We recently surveyed drug safety experts about the challenges facing the industry. Paul Beninger, VP global patient safety and risk management, Genzyme discusses the issues below:
What is the biggest change that you are seeing in pharma's drug safety strategies at the moment?
Without a doubt, outsourcing is the biggest change in safety strategies. Outsourcing can potentially involve almost every aspect of safety: ICSR management, aggregate review, signal detection, and risk management. The challenge is in making it happen seamlessly. Ironically, it is resource intensive, at least initially, in order to assure that the hand-off doesn't lead to dropped or lost cases, inconsistencies in reviews, missed signals, or inadequate risk management planning.
What are the key challenges that pharma faces in effective benefit/risk communication?
An important challenge is having people with the proper skill set. Communicating science and medicine to a larger audience does not follow the scientific method and does not lend itself to dispassionate, hypothetical discourse. The CDC learned this decades ago; they taught their corpse of epidemiologists to use the SOCO methodology: Single Overriding Communication Objective. We would do well to emulate this approach.
Paul will be looking at How to excel in the current global drug safety environment at the World Drug Safety Congress Americas 2012. Visit our website for more information.