​​​Why CGT Success Depends On Redefining Pharmacovigilance For Long-term Risk

Cell and gene therapies can deliver durable or one-time benefits, but their safety risks do not follow the predictable timelines of conventional drugs. Adverse events may emerge months or years post-treatment, making traditional signal detection methods insufficient and leaving gaps in risk management that regulators are increasingly scrutinizing. Regulatory bodies now evaluate CGT benefit-risk profiles across the full product lifecycle, which shifts the burden onto pharmacovigilance teams to anticipate, monitor, and report risks over extended timeframes, often with limited precedent or comparative data.

This requires structural changes to how PV functions are designed, staffed, and integrated into broader development and post-market strategies. Teams that continue applying standard drug safety frameworks to CGTs risk both patient safety gaps and regulatory friction. Understanding where conventional PV falls short and what a fit-for-purpose approach looks like is essential for any organization bringing these therapies to market. Read the full article to see what that shift requires in practice.