- Billy Dunn, the former director of the Food and Drug Administration’s Office of Neuroscience, is joining the board of neurodegenerative disease specialist Prothena.
- Dunn announced his departure from the FDA in February after running the office for four years and overseeing the approval of high-profile medicines like Biogen’s controversial Alzheimer’s disease drug Aduhelm. He served in a number of roles in the FDA’s neurology products division from 2005 to 2019 before leading the neuroscience office.
- Prothena, which is looking to transition its pipeline from experimental medicines to marketed products, said Tuesday that it will benefit from Dunn’s “wealth of experience” in regulatory and clinical development.
Dunn’s decision to join Prothena offers some validation of the company’s pipeline and the relationships that executives have with regulators, Jefferies analyst Michael Yee wrote in a note to clients. “Given his experience and knowledge in the space, we don’t think Dunn would choose to help guide a company with low probability, weak data or inadequate strategies and poor relations” with the FDA, he wrote.
In the company’s statement, Dunn highlighted Prothena’s “pioneering therapies” focused on misfolded proteins in the body. The company’s expertise “is clearly reflected in its diverse and promising pipeline guided by a commitment to patient-focused drug development, a patient-first approach that I strongly support,” Dunn said.
In his final years at the FDA, Dunn advocated for greater flexibility in considering drugs for patients who had few other options. After the approval of Aduhelm, Dunn played a notable role in pushing through another test case for the agency’s standards, a drug developed by Amylyx Pharmaceuticals for amyotrophic lateral sclerosis, or ALS.
Dunn’s participation in approvals became so important that the stock of Reata Pharmaceuticals, which had a pending application for an inherited nerve disease treatment, sank on Feb. 27 on news of his departure. The FDA ended up clearing the drug in another controversial decision a few days later.
Prothena’s pipeline aligns with Dunn’s expertise. The company’s lead drug is in Phase 3 testing for AL amyloidosis. It’s also developed medicines for Parkinson’s disease and ATTR amyloidosis — now in Phase 2 testing — and has two Phase 1 candidates for Alzheimer’s disease. Novo Nordisk bought the rights to the ATTR drug and Bristol Myers Squibb acquired rights to one of the Alzheimer’s medicines.
It’s not unusual for FDA officials to become directors on the boards of companies they once regulated after leaving the agency. Former FDA Commissioner Scott Gottlieb joined the board of Pfizer in 2019 and ex-FDA vaccine official Philip Krause joined Mesoblast’s board last year.
Still, the revolving door between agency and industry has prompted criticism and scrutiny.