique to enhance your drug development team’s chances of hitting their goals.

Agile methods were developed to overcome weaknesses in a conventional engineering process.  Agile development can provide important benefits. But most think that it is not applicable to all projects, products, people, and situations. In our experience, it can have a huge impact on clinical management team task completion and deliverables.

At its core, Agile Methodology promotes full team inclusion. It stresses the importance of individuals and interactions over processes and tools. It stresses customer collaboration over contract negotiation.   Also, it promotes responding to change over following a plan.

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How Agile Methodology Helps

It is often impossible to predict how a clinical management project will evolve as time passes. Market conditions change rapidly.  Clinical teams need to evolve as new competitive threats emerge without warning. In many situations, you can’t expect teams to define all the requirements fully before the project begins.  But your team must be able to respond as the development issues change.  Teams must remain fluid!

To maintain fluidity, the team must be responsive to change. Most process management models can deal with common problems but fail miserably with complex issues.

Responsive

Agile management is much more than an effective response to change.  It encompasses the philosophy espoused in the Agile manifesto. Agile encourages team structures and attitudes that make communication more facile.  It emphasizes rapid delivery of operational tasks and deemphasizes the importance of intermediate work.

Inclusive

Agile methods adopt the customer as a part of the development team.  It works to remove the “us and them” attitude that continues among many clinical projects and teams. Agile recognizes that planning in an uncertain world has its limits and realizes that a project plan must be flexible.

An Agile team is one that possesses rapid and adaptive responses to change. These teams are effective communicators to all stakeholders.  The result is drawing the customer into the process, thereby organizing the team so that it is in control of the work performed. Early, incremental but accurate data and results aid in team development decisions.  This can save the company much time and millions of dollars. It also puts in place an adaptable clinical management process to use in the future.

Additional Tools

Experienced PMs are always looking for the ‘Holy Grail’ tool to make our teams function more efficiently. Time is money.  And making early decisions with timely, quality data can save lots of money for the company or sponsor.

One of the new tools that embraces the Agile manifesto is Trello.  It is a tool designed when the Deming philosophy of quality work management was in vogue. Trello uses the Kanban paradigm for managing projects. This was popularized by the Japanese and Toyota in the 1980s for supply chain management.

Kanban is a method for managing knowledge work which balances demands for work with the available capacity for new work. Work items are visualized to give team members a view of progress and process, from task definition to customer delivery. Team members “pull” work as capacity permits, rather than work being “pushed” into the process when requested.

How Trello Works

In Trello, interactive boards represent projects (sort of like a whiteboard) which contain lists (corresponding to task lists). Lists contain cards (corresponding to tasks). Cards progress from one list to the next (via drag-and-drop).  For instance, mirroring the flow of a feature from idea to implementation. Users are assigned to cards. And you can group both users and boards into organizations. Everyone on your team has access to interactions and tasks at hand and work due with dates and responsibilities.

This management system is not meant to replace the full-blown, all-encompassing Microsoft Project Plan.  But it can give your team an upper hand in managing difficult parts of a plan or project to help prevent delays in the big picture. It brings your team out of the traditional silos in a collaborative way and helps them share the success together.

This will provide the transparency required for any team, or for any level of management.  It enables a tremendous amount of efficiency with less complexity. It allows each member to look at and complete any task assigned to them without having to wait for a reminder of the task or deadline.

By utilizing tools such as Trello along with an Agile approach to clinical project management, you can gain the advantage over your competitors in the clinical development arena.  Given what’s at stake, even a small edge can mean a lot a few years down the road.

References
Augustine, S. (2005). Managing agile projects. Upper Saddle River, NJ: Prentice Hall PTR.
Boehm, B., & Turner, R. (2004). Balancing agility and discipline: A guide for the perplexed. Boston, MA: Addison-Wesley.
Chin, G. (2004). Agile project management: How to succeed in the face of changing project requirements. New York, NY: Amacom.
Highsmith, J. (2004). Agile project management: Creating innovative products. Boston, MA: Addison-Wesley.

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