How can we speed up clinical development right now?
We are entering a period that demands both urgency and thoughtfulness. As we heard in our October convening, AI is already reshaping clinical development by helping us design smarter protocols, enroll faster, enrich more thoughtfully, and even communicate more clearly. Our understanding of biology is also accelerating, with human models and digital twins advancing rapidly. Yet despite all this innovation, clinical trials still haven’t had their breakthrough moment. They remain complex, expensive, and slow.
FDA’s new leadership has delivered a clear message: we have to go faster. We must use the creativity, expertise, and regulatory flexibilities already at our disposal to run better, more efficient trials. This is where CTTI plays a unique role. We know what the system is capable of when urgency is high. We also know how quickly it drifts back to familiar, cautious behaviors when that urgency fades. Our mission is to keep the field focused on what truly matters: trials that are fit for purpose. There will always be a tradeoff between certainty and time, but we can help make this tradeoff deliberately and transparently.
In 2025 we saw major policy shifts and real changes in funding and capacity. In this dynamic environment, one of CTTI’s biggest contributions was creating space for honest exchange, shared learning, and collective direction-setting. It was terrific to get to be with you all virtually and in person at CTTI events and professional conferences.
Looking ahead to 2026, CTTI will keep working both ends of transformation: the extraordinary new capabilities just coming into view, and the straightforward approaches we’ve long known we need to implement. We’ll be exploring how digital transformation across sponsors can support real-time measurement and regulatory assessment; how emerging technologies are making adaptive designs genuinely workable at scale; and how evolving federal incentives can spur smarter use of longstanding flexibilities in trial design and conduct. At the center of every project is the same question: how do we run trials faster while maintaining trust, safety, and data integrity?
As we close out the year, I want to thank our member organizations and the broader community of leaders who continue to show up with candor, generosity, and good faith. Your partnership makes this work possible, meaningful, enjoyable, and effective.
Morgan Hanger
Executive Director CTTI
Thank You to Outgoing Executive Committee Members
This year, we have three Executive Committee members who are completing their terms: Mike Cuffe (EVP and Chief Clinical Officer, HCA Healthcare), Ted Lystig (SVP and Chief Analytics Officer, BridgeBio), and Ed Ramos (COO/CSO and Co-founder, GSD Health Research). Together, they have provided countless insights into critical emerging areas, such as the evolving financing of clinical care, incentives for health system conduct of research, use of statistical methods and biomarker discovery, and RWE and observational research design. We thank each of them for their dedication, perspectives, and guidance during their tenures.
Farewell (for now) to Khair ElZarrad
After close to five years serving as the FDA co-chair on CTTI’s Executive Committee, Khair is moving on from his role in government. Khair’s tenure at the FDA has been marked by a unique combination of deep technical expertise, genuine humility, and a practical vision for regulatory infrastructure that supports innovation. As Director of the Office of Medical Policy (OMP) in CDER, he has consistently prioritized implementation, advancing policies that will work in the real world, and supporting the collaborative engagement that helps realize them as envisioned.
Stepping into his role as CTTI Executive Committee Co-chair is OMP’s Dianne Paraoan, with whom we have worked in the past on our RWD and IMPACT Afib programs. As with any new chapter, this brings exciting opportunities. We are appreciative of this seamless transition and are thrilled to identify fresh workstreams as we continue our collaboration with FDA.