CTI to Moderate First-Of-Its-Kind Panel Highlighting CBER, CDER, and CDRH at ATC 2026 Annual Meeting

FOR IMMEDIATE RELEASE [Covington, KY ~ 18 June 2026]

CTI Clinical Trial & Consulting (CTI), a global, therapeutically focused clinical research organization, today announced it will moderate a first-of-its-kind FDA panel at the American Transplant Congress (ATC) 2026 Annual Meeting, taking place June 20-24 in Boston, Massachusetts.

In addition to serving as a sponsor and exhibitor, CTI will convene current and past leaders from all three major centers of the U.S. Food and Drug Administration (FDA), CBER, CDER, and CDRH, bringing together expertise across biologics, drugs, and diagnostics and devices in a single forum. This level of cross-center alignment remains rare and unprecedented within transplant-focused scientific meetings.

Timothy Schroeder, Executive Chairman of CTI, and William Fitzsimmons, Founder of Tutela, will co-moderate the panel session:

"Meet the Expert: Promoting Dialogue Between the FDA and the Transplant Community - A Key to Innovative Synergy," on Monday, June 22 at 12:30 PM ET.

The session will bring together FDA experts representing:

• CDER (drugs) | Sundaram Hariharan, MD
• CBER (biologics, cell and gene therapies, including xenotransplantation) | Vijay Kumar, MD
• CDRH (diagnostics and medical devices, including biomarkers) | Arturo Hernandez, MD

to address how increasingly complex transplant therapies, spanning biologics, drugs, diagnostics, and engineered organs, are evaluated across regulatory pathways.

"This is where transplant innovation is heading," said Timothy Schroeder, Executive Chairman of CTI. "Today's programs are not evaluated by a single regulatory agency - they span biologics, drugs, and devices. Bringing representatives CBER, CDER, and CDRH into one discussion creates a more practical, aligned view of how development actually needs to work in practice."

Opportunities to engage all three FDA centers together in a single discussion remain limited, despite the reality that many modern transplant therapies require coordination. This session reflects a growing need for greater alignment across traditionally separate regulatory pathways as the field evolves.

The discussion will include real-world perspectives on regulatory considerations from IND and IDE through NDA, BLA, and PMA pathways, including the evaluation of emerging innovations such as novel diagnostics, biomarkers, and xenotransplantation - areas that increasingly demand cross-center collaboration.

CTI's role in moderating this discussion reflects its ability to operate at the intersection of complex science and regulatory strategy. With nearly three decades of experience supporting transplantation, rare disease, and immune-mediated programs, CTI partners with biopharmaceutical companies, academic institutions, and transplant centers globally to advance innovative therapies. CTI's rich history in collaborating on all approved transplant products and current oversight of more than 30 active programs accentuates the company's unparalleled experience in the field.

This session represents a rare opportunity for the transplant community to engage directly with FDA leaders across all relevant regulatory pathways in a single forum.

Connect With CTI at ATC 2026

Visit CTI at Booth #521 to learn more about our transplantation expertise or schedule time to meet with our team: Contact Form