Samantha Budd Haeberlein, United States of America
Biogen Neurodegeneration Development UnitSamantha Budd Haeberlein has twenty years of biopharmaceutical industry experience across Research, Translational Medicine and Clinical Development. Based in Cambridge, MA Samantha currently leads the Unit accountable for the clinical development of Biogen’s Alzheimer’s disease, Dementia & Movement Disorders portfolios across all phases of clinical development. Previously Samantha was at AstraZeneca where she held roles in the US, Canada and Sweden as Vice President of Translational Science & Global Program Lead in Alzheimer’s disease.
Samantha is a member of the World Dementia Council and she is an executive member of the Board of The Boston Home. Samantha has a BSc and a Ph.D. in Biochemistry from the University of Dundee in Scotland. Samantha was a Wellcome Trust Fellow and Instructor at Harvard Medical School at Children’s Hospital and Brigham & Women’s Hospital in Boston and conducted research at The Burnham Institute in San Diego before joining the biopharmaceutical industry.
Presenter of 3 Presentations
FORUM SPEAKERS
Session Type
FORUM
Date
13.03.2021, Saturday
Session Time
18:30 - 19:30
Room
Live Forum
Lecture Time
18:30 - 19:30
Presenter
Session Icon
EVALUATION OF ADUCANUMAB EFFICACY IN EARLY ALZHEIMER’S DISEASE
Session Name
Session Type
SYMPOSIUM
Date
13.03.2021, Saturday
Session Time
12:00 - 13:30
Room
On Demand Symposia A
Lecture Time
12:45 - 13:00
Session Icon
Abstract
Aims
To evaluate the efficacy of aducanumab treatment in EMERGE and ENGAGE, Phase 3 studies of aducanumab in early Alzheimer’s disease.Methods
EMERGE and ENGAGE were identically designed, randomized, double-blind, placebo-controlled, global Phase 3 studies that evaluated the efficacy and safety of aducanumab in patients aged 50-85 years with early Alzheimer’s disease (MCI due to AD or mild AD dementia, and confirmed amyloid pathology). Participants received high-dose aducanumab, low-dose aducanumab, or placebo, randomized 1:1:1, via intravenous injection monthly for 18 months. The primary endpoint was change from baseline on the CDR-SB at Week 78. Secondary endpoints included change from baseline on MMSE, ADAS-Cog13, and ADCS-ADL-MCI at Week 78. NPI-10 was a tertiary efficacy measure.Results
In EMERGE, treatment with high-dose aducanumab resulted in a consistent and statistically significant reduction of clinical decline across both the primary and secondary endpoints. ENGAGE did not meet its primary endpoint; dose exposure, amongst other factors, contributed to the discordant results observed between the two studies in the high-dose aducanumab arm. In each study, aducanumab showed statistically significant and dose-dependent reduction in brain amyloid beta (Aβ) pathology. Effects on downstream biomarkers specific to Alzheimer disease (tau PET and CSF p-tau) and neurodegeneration (CSF t-tau) further support the clinical findings.Conclusions
The results of the EMERGE trial indicate a beneficial effect of high-dose aducanumab in patients with early Alzheimer’s disease. The discordant results of the ENGAGE trial may be explained, at least in part, by lower exposure to the drug.LIVE DISCUSSION
Session Name
Session Type
LIVE SYMPOSIUM DISCUSSION
Date
13.03.2021, Saturday
Session Time
17:30 - 18:05
Room
Live Symposia Discussion A
Lecture Time
17:30 - 18:00
Presenter
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