Applying Lean in Pharmaceutical R&D Labs

Over the past few years, many of the leading Pharmaceutical companies have rolled out extensive programmes to the labs on their manufacturing sites.  The better programmes (i.e. those based on the key ‘Real Lean’ principles of levelling, flow and standard work and properly structured and supported) have achieved very impressive results. Pharmaceutical R&D labs however, are significantly different than the Product and Raw Material testing labs found in Pharmaceutical Manufacturing so can Real Lean work in R&D Labs?

Not all R&D Labs are the same

In R&D value streams there are significant differences in focus and activity between labs at different stages of the Pharmaceutical development process. Labs in the earlier part of the process (example Discovery) have significantly different work profiles than labs that are later in the process (such as development and analytical labs). However, the work profile in each lab will consist of a combination of (somewhat) routine activity & analysis and more creative & interpretative type tasks (e.g. report writing, interpretation of data and results, design of follow on experiments, project and portfolio management tasks, knowledge management tasks…etc.).  The ratio of the ‘routine’ to the ‘creative’ will vary from lab to lab and the significant ‘wastes’ can be different.  In some areas the real ‘value adding’ element is information, knowledge or a decision rather than test results.  This rightly has an impact on the application of lean in that area. 

In some labs along the R&D value stream there is variable work content and possible re-test / re-work loops at each stage. The work content of down-stream steps may only be clear after the preceding step is complete, adding to the inherent work load volatility. Consequently, short interval workloads for the lab and for individual personnel will be volatile. Work on individual projects and samples often ‘stops and starts’ with no real ‘Flow’ or ‘Standard Work’. Visibility on the progress of individual projects and samples can be difficult with constant re-prioritization and significant non value adding effort expended in tracking and managing projects. This reduces the time available for real ‘research work’ and personal development.

For more routine labs and work elements, a lean initiative should focus on analyzing workload volatility and developing strategies for leveling, flow, standard work, visual management and waste elimination. For less routine labs and work elements the focus should be more on improving the processes for:

• project planning & progression (i.e. plan in a way that allows you to be productive)
• knowledge management (allow for learning to be reused and applied across projects)