Mark Perry, MES business manager from Siemens Automation and Drives, explains how embracing manufacturing execution systems can have a real impact on the time taken getting a drug to market
Probably one of the biggest drivers for any pharmaceutical manufacturer has to be reducing the time it takes to get a potential product through the r&d phases and out to market. With the r&d costs needed to bring a new drug to release estimated to be around US$1m (b770,000) a day, rapid recouping of the massive investment undertaken by drug companies becomes important.
There are plenty of examples across many industries of companies being late to market with a product, only to find that competitor products have subsequently appeared with a resulting substantial hit in potential operating profits. Once a company is in the process of research, product development, testing and manufacture, it needs to shorten associated timescales for each area, while still adhering to all legal and regulatory controls, so that its new product has the best chance to succeed on the open market.
There are a number of key areas in which some enlightened thinking can have a powerful impact on the time it will take to launch a potential new product. A move towards the benefits offered by an MES electronic approach in some areas of research, testing and production can proactively affect r&d time input, improve information flow, increase knowledge and, ultimately, boost speed to market.
A good example of how an MES electronic solution can bring real and tangible benefit comes in the required area of paper-based sign-off procedures through the product r&d development process.
electronic sign-off
For some new drug development scenarios to reach fruition, many thousands of signatures can be required to satisfy all legal and regulatory approval processes before any launch to market. In a global industry, this will, inevitably, involve many participants often spread among research, testing and production sites across the world.
It is clear that it only needs an integral element of the human sign off process to be ill, away or on holiday for the paper- based signature system to grind to a halt. Such delays will prove costly at the end of the development and production process when you want your product in the marketplace making sales.
Instigating an MES system, such as Siemen’s Simatic IT, will remove the need to rely on associated paper-based systems and, instead, provide a single electronically driven signature recording process. Effectively, this means any number of people can concurrently review, test and sign off constituent parts of the development process without having to wait for someone else to complete their part. Crucially, the project leader has a clear overview of the ‘live’ sign-off and testing status at any one point and can make important strategic decisions based on the information easily to hand.
An electronic system also acts intuitively. For example, if integral sign-offs are missing from the overall process, they are flagged up as part of the holistic project plan. On some occasions, paper-based signature systems have seen a product developed and be ready for clinical trial stage only for a missing signature to be discovered; costly delays then ensue while the entire process is retraced.
Electronic systems, in the area of electronic batch records (EBR), remove the potential for human error and instead allow instant, continuous and concurrent product r&d sign-off processes to take place. It is a simple and easy remedy to what can be a long-winded, but necessary, part of bringing a new product to market.
Industry estimates predict that almost six months can potentially be taken out of r&d time scales through an electronic approach to the sign-off process. These six months at an r&d cost of $1m per day equate to something like $180m and can have a real impact on the bottom line and the financial viability of a new product.
MES can assist in other important time-to-market areas as well, such as forward planning. A pharmaceutical company will usually have no real idea of when it will be ready to initiate clinical trials of a potential new drug or product. Gathering the number of people required for such statutory required trials can take a number of months and with no forewarning about product availability delays are inevitable in getting the clinical trials established and underway.
accurate forecasting
The benefit of an MES approach is that the system will electronically map such timings and thus a more accurate forecast can be made of when the developed product will be ready for the clinical trial phase. This in turn allows the departments responsible for delivering the trials to be working alongside the r&d stage and not after it. This is a crucial element when it comes to assessing readiness for market and speeding up the delivery process.
MES products, such as Unilab, complement the benefits delivered by embracing an electronic approach.
Traditionally, the integrity of laboratory new product testing data may be open to question. With many results recorded on paper and with potential for human time delays in the testing process the testing information can be compromised, especially in a time- sensitive scenario.
robust data
The data gathered in the testing environment and recorded via systems such as Unilab is time-stamped and fully underpins the robustness of the information gathered. It takes out any manual intervention and automates the essential processes taking place in the lab. This not only speeds matters up, but also provides a wholly accurate and strong audit trail whenever such information is required.
With such MES solutions automating the lab testing process, other components can automate the product development and manufacturing process. They can bring together the many differing aspects of a product’s existence ranging from the raw materials that make up the product compounds, to the packaging and labelling. It allows concurrent specification management from across the globe that can ultimately reduce r&d and manufacturing time and drastically increase the financial benefits brought by earlier release to market.
minimise waste
Other areas after release to market, such as waste control, can also be more easily managed through embracing an MES approach. Exact control can be provided over production in terms of manufacturing processes and distribution control. Any faults on the production line can be quickly identified and remedial action taken, thereby minimising potential waste.
Embracing the advantages offered by MES is really a state of mind and requires a fresh-thinking approach compared with traditional ways of operating. MES provides real time information, allied to significant r&d timescale reductions and reduces the possibility of human error. Users can work alongside each other with greater flexibility and in the certain knowledge that data integrity is sound and can be easily traced.