Celgene and IBM are teaming up on a new patient safety monitoring platform to improve pharmacovigilance methods throughout the drug development process.
The platform, dubbed IBM Watson for Patient Safety, will combine Watson’s cognitive computing chops with Celgene’s extensive experience in drug safety and risk management. It will be an outcome- and evidence-based drug safety decision support system for life sciences companies, the duo said in a statement.
It will run on the Watson Health Cloud. The highly automated, modular, end-to-end drug safety platform will allow for the rapid collection, collation and automated analysis of vast amounts of data from a variety of sources, the companies said in a statement. It will help biopharmaceutical companies better manage and interpret large volumes of data relating to potential side effects associated with drug products, they said.
“For a long time, very big decisions around the use and disposition of drugs have been taken based on small datasets,” said John Freeman, corporate vice president of global drug safety and risk management at Celgene. “This is an opportunity to not only streamline the way that information is handled within pharma companies and regulators, but also to enable much greater clarity of insight born of an ability to access large datasets.”
IBM Watson for Patient Safety will use cognitive computing to understand structured and unstructured language and therefore use a lot of different sources to help in making decisions, said Lauren O’Donnell, vice president of life sciences at IBM Watson Health. These include anonymized electronic medical records and medical claims databases. In addition to analyzing and identifying trends in large datasets, IBM Watson also learns. And the case numbers are only continuing to grow: Between 2008 and 2011 alone, there was a 90% increase in serious adverse events recorded, she said.
While the obvious applications are for decision-making in the early stages of drug development, leading to greater efficiencies while developing products, there are also advantages post-commercialization, Freeman said. The platform can help patients who are at greater risk of side effects manage their condition better and reduce the likelihood of those side effects.
“Celgene established one of the first risk management systems and its commitment to pharmacovigilance continues with this partnership,” O’Donnell said in the statement. “Together we look forward to creating a cognitive solution that can be applied across the industry to help benefit patients everywhere.”
Celgene’s deep experience in risk management includes its reintroduction of thalidomide to the market in 1998, following difficulties in the 1950s and 1960s. Its program ensured that the “problems that were well-known for thalidomide were not allowed to occur in the modern era,” Freeman said.