
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:
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.
Thursday, October 22. A day on data sharing, co-organized with Vivli. Charlie Blanchard, Associate Vice President, Head of Global Privacy and Data Protection at Amgen, will give the keynote address: “Sharing is Caring. So Why is Trusted Sharing Getting Harder? A Privacy Officer’s View from the Intersection of Science, Privacy, and Sovereignty.” Panels will focus on U.S. developments affecting international data sharing, the European Health Data Space, and electronic health records in U.S.
Location: Ropes & Gray, Boston, MA, and hybrid.
The Annual Symposium will take place at the offices of Ropes & Gray, 800 Boylston St., Boston, MA, 02199
You will need a photo ID to enter. All attendees must pre-register to participate.
The Ropes & Gray offices are located inside the tower at the Prudential Center. Click here to view a map of the Prudential Center.
There is no charge to attend the MRCT Center Annual Meeting.
A continental breakfast, lunch, and cocktails/appetizers are offered. Please let us know if you have dietary restrictions.
Meeting slides and related resources will be shared with all registrants after the meeting.
Please share the registration information with others in your network.
You are also invited to attend a day focused on Data Sharing, co-organized with Vivli, on Thursday, October 22.
Location: Ropes & Gray, Boston, and virtual.
This event is also free for all registrants.
Click here for a list of hotels near the Prudential Center.
There are two separate Zoom coordinates, one for Wednesday’s program and one for Thursday’s program. Those coordinates will be shared one week in advance via email.
Yes! While in-person attendance is preferred, virtual participation – either entirely or in part – is welcome. Please indicate which events you will attend in-person or remotely on the registration form. Note: cocktails on Wednesday, October 21 are only open to in-person attendees for Wednesday’s meetings.
No, you can register for all events from the same registration form.