Pharma companies join to improve detection of side effects

A collection of some of the biggest global pharmaceutical companies have assembled to improve the detection of drug side effects.

The Drug Safety Research Unit (DSRU) established the international group which comprises pharma giants such as Pfizer, Roche, BMS, Takeda, Lilly, Gilead, Alexion and Celgene to explore improved ways of identifying adverse side effects from licensed medicines.

The independent research unit, called the International Working Group on Signal Detection and Management in Pharmacovigilance, convened an initial meeting of 40 international members from around the world to represent each pharmaceutical company, along with regulatory authorities and academic institutions.

The meeting, which took place in London, explored and discussed key topics, such as how big data and AI can aid signal detection in monitoring the safety of medicines in clinical use.

Peter De Veene, executive director, global drug safety at Alexion Pharmaceuticals, said: “Coming together as a multi-expert group provides the opportunity to find solutions to make the process of pharmacovigilance more efficient and to ensure that 21st century technology can be applied to the different types of new data sources that have emerged over the last few years.

“In the end, this will ultimately serve to better protect patients and ensure the detection of adverse events happens earlier in the process than ever before.”

The ultimate aim of the collaboration is to compile a report with recommendations for health professionals, pharmaceutical companies, regulators and Government to consider, which will update recommendations from a 2010 report on signal detection by the Council for International Organisations of Medical Sciences (CIOMS).

Professor Saad Shakir, director of DSRU and chair of the newly formed group, said: “The last major report and recommendations on signal detection were in 2010 and a lot has changed since then.

“Big data is becoming increasingly available, Artificial Intelligence and machine thinking are being included in broad areas of biomedical science and our knowledge of genetics and the relationship between genes and adverse reactions has also improved immensely in recent years.

We need to look at what the pros and cons are of incorporating these changes – and others – to the process of signal detection and management to ensure we make the best use of new information to better protect patients from the side effects of medicines.

For the public, this project is about identifying and monitoring adverse reactions more effectively by using new methods. Our aim is for safer, more effective medicines.”

Source: PharmaTimes