Cancer Diagnostics Company CEO is Stephen Hahn's Next Act

Stephen Hahn_Graeme Jennings- Pool/Getty Images

Graeme Jennings- Pool/Getty Images

Six months after joining Flagship Pioneering as chief medical officer of a new health security initiative, former FDA Commissioner Stephen Hahn has taken on the role of chief executive officer of Harbinger Health, a cancer diagnostic firm that harnesses artificial intelligence and machine learning.

Hahn served as the 24th commissioner of the U.S. Food and Drug Administration during the second half of the presidential term of Donald Trump. Before stepping into the commissioner's role, Hahn, a well-respected oncologist, served as the chief medical executive of The University of Texas MD Anderson Cancer Center. Hahn was named deputy president and chief operating officer of that organization in 2017. 

Prior to his time at MD Anderson, Hahn served as head of the radiation oncology department at the University of Pennsylvania's Perelman School of Medicine. At Flagship, Hahn will become a Flagship CEO-Partner and CEO of Harbinger.

Doug Cole, chairman and co-founder of the new company, and a managing partner at Flagship said the company's approach to oncology diagnostics is informed by its insights into specific biological events that take place early in the development of cancer. The platform then harnesses these insights in order to enable high-resolution, blood-based assays.

At Harbinger, Hahn will oversee the development of the Bio-AI diagnostics platform dubbed HarbingerHx, in hopes of detecting cancer in a patient before it is visible or symptomatic. He said the new company, which was backed by a $50 million investment from Flagship, has the potential to redefine the approach to oncology. Thus will move treatment beyond "staging" toward early detection that will enable the "diagnosis and treatment of cancer and ultimately to effectively reduce morbidity and mortality associated with the disease." He expressed his commitment to developing the platform to enable early detection of the disease for all individuals through a simple test.

"No one should be disadvantaged in the fight against cancer – it's our goal to bring the power of this platform not only to those with access to the top cancer centers – but to everyone," Hahn said in a statement.

Like most former FDA Commissioners, Hahn is moving back into a world that is not only familiar, but one where he can exploit his experience as the head of the world's gold-standard regulatory agency. 

Hahn's predecessor, Scott Gottlieb, has also been busy taking on new director roles in multiple pharmaceutical companies. He joined the board of directors at Illumina last year. Gottlieb also joined the boards of directors at Pfizer weeks after resigning from his role as FDA commissioner. He also joined the boards of health-tech company Aetion and FasterCures, part of the Milken Institute.

Another former FDA commissioner who is back in the news is Robert Califf, who helmed the agency during the administration of former President Barack Obama. Califf has been nominated by current President Joe Biden to step back in as FDA commissioner and replace interim commissioner Janet Woodcock. Califf's nomination hearing before the U.S. Senate is set for next week.

Since leaving the FDA, Califf has returned to Duke University, where he is a professor of medicine and vice chancellor for clinical and translational research. Before his year as commissioner, Califf served as the FDA's Deputy Commissioner for Medical Products and Tobacco. 

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