The processes used by P&B companies may be quite different from that of other types of manufacturing and services industries, but that has not dented the applicability of “Lean” concepts – because “Lean” makes way for reduced costs and improved quality, which have universal applicability, especially in today’s highly competitive globalized world.
For better understanding, let us discuss some of the critical areas where “Lean” concepts and methodologies can be successfully implemented in pharmaceutical and biotechnology companies.
Drug Research and Development (R&D)
Research and development is the backbone of every successful P&B company, and since R&D costs form a major chunk of the overall costs of such companies, it makes sense to deploy Lean concepts in R&D. By using time-tested Lean concepts and statistically sound methods, P&B companies can easily achieve the desired objectives such as identifying processes that are critical to the drug discovery and development, assessing the applicability of new processes and streamlining existing processes.
It is necessary for P&B companies to achieve these objectives because it is only then that they will be able to make way for increased capacity utilization, increased productivity, reduced drug failures, and the best possible use of existing staff, facilities and resources.
Increased cycle times can easily hamper the successful launch of new drugs and other clinical products, technologies and applications, because in today’s highly competitive P&B industry, getting the advantage of being first makes all the difference between success and failure. If a P&B company is infested with increased cycle times, it will not be able to make the first moves and chances are also high that competitors will come in to take its place by offering something very similar.
This is why it is necessary to use Lean concepts and methodologies such as “value stream mapping”, and “process modeling” that not only help in reducing cycle times, but also help in reducing operational costs and improving operational efficiencies.
The defect or failure rate is probably the highest in P&B companies because drug discovery and development is still a gray science, wherein even small variations can have a huge impact on the final outcome. If standardized tools, techniques, processes are not used, it will become quite difficult for P&B companies to develop the desired drug or other clinical products.
“Lean” concepts such as DFSS (Design for Six Sigma) can help because they make use of time-tested scientific and statistical tools that automatically reduce the probability of human as well as process errors.
For better results, P&B companies should start with small “Lean” projects that can be implemented with minimum costs and resources. They should give the go ahead for organization wide “Lean” deployments only when the initial project starts to deliver the desired results. Better still, they should wait a little longer, preferably four to six months, before giving the final go ahead. This way they will be able to ensure the applicability of the selected “Lean” project.