MRCT Center 2026 Annual Symposium - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Meeting

JOIN US! MRCT Center 2026 Annual Symposium

The MRCT Center Annual Symposium returns to Boston for a full day of discussions on ethical, actionable, and practical solutions to today’s global clinical research challenges. Free and open to all, in person or online.

Keynote: Karim Mikhail, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration

We are pleased to welcome Karim Mikhail as this year’s keynote speaker. Director Mikhail will give an update on Operation TrialBlazer, the HHS roadmap for maintaining U.S. leadership in early clinical research and development, and the initiatives planned under it. He brings more than two decades of leadership across industry and FDA.

Panel 1 | Response to Keynote: Ideation to Implementation and Scale

Leaders from industry and academic medicine respond to the keynote and discuss how Operation TrialBlazer’s planned initiatives can move from roadmap to practice.

Panelists: Ginny Beakes-Read, Johnson & Johnson; Karen Hartman, Mayo Clinic; Jennifer Sheller, Merck

Moderators: Barbara Bierer, MRCT Center; Mark Barnes, Ropes & Gray and MRCT Center

Panel 2 | Returning Summary Results to Participants: Lessons from the EU and UK Experience: Optimizing for US Application

NIH has released a draft policy on sharing summary-level study results with participants, with comments due October 26. Participant, researcher, and regulator voices from the EU and UK join NIH to discuss what they learned returning aggregate results, what they would do differently, and what they recommend for those just getting started.

Panelists: Adam Berger, U.S. National Institutes of Health; Johanna Blom, University of Modena, Italy; Clive Collett, Health Research Authority, UK; Veronica Popa, EURORDIS

Moderator: Sylvia Baedorf Kassis, MRCT Center

Panel 3 | Post-Trial Obligations: An Integrated Decision Model for Clinical Trial Placement

This panel explores the circumstances that challenge trial placement, when durable access is achievable in a host country or community, and when reciprocal benefits are acceptable if it is not. Panelists will also discuss the MRCT Center’s draft Integrated Decision Model for Clinical Trial Placement, developed by its Post-Trial Responsibilities Task Force to guide sponsors.

Panelists: Ginny Acha, Merck; Joseph Ali, Johns Hopkins University; Karla Childers, Johnson & Johnson

Moderator: Sarah White, MRCT Center

MRCT Center Updates

Select initiatives from across our portfolio:

• AI and the Administration of Research
• Childhood Cancer Academic–Industry Collaborative Platform Trials (C3PT)
• Proportionate Oversight in Decentralized Clinical Trials
• TRACE

Thursday, October 22 | Data Sharing

The second day focuses on data sharing and is co-organized with Vivli. Attend one day or both, in person or virtually. Please click here to view the draft agenda.

Agenda