Standardisation is the key to developing future solutions

The pharmaceutical industry is a very different animal compared with other industries, particularly when it comes to laboratory testing. In the case of chemical manufacturing, for example, each batch of product undergoes quality control testing and a record of these results has to be kept for a short time.

However, test data in a pharmaceutical laboratory must be kept virtually forever, from the moment when a scientist first looks at a compound and continuing for years afterwards.

“It might be 14 years and US$1b later before the same scientist sees the results of his or her efforts on the market as a commercially available drug. Along the way, a vast amount of testing data will have been generated, analysed and stored ­ because that's what the regulator requires. And the US Food and Drug Administration (FDA) is a very strong regulatory body,“ notes Jo Webber, who has over 15 years of experience with the development, implementation and marketing of enterprise software solutions to companies operating in FDA regulated environments and has worked with most of the worlds leading pharmaceutical companies.

Just at the moment, the FDA itself is coming under a lot of scrutiny, particularly with regard to Cox-2 inhibitors.

Last November, Merck announced a voluntary withdrawal of Vioxx from the market due to safety concerns of an increased risk of cardiovascular events including heart attack and stroke among its users. The FDA approved Vioxx in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Later Vioxx was also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

Then in April this year, the FDA asked Pfizer to voluntarily remove Bextra from the market. At the same time, it also asked manufacturers of all marketed prescription non-steroidal anti-inflammatory drugs (NSAIDs), including the Cox-2 selective NSAID Celebrex, to revise the labelling on their products. This must now include a boxed warning, highlighting the potential for increased risk of cardiovascular events and the well-described, serious, potential life-threatening gastrointestinal bleeding associated with their use.

“The whole issue of Vioxx and Bextra has left the public wondering just how safe Cox-2 inhibitors really are,“ said Webber. “The public have a very high expectation of drugs and don't expect to suffer from side effects. The challenge for pharmaceutical companies will come if the FDA decides to increase the amount of testing needed for new drugs. This will inevitably increase the length of time and the cost of getting a new drug to market. But you will still only have a relatively short time in patent before the generics come in.“

In effect, the capital investment will get larger, but the length of time in which to make returns will stay the same or be reduced.

Dave Champagne concurs: “The economics are already under great stress, before meeting any extra FDA testing requirements.“

Reducing variation, reducing cost

So what does this mean for Thermo Electron, a company that has spent nearly five decades developing analytical instruments, scientific equipment, software and services for the life sciences, drug discovery and many other industries?

“It's all about standardisation,“ explains Champagne. “By definition, variation has cost and regulatory implications. For one thing it makes it harder for companies to stay in compliance. Our LIMS, for example, are a catalyst to enable them to move to standardised practices. Our strategy is to develop complete solutions using commercial off-the-shelf (COTS) software, but at the moment industry standards are a bit of a free for all. Absent them, customers are tending to use implementations to herd all the scientists in one direction. There's always tension between the users in the lab and corporate IT: sometimes as vendors we are the grease between that friction.“

In terms of software, he believes that the changes being seen in the pharmaceutical industry are mirroring those seen in other industries 5­10 years ago. But there are important differences: “In other industries if you decide an ERP solution is needed you can go straight to SAP and it's embedded in business processes. We're nowhere near that rigid ­ there's too much diversity in the types of pharmaceutical testing being done. In drug development there are a lot of specialities.“

For Thermo, this has meant a drive to provide professional and technical services that has involved a number of acquisitions and geographic expansion planned for this year in Europe. One, a multi-vendor compliance group, is dedicated to developing operating procedures for instrumentation and software supplied by both Thermo and its competitors.

Another such business is involved with asset management. Champagne explains: “In a turnkey way, they do all the preventative maintenance and repairs on laboratory instrumentation. This brings compelling cost benefits. We have a unique database that tracks mean times between failures, so we can get tight pricing on our bids to maintain equipment. What we are dealing with here is a lot of healthcare companies with a lot of laboratory equipment, but who no longer see such maintenance issues as a core competence.“

Webber points to a similar situation in terms of IT: “Ten years ago many companies had large IT departments. They've moved almost totally away from that now as they don't have the time to make all the different technologies they use work together. They want us to provide COTS, out-of-box, plug-and-play software that integrates their labs. So we're developing drivers that will integrate much more equipment. Making it all easier to use is a big focus for us.“

Champagne agrees: “Over the last ten years we have moved more and more towards open standards with the result that there is much more connectivity and seamless joining of workflows now.“

While the benefits of such connectivity seem clear, vendors in the past have suffered from a lack of agreed standards. Step forward the FDA again, with its promotion of the analytical information mark up language (AnIML). This XML-based mark up language describes analytical chemistry results data to simplify data interchange and data archiving.

“In past, vendors have talked about standards, but with the FDA promoting this particular one, companies will be obliged to adopt it,“ notes Webber.

Also on the horizon is CDISC, an XML-based standard for handling clinical data.

A brave new frontier

In terms of the future, Webber believes that the mapping of the human genome will be responsible for all sorts of advances: “We're getting to the stage where we can look at someone's DNA and infer from it when they will have heart attack. We can already scan a one-day old embryo for 200 genetic traits. It's a brave new frontier with lots of possibilities, but also responsibilities.“

Champagne points to the opportunities for more individualised treatments. “Genentech's breast cancer drug Herceptin is a very efficient treatment for a small number of people. If you can isolate such groups and test them more thoroughly, you can create more tailored, individual treatments.“

One area in which everyone is focused, especially in light of the FDA and the Cox-2 incidents, is pharmacovigilance.

The FDA itself issued guidance on the subject in April. It describes a method for summarising the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk populations and situations where the product is likely to be used that have not been studied pre-approval. It proposes a structure for a pharmacovigilance plan and sets out principles of good practice for the design and conduct of observational studies

“We're already starting to see companies springing up to do this type of work. Of course for Thermo, as a supplier of equipment and services to the life sciences industry, any such increase in testing is good news. But the key point here really is that pharmacovigilance will require even more closely linked data gathered from all aspects of drug development,“ said Webber.

For more information about software in the laboratory, Thermo offers a series of free webinars running throughout 2005. For details contact

See p24 for an article by Mark Fish and Dave Minicuci from Thermo's Informatics business about overcoming the challenges of migrating LIMS.

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