Pharmaceutical companies are collaborating on a project to develop software that is expected to cut the costs of delivering drugs used in clinical trials by at least 10%.
Ten of the world's largest drugs manufacturers, including Johnson & Johnson, Pfizer and AstraZeneca, are taking part in the project, which aims to create a secure supply chain for medicines used in clinical trials.
The software allows pharmaceutical companies to buy drugs directly from each other, rather than relying on distributors, which may not have the right drugs available when they are needed for the trial.
Managing a cocktail of drugs
Pharmaceutical companies frequently test cocktails of drugs that include products from other companies. These trials typically last between three and five years.
But sourcing the right drugs from open market distributors and wholesalers has not always been straightforward, according to Terry Walsh, who is running the project at TransCelerate, a not-for profit company funded by the pharmaceuticals industry.
“The supply chain was not robust. It was not secure, in that you did not know where your next supply would come from. You would have to go to different wholesalers, different distributors,” he said.
The pharmaceutical suppliers undertook an 18-month pilot project, using spreadsheets and email to test the idea. The test went well, but it showed that the companies needed to have more sophisticated technology than Microsoft Outlook and Excel.
For example, people accidentally sent information to someone with a similar name in the wrong pharmaceutical company. “As volume started to come through, we went from one transaction a month to one every two days. We had to get a system that was more secure,” said Walsh.
Prescribing the right treatment
TransCelerate evaluated business process management technology (BPM) from Alfresco, Appian and Pegasystems. It chose Pegasystems when it became clear that the pharmaceutical companies were already using Pega's technology to process their commercial and clinical data.
The TransCelerate team hired Accenture to build the transaction system at its development centre in Boston in 2014. “We started with the manual process, automated it and put in extra controls,” said Walsh. “We were able to put it together very quickly in about four months, from whiteboarding it to rolling it out.”
Managing medicinal compounds
The system has provided the pharmaceutical companies involved with an automated and secure way of ensuring they get the drugs they need for clinical trials, Walsh told Computer Weekly.
The BPM system keeps a record of transactions so companies can go back and check the exact composition of a drug they were using in a particular test. The platform allows the pharmaceutical companies to share documentation about the drugs they are using. They can also alert other pharmaceutical companies when they need an urgent delivery of drugs.
Previously, drug companies would have to re-order drugs if, for example, a power cut meant they were stored at the wrong temperature. This would disrupt patients and delay the trial. “Now they can call up and say, The temperature was up 9°, is that a problem? We can say, No, it's fine,” he said.
A spoonful of sugar
The biggest project management challenge was trying to co-ordinate training for people in 20 different companies. “Everyone has a phobia of learning new systems, and it was a matter of trying to get it on everyone’s calendar,” he said.
Although the aim of the new system is to allow pharmaceutical companies to place orders securely, the technology is also saving the companies money, Walsh revealed. “There are definitely savings. It's 10%, or maybe 12%. When you have an R&D budget of $8bn, you are saving hundreds of thousands,” he said.
TransCelerate is looking at ways to develop the transaction engine, so that it will automatically feed critical information, such as the name of the drug and the dates they are required, into each pharmaceutical company’s IT systems.
This would make it possible, for example, for a company to order a drum of 5,000 tablets, rather than ordering multiple bottles of 30 tablets, which would then have to be manually emptied.
Walsh is also working on plans to develop electronic labels for medicines. Currently, pharmaceutical companies are required to attach a paper booklet to each bottle, giving instructions in the language of each country where the drug will be used.
With trials spanning as many as 20 countries, the booklets can quickly become unwieldy. “We had cases where we had instructions in Korean that were wrong. We had to re-do all the booklets. It was ridiculously expensive,” said Walsh.
Walsh is looking a proposals to replace the booklets with a 3D barcode that, when scanned, will take the patient to online instructions in their own language.
The pharmaceutical companies are working with regulators to secure approval for the idea, which would also allow them to change the instructions mid-way through a trial, for example. But there are still hurdles to overcome.
“If my two-year-old eats a tablet by mistake, and I drop my phone into the toilet, do we have an emergency number people can ring? We can see the regulators getting a little leery,” said Walsh.
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