David J. Balderson, vice president, Global Safety Operations at Sciformix - a Covance company - examines how automation is helping to reduce negative drug outcomes.
Automation
Pharmacovigilance (PV), the process of identifying, tracking, evaluating and preventing negative outcomes from drug therapies, is a sector that has seen huge growth in recent years. According to a Global Market Insights report, the PV market is predicted to exceed US$8 billion by 2024, with its growth attributed to factors such as: a rising number of adverse drug reactions (ADRs), an ageing global population and rising chronic disease burden; an increasing number of pharmaceutical companies and the emergence of personalised medicine. While PV starts during clinical development, it is not limited to clinical trials alone as post-market surveillance is crucial to monitoring a drug’s safety after it has been approved.
There are a range of challenges the pharmaceutical industry faces when establishing and maintaining increasingly complex PV systems. The evolving regulatory environment in a progressively global industry places demand on pharmaceutical companies to manage PV activities more efficiently than before. With the ongoing pressures of optimising costs, traditional PV strategies must be revised and revitalised with smarter spending in mind. The focus is now shifting from primarily safety operations to proactive risk management, personalised medicine, and completely transparent data between pharma, patients, healthcare providers and regulatory agencies.