WEBVTT - Eli Lilly Given Emergency Use Authorization for COVID Treatment

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<v Speaker 1>It's Friday, November. I'm Oscar Ramirez from the Daily Dive

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<v Speaker 1>podcast in Los Angeles, and this is Reopening America. The

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<v Speaker 1>FDA this week gave the emergency use authorization to Eli

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<v Speaker 1>Lily for their monoclonal anybody COVID treatment. It is similar

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<v Speaker 1>to the treatment that President Trump received when he was sick,

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<v Speaker 1>and it is aimed at keeping mild cases from turning

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<v Speaker 1>more serious. The process of getting this treatment developed and

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<v Speaker 1>improved was difficult, and that the company also had to

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<v Speaker 1>deal with the pandemic at the same time. They had

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<v Speaker 1>a trim down their staff, work remotely in some cases,

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<v Speaker 1>and the chief of the lab how to use a

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<v Speaker 1>robot with an iPad attached to it so he could

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<v Speaker 1>patrol that lab. Peter loftus healthcare reporter at the Wall

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<v Speaker 1>Street Journal, joins us for how Eli Lily got it done.

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<v Speaker 1>Thanks for joining us, Peter, Thanks for having me on.

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<v Speaker 1>I wanted to talk about this drug from Eli Lily.

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<v Speaker 1>It's a COVID nineteen drug that is very similar to

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<v Speaker 1>the one that President Trump took when he was receiving treatment.

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<v Speaker 1>It's a anti body treatment and the FDAY just authorized

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<v Speaker 1>emergency use of it. Peter if you can help us

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<v Speaker 1>out tell us a little bit more about how this

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<v Speaker 1>drug works. And then the difficulty in actually manufacturing this

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<v Speaker 1>because Eli Lily had to also go through a shutdown

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<v Speaker 1>throughout the pandemic, and the way they changed their practices

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<v Speaker 1>to be able to still get this out is pretty amazing.

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<v Speaker 1>So Peter, tell us what we know about this drug. Sure,

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<v Speaker 1>So the drug I believe is pronounced them lenivum ev.

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<v Speaker 1>So this drug is called a monoclonal antibody, and it's

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<v Speaker 1>from Eli Lily, and it's something that's essentially an engineered

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<v Speaker 1>version of the immune system antibodies that are produced in

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<v Speaker 1>response to the coronavirus and so, and the way that

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<v Speaker 1>they developed it was they analyzed a blood sample from

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<v Speaker 1>an early survivor of COVID nineteen and they kind of

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<v Speaker 1>isolated what they thought were the most potent antibodies in

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<v Speaker 1>that blood sample, and then they basically clone them in

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<v Speaker 1>a factory to turn them into a pharmaceutical treatment. And

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<v Speaker 1>so what has happened over the past twenty four hours

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<v Speaker 1>is that the FDA has authorized the emergency use of

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<v Speaker 1>this antibody, and in particular in patients with mild to

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<v Speaker 1>moderate COVID nineteen, So people who are not in the hospital,

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<v Speaker 1>who aren't so severe, but they wanted to be prioritized

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<v Speaker 1>for people that that they may have mild to moderate

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<v Speaker 1>symptoms of COVID nineteen, but for certain reasons, they might

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<v Speaker 1>be at higher risk of worsening to severe disease where

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<v Speaker 1>they did end up in the hospital. And so that

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<v Speaker 1>would include people, say over the age of six, or

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<v Speaker 1>people who are overweight or have other chronic conditions that

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<v Speaker 1>might put them at higher risk. And tell me a

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<v Speaker 1>little bit about how they make this, because we're talking

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<v Speaker 1>about the difficulties and we'll get into how the workers

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<v Speaker 1>there had to adjust to all this. But these drugs

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<v Speaker 1>are grown in living cells, they're fed nutrients, they're put

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<v Speaker 1>in stainless steel tanks with ovary cells from Chinese hamster.

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<v Speaker 1>I mean, this is like crazy science stuff when you're

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<v Speaker 1>really talking about it. It's always fascinating to hear about

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<v Speaker 1>the source material for some of the ingredients that go

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<v Speaker 1>into two pharmaceuticals. I think one of the vaccines has

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<v Speaker 1>a component that's derived from I think tree bark. But

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<v Speaker 1>in any case, yeah, in this case, this lilli antibody,

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<v Speaker 1>this is actually a fairly common manufacturing method for this

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<v Speaker 1>type of drug, where it's grown in living cells and

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<v Speaker 1>they use a medium, They use a solution that sort

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<v Speaker 1>of allows the protein of interest to proliferate, to spread

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<v Speaker 1>and replicate. And so in this case, they're using the

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<v Speaker 1>solution that includes Chinese hamster ovary cells. And what they're

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<v Speaker 1>doing is they're in this solution. They start with a

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<v Speaker 1>small amount, but eventually that helps grow a very large

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<v Speaker 1>amount of the antibody. And it's all the same antibody,

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<v Speaker 1>but it's just a large amount of it. And so

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<v Speaker 1>they grow that in large amounts and then they purify

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<v Speaker 1>it and then package it and biles so that the

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<v Speaker 1>amount necessary in each file to treat one patient. And

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<v Speaker 1>now tell me a little bit about the process that

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<v Speaker 1>the company had to go through to actually do this.

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<v Speaker 1>We just talked about how complicated that process is and

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<v Speaker 1>how very specific it is. But at the plant where

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<v Speaker 1>they were making this production, you know, they had maybe

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<v Speaker 1>about sixty five workers to begin with. They had to

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<v Speaker 1>whittle that down to twenty or thirty, and then everybody's

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<v Speaker 1>working remotely. Like I said, they had to go through

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<v Speaker 1>this and make this drug for the pandemic. While the

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<v Speaker 1>pandemic was ongoing, you know, as everyone knows, a lot

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<v Speaker 1>of companies in all industries had to make a lot

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<v Speaker 1>of adjustments having people work from home, that sort of thing,

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<v Speaker 1>and so the drug companies have to do that too.

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<v Speaker 1>But then they're the ones who are actually working on

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<v Speaker 1>the drugs and vaccines that hopefully will be effective in

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<v Speaker 1>ending the pandemic, and so they have to do that

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<v Speaker 1>while taking these steps to prevent the spread of the

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<v Speaker 1>virus in the facility and to protect their workers. And

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<v Speaker 1>so in Lily's case, they're based in Indianapolis, and they

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<v Speaker 1>back in March, I think when all the lockdowns were starting,

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<v Speaker 1>they sent a significant majority of their employees to work

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<v Speaker 1>from home. So that did include a lot of office jobs,

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<v Speaker 1>but it also included scientists, people that work in research

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<v Speaker 1>labs that it included in some cases manufacturing workers. And

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<v Speaker 1>so the idea was to reduce the number of people

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<v Speaker 1>on site two as low as they could go. But

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<v Speaker 1>obviously they're still going to need some people on site

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<v Speaker 1>both to work on the COVID projects but also to

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<v Speaker 1>continue to make other drugs that Eli Lily makes, and

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<v Speaker 1>so they just tried to keep that at a lower number.

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<v Speaker 1>So that would be fewer people there to transmit the

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<v Speaker 1>virus or to be just to be exposed. And yeah,

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<v Speaker 1>they had to just make a lot of adjustments. One

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<v Speaker 1>part of the of the manufacturing process was taking what

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<v Speaker 1>was manufactured in these big steel tanks out of the

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<v Speaker 1>solution that I just talked about, and then putting the

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<v Speaker 1>final product into vials. And they bought this mobile lab.

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<v Speaker 1>It basically looks like a tractor trailer, but it's customized

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<v Speaker 1>to sit outside the factory because they felt this was

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<v Speaker 1>the quickest way to do this, and that was where

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<v Speaker 1>they actually put the drug into vials. And they found

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<v Speaker 1>that it took some practice and training to get the

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<v Speaker 1>employees used to working in close proximity, even with protective gear,

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<v Speaker 1>because you know, at that point, earlier in the year,

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<v Speaker 1>people had become so accustomed to keeping distant from everybody,

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<v Speaker 1>and they just people were a little leery about it. Yeah,

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<v Speaker 1>I mean even one of the doctors was rolling around

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<v Speaker 1>on a little robot with an iPad attached to it,

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<v Speaker 1>just so they can live stream things back and forth.

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<v Speaker 1>So what are the next steps for them? The US

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<v Speaker 1>is going to start distributing this as soon as it can.

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<v Speaker 1>I think they started saying as soon as this week

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<v Speaker 1>they were going to start distributing some of it. What's

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<v Speaker 1>next for them. The federal government has signed a supply

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<v Speaker 1>contract where they're buying three thousand doses of this little

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<v Speaker 1>the antibody, and because they're buying it, they're in a

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<v Speaker 1>customer essentially, they're going to allocate it. And so right now,

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<v Speaker 1>I think there's about eighty thou doses that are ready

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<v Speaker 1>to go in fairly short order, and the federal government

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<v Speaker 1>has already made decisions about which states they'll go to

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<v Speaker 1>or or in what amounts to each state, and they

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<v Speaker 1>make that decision by looking at where this community spread

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<v Speaker 1>is the is the worst basically, so states like Wisconsin

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<v Speaker 1>Illinois have very high rates right now, and so they're

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<v Speaker 1>getting a fairly high number of doses. And then Eli

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<v Speaker 1>Lily is increasing its manufacturing of the antibody, and so

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<v Speaker 1>they're going to try to have many more doses by

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<v Speaker 1>the end of the year. And it will be a

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<v Speaker 1>situation where, at least for the time being, the federal

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<v Speaker 1>government will see how many new doses are produced in

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<v Speaker 1>a given week and then parcel them out to various

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<v Speaker 1>parts of the country, and then state officials. Local health

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<v Speaker 1>departments would be in charge of figuring out, you know

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<v Speaker 1>what hospitals or say, infusion clinics should get the doses

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<v Speaker 1>and then eventually into patients. Well, I mean good news

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<v Speaker 1>on all that front. Hopefully we can get this squared

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<v Speaker 1>away very quickly and get it to people that really

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<v Speaker 1>need it and help them out that way. Peter loftus

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<v Speaker 1>healthcare reporter at the Wall Street Journal, thank you very

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<v Speaker 1>much for joining us my pleasure. I'm Oscar Ramirez and

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<v Speaker 1>this has been reopening America. Don't forget efforts to day's

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<v Speaker 1>Daily Dive podcast every money through Friday, So follow us

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