Skip to main content

Case Study

Organizing Cross-Industry Workshop with FDA


A leading pharmaceutical firm sought to develop a cross-industry working group to pre-competitively collaborate on the new checkpoint inhibitor class of drugs. This new class of drugs was seeing tremendous promise in clinical trials but on rare occasion caused serious or even fatal myocarditis (inflammation of the heart muscle). By building a working group, the team could combine clinical trial data and seek to identify why the myocarditis events were happening.

Satori Solution

We worked with senior safety and legal representatives from five leading pharmaceutical companies to develop a team charter and a list of core team working members. Over the course of several meetings it was agreed that an in-person workshop with academics and regulators from all over the world would help to identify the cause for the rare incidence of myocarditis. Our team developed the agenda and supported development of speaker presentations. We planned and  facilitated the event, and supported the  writing of the executive summary for sharing with medical journals.


We built a pre-competitive collaborative global team. We productively gathered the limited data available, applied the right expert analysis, and elicited guidance for researchers and medical professionals that would benefit patients taking this new class of medicine.


Want to Know More?

contact us

Learn More About the Challenges We’ve Solved

View More Resources