Latest / CareTalk: Healthcare. Unfiltered. / Why Rare Disease Research is So Important

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Why Rare Disease Research is So Important · CareTalk: Healthcare. Unfiltered.

• 0:00
  David: Rare diseases are surprisingly common.
• 0:02
  David: They affect up to 10% of the population, mainly children.
• 0:06
  David: Only about 5% of the 7,000 or so known rare diseases have treatments, so that makes it a real challenge for families, foundations, pharma companies, anybody trying to do something about it.
• 0:16
  David: But there is hope, including the Orphan Drug Act, F D a, programs to speed development, advances in genomics, and the digitization and interconnectivity of patient data.
• 0:26
  David: Welcome to CareTalk America's home for incisive debate about healthcare, business and policy.
• 0:31
  David: I'm David Williams, president of Health Business Group.
• 0:33
  David: I'm hosting the podcast solo this week.
• 0:35
  David: Fortunately, I have a great guest here, Nasha Fitter.
• 0:38
  David: She's co-founder and CEO of FOXG1 Resarch Research and VP for Real World Evidence and Ciitizen Platform at Invitation.
• 0:44
  David: She's an expert on rare disease from both the personal and professional standpoint.
• 0:49
  David: Nasha, thanks for joining me today on Care
• 0:51
  Nasha: Talk.
• 0:52
  Nasha: Thank you for inviting me.
• 0:53
  Nasha: Excited for the conversation.
• 0:55
  David: Outstanding.
• 0:55
  David: So let's start about rare diseases.
• 0:57
  David: I said rare diseases are common.
• 0:58
  David: So what are rare diseases and why it is, IM, why is it so important to focus on them?
• 1:02
  David: Yeah, this
• 1:03
  Nasha: is a great question.
• 1:04
  Nasha: Rare diseases are not that rare.
• 1:05
  Nasha: When you add up all the, all the conditions and you know, now we're actually up closer to 10,000 is the the latest figure I heard.
• 1:13
  Nasha: Um, and they're defined to be a rare disease.
• 1:15
  Nasha: You have to have less than 200,000 patients in the United.
• 1:20
  Nasha: But the truth is, the majority of rare diseases are actually ultra rare, defined as ultra rare, where you have less than 2000 patients in the United States, and that is the big chunk of the problem.
• 1:30
  Nasha: You have a lot of very small conditions.
• 1:33
  Nasha: You don't, you know, the, the way that capital markets are structured, the cost of drug development, it doesn't align with actually finding therapies for these extremely small conditions.
• 1:43
  Nasha: So why a rare disease is important.
• 1:44
  Nasha: Number one, it's a public health crisis.
• 1:47
  Nasha: When you add up all these small diseases, it's a big number.
• 1:49
  Nasha: Um, every life Foundation actually put a report out that said they looked at about 400 rare diseases.
• 1:54
  Nasha: The cost to the US economy was $1 trillion, and that's direct medical cost.
• 1:59
  Nasha: It's loss of productivity.
• 2:01
  Nasha: Unpaid bills, et cetera, and then you just think of the mental, physical, emotional burden on families.
• 2:07
  Nasha: So it's a public health crisis.
• 2:08
  Nasha: That's one important reason we need to focus on these ultra rare conditions.
• 2:12
  Nasha: The second is that rare, rare diseases are a window into curing larger, complex mainstream conditions.
• 2:19
  Nasha: Take Alzheimer's.
• 2:20
  Nasha: Alzheimer's.
• 2:21
  Nasha: Why is so hard to find therapies?
• 2:23
  Nasha: Because it's such a complicated condition where multiple genes, many, many, many genes are impacted.
• 2:28
  Nasha: But if you start looking at rare conditions, the majority of them are what we call monogenic.
• 2:33
  Nasha: You have small patient populations.
• 2:35
  Nasha: You can actually trial drugs and figure out, we take FOXG1 for example.
• 2:39
  Nasha: Great.
• 2:40
  Nasha: We find out that if we increase FOXG1 expression, memory and cognition improve FOXG1 is one of the genes implemented, uh, impacted in Alzheimer's, could FOXG1 be a target for Alzheimer's?
• 2:50
  Nasha: So you start to be able to actually understand larger conditions.
• 2:53
  Nasha: So those are the two reasons that focusing on rare is so critical.
• 2:57
  David: Yeah, makes sense.
• 2:57
  David: And what are you seeing being done to prioritize, you know, rare.
• 3:01
  David: Treatment development.
• 3:03
  David: It's a challenging, he said it's this, you know, only a few people affected by any one of these rare or ultra rare diseases.
• 3:09
  David: So how, how does you make a
• 3:10
  Nasha: priority out Therein lies the struggle.
• 3:12
  Nasha: I don't think we're making enough of a priority.
• 3:14
  Nasha: You know, the Orphan Drug Act passed in the eighties, um, was great.
• 3:18
  Nasha: It was a great first step.
• 3:20
  Nasha: Gave incentives to pharma companies to focus on rare.
• 3:22
  Nasha: There is tax incentives, there's, you know, priorities, there's patent, um, exclusivities.
• 3:28
  Nasha: So that is all great.
• 3:29
  Nasha: But what we've seen happen is pharma companies will focus on large rare diseases like Huntington's, which is closer to that 200,000 mark.
• 3:37
  Nasha: They're not focusing on the ultra, ultra rare conditions, which again, are the majority of the rare diseases that we have today.
• 3:43
  Nasha: So I think it was a great first step.
• 3:44
  Nasha: I think it needs to be looked at again.
• 3:46
  Nasha: There are other things the F D A is doing, but to be honest, not enough.
• 3:49
  Nasha: And I also don't believe our current capital markets are set up to find scaled solutions for for rare.
• 3:57
  Nasha: .
• 3:57
  Nasha: David: So, you know, you mentioned the uh, for a while, and that's treating the rare, you know, it's affecting the rare conditions, but as you say, you know, the less rare, but within the, under the cap is sort of where it, where that goes.
• 4:08
  Nasha: And F D a in terms of accelerating approvals or making it easier to get into trials, what are some of those programs and are those effective?
• 4:15
  Nasha: Are those just sort of, uh, a footnote?
• 4:16
  Nasha: So in theory they're effective, are they being implement.
• 4:20
  Nasha: They're not being implemented and it's, um, you know, the Accelerated Approvals Act is amazing because it allows you to literally accelerate your trial.
• 4:29
  Nasha: So for an ultra wear condition, you don't have to go through phase one, phase two, phase three, mainly phase three.
• 4:35
  Nasha: If you think about a gene therapy for an ultra wear condition, it costs about 75 to a hundred million.
• 4:41
  Nasha: What pharma company is going to take that when you've got 500 patients?
• 4:44
  Nasha: Like, it's just, it doesn't make sense.
• 4:46
  Nasha: So we have to find ways to do an accelerated approval.
• 4:49
  Nasha: And what that basically means is using a surrogate endpoint instead of a clinical endpoint.
• 4:54
  Nasha: So if we take the FOXG1 U one case again, you could say, alright, an increase in protein expression, that's a surrogate endpoint.
• 5:00
  Nasha: We're not going to see the clinical manifestation of that for years following.
• 5:04
  Nasha: So what the accelerated approval process does is it says, alright, we'll approve you based on the fact that you can increase.
• 5:11
  Nasha: And then we'll follow patients in post-marketing after approval for 10 to 15 years to then document their clinical successes.
• 5:19
  Nasha: This is really powerful.
• 5:20
  Nasha: It allows us to skip that very large, you know, pivotal study.
• 5:24
  Nasha: The phase three study brings costs down, gets drugs to patients faster.
• 5:28
  Nasha: Is it riskier?
• 5:29
  Nasha: Absolutely.
• 5:30
  Nasha: But when you have patients with fatal conditions, high unmet need.
• 5:34
  Nasha: You know, leave it up to the patients to make the decision whether they want to take that risk.
• 5:38
  Nasha: And unfortunately, it's not being implemented fast enough.
• 5:41
  Nasha: You have a lot of pharma companies, autogenics is leading the charge there.
• 5:45
  Nasha: Praxis precision medicines, pushing the F fda.
• 5:47
  Nasha: Um, and what's unfortunately happening is a lot of companies are either dropping programs or they're taking that clinical trials to Europe, which, you know, we're seeing the, um, accelerated approvals being, being done in Europe and, and that's not, that's not good news for, for US patients.
• 6:05
  David: So when you talk about the surrogate endpoints, I know there's been some controversy about that, maybe less than the ultra rare side, but maybe with, with, uh, less rare conditions, maybe in oncology you have things that are approved with surrogate endpoints, and then, you know, in the end of the day, do they, they really work out and they are expensive.
• 6:19
  David: Here I think you're drawing a different distinction, which is you've got a fatal condition with, uh, no treatments.
• 6:24
  David: approved and the sort of the risk for work balance is a little bit different.
• 6:28
  Nasha: Exactly.
• 6:28
  Nasha: It's all about your unmet need and what is the risk.
• 6:30
  Nasha: And if your unmet need is greater than the risk, you should be able to do an accelerated approval.
• 6:35
  Nasha: And again, it's up to the patient.
• 6:36
  Nasha: Do you want to, or the caregiver, is this a risk you're willing to take?
• 6:40
  Nasha: And, and just to be clear, these drugs are going through toxicology first.
• 6:44
  Nasha: We're, we're testing safety first.
• 6:46
  Nasha: It's efficacy.
• 6:47
  Nasha: We're talking.
• 6:49
  David: talk about some of the other challenges or, you know, innovations with doing clinical trials when you've got small patient populations.
• 6:55
  David: So I imagine that, you know, if we're doing, if we're doing a trial of a blood pressure, I might have a placebo control.
• 7:01
  David: Uh, if you've got a fatal illness, you probably don't want a placebo control.
• 7:03
  David: You don't wanna be in that arm of it.
• 7:05
  David: There's not enough patients.
• 7:06
  David: What are, what are some of the special considerations?
• 7:07
  David: Yeah,
• 7:08
  Nasha: I feel like all I'm doing is talking about bad news on this podcast, but there are a lot of great innovations happening, , but, um, yeah, so, you know,
• 7:15
  David: the, yeah.
• 7:16
  David: I'll have to ask better.
• 7:17
  David: I'll have to ask better.
• 7:18
  David: I'll have to ask questions that lead themselves in that direction.
• 7:20
  David: Next, but
• 7:21
  Nasha: state the placebo arm is another big part of the accelerated approval trial, right?
• 7:25
  Nasha: The, the process, which is can you use a patient's own natural history study as their own placebo, like you mentioned, who have a gene therapy, a neurological condition?
• 7:34
  Nasha: You have to inject a child either in their spine or under their, like in the neck area, right under their brain, what caregiver is going to sign their child?
• 7:44
  Nasha: Where there's a 50% chance they could be a placebo, it's never going to happen.
• 7:48
  Nasha: And so this is what we're seeing.
• 7:49
  Nasha: Yeah.
• 7:50
  Nasha: So in addition to it being so expensive, you also can't fill your trial.
• 7:54
  Nasha: And these, these trials don't get filled.
• 7:55
  Nasha: They get dropped.
• 7:56
  Nasha: It's, it's a huge problem.
• 7:57
  Nasha: So again, you know, and what's exciting now is that, and this is, you know, where I got into Ciitizen, but there are, there is many technologies now that are allowing us to collect patient DA data at a much deeper.
• 8:09
  Nasha: And so using a patient's own information for a natural history study is becoming a reality.
• 8:14
  Nasha: We don't necessarily need to do placebos or we can at least, you know, do a smaller placebo, et cetera.
• 8:20
  Nasha: Like there's ways that we need to think about innovative trial design.
• 8:23
  Nasha: The placebo is a, is a huge area and the, the good news is that there are a lot of companies innovating in the space.
• 8:30
  Nasha: A lot of organizations looking for better endpoints, better biomark.
• 8:34
  Nasha: and the F FDA is open to listen and so, and I think the F D A basically needs to be convinced.
• 8:38
  Nasha: So
• 8:39
  David: just to be clear, so on the natural history side with that is we're doing, in a placebo controlled trial, you'd say, here's someone that is otherwise identical and one is gonna get an intervention and one isn't.
• 8:48
  David: And we'll compare the difference.
• 8:49
  David: Natural history, what you're saying is the patients on a certain trajectory.
• 8:52
  David: And, uh, when you have a medication or some sort of a therapy, does it alter that the course of their, of their history?
• 8:58
  David: So you're comparing the patient with themself Exactly.
• 9:00
  David: The, uh, is that the idea?
• 9:01
  David: Of course.
• 9:01
  David: It's within their own,
• 9:03
  Nasha: yeah.
• 9:03
  Nasha: Or it's their synthetic twin, sorry.
• 9:05
  Nasha: It's go aheads, their synthetic twin.
• 9:07
  Nasha: So it's a patient that's very similar, has this same mutation who's older.
• 9:12
  Nasha: We, you know, we look at their entire natural history course and we say, all right, the, the way this is looking.
• 9:17
  Nasha: at age 10, this patient will still not be able to stand.
• 9:21
  Nasha: I'm just putting an example.
• 9:22
  Nasha: You have a drug that the patient starts being able to stand.
• 9:25
  Nasha: Yeah, you said that.
• 9:25
  Nasha: Okay.
• 9:26
  Nasha: There's been a, there a therapeutic effect.
• 9:28
  Nasha: So it is exactly using the data and there's enough bioinformatics tools now that can even take a small size, a small population of data and extrapolate that so you can have a larger natural history study.
• 9:39
  Nasha: Those are the kinds of exciting innovations that are happening.
• 9:42
  Nasha: that can move us away from, you know, using actual patients as a placebo.
• 9:46
  Nasha: Great.
• 9:46
  David: So with, you know, with the use of patient as a placebo, you're, if, if you can get them in, which we wouldn't even recommend you Exactly.
• 9:51
  David: For ethical reasons, um, you're throwing away half the data in a, in a sense, and this way it sounds like there's a few different areas.
• 9:57
  David: One is there's better kinds of data that can actually.
• 10:00
  David: Be derived.
• 10:02
  David: Yep.
• 10:02
  David: Sounds like bioinformatic, uh, data.
• 10:04
  David: There's different ways to manipulate it, and then there's also probably, uh, different ways to share it and make it so that it's actually more, you know, you've actually can get the whole patient record together.
• 10:14
  David: Can you maybe just talk about what are the different components where you're seeing
• 10:16
  Nasha: progress?
• 10:17
  Nasha: Yeah.
• 10:17
  Nasha: You know, one of the areas which I find amazing when you have epilepsy trials is they look at endpoints based on a survey that.
• 10:24
  Nasha: You know, it's called a seizure diary that a caregiver takes.
• 10:27
  Nasha: I can tell you as a caregiver of a child, um, who has seizures, I know that I'm doing the seizure diary incorrectly.
• 10:34
  Nasha: It's very difficult to classify seizures to know what type of seizures to get the exact time, but we still need that.
• 10:40
  Nasha: This is the endpoint, the F d A uses for all epilepsy trials.
• 10:44
  Nasha: . So there's really innovative companies, beacon bio signals right here in in Boston as an example, looking at actually taking the e eeg tracing and analyzing spike burden.
• 10:55
  Nasha: They did a very interesting study where they looked at spike burden and then compared it to seizure diaries of the same population.
• 11:01
  Nasha: And, and caregivers are missing hundreds of seizures, right?
• 11:04
  Nasha: And they're classifying them incorrectly.
• 11:06
  Nasha: So there's really interesting, um, technologies coming out and that's going to help us understand are drugs actually effective?
• 11:13
  Nasha: Other things that I'm seeing, you know, there's really interesting companies that are sending iPhones home to, to families, homes, seeing, you know, just video your children's movement disorders.
• 11:23
  Nasha: Upload all of these videos to one site.
• 11:25
  Nasha: Let's then have a group of experts come and analyze the videos.
• 11:29
  Nasha: This is exciting for two reasons.
• 11:30
  Nasha: One is you're not taking the child out of their home environment.
• 11:34
  Nasha: The second you take a patient out of their home environment, you've already created a placebo.
• 11:38
  Nasha: You've already created an issue.
• 11:40
  Nasha: They're not acting the same way they normally would et.
• 11:43
  Nasha: Cetera.
• 11:43
  Nasha: So they're in the home.
• 11:44
  Nasha: You get to see the exact phenotype, exact symptom, and then you don't have one person evaluating.
• 11:49
  Nasha: You have a group of experts evaluating.
• 11:51
  Nasha: I mean this, it seems so basic when I talk to you about this.
• 11:54
  Nasha: In any other industry, you would think this is an obvious solution, but in healthcare, We're still not using technology enough to track patient symptoms minute by minute, day by day, and then use that tracking in a clinical trial instead of taking people as a placebo.
• 12:10
  Nasha: It's just, you know, it, it kind of, it, it boggle As someone who has come from tech and has not come from healthcare, I think there's a lot more we can do to innovate and, and make this experience better and, and mainly just have clinical trials that are more effective.
• 12:23
  Nasha: You know, even with everything we're doing, the majority of clinical trials.
• 12:27
  Nasha: Fast majority.
• 12:28
  Nasha: So we need better ways to track endpoints to make sure that, you know, these drugs actually have a therapeutic effect on patients track that effect.
• 12:37
  Nasha: Um, and so I'm excited about all the, the innovations.
• 12:41
  David: It sounds like the things that you're describing to increase the precision of the trials actually also may improve the quality of life for the people that are either living with the condition or their caregivers.
• 12:51
  David: I mean, you're, there's probably not too many people better than you.
• 12:54
  David: It would be able to do a seizure diary, and yet you struggle with, it also creates guilt for some people if they're, you know, supposed to be trying to do this and they're trying to track a record in addition to being a caregiver, et cetera.
• 13:04
  David: So it sounds like some of these things are just also taking the burden off of.
• 13:07
  David: Of individuals and also providing more precision and hope that the trials would actually work
• 13:11
  Nasha: as a result.
• 13:12
  Nasha: Yeah, you, you've absolutely hit it.
• 13:13
  Nasha: You know, a lot of trials, um, patients have to go into clinic sites or even before the trial to collect enough data.
• 13:19
  Nasha: Just getting a patient to travel to an academic center for a site visit.
• 13:23
  Nasha: Is hugely burdensome on patients that are living with really debilitating conditions, right?
• 13:28
  Nasha: You've got caregivers with children in wheelchairs.
• 13:30
  Nasha: Every time they take them somewhere, they have their feeding tubes, they have to worry, they're gonna have a seizure while traveling.
• 13:35
  Nasha: It's a lot to do just to take them to a center to collect data that could have been collected in their home environment.
• 13:41
  David: So, as I'd had, you know, started at the beginning alluding to it, and you mentioned more and even expanded the number of diseases out.
• 13:47
  David: , there's collectively a lot of diseases and a lot of people that are, that are affected by them.
• 13:52
  David: Obviously the cure has to be done presumably at the level of the, like the individual, you know, orphan mm-hmm.
• 13:57
  David: , patient sub, you know, ultra-orphan population.
• 14:00
  David: But what can be done at a little bit of a higher level?
• 14:03
  David: Are there ways that, you know, foundations work with, with what Another to aggregate certain things?
• 14:08
  David: Or is it, you know, how, how does
• 14:10
  Nasha: that actually work?
• 14:10
  Nasha: Yeah, absolutely.
• 14:11
  Nasha: And I think that's the beauty of the rare disease space is that it is a very collaborative environ.
• 14:16
  Nasha: Foundations do work together.
• 14:18
  Nasha: Many of my closest friends now run other advocacy groups for, for monogenic conditions.
• 14:23
  Nasha: And so there, and there are many projects that we have done together that we've pulled together.
• 14:27
  Nasha: You know, anytime that you're doing a project that, like you said, you're not treating the genetic core, you might be taking a downstream target, you can start looking at basket trials.
• 14:36
  Nasha: So there's many epilepsy basket trials, for example.
• 14:38
  Nasha: There's larger projects that we can do.
• 14:41
  Nasha: So there, there is a lot of, and there's a lot of know, knowledge sharing between groups on what is working for me, what could work for you, et cetera.
• 14:48
  Nasha: We're about to start a open study for Fin Tela, and that's a, that was a drug that is, you know, prescribed for L G s, Lenox, Gaso Syndrome, and Dravet.
• 14:56
  Nasha: And now we're able to take those learnings and apply it for FOXG1 G one.
• 15:00
  Nasha: So there's a lot of learning and collaboration in the space.
• 15:02
  Nasha: It's, it's very important.
• 15:04
  David: Let's talk a little bit about the behavior of the drug companies.
• 15:06
  David: You're saying there's some pathways available maybe from F D A that aren't being used or, or companies abandon them and you're contrasting it with some other industries?
• 15:14
  David: You know, my experience has been that sometimes.
• 15:16
  David: The companies are actually, you know, less, they, they have a lower threshold for risk taking or, or less of a willingness to believe F fda, whereas f FDA is often saying, no, give this a try.
• 15:27
  David: I, is that the case of what you see as well?
• 15:29
  David: Or how do you explain that phenomenon?
• 15:31
  Nasha: And 50000%, you know, when I went to Ciitizen, which is a platform we develop to collect medical records, patient medical records, and then extract information from those records and normalize the data.
• 15:43
  Nasha: Very simple.
• 15:45
  Nasha: Creating a natural history study with clinical data so patients don't have to go to an in-clinic site.
• 15:50
  Nasha: We're just taking the records they already have.
• 15:52
  Nasha: And we started speaking to pharma companies early on and no one wanted to take the bet, right?
• 15:57
  Nasha: No one wanted to invest and then take that data to the FDA cuz they were worried will the FDA reject it?
• 16:03
  Nasha: But you're right, the FDA wants you to take innovative solutions and then explain to them why the solution, why this data is superior.
• 16:10
  Nasha: The FDA truly does want to be educated.
• 16:13
  Nasha: All my discussions with the FDA have been very um, positive and it is, you are right.
• 16:18
  Nasha: You know, the pharmaceutical industry, especially big pharma there, it, there's a lot of risk aversion and for ultra rare diseases, we have to take some bets.
• 16:26
  Nasha: We have to take some risks
• 16:28
  David: often in, you know, pediatrics in general.
• 16:30
  David: I'm not even talking about rare disease when they're trying to get priorities in the pediatric world, usually.
• 16:36
  David: Interest, something that's going on on the adult side cuz it's, uh, bigger and, and better, uh, reimbursed.
• 16:40
  David: And I heard you go sort of right to that strategy at the start.
• 16:43
  David: Maybe it's cuz you're both educated at one of those schools that teaches you about strategy, but also hopefully cuz it's, cuz it's true that, you know, if you can, you know, where is there a lot of money spent?
• 16:52
  David: Right.
• 16:52
  David: And a lot of it completely futile on Alzheimer's, for example, and then epilepsy more, more broadly.
• 16:58
  David: And you were talking about these, you know, monogenic conditions being a window.
• 17:02
  David: Uh, into potential treatments, and there's been a lot of frustration on, on some of the treatments for these more common diseases that affect people that vote and have, you know, have money.
• 17:11
  David: Um, how does that play in, in, in practice?
• 17:14
  David: I see it's a good rallying call to say, Hey, get interested in this, but how do you actually execute that strategy to say, look, this could be a window into Alzheimer's.
• 17:23
  David: Help us leverage that in a population, you know, that we care about specifically, uh,
• 17:27
  Nasha: with a particular, you know, David, if you figure out how to do that, please tell me the trick because I I can.
• 17:33
  Nasha: I'll tell you, for FOXG1, we have really struggled.
• 17:35
  Nasha: Um, even with all the work that we have done, we've de-risked the disease.
• 17:40
  Nasha: We've invested in basic science, we've got our natural history together, we've shown that you know, you can increase protein expression in FOXG1 we're seeing phenotypic rescue in our animal models.
• 17:49
  Nasha: It's very difficult, especially in the current financial environment to get pharma to want to focus on a condition where there's only 600 patients that we know of in the United States.
• 17:59
  Nasha: So this is, you know, it comes down now there's newer biotech companies that are smaller.
• 18:03
  Nasha: Masi Therapeutics is a great example of a company that is only focused on ultra, ultra rare conditions.
• 18:09
  Nasha: They're in fact, um, taking on a condition with only 20 patients that they know of.
• 18:14
  Nasha: But these companies are far and few.
• 18:17
  Nasha: There is many rare diseases.
• 18:19
  Nasha: So we, it, it's a gap.
• 18:21
  Nasha: I mean, there is a literal gap in the market right now, and our current markets are not providing the incentives to solve that gap.
• 18:29
  David: Let me turn on a little bit, this is related to what we've been talking about, but maybe as a last question just to ask you a little bit about, uh, invitation and, and Ciitizen.
• 18:36
  David: You're talking about, uh, you know, using advanced techniques to gather the information and to analyze.
• 18:41
  David: , you know, what is the state of kind of, you know, record keeping, record gathering for, for medical records and how much is it possible really to leverage advanced techniques like, you know, machine learning, uh, today to really, you know, take advantage of that And how much is sort of still on the human abstracters and, you know, bringing paper records together?
• 18:56
  David: Yeah, that's a
• 18:56
  Nasha: great question.
• 18:57
  Nasha: Um, we, we started with, First, it was just getting the operations down to actually collect these medical records because it is very difficult for a patient to access their own medical records at this moment in American history.
• 19:09
  Nasha: So even though we have the HIPAA right of access, it's quite difficult.
• 19:12
  Nasha: So our first order of business was just, let's get that down.
• 19:16
  Nasha: And so we finally have that operation where we can use a patient's own hippo, right, of access and collect the entirety of their medical records.
• 19:22
  Nasha: So not just what's in the patient portal, but all of the clinic notes, eeg, tracings, MRIs, et cetera.
• 19:29
  Nasha: Load them onto a system.
• 19:30
  Nasha: So that's step one.
• 19:31
  Nasha: And this works very, very well with pediatric neurological conditions, for example, because patients are going to see their doctors pretty frequently.
• 19:39
  Nasha: So you can get really rich data.
• 19:42
  Nasha: That was the kind of first part of the um, equation.
• 19:45
  Nasha: The second part, as you mentioned, was how much is human extraction?
• 19:49
  Nasha: When we started, it was a hundred percent human abstraction.
• 19:51
  Nasha: We've moved, um, forward, we're at about 50% right now, but you're absolutely right.
• 19:56
  Nasha: There is still a huge requirement, especially for rare diseases, to have human quality control and human abstraction.
• 20:03
  Nasha: Now, I'm hoping with all the innovations we're seeing with chat, G P T and other ai, um, you know, Modularity that we can, we can get better.
• 20:12
  Nasha: Um, but right now the technology is, is, is sort of
• 20:15
  David: where it is.
• 20:17
  David: Got it.
• 20:17
  David: Well, thank you Nasha.
• 20:18
  David: There's plenty more we could be talking about, uh, here.
• 20:20
  David: This has been very informative and I really appreciate your time.
• 20:23
  David: Thank you.
• 20:24
  David: It's been a pleasure
• 20:24
  Nasha: to talk to you.
• 20:25
  Nasha: Well,
• 20:26
  David: that's it for another episode of CareTalk my guest today is Nasha Fitter from FOXG1 Research and Invitation.
• 20:31
  David: We've been talking about rare diseases and what's being done to find much needed.
• 20:35
  David: I'm David Williams, president of Health Business Group.
• 20:38
  David: If you like what you heard or you didn't, please subscribe on your favorite channel.