George Vradenburg (00:01):
This is a different kind of thing, a vaccine against Alzheimer's than it is a vaccine against an infectious disease where people are scared as heck that they're going to get the infection. We don't have an infectious disease here. So we have unique problems associated with trying to persuade public to take a vaccine. Even though they're cognitively healthy, they're not at risk of an infectious disease, they're only scared of potential future dementia.
Introduction (00:28):
Welcome to Brainstorm by us against Alzheimer's, a patient-centered nonprofit organization. Your host, Meryl Comer, is a co-founder, 24 year caregiver, an Emmy award-winning journalist, and the author of the New York Times Bestseller, slow Dancing With a Stranger.
Meryl Comer (00:45):
This is Brainstorm and I'm Meryl Comer. It's a tradition on BrainStorm to wrap up our wins or setbacks each year and jumpstart the next focused on the future of Alzheimer's advocacy both here and globally. Joining us is George Vradenburg, Chairman and Co-Founder of UsAgainstAlzheimer's, The Global CEOI and Founding Chair with the World Economic Forum of the Davos Alzheimer's Collaborative. Welcome, George. It's great to have you back.
George Vradenburg (01:14):
Well, Meryl, it's good you. You've been on this journey with me for 20 years now. We're beginning to nick the giant.
Meryl Comer (01:23):
George. Last year on BrainStorm. You forecasted the need to create, and these are your words, a many operational warp speed for an Alzheimer's vaccine. Now that's a nickname for the Covid Pandemic response effort. Can you give us an update?
George Vradenburg (01:39):
This year? We did create a working group of a variety of people that I'll scribe in a second to focus on whether or not we could get an Alzheimer's vaccine on market by 2030. Now, the participants in that work group are eight companies, each of whom has a vaccine in preclinical or clinical development, some more advanced than others of all different sizes of companies and with different potential targets for the vaccine, as well as regulators from Europe, the United States, the UK, and Japan. Medicare has just now invited itself to participate. In addition to those participants, which is a good group, all committed to figuring out the challenges associated with getting a vaccine on market by 2030. There are a variety of scientists and trialists who participate in that session to try and understand and make sure that we all understand the scientific challenges of getting an effective vaccine as well as a safe vaccine.
Meryl Comer (02:41):
George, are there social scientists in the group tracking the fallout from the last pandemic? So the same mistakes aren't made again,
George Vradenburg (02:49):
One of the challenges as I identified the regulators from the UK, Europe, United States and Japan, is that we don't now have regulators from China, from India, from low and middle income countries because the object of this is to reduce the cost and increase the access of something that will prevent Alzheimer's. And it will be critical as we go forward in the next year or two to get representatives from countries where basically they're never going to get access to these existing drugs that have just been approved by the FDA. And so we need to get a lot of countries involved to understand the barriers that we will have to get vaccines into Africa, Latin America, and Asia. That is yet to be done, but we recognize the challenge. And so we will figure out a way to get the conversation even more broad as we begin to get more traction. In terms of the product development,
Meryl Comer (03:39):
George, they're public facing issues like the heightened awareness and confusion about vaccines while the world wrestles with the health consequences of long-term Covid. Are these issues being anticipated and managed in parallel to this new initiative?
George Vradenburg (03:56):
Clearly, one of the essential elements if you're going to vaccinate tens of millions of people around the world is that it'd be safe. So safety is going to be a critical factor, both in understanding the scientific method of action of these vaccines, but also in a very wide clinical trial process that will try the vaccine in a lot of different kinds of populations to see if there are even some remote risks of safety. If you're going to vaccinate tens of millions of people, it could be a lot of people that are in fact adversely affected. So the great challenge to this vaccine process is a regulatory approval process that gives one high degrees of confidence in the safety of these products. But how big a trial do we have to have? How diverse a trial set of participants do we have to have to make sure it's safe? And that could be, as we saw in Covid, tens of thousands of people, that trial is very, very expensive. So there is going to be a capital requirement here that probably can only be satisfied with combinations of government and major foundation funding.
Meryl Comer (05:04):
So let's assume that you go out and vaccinate tens of millions of people and you give this vaccine to people when they're cognitively healthy because you think it will work and because in fact it's safe. The question, George, is will they stay on the vaccine? And if not, are they at continued risk of getting Alzheimer's?
George Vradenburg (05:23):
And the experience with Covid, if you call this a vaccine, it may be the people won't take it because are you representing to them that this vaccine is going to forever prevent them from ever getting Alzheimer's? Probably not the case unless they get their booster regularly. Well, are they really going to do that? So you really do have a problem here with vaccine hesitancy initially. And then with vaccine adherence, people don't trust vaccines. So you'll see the initial announcements on these products being called active immunotherapies, which for the public, they have no idea what that is. In fact, it is a vaccine or at least an intervention which is intended to prevent the accumulation or progression of disease. We will call this something differently. I think in the initial announcement then the payers are saying, do we want to invest the cost of investing in having tens of millions of people getting the vaccine if we don't get the payback of having a much lower priced intervention that affects lots of people.
George Vradenburg (06:22):
So there are major issues here that are a combination scientific regulatory payers. And so we are uncovering those issues, walking them through. This is a different kind of thing, a vaccine against Alzheimer's than it is a vaccine against an infectious disease where people are scared as heck that they're going to get the infection. We don't have an infectious disease here. So we have unique problems associated with trying to persuade public to take a vaccine. Even though they're cognitively healthy, they're not at risk of a infectious disease, they're only scared of potential future dementia. And will they stay on it as long as they stay healthy When they say, well, what the heck, if I can skip it this year, I can skip it next year because I'm healthy, I don't have to do it. And quite frankly, you know, maybe there's a little problem with this and it's inconvenient.
George Vradenburg (07:10):
So I do not pretend that this is an easy or issue free task that we're on, but we're on it, Meryl, because the cost of the medicine, the difficulty of infusing these medicines, the cost of getting a PET scan to detect whether you've got the disease or not is one. That means that the current crop of drugs aren't going to be very widely used. And if you and I have been in this battle for 20 years to try and prevent this disease, it's not good enough. We've got to try and do something transformative and leapfrog this high cost, high burden of getting on disease, high burden of staying on disease. But we recognize realistically that there are going to be challenges of getting people on vaccine and staying on vaccine.
Meryl Comer (07:53):
George, you recently attended a Saudi Arabian investment conference. Does the top line agenda that focuses on prevention and longevity include the development of vaccines?
George Vradenburg (08:05):
This is a new Saudi national effort called a evolution foundation. Its point is that we are living longer, but are, we're not living healthy longer. That is we're living the last 10 years of our lives, even though life has been extended with chronic diseases of aging, dementia, cancers, and a variety of others. So their mission is to extend health span to equal lifespan, and is actually your phrase that I have repeated to them. We need to make sure that brains span equals health span equals lifespan. They're focused on how it is that we can extend healthy aging even as we live longer. Their focus, as I've learned, is primarily on the biology of aging. If aging is a risk factor for cancer or dementia for diabetes, for heart disease, can we interfere with the process of aging in a way that actually diminishes the risk or eliminates the risk of all those chronic diseases of aging?
George Vradenburg (09:06):
So they're looking at investing in both the companies and science and academic institutions establishing institutes for the biology of aging. They announced an XPRIZE there. You and I have worked on XPRIZEs in the past and know how challenging they are. They have announced an XPRIZE of $101 million, the largest XPRIZE in XPRIZE foundation's history. Basically to say the winner of this prize will get in stages, but up to a hundred million dollars if they can identify an agent and prove it in a clinical trial that will interfere with your cognitive decline, your muscle weakness, and your immune system. You have to find an agent that will attack all three of those. Now my point there was this is all fine and good, and this will be Jim Dandy in the next 30 years if we're able to do this. But in fact, you have to have a lower cost method of action, lower cost intervention that is available to people in low income settings, whether in the United States or whether around the world.
George Vradenburg (10:10):
And that can be administered by primary care physicians and not specialists because the Saudi Neurology Society announced that they were recommending against prescribing of Lecanemab and Aducanumab because the participants in the clinical trials of those drugs did not include individuals with the characteristics of the Gulf population. And because they don't have PET scans in the study population and because they don't have enough neurologists. So we have to find a way to get the cost of these medicines down. We have to find a way to get lower cost means of screening and detection for these products. And so I am emphasizing vaccines. I brought up vaccines as a lower cost, much more accessible method. If one goes to the World Health Summit, they're focused entirely on infectious disease. They're focused entirely on vaccines. No one's thinking about vaccines in these chronic diseases of aging. And so we have to think through what it is. The scientific regulatory payer, public policy capital strategies to get much lower cost products that are accessible to people around the world and the primary care world knows how to administer a vaccine.
Meryl Comer (11:21):
Georgia country like Saudi Arabia has the wealth to model the future and bypass the politics to advance the science. Was there a discussion about broad-based applications of artificial intelligence toward accelerating clinical trials and diagnostics for early detection?
George Vradenburg (11:39):
There's certainly an interest in AI in Saudi Arabia on how to understand the individual characteristics of the clinical trial participants to make sure that you're targeting your product at precisely the right people. AI in clinical trials holds promise because participants in the trials are of people that have beta amyloid or tau or some other target condition in their brain. And where you basically try and keep out of the trial things that are confounding other kinds of diseases that might be impacting what you're aiming at. AI gives you the opportunity potentially to be really very refined, call it precision medicine, very refined on the clinical trial population that you're targeting and that you're targeting something that relates to the product that you're testing. So AI and clinical trials is useful there. The other application of AI that was discussed was whether or not you can take massive amounts of biological and non-biological evidence and begin to sense out whether there are interventions that can in fact interfere with the process of aging, that treating aging as a disease itself and something that we can cure. AI gives you the possibility of combining a wider variety of biological signals to assess whether or not you can with a particular drug or target actually interfere with multiple processes simultaneously. So ai, it was actively discussed. Saudi Arabia has attracted with this potential large foundation scientists from around the world on how to best use AI to get at this problem of the biology of aging.
Meryl Comer (13:21):
Our guest, George Vradenburg, Chairman and Co-Founder of uUsAgainstAlzheimer's. In part two, we continue our conversation about the domestic and global challenges to shift the Alzheimer's treatment paradigm to include disease prevention through brain health. That's it for this edition. I'm Meryl Comer. Thank you for brainstorming with us.
Our team is on a mission to help you stay up with the latest scientific breakthroughs from new therapies to technologies on early diagnosis and personal brain health advice from well-known experts using an equity lens that promotes brain health for all. Now we'd like to hear what's on your mind, what are the topics and guests you'd like to hear featured on brainstorm? Send your comments to BrainStorm@UsAgainstAlzheimers.org.
Closing (14:15):
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