About Michel Vounatsos
Michel Vounatsos, CEO of Biogen, has been a central figure in discussions around the company's Alzheimer's disease drug aducanumab. Following the FDA's approval of the drug in June 2021, Vounatsos described it as a "historic day" and said it provided "hope finally for the patients and families" after nearly two decades without a new treatment for the disease. He noted that the accelerated approval pathway is a well-established process used by the FDA and stated that the company is committed to continuing to study the product. In earlier appearances, Vounatsos discussed the company's decision to seek FDA approval for the drug after initially discontinuing trials, attributing the reversal to new data showing that a "sufficient and sustained high dose" of the drug could remove amyloid plaques.
Vounatsos has also spoken about Biogen's environmental initiatives, announcing a 20-year plan called "Healthy Climate Healthy Lives" with a goal of eliminating fossil fuel emissions by 2040. He stated that "the pharma industry... can't lead in health without reducing our operational impact on the planet" and argued that climate solutions should also promote human health. On drug pricing, Vounatsos has called for the industry to be proactive, suggesting the adoption of innovative contracts that require payers to share risk, and has said Biogen aims to be the "Tesla" of the drug pricing model. He has also expressed a vision for a shift toward personalized medicine and preventative care, and identified neurodegenerative diseases as a priority area for the company.
Source: AI-verified profile updated from Michel Vounatsos's recent appearances.
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Transcript (7 segments)
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Michel Vounatsos0:12
Alzheimer's disease and the people saying this was the wrong decision by the FDA and they need more data.
Thank you, Meg, for having me. It is a historic day for the company. I want to applaud the amazing job made by the colleagues. It is an honor to be leading the company at this stage, but today I want to think first about the patients, the caregivers, and the families. After almost two decades without any innovation, it is a new day. It is some hope finally for the patients and families. It is a new chapter that is being opened that we are going to write together with the patients, the families, and the caregivers.
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Interviewer1:13
Progression of the disease and requiring a postmarketing study, essentially a Phase Four trial. What can you tell us about those results?
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Michel Vounatsos1:29
Accelerated approval is a well-established pathway by the U.S. FDA, so there is nothing new here. It is used mostly for oncology products. This is a new way to open a new space with an eventual indication of clinical outcome over time. We are delighted about this approval and committed to it.
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Interviewer2:11
If the confirmatory trial does not prove the clinical benefit of the drug that it's hoped to prove, would you support the FDA pulling the drug back off the market?
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Michel Vounatsos2:25
If I'm not mistaken, we have more than nine years to deliver, up to nine years to deliver the results of the study that we will design together with the U.S. FDA, and the protocol is not yet finalized. And importantly, before the nine years, we are committed to deliver the data as soon as we can. We will be in the position to do so.
Three studies showing binding characteristics and similar results. So it's not a map. Now we have three independent compounds that are able to target the toxic plaque of peptide that is bad in the arteries, the heart, also around the brain. And here we are able to decrease the plaque burden that is affecting the neuron.
