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