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Backed by AstraZeneca, this company is helping radioligand cancer therapies hit the shelves

"Think of us as a critical partner in the ecosystem, ensuring that brilliant innovation doesn’t get stuck in the development phase but actually reaches the patients who need them."

Charles Conroy, CEO, Nucleus Radiopharma.

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Part of our CEO feature series for Vital Signs, published in Fortune on December 1, 2024

Charles Conroy, CEO of Nucleus Radiopharma, sat down with Onyx for a feature-length interview.

To kick things off, could you share a bit about your career journey that led you to lead Nucleus Radiopharma?

I'm a board-certified nuclear pharmacist by training. I kicked off my career in operations and sales management, spending roughly the first ten years there. After graduating from the University of Michigan, I went back to business school and then ventured into strategic and operational consulting with Bain. I also spent some time at Big Pharma—specifically Eli Lilly—before returning to the nuclear medicine world with what’s now Curium. The last third of my career has been deeply rooted in startups within this niche. Before joining Nucleus Radiopharma, I was the CEO of ARTMS, Inc., a company that manufactures solid-state targetry for producing more isotopes. Prior to that, I led the Jubilant Pharmacy Radiopharmacy distribution network, delivering doses to hospitals and patients nationwide. These roles opened my eyes to the thrilling potential of the radioligand therapy (RLT) space but also highlighted a glaring gap—the infrastructure to support it wasn’t there. That gap drove us to form Nucleus: to build the infrastructure needed to support this groundbreaking science as it makes its way to patients.

What are the main challenges when it comes to manufacturing in the radiopharma industry?

Great question. The primary hurdles we face today are securing raw materials from reliable suppliers and ensuring we can manufacture these drugs in quantities that meet both current and future patient demand. As more molecules transition into commercial drugs, developing and manufacturing them becomes increasingly complex. Building an infrastructure robust enough to support a diverse array of commercial agents over the next decade is something that hasn’t been fully achieved yet. We’re really excited about the potential to develop this capability. It’s a massive undertaking, but the rewards for patients are immense.

AstraZeneca partially funded your Series A, which is a significant vote of confidence. Why do you feel that radiopharma is a particularly hot topic now, and what changes have ignited so much excitement in the space?

It’s really the therapies themselves that are driving the buzz. Radioligand therapy is showing impressive efficacy and efficiency, drastically improving patients' lives. Unlike chemotherapy, RLT doesn't wreak havoc on patients’ daily activities. They experience quick results without the severe side effects typical of other treatments. The efficacy, combined with a better patient experience, is a game-changer. Plus, the science is advancing at a rapid pace, with new therapies on the horizon that target various tumor types. This convergence of scientific breakthroughs, improved patient outcomes, and a robust pipeline of new treatments make the space incredibly exciting. It’s a perfect storm of innovation and practical benefits for patients.

Can you give us an overview of Nucleus’ products, services, and technology, and how that fits into the industry landscape?

We’re a development and manufacturing organization—not a traditional pharma company. We don’t create drugs under our own label. Instead, we collaborate with innovators and commercial entities to help them navigate the clinical and regulatory pathways, moving from ideation to commercialization. Over the past five years, more than 80 companies have launched in the RLT space, and they need resources and guidance to bring their ideas to market. That’s where we come in. Our expertise lies in helping these companies get their lifesaving medicines to patients. We don’t manufacture isotopes or drugs ourselves; instead, we support others in bringing their innovative ideas to fruition. Think of us as a critical partner in the ecosystem, ensuring that brilliant ideas don’t get stuck in the development phase but actually reach the patients who need them.

How would you describe the main patient population benefiting from most radiopharma treatments today?

Right now, prostate cancer is the primary focus, specifically with the success of treating pTO. But looking ahead to the next five years, we anticipate radiopharma treatments expanding to a variety of solid tumors. Over the next decade, I believe we’ll see treatments covering almost all tumor types, including renal, breast, and lung cancers. The patient population will diversify significantly as these therapies evolve and become applicable to more prevalent cancers. It’s an exciting time because the impact of RLT isn’t confined to one type of cancer—it’s poised to make a difference across the board.

What are the main goals and milestones for Nucleus in 2025?

Our immediate focus is getting our Rochester facility up and running, which is on track to have commercial capacity by mid-2025. Alongside that, we’re breaking ground on two new larger commercial manufacturing sites—one near Philadelphia in Springhouse, Pennsylvania, and another near Phoenix in Mesa, Arizona. To give you an idea, our Rochester facility is about 15,000 square feet, primarily focused on research and development. Each of the new facilities is around 50,000 square feet, bringing our total manufacturing space to about 100,000 square feet by late 2026. This expansion is crucial for meeting the growing demand for RLT treatments and supporting the influx of new therapies entering the market.

Why did you choose Rochester as a new site?

Rochester is a strategic choice for us because of its proximity to the Mayo Clinic, which is an invaluable partner. Being close to Mayo means we have access to patients for studies and can collaborate closely with some of the best doctors in the world. For instance, Geoff Johnson, our Chief Science Officer and the enterprise chair of nuclear medicine at Mayo can easily move between Mayo and our site. This proximity allows for seamless collaboration, keeping us at the cutting edge of science and ensuring that we can respond rapidly to patient needs. It’s all about being close to where the action is—both in terms of research and patient care.

From a supply chain perspective, where do you source all your raw materials?

We contract with a wide variety of isotope manufacturers to secure our raw materials. For example, we've partnered with SHINE and North Star, among others, to supply us with isotopes. Our partners are eager to work with us during the drug development phase so they can be included in the original package insert. This approach eliminates the need for separate submissions later on, which streamlines the process. We’ve established strong manufacturing contracts and maintain important partnerships to ensure a steady and reliable supply of raw materials. It’s all about building a robust supply chain that can support the demands of both current and future therapies.

Considering isotope decay, what are the main initial compounds you're dealing with?

We’re handling a broad spectrum of isotopes. Our sites are designed to be isotope-agnostic, meaning we can manage any diagnostic or therapeutic agent, whether it’s alpha or beta-emitting. Currently, we’re working with Lutetium-177, Actinium-225, Lead-212, and various Copper agents, among others. This flexibility allows us to support a wide range of therapeutic and diagnostic applications. By being isotope-agnostic, we ensure that we’re not limited to specific types of treatments, which is crucial as the field of radioligand therapy continues to expand and diversify.

Looking forward to 2025 and beyond, what are your expansion plans domestically and internationally?

Right now, our primary focus is getting the Rochester site operational and developing the two new sites. As we grow, we’re exploring opportunities both within the United States and internationally to expand our reach and support a broader patient base. The goal is to be as close to patients as possible, which means strategically placing our facilities where they can have the most impact. International expansion is definitely on the horizon, but our immediate priority is solidifying our domestic footprint to ensure we can meet the growing demand effectively.

As you scale, are there ways to cut the cost of radiopharma manufacturing, both for Nucleus and the wider industry?

Absolutely. As the commercial space expands and more agents enter the market, economies of scale naturally drive costs down. Producing a larger volume of agents spreads the infrastructure costs over more products, reducing the per-unit cost. Additionally, isotope suppliers are investing heavily in their infrastructure to produce at lower costs, which benefits the entire industry. We’re also developing technologies to maximize the efficiency of isotope usage, ensuring that the majority of what we purchase makes it to patients with minimal loss. This efficiency reduces overall costs significantly as therapies advance. It’s all about leveraging scale, investing in better infrastructure, and innovating to minimize waste.

What is Nucleus's main competitive advantage over its contemporaries?

There are two key factors. First is volume—both our manufacturing and isotope production volumes will drive down costs as we scale. Second is our technology aimed at minimizing leakage from production to patient delivery. By ensuring that most of the isotope we purchase is efficiently delivered to patients, we reduce waste and lower costs. Additionally, our multi-site footprint across the country allows us to be closer to patients, reducing the time isotopes have to decay and enhancing our service capabilities. This extensive and flexible manufacturing presence is unmatched in the marketplace, providing us with a significant edge. It’s about being big enough to drive costs down but also nimble enough to deliver efficiently.

Are there any other key dates or timelines for Nucleus in 2025?

The main focus is getting the Rochester facility operational and starting to produce doses for patients. We’re also working on fulfilling existing partnerships and contracts, ensuring that our expansion aligns with our strategic goals and patient needs. These milestones are critical for setting the foundation for our future growth and ensuring that we can meet the demands of the market effectively.

Yes, the influx of new innovators into the market is incredibly exciting. We’re seeing a lot of new science emerging, and major announcements from big pharma, like AstraZeneca and Eli Lilly, investing heavily in this space. These significant investments by established pharmaceutical companies generate more excitement and drive the market forward, which in turn allows us to expand our capacity and serve more patients. It’s a fantastic trend that supports our growth and the overall advancement of the industry. Watching how these big players influence the market and drive innovation is something we’re keeping a close eye on.

On a personal note, running a company with so many moving parts must require strong leadership. What do you believe is the secret to producing the perfect culture and achieving optimal outcomes?

For us, it all boils down to the people. We’ve been meticulous in hiring the best team in the industry. I’m incredibly grateful for the leadership team we’ve assembled, many of whom have over 25 years of experience in the radiopharmaceutical space. Bringing together individuals with the right skill sets and fostering an entrepreneurial yet well-funded culture has been key. We focus on building robust processes and procedures that allow us to scale effectively and sustainably, ensuring long-term success as the science continues to evolve. It’s about creating an environment where people feel empowered to innovate while having the support and resources they need to succeed. Our culture is built on trust, collaboration, and a shared vision for transforming patient care.