Talking Biotech is a weekly podcast that uncovers the stories, ideas and research of people at the frontier of biology and engineering.
Each episode explores how science and technology will transform agriculture, protect the environment, and feed 10 billion people by 2050.
Interviews are led by Dr. Kevin Folta, a professor of molecular biology and genomics.
Talking Biotech Podcast 383
Inspiring Innovations; State of Alzheimer's Therapies
Dr. Leen Kawas
===
[00:00:00] Kevin Folta: Hi everybody, and welcome to this week's Talking Biotech podcast by Colabra, and this week has really broken down into two different sections. In the first section we'll talk about what is the ecosystem of biotech development and a topic that we've touched on a few times before. How can emerging interests with a company that has some expertise in nav.
Business and science side really help to propel a small business forward, and it really is a lesson in entrepreneurialism, but also modern innovation and the way that it happens and the way in which scientists and business people are colliding to ensure the success of small business ventures. This is a really important part.
But on the other side of this is the innovation around Alzheimer's disease, and it's been a little bit controversial and difficult to understand. So our guest today provides some insight into where are the current therapies and how are the trials and validations different for Alzheimer's than they are for potentially other therapies.
A number of companies have brought several possible candidates to the floor, yet it's challenging to think about the rules we need to see to test for. Does it really work? Alzheimer's has a number of challenges with. How you identify it and who really suffers from it, and does it really work or does it really not, because you're looking at someone in cognitive decline.
So how do the new therapies have to be looked at through a slightly different lens and. How do clinical trials have to be structured and thought of in maybe a little bit different way to shed light on this? We're speaking with Dr. Lean Kawas. She's the managing general partner at Propel Bio Partners.
Welcome to the podcast, Dr. Kawas.
[00:02:02] Leen Kawas: Thank you,
[00:02:02] Kevin Folta: Kevin. Yeah, this is a really interesting. Different approach than we normally do on the podcast in that you have a much bigger view of the, of the industry and the field and what's going on, and there's some important questions and some things that are going on that I'd really like to tackle.
So what's happening currently with Propelled Bio Partners and what exactly does your company do?
[00:02:25] Leen Kawas: Yeah, Kevin. So we are an investment firm. We launched over a year ago. And the, I think what's unique about Propel is we are a group of people that have extensive experience. To start companies. We are operationally very strong from specialize in the healthcare industry as well, investment and business building.
And we really started propelled with the premise that we can support companies more than just with capital. Right? There's. Capital out there. Maybe today it's harder to get to, but I think from my experience as an entrepreneur who started the company, took it all the way through public offering and beyond getting specialized access to a network was one of the things that helped me become successful.
And that's what we are trying to provide with rappel, really propel. The mission and vision of entrepreneurs and companies that we invest in, whether they're private or public, cuz we invest in both sides private companies as well as public companies. .
[00:03:24] Kevin Folta: Okay. So, cause this is something that's always been really interesting to me in how this works.
So there's a lot of good science out there, lots of startups with excellent ideas, good dreams, lots of academics with some ideas, myself included. But , what are we missing that , that guidance from someone like you could really help us with?
[00:03:43] Leen Kawas: I, I appreciate that you started your question with, there's a lot of good ideas out there.
what makes a good idea into a successful company or venture is execution and innovation around execution. And we are looking for entrepreneurs, companies that have great science. Of course, it always starts with the science in our industry, but at the same time, we are looking for people who have in innovative approach for how to acceler.
Drug development with a clear focus on patients. You know, we look at a lot of, there's a lot of redundancies in our industry. There's a lot of traditional ways that people run programs and, and, and the life science industry. But now with the technology and connectivity that we see, there's different ways.
Things can be done. Of course, it has to follow science and logical product development. But we we're, we're not really excited about traditional way of corporate development, traditional drug development because there's a lot of exciting science, but also a lot of. , exciting execution strategies. So execution is very important.
It's something that we spend a lot of time after we build convection around the thesis for the science, the team execution and plans around it, which, what makes, you know, successful companies successful.
[00:05:15] Kevin Folta: Okay. So you provide some of this execution strategy to help people maybe pull off the, the business side that maybe that scientists aren't necessarily conditioned to, to do, but also do you provide some scientific oversight?
We're
[00:05:30] Leen Kawas: not providing traditional oversight. We're trying to provide a space where talented entre. are able to share their ideas and we just ask question and bounce ideas off of them. We provide network, we provide ideas, we provide, you know, a safe place that innovators come to us and share their ideas and, you know, part of what we look for people who are op open to feedback bullish about their ideas, but they understand that they can do it on their own and how they're able to cultivate and network within their organization and outside of their organization to bring forward the best solutions.
And, and one thing I wanna highlight is mindsets are very important. We have to be in a, in this. Time In this era, we have to have a growth mindset approach, problems with the beginner's mindset, and lastly, build your organization. With an intention behind how you hire and, and how you build your companies.
This like traditional corporate structure, top down really limits innovation and acceleration of product development in life sciences, a multidisciplinary industry. Let's bring all the talent in one place to bring the best solution forward.
[00:06:55] Kevin Folta: Yeah. But is, is that traditional way of doing this? Is it so entrenched that it's difficult to change or are people actually shifting the way that innovation is happening and the way that companies are, the way investors are, are, are helping to support it?
[00:07:10] Leen Kawas: I mean, Kevin, I'm sure from your place in conversations that you've had change and innovation, when, when something could have a significant and huge impact, it's never easy. And . You know, I think that's something that drives us as a team and, and that's why I enjoy my new position as an investor and, and a person who's running a fund that is trying to support different companies at different stages.
We're looking to have a meaningful impact on our industries, and it's not only science, you know, if it was only science. And as you said, a lot of scientists all over the world in different academic labs would've been able in a more efficient way to move things forward. But it's, it's the whole innovative corporate development, corporate strategy, drug development strategy.
And, you know, I. . The thing with the biotech is there's another industry, the tech industry, we can take a lot of the learnings from there and models and apply it in a way that fits our industry. So it's not easy, but it's definitely exciting and we are, I could feel it like there is a momentum that's happening.
Where we will see significant changes in our industry in the next decade or so. Yeah,
[00:08:28] Kevin Folta: I, I agree. I, I think as somebody who's an academic scientist who's been do studying biotechnology since he was 10 I, I tell my students, I say, I need you to get up to speed on biotech and really think about potential careers there, no matter how far you want to go, if it's PhD or bachelor's, whatever, because there will be a chair for you to sit down in if you're creative and wanna work hard.
It's the next big tech wave, in my opinion. And do you kind of see that being the same thing?
[00:08:55] Leen Kawas: I do think that there are some learnings. I don't think that we would be a me too industry like the tech, but but there is a lot of learnings that we can take from that industry and how they enabled growth without losing the innovative , guess, magic at, at every stage.
I, I really love A lot of interviews around the different, you know, Steve Jobs and, and CEOs for Apple. It's, you know, the idea that it's the biggest startup. And I don't think it's the biggest startup. They just have a very unique corporate structure, network structure that we are trying to promote as part of our, you know, investment thesis.
Because it's, it gives you intentionality in how you build your team, but at the same time, allowing. System and environment for innovation and growth. We are starting and we will see in the biotech industry.
[00:09:48] Kevin Folta: Well, all this is really good. I, I was excited to have you on because I didn't wanna just do an infomercial for Propel Bio Partners.
I was really excited because I've read a lot of what you've written about clinical trials and recruitment for Alzheimer's disease, and especially some of the thoughts that you might have on the recent happenings around Alzheimer's because it, it's a. We haven't touched on much here, but yet in the last month or so we've seen last, well, shouldn't say that last year we've seen some real push for release of several potential therapies, and I'd really like to touch on that a little bit.
So what is currently happening with respect to Alzheimer's disease and some of these new monoclonal antibody directed therapeutic? .
[00:10:30] Leen Kawas: Yeah, I mean this is a hypothesis. The Abeta, Amy Myeloid hypothesis has been a hypothesis that been pursued for close to 20 years right now. And as we know, Alzheimer's is a very tough to see disease.
There's multiple underlying pathologies we don't fully understand. How it starts and, you know, why do some people develop Alzheimer's versus others don't. But we absolutely know that the Abeta amyloid protein plaques different forms of Abeta are part of the disease presentation and pathology. So we cannot deny that it's part of the pathology.
But the, because there has been a lot of failures, I think Biogen did a really good job. Putting together two programs that clearly show the ability to reduce the biomarkers, there is some clinical benefit. , although, you know, not very clear. Clinical development, by the way, I just wanna say this to the audience, it's never black and white.
I think a lot of people expect that there's gonna be a very clear answer if a drug works or not. It's never the case. It's a cumulative effort. You start with early stage clinical development and you. Continue to build evidence if the drugs work or not.
[00:11:44] Kevin Folta: Well, well, one big part of this might be that Alzheimer's is a little bit of a slippery issue to diagnose because isn't, isn't most of the diagnosis postmortem.
[00:11:54] Leen Kawas: that used to be that, yes. I mean confirmation but then now there's a lot of imaging techniques that confirms the a beta ameloid or plaque accumulation in the brain. And, you know, we've, we've had significant advancement in the PET imaging although the problem is it's not reimbursed. Yet. So that's another challenge of access to full diagnosis for Alzheimer's disease, which is something I think right now with approval of two drugs there should be some path towards reimbursement for some of the imaging modalities.
That confirms their diagnosis for Alzheimer's disease. So do we have the tools to diagnose it? Yes, we do. Is it accessible to everyone? No, because it's not reimbursed yet. But I think with the two drugs that have been approved, provided accelerated approval, nobody can deny that there is a clear.
Removal of a biomarker that we know that is part of the presentation of the disease. To say that okay, it doesn't have that major clinical benefit. I think I heard Billy Dunn one time give a presentation and kind of like give a rationale behind why as an industry we should be pushing towards approval of these monoclonal antibodies.
Abeta myeloid, Kevin starts accumulating in the. 10 to 12 years before we start seeing any type of clinical presentation of Alzheimer's disease. To ask a company to run a 10 year clinical trial is kinda like crazy, right? But what the F D A did is they give accelerated approval to Biogen. and they ask them that you have nine years to give us confidence that there is clear clinical benefit from this approach.
And nine years, and I thought was very smart that the, the FDA gave nine years because then they can truly test the hypothesis if a beta ameloid, once it's cleared from the brain over the same time course. where these proteins starts to aggregate to start seeing clinical benefit. And on top of that, which that's something that you cannot quantify in a clinical trial because of the endpoints there for, in my point of view, the, a lot of the end points in, in the way that we test Alzheimer's is ancient and there's a clear need for new ways that we test Alzheimer's.
But in the real world, we are gonna be able to clearly measure delays. , you know, any type of moving the patients into memory unit how much, how much time are they able to be independent from my interaction with Alzheimer's patients? It was very interesting. They're so excited that they're able to make their coffee.
They're read the newspaper versus when they go to get tested in clinical trials, they're being asked about the date, the day the, there's a lot of things that don't matter, and I do believe that allowing more drugs to be approved and tested in the real wo world for Alzheimer's could lead to significant understanding.
For us as a whole, you know, industry, you know,
[00:15:09] Kevin Folta: maybe I should have asked this first, but you know, how bad of a problem is Alzheimer's disease and is it something that is becoming more common?
[00:15:17] Leen Kawas: Alzheimer's disease is the most expensive disease. on our systems, like I think it cost over 300 billion to take care of Alzheimer's patients.
Of course, there's it's accomplice disease, there's multiple type of dementias, but it's a really expensive disease. And we don't think about the indirect cost. Once a family is impacted by Alzheimer's, it's not only the patients, Kevin, it's the caregiver who's gonna give up their jobs. To start caring for Alzheimer's for their family member.
The cost, the additional cost around taking care of Alzheimer's, the indirect cost. A lot of people think about it as the direct cost. There's significant indirect cost on our society. That's why I say Alzheimer's is never a single person disease. It's a, it's a unit. It's either the patient and their caregiver or multiple people that are impacted by the disease.
So it's, it's a very expensive disease. The last time I looked at it, it was 5.6 million diagnosed patients in the us. And by the way, that's not everyone, because there's not a lot of tools that physicians can use to manage Alzheimer's, and a lot of them don't diagnose Alzheimer's because it's a, it's a scary diagnosis and they try to delay the news to the patients as much as possible.
But I think with these drugs at Yahel all the a Yahel had was commercially, obviously did not have a successful outcome. Hopefully, Isai and Biogen will lead a successful commercialization effort with Libi and Lilly. Albeit delay delayed in their approval with their drug don map. Hopefully they're also going to get approval and help us as a society, as a scientific community, as an industry understand Alzheimer's and the different.
phenotype and genotypes of Alzheimer's patients. And you know, the first, I always say this, the first cancer drug that was approved was really, you know, had significant side effects, didn't work well, but once we saw approvals and understanding of the real world impact of these drugs, cancer therapeutic and drug development improved significantly.
So I hope that we see a similar trend for Alzheimer's. .
[00:17:38] Kevin Folta: Well, when you talk about cancer, you know there isn't one thing. Cancers have different etiology. They have different treatments. It's very, very different. Is Alzheimer's kind of the same thing? That it really is a heterogeneous spectrum of different disorders that tend to, to share some commonalities like this accumulation of beta, Amy.
[00:17:57] Leen Kawas: Absolutely. Alzheimer's is a as complex, if not more complex than cancer or oncology. There is different genotypes, there is different dis like the level of these protein accumulation, a beta tau, the different regions of the brain that are being impacted. There's cardiovascular. Cardiovascular impact, you know, the apo e genes that have different type of disease progression.
Gender, the type of, like, it's even more complex because I think it. Cancer or oncology is, doesn't discriminate I guess based on the background of, of a patient. But in Alzheimer's, even the I guess the, the background of the patient, the way that is, Alzheimer's presents itself for someone who is, let's say NASA scientist is very different than someone who use different domains in their brain, in their career and day-to-day activity.
So the way that they actually. Show the disease and the way that they progress will be very, very different, which makes the way to test for improvement in clinical studies. Much more challenging than cancer. Because cancer, it's, the endpoints most of the time are quantitative, you know, the tumor size, cell count, it's very much easier to quantify compared to.
recovery in, in the cognitive network.
[00:19:33] Kevin Folta: The, the other big impediment with Alzheimer's to me seems to be that the animal models that have been developed, present some data, but they're difficult or don't translate well to humans that you can make, you know, knock out. Beta amyloid or knockout thal mice that they still behave, they still have similar behaviors with their memory skills and other types of that we might anticipate with Alzheimer's.
Is that true or how does that just really speed the lack of understanding of how, what we see in animals translate to humans?
[00:20:07] Leen Kawas: Yeah, that's a very good point, Kevin, which is Cognitive network, different type of memories. Like humans, we have executive. That's something that is animals don't have or we cannot, we are not able to measure.
So translation is a big challenge here. You know, I, I always say the, all of these type of maze that we test, we we're not testing it in the same way for Alzheimer's patients. So it's really hard to translate. You know, I worked in a company Athera. Develop different type of quantitative biomarkers that are more translatable, like e EEG and P 300.
But there's alwa always, you know, as part of the translational challenge is in humans and clinical testing there, there's more variables. Around human testing in animals. When you are looking at these, it's a very uniform environment that has less impact on these type of biomarkers. And that's why, you know, running clinical trials in an, in executing on clinical trials is a very important part of successful outcome in central nervous.
Diseases, Alzheimer's and other depression Parkinson's. So which makes the translation even more challenging.
[00:21:27] Kevin Folta: Well, we're speaking with Dr. Lean Kawa. She's the managing general partner of Propelled Bio Partners, and we're speaking a little bit about entrepreneurialism, but we're also speaking about what's happening with Alzheimer's therapeutics.
It's a disease that seems to be coming increasingly more prevalent, both in its enhanced surveillance and diagnosis, as well as folks living a little longer and more likely to suffer from some degree of neurodegenerative disease. Talking Biotech podcast by Collabora and we'll be back in just a moment.
And now we're back on Col Collaboratives talking Biotech podcast. We're speaking with Dr. Lean Kowas. She's a managing general partner with propelled bio partners and someone who's been keeping a finger on the pulse of developments in Alzheimer's disease and associated Therapeutics. And over the last year or so, we've seen a number of blips on the radar screen that, you know, here we are looking at this disease, which is devastating, has tremendous cost for society as well as families.
Yet there are. Therapies available, a few therapies that are available at least prior to the le recent spade of releases. And so could you tell us a little bit about the specific therapies that have emerged and some of the controversies around them and, and where they, where they stand right now?
[00:22:46] Leen Kawas: Yes. So Biogen, last year, they had the approval of AG hem.
, which, you know, there's three main drugs right now. Adu hem from Biogen libi, which is a drug that was co-developed by Sai and Biogen. And then donor which is a drug that is being developed by Lilly. They all target the same type of pathology. Abeta Ameloid protein. aggregation in the brain.
Like I don't, it's a more complex, like, I don't wanna go into the details, but this is one of the main pathologies or presentation of Alzheimer's disease. ADU Helm was approved based on accelerated approval based on changes in the plaques, a beta plaques. They give the antibody, it clears the plaques.
They looked at imaging. There's consistent and dose dependent and time dependent change or reduction in the plaques, it was approved. There was a big pushback from everyone that it doesn't have the safety profile or the efficacy profile. Which I, you know, I think that any drug that gets approved has side effects.
and I think that Biogen did a really good job in testing the drug in a large number of patients to give comfort around the safe use of the product. We can talk about the endpoints after I explain libi, which is the same type of product antibody targets the plaques show time, and, and those dependent change or reduction in the plaques in the.
[00:24:25] Kevin Folta: So these are similar in that they're monoclonal antibodies and are they targeting the same type of epitope or what
[00:24:32] Leen Kawas: makes them different? Different, they're, they're slightly different within this, with, you know, within the pathway. Nulo, neurofilaments or basically filaments or, or plaques or, it's the, it's a, it's a very complicated, I would say Path for how we get from the start of the pathology up to plaques, but it's a continuum.
So if you impact one component, of this pathway, you will see an overall reduction in, in, in the protein and the different types of protein and ultimately plaque accumulation in the brain. So they're, they are different. They're not the same product. They don't target the same proteins within the continuum, but ultimately they lead to reduction in Abeta amyloid that is very clear with pet.
[00:25:21] Kevin Folta: Yeah. So the pet imaging is a big part of this that you can, we mentioned earlier that this used to be postmortem, but it's really this positron emission tomography that allows you to see these plaques in the brain. And does that but, you know, does that also, you have a decrease in the number of plaques or the amount of plaque, but does that coincide with a reversal of cognitive decline or better symptomology of.
[00:25:47] Leen Kawas: That's the big debate, Kevin, is we've seen a clear reduction in Abeta plaques in the brain in these two cases, as well as donor like Lilly's drug donor. And since this patho, this type of mechanism of action has been pursued for, you know, a couple of decades, people are resisting the idea that we, we removed the plaques.
It never led to improvement in clinical. Why is the F D A. Moment allowing the approval of these drugs. I think we have way more data coming out of these two trials. You know, there's tau PET imaging to tau, which is another protein pathology in Alzheimer's. There is consistent. It's not like one off.
There is consistent, slight improvement in the different. Cognitive, or not necessarily just cognition. Clinical endpoint, clinical domain endpoints. And it is, I think there's, there's clear evidence. When I looked at the data, I actually listened closely to the ADCOM committee. Although it's not groundbreaking the data, but there is consistent and clear effect across different.
areas, whether it's biomarkers functional and, and cognition. And these endpoints are very hard. You know, a lot of people don't understand clinical trials, especially for Alzheimer's. Those are not easy to measure. And I thought the F D A did a really. Good strategy with saying, okay, we're not gonna give them full blown approval.
We're gonna give them accelerated approval. We are gonna give them nine years to give us confidence that this actually leads to improved in the quality of life, improve in the clinical endpoint and cognition. Again, I wanna highlight cognition. changes in every Alzheimer's patients is very different because we have a very different base in our brain cognitive network when the disease starts.
So I do think that the F D A did the right thing getting these drug into the market. Unfortunately, the pricing was a little bit, you know, also, I don't think it was perfect from Biogen with their first drug. Hopefully with Libi they will do better, but it will help us. I wanna tell everyone who's like saying this, you know, the F D A is has not showed the same type of rigor I think they did.
That they care about two things, safety and efficacy. They've done a lot of. Studying the safety of these two drugs, efficacy, we have an indication that these drugs work. We need now to think outside of the box. We need to start testing these drugs in the real world and get evidence, evidence from the real world that there is clinical benefit in the way, in the real way that.
important for the patients, not just scales, you know, going into the clinic and testing. What's the date of the day? What's the season that we are in? Where are you real ways that patient care about and, and real ways to test for the economical impact of these treatments on our economy and our society.
Well, when
[00:29:00] Kevin Folta: you talk about endpoints for Alzheimer's disease clinical trials, you know, what is it specifically that makes them especially challenging? Is it because of the different presentations of disease or the advanced age of patients with comorbidities that may influence them, or, you know, what, what is it that makes it particularly challenging?
[00:29:19] Leen Kawas: I think two things. Actually multiple three. I'm gonna highlight three things. One, the cognition is a such a big definition topic. You will see cognitive decline and dementia and Alzheimer's disease and other dementia presents in different. And, and depends on the type of profession. There's people that are able to compensate for some of the con cognitive decline.
Different regions in our brain develop differently based on our day-to-day life, the languages that we speak, the environment, if you're living in the city versus in the suburbs, versus, you know, in, in in, in. In a form. So it, it's already a very heterogeneous baseline of cognition and the way that we advance is also very heterogeneous.
So it's, it's very, it's already a heart disease to predict progression and the rates of progression is very different for each patient. . And then the second part are the scales that are being used currently in the clinic. A lot of them are very old. You know, when you say cognition, the gold standard right now for how to test for cognition is Aras Cog.
You know, it's a tool or a questionnaire that Clinical developer or drug developer used to measure in a, in a uniform way, right? They're trying to uniform to use it in a uni. It's a very old scale, like I was developed in 1984. , you know, I keep saying this, I'm gonna keep saying I was born in 1985. I, I can, I, I can't live with the idea that we're still using tools in the clinic that are older than me when we have all of this advancement in technology and much more advanced understanding of the disease.
And then third part is execution. , when you're testing for cognition, it's not a tangible, it's not like blood pressure, it's not the size of the tumor. These are heavily impacted with the environment. If I come, you know, if you, if you go through a very stressful experience, let's say that you're stuck in traffic for two hours, you get into the clinic, do you think you're gonna test in the same way when a patient in another clinic walked?
To the clinic, five minute walk, pleasant, you know, weather. They're having their cup of tea or cup of coffee. It's very different. So there's also a lot of that co variance or variability in the environment around testing for cognition and, and, and these, you know, less quantitative endpoints.
[00:32:01] Kevin Folta: It's a challenge to really put a finger on what PR progress really means, and then you put that on a heterogeneous genetic background and other issues with aging that can confound results.
And I can understand why this is so challenging, but could you give us a little bit more illumination on, on the recent situation with. Aducanumab, which is one of the drugs from bio one of the monoclonals from Biogen. And you know, what exactly happened there, where there was skepticism around its efficacy or its safety, and then how that maybe kind of poisoned the well for the next couple waves of therapeutics that are have been given this kind of a.
Fast track approval.
[00:32:40] Leen Kawas: Okay, so ADU Helm, which is the same drug as aducanumab. It's, I don't, I mean, from my point of view, I have very different point of view than a lot of people that are in the Alzheimer's ecosystem. I don't think it's poisoned the, well, honestly, I. . If people are open-minded, I think it will open up new horizons.
It failed commercially. So I'm hoping the Cambi will be that drug, which is the second antibody that was approved via Biogen and Isai. If we studied this in the real world and. Patients to be followed for the same timeframe where again, I, I mentioned this earlier, but it takes around 10 years to see clinical outcome from the start of accumulation of these proteins.
So I think allowing us to study in the real world, there's gonna be a lot of academicians who will study these drugs in controlled clinical trials that will give additional data that you cannot have in just traditional drug development path. So I think it's gonna open up opportunities for. , other modalities, other drugs that are in the pipeline for Alzheimer's.
It will give us better understanding of the impact of these drugs in the real world evidence, and hopefully it'll give us tools to how to test Alzheimer's disease. within a controlled double blind clinical trials. I think it's a good thing. I hope more people would see it as a good thing and really support a successful launch of embi and successful understanding, better understanding for us on the impact of these treatment on Alzheimer's disease and how we can test Alzheimer's disease in a better.
[00:34:30] Kevin Folta: Now one other question that maybe I should have asked right off the bat is, what is the biological normal role of beta amyloid? Is it, I mean, we're obviously synthesizing this thing as a, a gene that makes a protein and you know, what is it and is it just that it goes wrong somehow? .
[00:34:47] Leen Kawas: Yeah, I think it's a pathway.
Typically there, there is a pathology within the, the pathway. It's different for different patients, but there's an aggregation of these proteins. And when these pro, there's two, two philosophies here. Some say that there is. The degenerative process. So when the brain starts going through I guess the dying process or and lose loss of synapses and brain cells starts to degrade or stop functioning as well, that we start seeing that the br the brain cells are not able to traffic and get rid of these proteins.
So they a. . Then there's the other part that of the community that says, well, that's actually the other way around. We start seeing an imbalance of these proteins, aggregation of Abeta plaques in the brain, and we ultimately see this leads to neurodegeneration. There's some people that say neurodegeneration leads to Abeta plaque accumulation and the others.
And there's the other side that says, no Abeta am myeloid. Plaque aggregation leads to de degeneration, and we're not gonna be able to understand this fully until we test this drug in the real world with longer period of time and have these Rey trials and which will lead to access to the treatment to better understand the exact biological role and pathological role of Avia to amyloid in Alzheimer's.
[00:36:16] Kevin Folta: Well, you, you said that you know, we do the experiments and may allow access to these drugs, but right now there's not even reimbursement for screening with the with the pet test. And so what are the costs of these things projected to be? And is this something that's covered by, by Medicare or is this something that is, looks like insurance will.
[00:36:38] Leen Kawas: So c m s they, it's a very unique thing that they did with these drugs that they said that we are only gonna reimburse pet imaging and adu hem and Avi any other. Drugs that are within this class only within clinical trials or, or testing ORs, which I think still is a good thing. It's not like completely closed, and that's why Lilly sorry.
Biogen and, and Isai as well as Lilly are, are pursuing a full approval. C m s said, if you go through the accelerated approval, we are gonna limit our reimbursement, but Biogen and ECI can still have a huge registry trial. You know, 30 plus people that go into their registry trial and follow the progression of patients that are on treatment for a long period of time to help, to help us better understand.
yes. Access is not great, but we need to think. That's why I said at the beginning of the podcast, I would love to see more people thinking outside of the box and executing on strategies that are outside of the box. Having a huge re trial for MBI could allow for more. Access and at the same time, better understanding because we are gonna collect data in a more uniform and organized way in the real world.
As well. I'm sure there's gonna be more academic institutes and researchers that will be looking to test for the hypothesis and the impact of this drug alone or in combination with other modalities. access is not perfect. Still is. I, and, and, and Biogen price this at 20,000, $26,000 a year.
Higher. It's lower than the previous pricing. Still high. But I think there are ways that they can allow access.
[00:38:27] Kevin Folta: Well, it, it sounds, it, it still sounds pretty high and then it's been a, a point of discussion around a number of therapies that have come through biotech in the last six months. But how can legislation change this and is there room under the, you know, inflation reduction act to potentially change the structure of how these types of therapies may be reimbursed?
[00:38:48] Leen Kawas: I, I think the biggest burden for Alzheimer's. You know, Alzheimer's, the biggest burden is in, on the, on the c m s because of the nature of the population that it impacts. According to a study that si and, and and Biogen has done, it's that it costs the system $37,000 to take care of an Alzheimer's patient.
I don't know if this includes the indirect costs $26,000. I think they priced it at this high of a, and even with, with ed U Hem, I think they knew that they're gonna have limited access with this treatment. And, and we need capital to go into innovative organizations back to the innovative organization to.
Allow for additional drugs to go forward. I'm not sure if the Anti Inflation Act will have an impact on, at this point, at least on MBI and ahe, although there has been a lot of pushback from the industry as well. I, I do think that the anti inflation act, the outcome on our industry. , at least initially.
It's very minimal. There has been a lot of reaction. I wish people read into the details, not just the headlines, because, you know, better management of pricing could allow to more access, right? If, if the drugs are more affordable, there could be higher access. meaning more people will get the treatment and ultimately, you know, more consistent.
So people will, not, a lot of people stop taking their medications because of the expense that's on them, but there's more protection on patients in this new affordable and anti inflation act bell. That I think will be a good thing for the industry and for the.
[00:40:33] Kevin Folta: Well, you know, the access is one thing, but the public's willingness to access it is something else.
And as you mentioned, you know, cost can be one of the issues, but we've seen such a big pushback against big pharma. You know, you look at Covid 19 and at least a very palpable presence, if not, you know, many people, a small but vocal cadre of folks who are speaking out against things. COVID 19 Vaccines and Agriculture and Genetic Engineering.
And do you think that new therapies of biotechnology really even stand a chance for widespread public acceptance? Overall,
[00:41:08] Leen Kawas: I think Covid has had a positive impact on the industry because what we've seen is a whole industry coming together to promote innovation and we had multiple vaccines that had helped to manage the pandemic and allowed us to go back to some sort of a new norm.
Right. Kevin? And I do hope that people go beyond the headlines and go beyond the, just the general reaction and go into the details of things. And they will see that there's a lot of great things that come out of our industries, including therapies that help, you know, cure some type of cancers, deliver vaccines that help give optionalities for people and.
You know, hopefully Alzheimer's is, is on the path for breakthrough. We, you know, to be realistic, none of the drugs that are approved to date are, are these breakthroughs, but with more approvals and more access and more understanding of the different type of diseases. , I think there will be continued increase in acceptance and appreciation of the hard work of a lot of people in our industry.
[00:42:25] Kevin Folta: Well, that would be a really good place to end, a really good forward thinking place to kind of put some, put some punctuation. But I'd like you to take out your crystal ball for a second. And is there anything. , is there something that seems really promising on your ar, on your radar that really is exciting?
I
[00:42:44] Leen Kawas: would say cell therapy. We're looking at a lot of new curative approaches and synthetic biology. The microbiome understanding is also another exciting area that we've been looking. . And the third thing that is really I think gonna be transformative for our industry is the overlap between the high tech, the traditional technology industry alongside the life science and biotech, where we are gonna see tremendous innovation in clinical trial testing.
and data processing and I guess the blockchain of data and, and you know, new ways that we can develop treatments. or tools to help us lead a healthier life. Yeah. I
[00:43:31] Kevin Folta: only see it accelerating. I, I think I, as, as these dominoes begin to fall, we'll see more fall and it, it's the way that science is shaking out.
I mean, 10 years ago we barely had CRISPR cast nine gene editing. You know, it was a blip on the radar and now has revolutionized the way we do things. So the next couple of years are gonna be really incredible and I, I'm really excited that we took the time to talk about some of this. If people wanted to learn more about propelled bio partners or, or you where could they find you online or maybe in social media?
[00:44:05] Leen Kawas: Yeah, I think like propelled bio. Pardon? We have a website, propelled bio.com. We are on LinkedIn as well. Me personally, I'm on LinkedIn. I'm very responsive to entrepreneurs. I. and I'm on Twitter, very active , but social media, if you type my name, I have a very unique name. You'll find me. And if you, if anyone wants any advice or to start the conversation, happy to.
[00:44:31] Kevin Folta: Yeah, I need some advice. Actually, what I need is a little bit of funding to put a revolutionary idea in order , and it doesn't fit in any of the national funding programs very well. And it's really cool because it works like a charm, but I. Find support. So maybe we'll have to have a conversation with some ex, some exciting entrepreneurs someday.
But, well, thank you very much, lean Kawas. Thank you so much for your time and we'll talk to you again after the next big breakthrough.
[00:44:57] Leen Kawas: Thank you so much Kevin,
[00:44:59] Kevin Folta: and for everyone listening, thank you so much for joining us on The Talking Biotech Podcast by Col Collabora check out collabs web, website, and products and keep in mind that their products do help you do what you do a little bit easier.
So this is The Talking Biotech Podcast by Col Collabora, and we'll talk to you again next week.