- Nucleus RadioPharma has appointed Dr. Stephen M. Hahn as CEO, bringing extensive regulatory, clinical, and operational experience.
- The company aims to expand radiopharmaceutical infrastructure, increase manufacturing capacity, and improve global patient access to targeted cancer therapies.
Nucleus RadioPharma, a next-generation CDMO specialising in radiopharmaceuticals, has announced the appointment of Dr. Stephen M. Hahn as chief executive officer. Hahn joins the company with a background as CEO of Flagship Pioneering and Harbinger Health, and as the 24th commissioner of the U.S. Food and Drug Administration (FDA), where he oversaw both COVID and non-COVID regulatory affairs.
Founded in 2022 through a collaboration between Eclipse and Mayo Clinic, Nucleus RadioPharma has raised $72 million in funding, including support from AstraZeneca. The company is building advanced facilities in Mesa, Arizona, and Spring House, Pennsylvania, integrating research, development, and commercial-scale production to streamline contract manufacturing and distribution.
Radiopharmaceuticals are emerging as a promising area in oncology, offering targeted, minimally invasive therapies. However, supply chain limitations—such as a fragile supply of isotopes, limited GMP-compliant infrastructure, and constrained operational capacity—have restricted patient access. Hahn emphasised the importance of scaling infrastructure to overcome these challenges, stating: “Radiopharmaceuticals are the next frontier of precision oncology care. But without the infrastructure to deliver these treatments, their impact is fundamentally limited. At Nucleus RadioPharma, we have an extraordinary team that is committed to breaking those barriers.”
Under Hahn’s leadership, the company plans to focus initially on completing GMP readiness at its Rochester, Minnesota, facility, expanding research and development, launching its data platform, and establishing strategic partnerships. Over the next five years, Nucleus RadioPharma intends to increase manufacturing capacity significantly and advance initiatives to improve patient access worldwide.
Board member Justin Butler highlighted Hahn’s dual expertise in clinical care and regulatory oversight, noting that his appointment signals the company’s commitment to advancing precision cancer treatment. Mayo Clinic’s Dr. Cheryl Willman added that Hahn’s leadership positions the company to innovate in developing new targeted diagnostic and therapeutic radioisotopes for patients.
