Case Study: Agios Pharmaceuticals achieves streamlined tracking of health‑authority interactions and faster regulatory decisions with Veeva Systems' Vault RIM

Agios Pharmaceuticals Actively Manages Health Authority Interactions with Veeva Vault RIM

Agios Pharmaceuticals, a Cambridge, MA–based biotech focused on oncology and rare genetic diseases with 500+ employees, realized that while Veeva Vault Submissions delivered better document tracking and reporting, their regulatory information management (RIM) processes—especially health authority interactions—remained fragmented. Communications were uploaded or tracked inconsistently across Vault, Excel, and SharePoint, leaving product owners with different processes and the team spending excessive time compiling accurate, portfolio-wide information.

Working with Veeva’s value consulting team, Agios completed a RIM maturity assessment, defined required metadata, and implemented additional Vault Submissions features in May 2019. Vault is now the system of record for commitments, queries, and correspondence: workflows and audit trails capture each notification, they track more than 700 health authority questions, and flash reports notify commitment owners for items like DSURs, PMRs, PADERs, and IB annual reviews—improving consistency, visibility, compliance, and decision-making.

Agios Pharmaceuticals

Jamie Scialdone

Director of Regulatory Operations