The Accelerating Solutions for Cell and Gene Therapy Evaluation and Novel Delivery (ASCEND) program represents a new chapter in the University of Colorado Anschutz’s commitment to patients with serious and rare diseases. ASCEND was created to coordinate and accelerate cell and gene therapy clinical trials—an area rich with promise, but complex in execution.
From its inception, ASCEND has recognized that the campus already possesses extraordinary strengths. Among them, the Gates Institute at CU Anschutz stands out as a nationally recognized hub for investigator-initiated cell and gene therapy research. As ASCEND’s program lead, School of Medicine Senior Associate Dean for Clinical Research Adit Ginde, MD, noted in a recent interview, the Gates Institute is “a gem of this campus”—a convener of expertise spanning discovery science, preclinical development, manufacturing, regulatory strategy, and clinical partnership.
“Yet excellence alone does not guarantee efficiency,” said Dr. Ginde. “Prior to ASCEND, cell and gene therapy trials were advancing within strong but relatively siloed pockets—hematology and oncology among the most experienced—while other specialties, from neurology and cardiology to rheumatology and ophthalmology, faced steep barriers to entry.”
Nearly 20 committees across campus touched different aspects of these highly specialized trials, from regulatory review and safety oversight to budgeting and operational implementation. The result was deep expertise, but fragmented processes.
ASCEND was designed to bring these elements under one umbrella—not to replace existing strengths, but to align them. For seasoned groups running complex cellular immunotherapy trials, ASCEND enhances coordination, scalability, and new partnerships. For researchers new to the space, it offers structured guidance, regulatory navigation, and access to campuswide expertise that might otherwise feel out of reach.
In this model, the Gates Institute is not simply a component in a larger system; it is a catalytic force. The Institute’s on-campus manufacturing capabilities, experience advancing investigator-initiated trials, and leadership in investigational new drug (IND)-enabling strategy have helped shape regulatory infrastructure across the campus. Offices such as the IND/IDE support functions evolved, in part, to meet needs driven by Gates Institute-led programs—benefiting not only cell and gene therapy studies but clinical research more broadly. ASCEND now leverages this mature ecosystem to expand access and impact of clinical trials.
Importantly, ASCEND also strengthens partnerships beyond campus. Industry collaborators are drawn not only to clinical trial capacity, but to the presence of a sophisticated translational engine. The depth of expertise housed within the Gates Institute enhances the campus’ attractiveness as a site for externally sponsored trials, even when products are not manufactured locally. The energy and credibility generated by the Institute ripple outward.
“Since the launch, ASCEND has seen strong engagement from investigators who previously viewed cell and gene therapy trials as prohibitively complex,” said Ginde. “With centralized coordination and visible leadership, new opportunities are emerging across disciplines.”
ASCEND is governed by a steering committee composed of leaders across campus and led by an executive leadership team:
For the Gates Institute, participation at the leadership level ensures that its scientific, manufacturing, and translational expertise continues to shape the campus strategy.