Radiopharma CDMO Nucleus names former FDA boss as CEO

Nucleus RadioPharma, the radiopharmaceutical-focused contract developing and manufacturing organisation founded by Eclipse and the Mayo Clinic, has tapped Dr. Stephen Hahn, a former FDA commissioner under the first Trump Administration, as its new CEO. STAT first reported the news.

Founder and former CEO Charles Conroy, who is now serving as a Managing Partner at the recently-created Radion Advisory Group, said the transition was a mutual decision based on the merit of having a physician leader in the company's next stage of growth. 

"Steve is going to be a great leader for this next phase," Conroy told pharmaphorum. "I could not be more impressed with him personally and I look forward to continuing to support him in his success."

Since he left the FDA in 2021, Hahn has been serving as CEO-partner at Flagship Pioneering and CEO of Harbinger Health, a Flagship company focused on early cancer detection. He remains involved with Harbinger as an advisor. Prior to his posting as FDA Commissioner, Hahn, a well-known cancer researcher and oncologist, served as chief medical executive of the University of Texas MD Anderson Cancer Centre.

“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,” Justin Butler, partner at Eclipse and a Nucleus board member, said in a statement. “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.”

Radiopharmaceuticals are indeed having a moment, with multiple pharma companies buying their way into the space in the last couple of years. Founded in 2022 by Eclipse and the Mayo Clinic, Nucleus is attempting to meet that moment by providing for the complex manufacturing needs presented by radiopharmaceuticals with a network of advanced facilities starting in Mesa, Arizona and Spring House, Pennsylvania. The company raised a $56 million series A round in 2023.

The company says three major issues plague the supply chain for radiopharmaceuticals: a low supply of key isotopes, limited infrastructure capable of handling those isotopes safely and legally, and "underdeveloped operational capacity" to manage the drugs themselves.

“Radiopharmaceuticals are the next frontier of precision oncology care,” Hahn said in a statement. “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.”