NC a rising hub for radiopharmaceutical innovation

Radiopharmaceuticals, once a very niche drug class, are now on the brink of transforming cancer treatment and diagnostics, and North Carolina is at the heart of this change.

These radioactive drugs consist of radioisotopes linked to targeting biomolecules that recognize specific types of cells. This combination allows precision delivery of radiation to cancer cells, without the collateral damage that comes with traditional radiation treatments. 

These drugs can also enhance disease detection with imaging techniques like positron emission tomography (PET) and single-photon emission computed tomography (SPECT). 

Radiopharmaceuticals also make it possible to combine therapy and diagnostics into a single streamlined treatment process. This emerging approach, known as theranostics (also known as theragnostics), has the potential to offer highly personalized and effective options that reduce hospital visits for patients while also bringing down treatment costs. 

N.C. is a prime location for advancing healthcare innovation and supporting the specialized demands of industries like radiopharmaceuticals. “We have university faculty at the front edge of this science,” said John Bamforth, Ph.D., executive director of Eshelman Innovation, a healthcare innovation engine within the North Carolina at Chapel Hill Eshelman School of Pharmacy. “As a major hub for biomanufacturing and the CRO industry, the state is also well-positioned to support the unique manufacturing and just-in-time delivery needs of radiopharmaceuticals, making it an ideal location for industry growth.” 

Building bridges

Earlier this year, Eshelman Innovation and the North Carolina Biotechnology Center hosted the 2024 N.C. Radiopharmaceuticals Summit, which brought together university researchers, industry leaders and biotechnology investors. 

“With the summit, we aimed to bridge the gap between university research and future startups,” said Mike Carnes, vice president of emerging company development at NCBiotech. “Our goal was to equip emerging companies with the critical data they need, positioning them to raise funds more effectively once they launch. Connecting researchers with insights from industry helps ensure that the products developed are aligned with market needs.”

Carnes adds that the state boasts remarkable talent in this field. “We have unique infrastructure assets that enable us to produce the specialized materials needed for this industry,” he said. “Additionally, our outstanding hospital systems are well-equipped to conduct clinical studies, facilitating this important work.” 

Fueling radiopharmaceutical research

A key driver of this growing industry is the research being conducted at Duke University, UNC, Wake Forest University and other N.C. institutions and the talent produced by their specialized labs. It's rare for a single state to host multiple university research groups focused on radiopharmaceuticals, given the need for advanced facilities and labs capable of safely managing radiation.

Kiran K. Solingapuram Sai, Ph.D., director of radiochemistry and cyclotron operations at Wake Forest Baptist Health, was a panelist at the summit. His group is developing novel imaging biomarkers that could one day enable the diagnosis of Alzheimer's Disease and related dementias before symptoms arise.

He emphasizes the need to collectively focus radiopharmaceutical research on N.C.’s unique health challenges — diabetes, nicotine use, and specific cancer risks — to ensure that it directly benefits residents. For example, he is involved in a study that is leveraging radiopharmaceuticals to learn more about how nicotine levels differ in the bodies of e-cigarette users and regular smokers. His lab is also looking into scanning the brains much earlier than symptoms show up in Alzheimer's disease — which is very critical for improving the quality of life early on.

“We need to come together as a collaborative network, recognizing that each of the state’s academic centers has unique strengths and limitations,” said Solingapuram Sai. “By understanding our collective capabilities — whether in neuroscience, oncology or technology development — we can better serve the needs of North Carolinians. It’s essential to focus on local issues and leverage our combined innovations to make a meaningful impact in our communities.”

Transforming innovations into businesses

Jeff Schaal, senior vice president for theragnostics at Solve Therapeutics Inc., was also a panelist at the summit. SolveTx is a venture-backed biopharmaceutical company that has invested in radiopharmaceutical R&D and clinical development. 

Schaal was part of the Duke University spinout Cereius Inc., which was acquired by SolveTx Therapeutics in June 2023 to combine SolveTx’s expertise in drug development with Cereius’ strong chemistry platform to develop next-generation radiotherapeutics and radiodiagnostics. Cereius was supported by two NCBiotech loans to assist with developing its targeted radiopharmaceuticals for cancer patients.

“We have exceptional radiopharmaceutical talent being cultivated right here at our major universities,” said Schaal. “It’s incredibly rare to find individuals formally trained in this field, so discovering a wealth of local expertise with the diverse skills we need has been instrumental in getting our team up and running quickly.”

Schaal said that a key takeaway from the summit was the critical need for education and collaboration among clinical leaders, biotech startups and investors to advance radiopharmaceutical development. “A lot of false starts in radiopharmaceuticals have stemmed from misunderstandings between these groups as the scientific development process is different from traditional drug development,” he said. “Ensuring everyone is fully educated and aligned will ensure the best drug candidates are developed and brought into the clinic, ultimately for the benefit of the patients.”

He adds that a major challenge in radiopharmaceutical development is the limited access to isotopes. Radioisotope production and supply constraints often dictate which drug candidates successfully reach the clinic, rather than selecting the radioisotope that best meets the therapeutic goal. Addressing this issue will require advancements in production technology, regulatory streamlining, and significant investment in infrastructure. As such, collaboration and partnership between academic institutions, industry and government are greatly needed to foster innovation and reduce regulatory burdens. 

“With the wealth of resources, companies and academic research at our disposal, N.C. is well-positioned to emerge as a regional and national leader in this field,” said Schaal. “We have an abundance of talent and exceptional programs, and it’s inspiring to witness the enthusiasm from seasoned academics in this area. By building on their legacies, we can truly establish ourselves as thought leaders nationally.”

To move radiopharmaceuticals forward, Eshelman Innovation partnered with Lineberger Comprehensive Cancer Center to provide translational grants to university researchers who are dedicated to translating radiopharmaceutical cancer therapies to patients. 

“We hope these proposals will fuel next-generation innovation in the field,” said Bamforth. “They’ll be reviewed by top leaders in academia, industry, and venture, and we expect to select 2-3 of the highest-ranked proposals after thorough diligence.”