Scaling Operations in Theranostics Clinical Research: Integrating Teams, Processes, and Regulatory Strategy "Presentation" - Stephanie Lira

May 8, 2026

At the 2026 UCSF-UCLA PSMA Conference, Stephanie Lara describes how UCLA's theranostics clinical trials program scaled from 11 studies and 10 staff in 2019 to over 60 trials. She outlines the operational strategies that enabled this growth including dedicated research scanner slots, staggered trial activations, outsourced nursing support, and cross-departmental alignment across nuclear medicine, urology, medical oncology, and radiation oncology.

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Biographies:

Stephanie Lira, Clinical Trials Program Manager, UCLA Nuclear Medicine and Theranostics, Theranostics Clinical Research Program, University of California Los Angeles, Los Angeles, CA


Read the Full Video Transcript

Stephanie Lara: My name is Stephanie Lara. As Jeremie mentioned, I am the clinical trials program manager. Theranostics is transforming how we approach precision medicine, particularly in oncology, but while science is advancing rapidly, operations often lag. So the question we ask ourselves, how do we scale theranostics clinical research program efficiently without compromising regulatory, patient experience, or collaboration? That's what I'll be sharing with you today. A practical real-world perspective on integrating teams, processes, and regulatory strategy to support growth.

In 2019, we had a total of four research MDs, four coordinators, two regulatory specialists, and two student volunteers. Today, in 2026, the theranostics research program has grown significantly. As you can see, there's cross-collaboration amongst different MDs in UCLA as well as internally.

My professional background and developmental focus, well, when I joined UCLA in 2019, I came from a pharmaceutical clinical operations background. I had experience in phase-one and phase-three trials across oncology, infectious disease, and liver disease. I understood feasibility and study startup and regulatory processes, but I was completely new to theranostics and the site-level operations. So I was stepping into an environment that required, not only learning a new scientific domain, but also understanding institutional workflows, patient care integration, and highly specialized regulatory pathways. That learning curve became the foundation for everything we built next.

To scale effectively, we focused on five key pillars. First, deep institutional understanding. Learning UCLA's patient care, regulatory and administrative system inside and out. Second, patient-centered engagement, guided by the CICare framework. CICare components are to connect with courtesy, introduce yourself and your role, communicate with care, ask with discovery, respond with respect and empathy, and exit with excellence. This is always important because no matter how complex the trial, the patient experience must remain seamless.

Third, tailored regulatory workflows. Theranostics trials don't fit neatly into traditional models, so we had to build processes for both IIT studies as well as industry-sponsored studies. Fourth, workflow optimization. Not just within our team, but across departments. And finally, cross-functional alignment. The most critical piece. Success dependent on strong partnership across internal teams and external sponsors.

If you look at the study activation process, it's clear why scaling is difficult. We're coordinating across multiple committees and steps, starting with the feasibility stage, which could include PSSVs, SSVs, and the DSG committee group here at UCLA. Once selected, we move on to the IRB submission, and then thereafter ISPRC, DSMB, MRSC, and additional ancillary services. I would say the major bottleneck that I have recognized is the budget. Negotiations cannot be initiated until all necessary service requests have been submitted and correct coding has been generated.

Once the subject calendar with coding is received, I can then begin budget negotiations. And once the budget is finally finalized, the contract can be signed and finalized to activate the study. And this process can take about six to nine months or longer before it's activated. Each step introduces dependencies, each dependency introduces potential delays. So scaling isn't just about adding more trials. It's about reducing friction across the entire ecosystem.

The work doesn't stop there. So once the study is activated, the operational complexity continues. From referral to enrollment, we're managing pre-screening, eligibility confirmation, consenting often both in person and/or remote, coordination with the clinical teams, that include technologists, nurses, attendings, as well as data oversight, data safety oversight. So one of our key priorities was to improving efficiency without sacrificing compliance or patient safety.

Origins and early growth. Between 2019 and 2023, we experienced a steady growth. Our team expanded from 10 to 19 members. We operated out of a single outpatient clinic with one SPECT/CT, two PET scanners, and two infusion chairs. During this time, most of our trials were image-based, which meant lower complexity, faster activation timelines, and less regulatory burden. This phase allowed us to build a foundation, but it didn't fully prepare us for what came next. So as you can see, in 2019, we had 11 studies, and in 2023, had a total of 22 studies.

Also, with the gap of 2019 and 2023, two major milestones were reached. The Gallium PSMA-11 injection received FDA approval here at UCLA and Pluvicto received approval in 2022. Oh, something's going on. It's not catching my slides. It's okay. After the ending of 2023, it was important for me to think about key considerations for the upcoming year. Driving operational growth to meet the growing demand of new imaging and therapy trials, continuous improvement of SOPs, staying connected through our internal meetings where we discuss about all studies during activation, study startup and active, and the milestones that came from 2020 and 2023.

I don't know what's going on with my slides, but we're going to get through it together. So this is our theranostics center. The grand opening was April 29th, 2024. It's an outpatient center in the 100 Med Plaza right across the parking lot from our 200 Med Plaza. We had eight infusion chairs and two nuclear medicine technologists.

And then came 2024. This is a major shift. From 2024 to 2025, we saw a significant surge in program growth. We expanded to two outpatient centers. We strained collaborations with med, medical oncology, hematology, oncology, urology, and radiation oncology. And most importantly, our trials became far more complex than we ever thought. The integration of therapy and imaging, increased asymmetry requirements, more sophisticated regulatory considerations. This was the moment where existing processes were no longer sufficient. There were a total of 33 trials in 2024 and doubling in 2025.

Some obstacles that I consider with the growth that came challenges, we encountered limited scanner availability. Current trials only provide a tracer round one day out of the week, or there are multiple SPECT/CT scans with more than four-bed positions for one research patient to complete. So it definitely caused a lot of time constraints with our appointment slots. There were increased regulatory complexities, coordination challenges across departments and resource constraints.

So what did we do? We shifted from reactive problem-solving to intentional operational design. We had dedicated research slots, protocol feasibility review. We outsourced to CTRC units, which are mobile nurses to meet the high demand of our trials. We staggered activation so that not all trials were being activated at the same time, as well as our research appointments, so it doesn't cause a delay with our technologists and our nurses. If we have, let's say, an actinium on the same day or lutetium on the same day. It's depending on how long those infusions last.

And overall, teamwork. For myself, I had to learn the technical components for scanning and infusion, as well as gamma counting, to then relay to the technologists. Having the partnership with the CTRC unit also gave me the opportunity to understand the nurses' assessments.

Now I'm going to show you the appointment output for 2025, which was, I would say, a pretty rough year for us, but we strived through it. In 2025 alone, we managed 309 scan appointments. Those can include SPECTs as well as PETs. 209 infusion appointments. They can be alpha emitters, beta emitters. And 72 clinic visits, which could include just blood draws, questionnaires, things like that that take the nurse's time.

And in 2026, we're already seeing a strong momentum. 69 scan appointments, 46 infusions, 17 clinic visits. Overall, our clinical trials have increased. And mind you, this is just in January and February. Based off the growth surge from 2024 and 2025, it became apparent to me that additional preparation for 2026 is needed. Research appointment slots, we needed more of those. New scanners, because a couple of our scanners go down from time to time. Advancement in our documentation and workflow, and most importantly, growing our team. Overall, our clinical trials have increased fourfold from 2019 to 2026. That level of growth is only possible when operations are designed to scale, not just stretch.

I want to thank our collaboration with other UCLA MDs and ancillary services that we have outsourced to. These include PRP, IDS, RSO, CTRC, and now dentistry. And none of this would be possible without the team. Our nuclear medicine theranostics group is made of coordinators, regulatory specialists, physicists, clinicians, imaging infusion experts, Cytotron team members, and operational leaders. Each role is critical and scaling required us, not to grow the team, but structure it intentionally. Thank you.