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European Biopharmaceutical Review

Against the Clock

Dale McQueen at Lanner Group looks at how simulation can provide scientific manufacturing forecasts and predictions, reducing the time needed to bring new products to market

Reducing the time and associated costs of taking a new drug to market is the holy grail of the biopharmaceutical industry. Once a patent has been granted, the profit clock starts ticking. In todayís highly competitive biopharmaceutical business climate, speed-to-market is crucial.

A Harvard Business School study of 23 pharmaceutical companies concluded that, due to limited patent-life, each month of delayed market penetration could result in permanently lost revenues of up to US$45 million. This highlights that speed to market is vital if biopharmaceutical companies are to reap the maximum benefit from any patent. Furthermore, newfound challenges brought about by increased competition, challenging targets, higher customer expectations and shareholder influence has put added pressure on the shoulders of biopharmaceutical manufacturers.

Whereas traditionally manufacturing capacity and capability forecasts and questions could be answered by a system of spreadsheets, the biopharmaceutical companies of today need to be more scientific in their approach. To thoroughly factor in all variables in order to calculate the exact manufacturing timescales involved in bringing a new drug to market, more indepth information is required. Simply inserting this information into a variety of interlinked spreadsheets is no longer enough. The real question is how to make best use of this information.

Adopting the plethora of solutions which promise to reduce time and cost can be an overhead in itself. So, how can biopharmaceutical companies accurately map out the manufacturing lifecycle of bringing a drug to market, identifying key areas for time and cost savings, as well as creating a bespoke solution at the level of granularity required to maximise manufacturing efficiency? Ultimately, the main question is, how can biopharmaceutical companies ensure that they add science to the decision-making process?

RIGHT INFORMATION, NO COMMUNICATION

In order for biopharmaceutical companies to make informed changes to their manufacturing processes, information is key. It is vital that biopharmaceutical companies know what they are currently dealing with before making any radical changes. Prior to spending any capital or implementing new processes and procedures, biopharmaceutical companies need to be certain of the outcome of proposed productivity improvements. This can only be achieved through the use of dynamic simulation.

The static planning methods used by the majority of biopharmaceutical manufacturers today are not sufficent to deal with unplanned stoppages. Spreadsheets and experience alone are not enough to sufficiently inform manufacturing change, and are definitely not enough to add value and certainty to strategic business decisions.


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Dale McQueen is Lanner Groupís Practice Leader for the pharmaceutical sector. He has been bringing IT solutions to industry for 23 years, with many of those years spent within the pharmaceutical sector. An Engineer by training and education, with a BSc Hons from Heriot Watt University in Edinburgh, he targets areas for efficiency gains and delivering technology solutions to achieve real financial benefit. He is a Chartered Member of the Institute of Mechanical Engineers and the International Society of Pharmaceutical Engineers.
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