The pharmaceutical industry has made impressive strides forward over the past decade in optimising how it manages clinical development. One important result has been a significant decrease in the time required to gain regulatory approval for a new drug. In the past it was common for clinical development to require in excess of ten years whereas today, especially for innovative treatments for unmet needs, this can be as short as 3 to 5 years.
The impact of this time compression on technical development and manufacturing is significant. In the old days, process technologists and chemists had many years during which to develop the manufacturing and analytical processes. A good example is the time to optimize chemical processes for active pharmaceutical ingredient (api). Best practice in drug development today means that the launch formulation of the drug should be the same as that used in the pivotal trials (late phase II and phase III). In order to have the formulation ready for these trials, the process chemists need to have frozen the final synthetic route shortly after the first trials in man have commenced. This means they have months in which to work compared to the years they had in the past.
Transfer of technology between development and manufacturing is now a key success factor to achieve robust processes and minimize cost of goods. This demands standardization of equipment, processes and materials between development and manufacturing, but also much greater interaction and dialogue from the earliest days of new product development. In the past this involved having experts from manufacturing participate in development project teams, often attending meetings during which their input was minimal and for projects for which the success likelihood was low. In manufacturing parlance this process is not fit for purpose and a better way of sharing and managing knowledge is needed.
The Life Sciences industry has recently started implementing concepts such as “Design for Manufacture” (DFM) which have been in use for over thirty years in industries such as automotive and electronics. These concepts recognize that most of the cost of a product is locked in early during the design phase and with ever-decreasing life cycles, the opportunity to optimize production processes post-launch are minimal.
In life sciences we face subtly different challenges. Life cycles are not so short, but the pressures on technical operations to reduce cost of goods sold (CoGS) are immense and this, combined with the new approach by regulators, such as the FDA, to compliance mean that improvements in integration between technical development and manufacturing operations will bring significant benefits. These benefits are to be found not only in costs but also in faster product throughput times, robust processes and greater control over issues affecting regulatory compliance.
Knowledge management is key to making this work. Research and development functions need to have a better understanding of preferred standards in equipment and materials used by technical operations; on the other hand technical operations need adequate warning of new product technologies which might require new investments or the selection of strategic outsourcing partners. In the past the high attrition rates suffered by early phase compounds made it difficult to set priorities and allocate time for technical operations’ involvement in development projects. This cannot be allowed to continue because development times are reducing with the implication that the launch molecule and formulation need to be finalized relatively early.
We will be having two workshop sessions this Autumn to address and discuss the above issues:
InterAction Meeting Session, Philadelphia, USA, 12 October 2005
chaired by Jack Vinson (Knowledge Jolt)
InterAction Meeting Session, Basel, Switzerland, 9 November 2005
Workshop delivered by Jim McKiernan (CEO, McKiernan Associates) and Mike Dey (VP, Pharmaceutical Development, Ipsen)
During these sessions case studies from pharmaceutical companies where knowledge management issues in transfer from R&D to manufacturing have been successfully addressed will be presented. They will then facilitate an interactive workshop with the participants in order to identify key concerns and to identify the steps to be taken to achieve excellent knowledge management in technical development and manufacturing.
You can SignUp for these sessions through the InnovationWell website.
InnovationWell Community of Practice Manager