This was the subject of many discussions at the recent World Drug Safety Congress Americas 2019 in Philadelphia. As has been the case at many pharmacovigilance meetings in the last few years, artificial intelligence, outsourcing solutions and automation were hot topics, with debates over the future use of such strategies to achieve operational efficiency whilst strengthening patient safety.
Susan Welsh from CSL Behring set the scene in the opening session by noting that the 14.5% CAGR growth rate for outsourcing PV activities is expected to reach a market value of over $US8 billion dollars in 2024 – that is only 5 years away. So for vendors and service providers of either human or machine pharmacovigilance solutions, this is an opportunistic space to be in. However, the number of players in the field is also increasing, with a growing number of technology companies moving into the realms of pharmacovigilance. However, this trend for partnering with external vendors is not just because pharmaceutical companies don’t want to do the work themselves. One of the key drivers to seek outside help is the increasing expectation to capture and analyse real world data; that is, data that is vast and ever growing in volume and diversity.
Additional challenges faced by pharmacovigilance departments were outlined by Alexandre Kiazand from AstraZeneca. Not only did he echo some of the issues with using real world data, but he also highlighted that pharma is in effect in a productivity crisis. With a downward trend in the number of drugs being approved per $US 1 billion dollars spend, and the high cost of clinical trials, then the output from drug development and research efforts is not optimal. Added to the picture is that many existing pharmacovigilance tools e.g. causality assessments, are not applicable for some of the newer therapeutic modalities such as immune therapies and genomics. Therefore Kiazand emphasised that pharma must be take a proactive approach, and assess the potential solutions to help overcome these challenges. There are pros and cons for outsourcing, using technologies, and strengthening internal capabilities, so a combination of strategies may be required in order to reach the patient safety strategy of tomorrow.
As a service provider, one of the most interesting sessions I attended was a panel session on outsourcing versus innovation. Many different views were shared on this topic by both pharma and vendors, although many agreed that these were not necessarily mutually exclusive. In fact a potential strategy proposed was to work in partnership with the outsourcing partner to both drive the innovation. In fact some delegates noted that service providers who work with multiple pharma companies are in a position to share best practices due to their vast expertise, and make recommendations on efficiencies and cost-savings. The pharma delegates concurred that even with a successful partnership, there needs to be a governance process and vendor oversight.
It was great to hear about some initiatives that are already underway in the TransCelerate organisation, whose mission is to foster global collaboration. Their goals are to develop pragmatic solutions to overcome inefficiencies with a focus on harmonising processes and sharing information, improving the patient and site experience, and enhancing sponsor efficiencies and drug safety. Of particular relevance is a project to share expertise to more efficiently and effectively meet the intention of ambiguous regulations and guidelines. The topic of my presentation at the congress this year was “Harmonizing literature monitoring: how to approach the diversity in application and interpretation of literature monitoring guidelines”, so the TransCelerate project is very close to my heart.
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