Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO to Scale Patient Access to Radiopharmaceutical Therapies

Hahn brings a rare combination of regulatory experience, clinical expertise and operational leadership to unlock the full potential of radiopharmaceuticals.

ROCHESTER, Minn.--(BUSINESS WIRE)--Nucleus RadioPharma, a next-generation contract development and manufacturing organization (CDMO) specializing in radiopharmaceuticals, today announced the appointment of Dr. Stephen M. Hahn as chief executive officer. Hahn’s leadership signals Nucleus RadioPharma’s urgency in scaling the infrastructure necessary to make minimally invasive, targeted cancer therapies accessible to patients around the world.

Hahn joins Nucleus RadioPharma after serving as CEO-partner of Flagship Pioneering and CEO of Harbinger Health since 2021. He served as the 24th U.S. Food and Drug Administration (FDA) commissioner from 2019 to 2021, overseeing both COVID and non-COVID regulatory affairs. Before joining the FDA, he was the chief medical executive at MD Anderson Cancer Center in Houston. The combination of regulatory, clinical and operational knowledge gives him deep insight into how therapies move from clinic to patient.

Radiopharmaceuticals represent one of the most promising frontiers in oncology​, offering treatments that are less toxic, less invasive and far more precise in targeting cancer cells. When patients receive these therapies, outcomes improve and quality of life is preserved. However, widespread access to radiopharmaceuticals remains extremely limited​, not due to scientific barriers, but logistical ones. Three interdependent issues drive these supply chain challenges: a fragile and insufficient supply of key isotopes, limited GMP-compliant infrastructure capable of handling a range of medical isotopes and an underdeveloped operational capacity to manage radioactive drugs.

“Radiopharmaceuticals are the next frontier of precision oncology care,” said Hahn. “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. Together, we will scale the systems and infrastructure needed to make these lifesaving therapies available to all who need them.”

Under Hahn’s leadership, Nucleus RadioPharma is uniquely positioned to tackle these issues, take radiopharmaceuticals to new levels of precision and efficacy and make minimally invasive therapies the new standard for cancer treatment.

“Steve’s experience as both a physician treating patients and as a leader at the FDA brings an unparalleled perspective to Nucleus as the company works to build the infrastructure needed to accelerate the widespread availability of radiopharmaceuticals,” said Justin Butler, partner at Eclipse and Nucleus board member. “His new role is a major indicator to the oncology community that radiopharmaceuticals are the future of precision cancer treatment, and that Nucleus is poised to lead the next era.”

Founded in 2022 through a collaboration between Eclipse and Mayo Clinic, Nucleus has raised $72 million in funding to date, including participation from AstraZeneca. The company is building a network of advanced facilities, starting in Mesa, Arizona, and Spring House, Pennsylvania, that integrate research, development and commercial-scale production under one roof, enabling faster, more reliable distribution to clinical trial sites and treatment centers.

“With one of the largest cancer theranostics practices in the world, we have a responsibility to drive continual innovation and develop new targeted diagnostic and therapeutic radioisotopes for our patients,” said Dr. Cheryl Willman, Stephen and Barbara Slaggie executive director for Mayo Clinic Cancer Programs and Mayo Clinic Comprehensive Cancer Center. “With Steve’s exemplary leadership skills and expertise as a cancer physician and scientist, our future could not be brighter.”

In his first year as CEO, Hahn will focus on completing the company’s GMP readiness at its Rochester, Minnesota, facility, expanding R&D capabilities, launching Nucleus’ data platform and forging strategic partnerships. Over the next five years, the company aims to dramatically increase manufacturing capacity and advance initiatives that improve patient access worldwide.

For more information on Nucleus RadioPharma, see here.

About Nucleus RadioPharma:

Nucleus RadioPharma is an innovative CDMO dedicated to the development and manufacturing of targeted radiotherapies. With an emphasis on innovation and quality, Nucleus provides an array of services, from formulation and analytical development to regulatory documentation and drug product manufacturing. Its technology platforms are at the forefront of radiopharmaceutical research, designed to advance new therapies through clinical trials to commercialization. Learn more at https://nucleusrad.com/.