Co-facilitators
Two billion people still lack timely access to essential medicines.
In June 2025, Boehringer Ingelheim proved that this gap can be closed. Through Project PRISM, the company submitted and had a full global dossier reviewed by the FDA and EMA simultaneously in a single, trusted cloud space – no data copies, no email chains, no waiting for turn-taking. This included real-time review with multiple regulators, all within one end-to-end process flow.
Built on the open-source Trusted Regulatory Space delivered with DNAnexus, the live pilot reduced months of work to weeks and showed how any health authority – even those with limited IT – can plug in and participate in real time. Regulatory reliance has just become practical.
Join Vada Perkins – VP, Global Regulatory Intelligence & Policy Lead, PRISM Principal Investigator at Boehringer Ingelheim – and Omar Serang, Chief Cloud Officer, DNAnexus, for a fireside chat walking through the objectives of the project, the results and learnings from the POC, and a demo of some of the most critical steps, the architecture behind it, and the immediate actions sponsors and agencies can take to join the movement.
Aspired Learning Impact
This webinar will give you:
- A clear overview of Trusted Regulatory Spaces and the PRISM initiative
- First-hand lessons from BI’s 10-week “CRYPTx” pilot connecting multiple regulators live
When applying the learnings, you will be able to:
- Identify where cloud-based multi-agency review can potentially reduce cost and latency in your own submissions in the future
- Explain to stakeholders how a shared, secure ecosystem advances regulatory reliance – and accelerates patient access worldwide
Preparation
Find a quiet area to sit. Grab a pair of headphones. To avoid echo, make sure to check your audio and microphone is working before joining us.