Playing It Safe

At BMS, I oversee three areas of focus relating to pharmacovigilance. First, medical safety, concerning the safety and risk/benefit of all compounds going through the research and development process and all marketed medicines; second, the increasingly emphasized pharmacoepidemiology function; and third, the management of medical affairs for Bristol-Myers Squibb’s mature products.

Drug safety is of paramount importance in the pharmaceutical industry and it’s very clear that today, pharmacovigilance has become a CEO-level agenda item for most major companies. In terms of where companies focus their efforts, pharmacovigilance is clearly a sensitive lever for businesses – it can make a vast difference to both drugs undergoing research and to marketed medicines.

I believe that Bristol-Myers Squibb is setting new industry standards in the areas of pharmacovigilance. We’ve recently completed a comprehensive transformation of our pharmacovigilance organization, including the structure, processes and operating model. This reflects the re-emphasis of the importance of patient safety and an evolution to increasingly productive, innovative and impactful pharmacovigilance – what some have described as ‘next generation pharmacovigilance’*.

Quantum leap

The increasing focus on drug safety across the industry relates to a variety of factors. The environment has changed around us but in addition, for example, we also now have capabilities and innovations that were not there just a few years ago. The combination of innovation and a receptive environment presents us with an opportunity to make a quantum leap – to understand medicines in a more thoughtful way, to set new standards for transparency and communication of that new understanding, and ultimately to offer a better quality set of options for patients. When I consider what the industry has an opportunity to do with drug safety in the next five to 10 years, I find it very exciting.

The majority of pharma and biotech companies will encounter a very similar set of challenges in the next few years – including the need to truly optimize the way they address benefit:risk for their products, and pharmacovigilance is central to that. Looking at the future, there is no question in my mind that pharmacovigilance will continue to transform in the next five to 10 years.

When you look at the parties that are involved – patients, prescribers, biopharmaceutical companies, health authorities, payers – all of them have a strong interest in drug safety. There will be new opportunities to harness science, examine new data and develop new collaborations. This includes, for example, examining data that we previously haven’t been able to bring together and operating via collaborations such as industry-government, industry-academia and cross-industry. New partners will have an opportunity to work together – including academic institutes, governmental entities such as Reagan-Udall, and new technology providers. My feeling is that these new collaborations will present us with new opportunities in the next few years – all with the goal of bringing new insights that benefit patients.

Amrit Ray is Vice President for Pharmacovigilance – Medical Safety Assessment atBristol-Myers Squibb, in Princeton, NJ. He is responsible for global medical safety, epidemiology and risk management for BMS’s R&D portfolio and marketed medicines.

* “The Next Generation Pharmacovigilance”, Balian JD, American Pharmaceutical Outsurcing – May 2008