Who: Samantha Budd Haeberlein, senior vice president and head of neurodegeneration development at Biogen since 2020, has left the company, a spokesperson confirmed to PharmaVoice.
Background: Budd Haeberlein joined Biogen in 2015 as vice president of clinical development, where she was responsible for the late-stage development of the company’s Alzheimer’s, dementia and movement disorder medications, including Aduhelm. In that role, and later as senior vice president of neurodegeneration development, she played a pivotal role in Biogen’s controversial decision to seek FDA approval for Aduhelm, despite data discrepancies in two large clinical trials of the drug. She also publicly defended the conflicting trial results on numerous occasions, including at the Clinical Trials on Alzheimer's Disease congress in 2019.
Why it matters: Her departure is the latest in a smattering of recent top-level exits at both Biogen and the FDA of leaders who were instrumental in the development and approval of Aduhelm.
Just two weeks ago, FDA neuroscience head Billy Dunn, who helped usher the controversial treatment to approval, retired. Dunn’s relationship with Biogen during the Aduhelm review process has been closely scrutinized, and was described as “highly atypical” in a congressional report last year. STAT News reports also shed light on an off-the-books meeting between Dunn and Biogen’s then-head of R&D Al Sandrock during the Aduhelm review process. And Dunn notably oversaw the review of Biogen and Eisai’s Alzheimer’s drug Leqembi, approved earlier this year through the accelerated approval pathway.
Since the fallout of the Aduhelm controversy, Biogen’s gone through a musical chair of personnel changes. After a six-month search, the company appointed Christopher Viehbacher to replace former CEO Michael Vounatsos, who stepped down in May after several Aduhelm-related business setbacks, and set Biogen on a new path.
Since taking the role, Viehbacher’s made several other personnel changes. In January, Viehbacher divided the R&D leadership role – which had been left vacant since Sandrock’s departure in 2021 – into two positions, creating roles for a head of development and head of research. Priya Singhal, the interim head of R&D since 2021, was appointed head of development and is continuing to oversee research operations as the company searches for her permanent co-executive.
Biogen’s longtime board chair Stelios Papadopoulos also stepped down earlier this month after reaching the company’s mandatory retirement age and was replaced by current director Caroline Dorsa.
With these changes, it appears a new guard is in control at Biogen — although it remains to be seen how much their leadership styles will differ from those of their predecessors. All eyes will be on how the Biogen leadership team handles the launch of Leqembi with partner Eisai, and the review for its ALS treatment tofersen, which will be the subject of an FDA ad comm meeting March 22.
What now: Biogen has yet to name Budd Haeberlein’s permanent successor. But, in the interim, it told PharmaVoice that Kate Dawson, current head of therapeutics development, will oversee the Aduhelm program. Dawson oversees the development of neurovascular, neuropathic pain, neuropsychiatry, neurodevelopmental and ophthalmology treatments but, despite her long tenure at Biogen, appears to have never been publicly linked to the company’s Aduhelm program. Given her role, however, she’s likely been an integral voice in the development of the drug, as well as Leqembi and tofersen.
Diana Gallagher, current head of MS and immunology development, is slated to temporarily take over Biogen’s other Alzheimer’s programs, as the company looks to launch Leqembi with partner Eisai under accelerated approval, and work toward traditional approval later this year. In addition to leading MS and immunology drug development, Gallagher also heads up the company's external innovation efforts, working closely to bolster its portfolio of candidates.
And Toby Ferguson, head of neuromuscular development, will lead movement disorder programs previously under Budd Haeberlein’s purview on an interim basis, including its ALS, Parkinson’s and Huntington’s disease candidates.