Speaker 1: It's Friday, November. I'm Oscar Ramirez from the Daily Dive
Speaker 1: podcast in Los Angeles, and this is Reopening America. The
Speaker 1: FDA this week gave the emergency use authorization to Eli
Speaker 1: Lily for their monoclonal anybody COVID treatment. It is similar
Speaker 1: to the treatment that President Trump received when he was sick,
Speaker 1: and it is aimed at keeping mild cases from turning
Speaker 1: more serious. The process of getting this treatment developed and
Speaker 1: improved was difficult, and that the company also had to
Speaker 1: deal with the pandemic at the same time. They had
Speaker 1: a trim down their staff, work remotely in some cases,
Speaker 1: and the chief of the lab how to use a
Speaker 1: robot with an iPad attached to it so he could
Speaker 1: patrol that lab. Peter loftus healthcare reporter at the Wall
Speaker 1: Street Journal, joins us for how Eli Lily got it done.
Speaker 1: Thanks for joining us, Peter, Thanks for having me on.
Speaker 1: I wanted to talk about this drug from Eli Lily.
Speaker 1: It's a COVID nineteen drug that is very similar to
Speaker 1: the one that President Trump took when he was receiving treatment.
Speaker 1: It's a anti body treatment and the FDAY just authorized
Speaker 1: emergency use of it. Peter if you can help us
Speaker 1: out tell us a little bit more about how this
Speaker 1: drug works. And then the difficulty in actually manufacturing this
Speaker 1: because Eli Lily had to also go through a shutdown
Speaker 1: throughout the pandemic, and the way they changed their practices
Speaker 1: to be able to still get this out is pretty amazing.
Speaker 1: So Peter, tell us what we know about this drug. Sure,
Speaker 1: So the drug I believe is pronounced them lenivum ev.
Speaker 1: So this drug is called a monoclonal antibody, and it's
Speaker 1: from Eli Lily, and it's something that's essentially an engineered
Speaker 1: version of the immune system antibodies that are produced in
Speaker 1: response to the coronavirus and so, and the way that
Speaker 1: they developed it was they analyzed a blood sample from
Speaker 1: an early survivor of COVID nineteen and they kind of
Speaker 1: isolated what they thought were the most potent antibodies in
Speaker 1: that blood sample, and then they basically clone them in
Speaker 1: a factory to turn them into a pharmaceutical treatment. And
Speaker 1: so what has happened over the past twenty four hours
Speaker 1: is that the FDA has authorized the emergency use of
Speaker 1: this antibody, and in particular in patients with mild to
Speaker 1: moderate COVID nineteen, So people who are not in the hospital,
Speaker 1: who aren't so severe, but they wanted to be prioritized
Speaker 1: for people that that they may have mild to moderate
Speaker 1: symptoms of COVID nineteen, but for certain reasons, they might
Speaker 1: be at higher risk of worsening to severe disease where
Speaker 1: they did end up in the hospital. And so that
Speaker 1: would include people, say over the age of six, or
Speaker 1: people who are overweight or have other chronic conditions that
Speaker 1: might put them at higher risk. And tell me a
Speaker 1: little bit about how they make this, because we're talking
Speaker 1: about the difficulties and we'll get into how the workers
Speaker 1: there had to adjust to all this. But these drugs
Speaker 1: are grown in living cells, they're fed nutrients, they're put
Speaker 1: in stainless steel tanks with ovary cells from Chinese hamster.
Speaker 1: I mean, this is like crazy science stuff when you're
Speaker 1: really talking about it. It's always fascinating to hear about
Speaker 1: the source material for some of the ingredients that go
Speaker 1: into two pharmaceuticals. I think one of the vaccines has
Speaker 1: a component that's derived from I think tree bark. But
Speaker 1: in any case, yeah, in this case, this lilli antibody,
Speaker 1: this is actually a fairly common manufacturing method for this
Speaker 1: type of drug, where it's grown in living cells and
Speaker 1: they use a medium, They use a solution that sort
Speaker 1: of allows the protein of interest to proliferate, to spread
Speaker 1: and replicate. And so in this case, they're using the
Speaker 1: solution that includes Chinese hamster ovary cells. And what they're
Speaker 1: doing is they're in this solution. They start with a
Speaker 1: small amount, but eventually that helps grow a very large
Speaker 1: amount of the antibody. And it's all the same antibody,
Speaker 1: but it's just a large amount of it. And so
Speaker 1: they grow that in large amounts and then they purify
Speaker 1: it and then package it and biles so that the
Speaker 1: amount necessary in each file to treat one patient. And
Speaker 1: now tell me a little bit about the process that
Speaker 1: the company had to go through to actually do this.
Speaker 1: We just talked about how complicated that process is and
Speaker 1: how very specific it is. But at the plant where
Speaker 1: they were making this production, you know, they had maybe
Speaker 1: about sixty five workers to begin with. They had to
Speaker 1: whittle that down to twenty or thirty, and then everybody's
Speaker 1: working remotely. Like I said, they had to go through
Speaker 1: this and make this drug for the pandemic. While the
Speaker 1: pandemic was ongoing, you know, as everyone knows, a lot
Speaker 1: of companies in all industries had to make a lot
Speaker 1: of adjustments having people work from home, that sort of thing,
Speaker 1: and so the drug companies have to do that too.
Speaker 1: But then they're the ones who are actually working on
Speaker 1: the drugs and vaccines that hopefully will be effective in
Speaker 1: ending the pandemic, and so they have to do that
Speaker 1: while taking these steps to prevent the spread of the
Speaker 1: virus in the facility and to protect their workers. And
Speaker 1: so in Lily's case, they're based in Indianapolis, and they
Speaker 1: back in March, I think when all the lockdowns were starting,
Speaker 1: they sent a significant majority of their employees to work
Speaker 1: from home. So that did include a lot of office jobs,
Speaker 1: but it also included scientists, people that work in research
Speaker 1: labs that it included in some cases manufacturing workers. And
Speaker 1: so the idea was to reduce the number of people
Speaker 1: on site two as low as they could go. But
Speaker 1: obviously they're still going to need some people on site
Speaker 1: both to work on the COVID projects but also to
Speaker 1: continue to make other drugs that Eli Lily makes, and
Speaker 1: so they just tried to keep that at a lower number.
Speaker 1: So that would be fewer people there to transmit the
Speaker 1: virus or to be just to be exposed. And yeah,
Speaker 1: they had to just make a lot of adjustments. One
Speaker 1: part of the of the manufacturing process was taking what
Speaker 1: was manufactured in these big steel tanks out of the
Speaker 1: solution that I just talked about, and then putting the
Speaker 1: final product into vials. And they bought this mobile lab.
Speaker 1: It basically looks like a tractor trailer, but it's customized
Speaker 1: to sit outside the factory because they felt this was
Speaker 1: the quickest way to do this, and that was where
Speaker 1: they actually put the drug into vials. And they found
Speaker 1: that it took some practice and training to get the
Speaker 1: employees used to working in close proximity, even with protective gear,
Speaker 1: because you know, at that point, earlier in the year,
Speaker 1: people had become so accustomed to keeping distant from everybody,
Speaker 1: and they just people were a little leery about it. Yeah,
Speaker 1: I mean even one of the doctors was rolling around
Speaker 1: on a little robot with an iPad attached to it,
Speaker 1: just so they can live stream things back and forth.
Speaker 1: So what are the next steps for them? The US
Speaker 1: is going to start distributing this as soon as it can.
Speaker 1: I think they started saying as soon as this week
Speaker 1: they were going to start distributing some of it. What's
Speaker 1: next for them. The federal government has signed a supply
Speaker 1: contract where they're buying three thousand doses of this little
Speaker 1: the antibody, and because they're buying it, they're in a
Speaker 1: customer essentially, they're going to allocate it. And so right now,
Speaker 1: I think there's about eighty thou doses that are ready
Speaker 1: to go in fairly short order, and the federal government
Speaker 1: has already made decisions about which states they'll go to
Speaker 1: or or in what amounts to each state, and they
Speaker 1: make that decision by looking at where this community spread
Speaker 1: is the is the worst basically, so states like Wisconsin
Speaker 1: Illinois have very high rates right now, and so they're
Speaker 1: getting a fairly high number of doses. And then Eli
Speaker 1: Lily is increasing its manufacturing of the antibody, and so
Speaker 1: they're going to try to have many more doses by
Speaker 1: the end of the year. And it will be a
Speaker 1: situation where, at least for the time being, the federal
Speaker 1: government will see how many new doses are produced in
Speaker 1: a given week and then parcel them out to various
Speaker 1: parts of the country, and then state officials. Local health
Speaker 1: departments would be in charge of figuring out, you know
Speaker 1: what hospitals or say, infusion clinics should get the doses
Speaker 1: and then eventually into patients. Well, I mean good news
Speaker 1: on all that front. Hopefully we can get this squared
Speaker 1: away very quickly and get it to people that really
Speaker 1: need it and help them out that way. Peter loftus
Speaker 1: healthcare reporter at the Wall Street Journal, thank you very
Speaker 1: much for joining us my pleasure. I'm Oscar Ramirez and
Speaker 1: this has been reopening America. Don't forget efforts to day's
Speaker 1: big news stories. You can check me out on the
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