Drugs

Cancer Drug Company Adds Former FDA Head Hahn as Advisor

BreakBio, a biotechnology company developing personalized cancer immunotherapies, has appointed former FDA Commissioner Stephen M. Hahn, who led the agency from 12/2019 to 1/2021 during the first Trump Administration, as an advisor.

The company says Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and corporate strategy.

Before joining FDA, Hahn chaired the Department of Radiation Oncology at the University of Pennsylvania and later served as chief medical executive at MD Anderson Cancer Center. He subsequently joined Flagship Pioneering as chief medical officer of its Preemptive Medicine initiative, became a Flagship CEO-partner and CEO of Harbinger Health, and currently serves as CEO of Nucleus RadioPharma, according to BreakBio.

BreakBio says it is developing personalized peptide-based immunotherapies designed around the unique molecular characteristics of each patient's tumor.

“Unlike approaches focused primarily on mutation-derived neoantigens, BreakBio targets both mutated and non-mutated cancer-associated proteins, potentially expanding personalized immunotherapy to a broader range of solid tumors and patients,” the company says.

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Quality Procedures, Investigations Top FDA Drug Citations

Risk Management, Corrective Actions Lead Device Inspection Findings

FDA Posts 172 Additional Inspection Records

Brand, Generic Drug Groups Seek Changes to Approval Pathways Guide