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Reducing the Time To Market From Fast to Ultrafast Track – Why Big Pharma Kicks Into Overdrive

| Author / Editor: Gert Moelgaard / Anke Geipel-Kern

For many years the challenge of bringing down time to market has been a main driver within pharmaceutical manufacturing — The results have been mixed and there is no clear winning concept yet. Within product development, there are methods available to significantly shorten the time from a pivotal phase 2 clinical study to a full-scale commercial manufacturing. For pharmaceutical production, the need on new production technologies for fast track implementation and commissioning as time to market driver is getting more and more important.

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Time to market is a key issue for all manufacturing companies. In the pharmaceutical industry, it is complicated by the fact that uncertainty from clinical trails has become so significantly that most companies wait until the result of a pivotal phase II clinical trial or even a phase III result before they commit the necessary investment for the capacity of producing a new drug.

For years, the time to market driver has been how much planning can be done without committing to investment projects by purchase order and execution - and still hit the market as soon as the marketing authorisation of a new drug is received.

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Some engineering and equipment companies have specialised in this fast track niche and there has been a number of technologies and methods to deliver really fast facility projects based on parallel execution and/or modular facility solutions with several success stories.

However, we are approaching a new pharma reality where products may be approved significantly faster than so far. New regulatory programs support fast track product approvals and looking across some of the most significant drug approvals within the last couple of years, some of them are coming scaringly fast - from an engineering and supply chain perspective …!

Besides, drugs approvals often follow a new strategy of showing “proof of concept” on a small disease indication and then increase by additional clinical studies of more indications. Some of the next generation of monoclonal antibodies and immunotherapies are following this strategy and for some of them it has led to approval for new indications within very few weeks. This puts a significant challenge on manufacturing ca­pacity — and even more on the flexibility.

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