Nucleus RadioPharma, a CDMO that specializes in the burgeoning field of radiopharmaceuticals, named former FDA Commissioner Dr. Stephen Hahn as its chief executive officer.
Hahn, who led the federal agency from 2019 to 2021, most recently was CEO-partner of Flagship Pioneering and the chief executive of Harbinger Health. Prior to leading the FDA, Hahn was chief medical executive at MD Anderson Cancer Center in Houston.
At Nucleus, he will be tasked with tackling three big obstacles facing the growing radiopharmaceutical industry: expanding the currently short supply of key isotopes, building out the currently few GMP-compliant facilities that can handle a variety of medical isotopes and increasing the operational capacity to manage radioactive drugs, the company said in an August 20 press release.
“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 the venture capital firm Eclipse and Nucleus board member, said in the release. “His new role is a major indicator to the oncology community that radiopharmaceuticals are the future of precision cancer treatment.”
Radiopharmaceuticals are guided radioactive drugs that can help diagnose diseases in smaller quantities and treat cancer and other conditions in higher amounts.
“Radiopharmaceuticals are the next frontier of precision oncology care,” Hahn said in the release. “But without the infrastructure to deliver these treatments, their impact is fundamentally limited.”
Nucleus was founded in 2022 as part of a collaboration between Eclipse and the Mayo Clinic. So far, the CDMO has raised $72 million in funding, with financial participation from drugmakers like AstraZeneca.
Last October, the company announced plans to boost its production capacity by 200% by adding new sites in Mesa, Arizona, and Springhouse, Pennsylvania, and bringing on new staffers. The expansion is intended to allow the company to offer services spanning research, development and production under one roof at each location.
Radiopharmaceuticals have a limited shelf-life, and the addition of those sites to Nucleus’ operations in Rochester, Minnesota, means that its production operations will be within a four-hour drive of 60% of the U.S. population.