- Do the efficacy data demonstrate in a convincing and meaningful way that aducanumab slows the progression of Alzheimer’s disease in patients with early or mild symptoms?
- Is aducanumab sufficiently safe to administer to these Alzheimer’s patients? Specifically, are the reported cases of brain swelling and bleeding attributed to aducanumab a safety risk that can be adequately monitored and managed?
- Does the overall clinical benefit of aducanumab outweigh its safety risk enough to support the drug’s approval to treat Alzheimer’s patients?
Preparing for the FDA Panel on Aducanumab: What might panel members, the agency, and physicians be thinking about Biogen's application days before the Ad-com?Ticker(s): BIIB
Name: Dr Jeffrey Cummings - MD
Institutional: UNLV | Research Professor, School of Integrated Health Sciences
- Previously: (until 2019)
- Founding director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas.
- Director of Alzheimer’s Disease Research, Center for Neurotherapeutics, both at UCLA.
- Ranked in the top 0.01% of scientists and #5 in Alzheimer's disease research in a recent publication in PLoS Biology.
- Published nearly 800 articles and 44 books devoted to neuroscience, Alzheimer’s disease, and clinical trials. Lead author on: "Drug development in Alzheimer's disease: the path to 2025"
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