So, yeah, I'm the project officer from the Influenza and Emerging Infectious Disease Division, Therapeutics Branch. But a little bit personal connections, you know, before that I was assistant professor working at the National Jewish Health at the University of Corrado. So I'm happy back to the community with different role. Okay, so a little bit about parent organization aspects. So we really just want to prepare, respond, or recover for any public health emergency or disasters. And for our organization, we're really focused on developing the medical countermeasures. So that's going to help us save patients' lives. So a little bit for our program. So our program is IEIDD. That means we focus on influenza. That's including seasonal influenza or pandemic influenza. Meanwhile, we also care about COVID and other emerging infectious disease. So as you can see on the left, so we're working hard to try to develop the good vaccines. And that's for the vaccine branch for sure. And we also try to have the good treatments for the other patients with influenza so they would not go to the hospital or even end up in the ICU. And as you can see in the lower bottom, so even during the COVID pandemic, we were able to support a good trust and work with the whole community for some useful or effective treatments for COVID. However, there's no effective, you know, treatment for hospitalized flu patients except some of the label use of the acetaminophen. So with that, we will continue our efforts developing more drugs for outpatients with influenza. We also want to have the long-acting antivirals so they can do a good job for the bridging period for pre-exposure prophylaxis. But more important, we try to shift our focus from hospitalized influenza itself to a general ARDS and with a focus in whole-stripe therapeutics. So this slide to give you a little why. So I don't want to, you know, waste time for this current audience. You know why ARDS is important. But I just want to leave a cover to Kim's point early. So we found a loss of hospitalized flu trials, testing virus, antiviral drugs, unfortunately, over their field. And at the time, we were thinking what's the best or novel approach we can take to save the life with these severe flu patients. But we're also knowing that's really limit market for the influenza-induced ARDS. So that's why we try to develop a whole-stripe therapeutics that's kind of on top of the standard care you treat on the lying infection courses. However, that will also give you the chance, make you ready not just treat for influenza, worse of COVID, and the other endemics or passages in the future. And meanwhile, so you will listen more about, you know, Kim's presentation regarding other priority areas from BARDA like sepsis-induced lung injury or even radiation or chemical exposure-induced lung injury. So this slide is really actually when we deal with COVID responses, we really encourage us, how should we learn from the COVID, right? COVID is a historic moment. We will not have the chance to have 48,000 patients like recover trial. So we should do a better job of design of a trial so we can develop an effective treatment for ARDS. So as you can see on the left, I just lay out based on my understanding. So first of all, ARDS is really a challenge, not just a challenge for the enrolling patients. Also, that's a big investment for every company. So that's why as a government, we realize and that we try to do a little bit more, try to do our investment wisely. And now, since you can see before COVID, we had a hesitation to test horse-dragged therapeutics in these very sick, sick patients, right? Because there are lots of side effects we don't know what happens. But learn from COVID, if you can design your trial better and you have the right population, you will have some positive signal from there. So with that, I put some, you know, strategy. So first of all, is really do the drug repurposing, right? A lot of drugs really have extensive database and they're safe. If they can be used based on a mechanism of action, they absolutely can be the low honey fruit for ARDS treatment. And the second I mentioned many times, we need to do a little bit better job design of a trial. So I will talk a little bit more on my following slides. And we'll also touch about how to use the biomarkers based stratification for the ARDS trial. So on these slides, I just try to summarize from the literature. So what's the issues? What's the potential solution? We can improve our ARDS clinical trials when we evaluate host drug therapeutics. So the major issues I put here is so because ARDS patients will always do one strategy fits four. So that's made everybody to the trial called ARDS. And we have no idea what's the underlying causes, which stage they are. And we try to treat them and consider the cost of a trial. The majority of the trial itself would be either from a single center, which has a small size, like 20 or 30 patients. And sometimes they just open labeled for good reason. And when we just do a little bit more, we were sort of trained from the community, try to, you know, study about markers. However, the current approaches is really just do the blood. But we just have no idea. Those cytokines will biomarker from the blood is actually reflect what's going on in the lung. And we're so the majority of work actually has been done with one research lab or just one academic center. So we said we just considering if we want to have a good, you know, trial for ARDS, we probably need folks on the large randomized and double blind placebo control and a much center clinical trials. And meanwhile, we probably will see continual excitement from Covey to stick or try to use the platform trial because this gave us the master protocol and we can add more treatments. Eventually, evaluate medical therapeutics to save time and save money. And the last one, we always think we want to treat the right patients at the right time is, you know, right drug. So that's why biomarker based strategy could be option. So but we also understand as the ARDS, no single biomarker can do all. So we definitely need to identify a cluster of the biomarkers. And also we need to develop a really reliable point of care biomarker platform so we can do the ARDS phenotype in real time. So we start, we just launched our phase two ARDS platform clinical trial, as it goes. So for this trial, which will be US, you know, only trial for a good reason. We want to have relative standard, standard of care. And we were going to recruit 600 adults patients with ARDS. And we were tested three whole strike therapeutics with the trial. So with that means 200 patients per cohort. And then these 200 patients will be randomized one to one to either treatment or placebo control. And we were going to collect, you know, as many as possible information because we treat this is a learning opportunity for us to understand the disease and all other things. So on this slide to give you more flavors, what are we going to do? So you can see it on day 30 based on different ARDS disease. We will look at a different endpoints. But this is, you know, back when we develop the synopsis is October 2021st. And we know we have the new definition. So we try to get input from the key opinion leaders and try to adapt it to our trial design. And meanwhile, you can see, in addition, look at for the multiple time points of the mortality rate. We were so want to collect the biomarker samples in all patients. This is the biggest investment from a government. Try to, you know, learn about this disease. We're so in the real drug. So these slides are just want to see. We have a lot of field trials when we're testing immunomodulators. But we do have some positive things. It's there. We post a hard analysis. We see the positive signal. So how about we just do the reverse way, right? We have everything ready before you design your phase three. So that's why we will have a big portion of our trial. So we will collect the blood samples, which includes whole blood, plasma, serum, and a worse isolated PBMC. And we will also collect trichosporin from those incubated patients. So we want to do the comparison. So the blood samples, virus to every sample that are the same. What's the difference? Anything we can learn from our samples can be used in the blood, which will be the most, you know, relevant or a popular way when we do the clinical practice. And as you can see, we try to look at multiple different layers. So we want to validate any protein markers, which we really know in the literature. We also want to explore a little bit based on a platform do the polyomics or worse, or do the single cell sequencing from PBMC. So, yeah, at least at this stage, we try to do that. Let's see how it works. And we start to hope that we can better understand the disease itself. We're also trying to learn about the drug, right? This is the real drug in development for the ARDS. And yes, thank you. So then we can do the trigger treatment to help us design a phase three trial. So I will skip the last two slides because this is really interesting to those, you know, industry partners. So we do have the open topic to support the latest stage phase three ready drugs for ARDS. We also have the targeted product profile on our website. You can have a look what we are looking for from the BADA standpoint. So with that, I just want to thank you for inviting me. We're so try to reach out if you have any questions, suggestions, and you can find me by this email.

therapeutics

medical countermeasures

ARDS

biomarkers

industry collaboration