Dr. Stephen M. Hahn was sworn in as the 24th Commissioner of Food and Drugs on December 17, 2019.

Dr. Hahn is a physician, scientist and health care leader with an extensive background in patient care, academic research and executive leadership.Dr. Hahn is a dedicated clinician, having trained in both medical oncology and radiation oncology. In his previous leadership roles, he has always carefully balanced executive management with clinical time to continue to serve oncology patients, his true passion. He specializes in treating both lung cancer and sarcoma.

Throughout his oncology career, Dr. Hahn maintained a keen interest in research, authoring more than 220 peer-reviewed original research articles. His research focuses on the molecular causes of the tumor microenvironment, particularly the study of chemical signals that go awry (known as aberrant signal transduction pathways), and the evaluation of proton therapy as a means of improving the effectiveness of radiation therapy.

His experience in medical product development and clinical trials spans drugs, biologics, medical devices, and diagnostics.

Prior to joining the FDA, Dr. Hahn served as the chief medical executive (CME) at The University of Texas MD Anderson Cancer Center, a facility that cares for more than 140,000 patients a year. He has proven executive leadership that spans research, development, clinical trials, patient care, health system management and education.

In his role as CME, he was responsible for day-to-day management of the institution, including business, clinical and faculty matters. Under his purview was one of the largest clinical trial groups in the country.

Dr. Hahn joined MD Anderson in 2015 as Division Head, Department Chair and Professor of Radiation Oncology. Before joining MD Anderson, he served as chair of the Radiation Oncology department at the University of Pennsylvania’s Perelman School of Medicine from 2005 to 2014.

Dr. Hahn earned the rank of Commander in the U.S. Public Health Service Commissioned Corps while at the National Institute of Health’s National Cancer Institute, where he also completed a fellowship in medical oncology and a residency in radiation oncology.

He also a completed residency in internal medicine at University of California, San Francisco. He graduated from the Lewis Katz School of Medicine at Temple University in Pennsylvania and received his bachelor’s in biology from Rice University in Texas.¹⁾

He authorized Moderna's vaccine 6 months ago.

Now, ex-FDA chief Hahn joins biotech's backer

Fierce Biotech by Kyle LaHucik | Jun 14, 2021

Money and high-profile names, they’re a double threat. Flagship Pioneering, the venture firm behind Moderna, snagged both during a busy Monday.

After raising $2.2 billion in an extension to its seventh fund Monday morning, Flagship followed up in the afternoon by confirming that ex-FDA commissioner Stephen Hahn, M.D., will join the biotech incubator in a chief medical officer role.

Hahn led the FDA through the beginning of the COVID-19 pandemic and made statements that irked scientists, including his comments on convalescent plasma while standing by former President Donald Trump’s side. He faced pressure from all sides: including reported calls from Trump himself to authorize a COVID-19 vaccine or go, and from the public, industry and others urging him to take his time and get it right. 

But now, Hahn will head for another high pressure environment: biotech investing. He is now joining Flagship, the venture fund that birthed Moderna, the very company that earned Hahn's nod six months ago. 

Under Hahn's watch, the FDA granted emergency use authorization to the company's COVID-19 vaccine just behind a similar ok for Pfizer and BioNTech's jab. Tens of millions of Americans have now received a Moderna shot.

Hahn will be tasked in his new role with leading Flagship’s nascent Preemptive Medicine and Health Security business. Flagship founder and CEO Noubar Afeyan, Ph.D., is also chairman of Moderna

With today’s funding, Flagship has a stockpile of cash to support the program, which Hahn begins leading on Wednesday. Hahn said funding and new ideas in preemptive medicine have “never been more heightened,” according to a statement. Prior to the Food and Drug Administration, Hahn was chief medical executive at MD Anderson Cancer Center.

“We are delighted that Flagship will benefit from Steve’s clinical and administrative leadership in helping us dimension and pursue our growing number of explorations and companies in this emerging field,” Afeyan said in the statement.

Hahn is not the only former FDA higher-up to land in the private sector in recent weeks. Two weeks ago, ex-FDA deputy Amy Abernethy, M.D., Ph.D., joined Alphabet’s life sciences (Google) unit Verily as president of clinical research. Abernethy suddenly departed the FDA recently after having been a contender for the agency’s top spot, a role for which Fierce Pharma voters deemed her to be the No. 1. choice.

Hahn also follows the precedent of Scott Gottlieb, who ran the FDA from May 2017 to April 2019. Less than three months after leaving, he joined the board of Pfizer after partnering with VC firm New Enterprise Associates and think tank American Enterprise Institute, all of which went against Trump's pledge to “drain the swamp.“

The appointment also comes a week after Hahn's former place of employment gave conditional approval to Biogen’s controversial Alzheimer’s drug Aduhelm.

Doug Cole, managing partner at Flagship, told Fierce Biotech last week that the approval would be a sign of encouragement for people “who may have been waiting for some indication that there was a path to products” in the Alzheimer’s space.

Flagship-backed Denali Therapeutics is also working on Alzheimer’s treatments.²⁾