Junaid Kalia MD (00:06.938) Good morning, everyone! Today's episode is going to be fascinating. I'm going to give you updates from how the FDA has changed its tune. We're going to talk a lot more about it. And then of course, our own amazing Edward Marks has been at JPM. He's going to give us the sentiment of how this all ties together.

Junaid Kalia MD (14:29.188) And by the way, this is going to become extremely important. And I'm going to give you some updates. I think your friend Sherry Diwala, and by the way, our good friend Harvey is working on some AI governance structure because that whole clinical decision support is out. It does not require FDA approval. So FDA has said, we just cannot regulate it. Go ahead and do it. Now the problem is that if you are going to go ahead and do it, you need to

create proper frameworks, organization frameworks, which we have talked about from the very beginning. But now this is the first time that we're getting green light from FDA. Of course, this is where the whole, by the way, this definitely needs to be updated in the show notes. If you want to understand what Marty McCarrie's FDA is all about, this is the one that is done by Olloman Podcast, and he goes through all of it.

like accelerating drug approval. Then he talks about biosimilarities, food, everything. And this is really one thing that you need to understand how FDA is reshaping itself and how they're making fast. And one of the things that he said that they're not going to miss a deadline, and they didn't, because we put three FDAs, we're putting the fourth one, and believe it or not, I can attest to it, they are actually not missing any deadlines. So I cannot believe that FDA is becoming this efficient and this better, and then realizing what they can and what they cannot.

So big news out of FDA at the CES 2026, that the biggest problem, remember that we talked about whoop and aura and everything, there are basically now wellness devices. And they officially said that in the wellness space, we are not going to do regulation.. So first and foremost, let's talk about this, Ed and JPM. What are your thoughts? Is it face a good thing, bad thing? let's just talk about wellness first and then we'll talk about, I'll explain what CDS means and then we'll go.

Ed (17:22.583) Yeah. Well, I mean, I'm not Pollyanna, you know, I know, for instance, when we talk about peptides, where, where it's not super regulated. And if we waited for regulations, it take forever. Prices would increase all that kind of stuff. And we lose, you know, again, sort of the ability to execute our businesses. So you have to balance that with letting, letting loose a little bit and letting capitalism flow, which obviously that's sort of.

how I'm bent. So the last thing we want to do is encumber them with this. I think we should let this area go and let's see what develops out of it. you know, I think it'll accelerate innovation.

Junaid Kalia MD (18:51.014) Okay, so my two cents, number one. there's something called a remote patient monitoring, or remote physiological monitoring. We used to get $80 per month. And the way we used to do it is that we had an FDA approved device, of course, at that point in time, because then you have to go to Medicare to submit a fricking bill. That whole market is gonna go away, dude.

And I think stroke patients, Parkinson's patients should have RPM. And it's really helpful because we need to adjust micro adjust medications, even epilepsy, all of that, because right away, like what the frick is going on? Every three months I'm going to have an adjustment in medication. What is like, this is total bullshit. I mean, the medication has a high fly for five days. I should have a make another adjustment at seven days, right?

Because I don't have the data. don't like this should be better

So I'm really worried about that space because here's my problem as a clinician and I don't know what your thoughts are. Can I use this for clinical decision support, which is the next one? Now let me explain what clinical decision support is. Clinical decision support means that I get the data from multiple different sources, cardiologist notes, nephrology notes, whatever. That is pure clinical intelligence from a, that's it. The second thing is,

Continuous widely which is not fast and now we're getting continuous vital from potentially whooping aura Now I have to do clinical decision support, which is fantastic that they actually move clinical decisions board as well But then there's no pathway for reimbursement Why would I use it as a physician or as a board member? You're gonna say well, how is gonna? hospital system Basically put energy and time into it except for one thing is for sure right there's a clear

marginal benefit because my time saves. So therefore my time actually is going to be used, utilized better

So now

Ed, as a board member, as CEO comes and talks to you and tells you, number one, how to incentivize physicians to actually use it better. I mean, we're going to still use it for complex cases more so, right?

Ed (22:30.136) Yeah. Well, it's definitely a conundrum. Yeah. It's definitely a conundrum.But yeah, it's a conundrum and that's why population health is a cure-all where we just take, we get incentivized to take care of our population. So then we'll be incentivized to use whatever it means we can, get all the data we can. We don't have to worry about the payment structure in order to get it.

But you're right. Patients are now presenting on that type of patient with all sorts of data and the clinician is not, or the health system is not getting reimbursed to look at all my data all the time and they're to get data fatigue and all that kind of stuff. And then also there's the liability, right? Who's liable? Like just cause I send you my data, it doesn't get me off the hook as a patient. Does that, the responsibility now transfer to you? You didn't want all that data. You didn't ask for all that data.

You got to follow the money. What are we going to do? What's the solution? Because you're not getting paid to look at all this data and it's taking a lot of time, but you're a great clinician. You care about your patients. So you kind of want to see the data because you know you can make changes. I guess my answer goes back to that intermediary step I was talking about where

we have some sort of filtering capability, leveraging AI, and I'm sure it exists today. And so that you only are alerted to the highest, know, whatever you need to see, you see. Otherwise you don't see it. And you put the risk back on the patient saying, hey, you can give me all this, but you're going to sign off the fact that, hey, you're at the end of the day, you're still responsible. Just because you sent me something does not absolve you from responsibility. I think it comes back to also making the patient responsible for their own.

Junaid Kalia MD (25:53.221) No, agreed But the idea is, and in my opinion, providers will have a choice in the sense that they can go through this properly governed structure with people who are like you, veterans, Sherry, Harvey, that understand at the level of ministries that have worked to actually produce that. That's number one. And then number two will be that the way that you structure platforms is important.

Look, I will pay for it. Why? Because there's a clear pain point. Just pay to pain is there.

Junaid Kalia MD (28:19.686) And I still do not believe that patients should pay for it. What are your thoughts about it? I know you're looking for a platform as a patient, for example. Do you think we should build platforms just for patients to be accessible, giving you a history? Google tried to build Google Health, failed, removed that project. Microsoft tried to build and started, actually they charged $10 per month, scratched that project. Keeping that in mind.

What do you think a survivability of a startup will be for just patient level?

Ed (28:54.904) Well, I mean, it's different era. mean, that was like 20 years ago and you know, technology was different, slower capabilities were less and the population in general was less educated. But now you're doing so much with AI is it's becoming so mainstream that I think it's worth it's worth another shot. think it's going to happen. So I'm not inundating you with all the data that we talked about, but it's just sending you like the relevant data per parameters that the user might've set up with you at an initial consult or something. So I think we are headed there for sure.

And again, it's moving fast.

Junaid Kalia MD (29:55.271) So different era, I agree 100% Now, first give us what JPM is, what JPM signifies for the world. And then you were there. You had massive amount of meetings. Your thoughts, the overall sentiment in the rooms that you were in. What do you see the future of JPM? Ed (33:34.2) Yeah. Yeah. Yeah. So, JPM and you can look up the site and they'll explain it much better for those who have no idea, but it's an annual conference by JP Morgan. And it's focused on healthcare always in San Francisco, usually the second full week of January,So health systems show up typically CEO, CFO, and they do presentations to investor communities, to banks. And they're really sort of working on, and they do it for a wide variety of reasons. And one is for sure to up their bond ratings, right? Hey, look what we're doing. We're financially sound and we have these investments coming in and we're doing our own AI. We're doing cool things, you know, so, you know, up our bond ratings, you know,

Ed (35:56.568) that sort of thing. that's a part of it. A lot of it is investors are there with their company. So I spent time with various companies that take in a lot of investment and talking to them about the future. What does it look like for them in the post-acute world, the acute world, the ambulatory space. That was super fascinating So this is a chance where everyone is in the same space. That's why it's so popular. So what were some of the uber themes? So therapeutic area highlights, you know, the whole oncology boom with antibody drug conjugates things that I was just learning about obesity drugs, of course, GLP big time radio pharmaceuticals.

big time. So sort of like, Hey, where are going with therapies, the dominance of AI? Then, then there was a big focus on, and again, I sort of alluded to this earlier on strategic &A and partnerships. And of course, know, investors typically sort of a positive outlook.

Ed (40:34.638) when it comes to the futures, but with biotech and pharma, I'm not talking about the viability of health systems. I'm talking about, you know, healthcare tech, that there is generally a positive outlook and the R and D process because AI is getting more efficient, right? We talked about this before, a bench to bedside, how long that takes with pharmaceuticals, things like that. That's all being dramatically cut now, which is saving a lot of money, getting things to market faster. so number one, so JPM is basically series A and after people ask me, why aren't you going? Well, I'm actually at seed stage. The second thing that JPM really is all about

is actually those billion dollar problems. New drugs, new biologics, new biosimilarities, et cetera. And then again, putting that through, as he suggested, improving the bond value, the financial structures, et cetera.I get invitations every year, by the way, and it's $30,000 at least just to fricking register for a conference and everything. But I'm not going there because of that. And I will, because when the time comes. However, these side conversations are very important. Why is it important? Because you're looking at key decision makers looking at a specific team.

And we have talked about this in the age of AI, the most important thing is human trust. And you're going to see that more and more valuable over time. And that's why we are here. That's why we're saying this. That's why we're teaching you how to build trust in your processes and also your products. product is one thing, but governance is about processes. And you need to build trust in your processes so that your product sells.

Junaid Kalia MD (45:15.846) And then lastly, as you were pointing out, is that, of course, it's very hard to get in front of people, which is very simple. I it's hard to get in front of me, for God's sakes, and I'm nobody. But what I'm saying is that it is getting harder and harder. And that's why, again, these conferences are helpful, that even small introductions from not directly the key decision makers, but key advisors can get you in front of tables and conversations.

Ed, now, what is one big thing that resonated? But number two, what is the pain point other than China that everyone said, and especially given the new updates from FDA And number two, thoughts on biologics and biosimilars

Ed (47:11.31) Well, I think there's definitely because there's less bureaucracy they deal with and there's probably government subsidies. the price points are much cheaper. so it's hard to compete when, you can be flooded inundated with a lower cost items So it's kind of like, how do we make sure that these biologics, these other things that are coming through, great that they're less expensive, that's great, because then it forces people to sharpen their pencils a bit and get more price competitive, but to make sure that those...

corners are cut when it comes to patient safety and quality of care.And one way of doing that is to cut out regulation. And again, we're not taking a political point of view here. We're just saying that.

That's the impetus behind what's going on. And it's true.

Ed (49:04.943) We had a policy of policies. We had so many policies that we had policy over the policies. So we did things safely with high quality care. Very good, very important.

But then we added rules upon rules upon rules and pretty soon we're like, my gosh, we created a monster. And so I think what they're doing is trying to dismantle that monster. Hopefully they can do it in a very smart way, leveraging AI. So again, the synopsis of the answer is, hey, we're not price competitive. They're coming at much lower price and then they're much faster to market. And so we are reversing that by the actions you're seeing taken at the FDA.

Junaid Kalia MD (50:27.694) Yeah. Specifically, why am I excited about biologics and biosimilars and everything? Well, this is truly where...

medicine comes in in the part like, for example, we have a lot of autoimmune disorders and that's where the peptides and all that discussion is coming through is both because we have to understand that that section is wellness, which is biohacking, which is different. And then there is pure medicine health. So wellness and health are two different wellness. have peptides and everything. then health is basically biologics and biosimilars. Within the modern era, there are two major issues that

came up, right? We came from this dual sort of infectious disease. Malaria is generally gone. Then we came to heart disorders. We know exactly what the problems with the heart is. We have fixed it. Now then there's autoimmune and cancer. So the latter of medicine is basically that, right? So cancer medication is, of course, are also reactive to RNA, DNA, proteins, et cetera.

given the alpha protein and we talked about it, drug. Biologics are something that at least me as a person get a lot of pitch decks and that's nothing to do with US by the way. Because they can be manufactured in India, Pakistan, Bangladesh. And I mean, by the way, in all honesty, some of this is a little bit privileged, but still, I'm not gonna name the country, but in the Middle East, you're gonna see factories that are going to be built.

Ed (52:04.859) Yeah.

Junaid Kalia MD (52:05.265) for the biologics because that is it. And it's very important that I get my DNA sequenced, including the RNA or the proteins, everything. And then there's a specific biosimilar for me built. And that will be truly important for personalized medicine because that will significantly decrease the overall chances of et cetera. And this autoimmune disorder, cancer, and all of this is the driving factor, which by the way is the driving is really where, you know.

Ed (52:23.055) Yeah.

Junaid Kalia MD (52:34.758) unfortunately, the modern disease states are. And I think personally, that we are entering in a new era. I did not, and that's another freaking amazing thing is that within a year, things change so fast. Ed is going to talk about the insane pace of change because he goes to many conferences more than I do. So.

Ed (52:37.209) Yeah.

Junaid Kalia MD (53:04.208) What is like, is it? This is the first time and I'm a super learner as you can see, right? can do these and make it structure, make sure everything is so like, it is getting out of hand for me to keep up, which is very, because I've been reading this. Junaid Kalia MD (53:32.012) The minute I get out into the house, I want to update myself, but this is the first time in my life that I feel overwhelmed. And just to remind you, I'm a neurocognitive care stroke and epilepsy specialist while building a founder. And the first time I feel overwhelmed.

Ed (53:51.516) Yeah, it's the pace change is, is wild and you have to remain sane and keep your mental health and your physical health, uh, through all of it. Anyone watching this probably in the top 5%, we're probably in the top 5 % in terms of staying up ahead of things, staying alerted. Yeah, there's always gonna be something more, something more, something more. But I took a little bit of comfort to think to myself like, you know what, I'm doing okay. I don't need to get up any earlier. I don't need to, you know, get overwhelmed by the situation.

but I should just remain focused on what I do and what I'm called to do, but continuously learn, but at an appropriate level and then just try new things. I'm always like, that's just my general counsel when it comes to AI or anything in life is like always try new things. And that's a beautiful thing. I'll just close with this, just continue to educate yourself in different ways that are best for you.