Our
COVID-19 Response

Our COVID-19 Response
Filling of investigational

When the COVID-19 outbreak began to emerge – well before it was declared a pandemic by the World Health Organization – Gilead’s scientists took note. We asked how, given our decades of antiviral experience, we could help. We began to examine the potential of our then-investigational antiviral Veklury (remdesivir), which had shown potential utility against other coronaviruses in laboratory and preclinical experiments. In early 2020, the first patient received Veklury for the treatment of COVID-19 through a special regulatory emergency use process, and we prepared for the possibility of rapidly initiating clinical trials to evaluate Veklury as an investigational treatment for COVID-19.

Even before clinical trials demonstrated Veklury’s efficacy in patients with COVID-19, we accelerated our production capacity and assembled an international group of pharmaceutical and chemical manufacturers to help with global supply needs. To further expand supply of Veklury, Gilead also signed non-exclusive voluntary licensing agreements with generic drugmakers in India, Egypt and Pakistan.

we accelerated our production capacity

The FDA granted Emergency Use Authorization of Veklury in May and, by late October, less than a year after the first case report of the disease, Veklury received FDA approval for the treatment of COVID-19 in patients requiring hospitalization.

The FDA granted Emergency Use Authorization of Veklury in May

Our Impact

Innovating to Treat COVID-19

Gilead responded quickly to advance Veklury, deploying decades of antiviral expertise and significant internal resources to help patients and communities working to ease the burden of the pandemic. By the end of the year, approximately 1 million people in the United States had received Veklury.

Veklury manufacturing line

Clinical Trials Expedited

We completed clinical trials rapidly while maintaining the highest bar for safety, through collaboration with patients, healthcare providers, regulatory authorities and clinical trial investigators.

Gilead employees operating machinery to wash empty vials for investigational Veklury
Increasing Veklury Supply

Increasing Veklury Supply

Our partners, new and longstanding, were instrumental in providing adequate supply. Gilead invested in ramping up manufacturing before seeing clinical data that demonstrated the medicine’s efficacy. Without compromising safety or rigor, Gilead teams worked collaboratively to find ways to shorten the manufacturing process and to bring on more than 40 additional manufacturing partners.

Donation

Through the end of June 2020, Gilead provided our entire existing supply of Veklury at no cost for clinical trials, for emergency access programs and in countries where the medicine had received regulatory authorization. We did this to help Veklury reach patients as quickly as possible, in light of the public emergency posed by the pandemic.

Gilead Ramps Up Veklury Manufacturing

A Q&A with Ken Kent, Senior Vice President of Chemical Development and Manufacturing Operations

As the COVID-19 outbreak became a global pandemic, Gilead’s deep history in antiviral drug development suggested one of the company’s medicines could potentially be used to treat the virus. Ken Kent takes us behind the scenes to share how Gilead took bold action to meet an unmet global need.

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Ken Kent VO:

2020 made us think about collaboration differently in that, you know, we had to get better at it. You know, we were used to collaborating most effectively in a room together.

Title sequences:

“A possible connection”
“Finding ways to speed production”
“A reduction in timing”
“Meeting the needs of a global pandemic”
“Rising to meet the challenge together – Gilead Logo”

VO continues:

Hi, I’m Ken Kent. I’m the Senior Vice President of chemical development and manufacturing operations at Gilead.

January of last year, a colleague of mine informed me that there was a virus spreading rapidly within China, and it was a type of coronavirus and it was thought that potentially one of our investigational medicines could be effective against this. He gave me kind of the heads-up and said we may need to be ready to move quickly if this turns out to be as bad as it might look.

So, my thought was, it could really help. My concern was we had really set up our supply chain for a much smaller population.

So we knew we were going to have to scale up the manufacturing process and scale it out. By that I mean, use more than one supplier and more than one part of the world.

So, having diverse geographic footprint really was going to be an imperative for us.

The only way we could meet all of the potential needs for this program was to do a lot of things in parallel, hoping that we’d all hit the finish line at the same time.

The first order of business was to get multiple sites in multiple continents working on the same key raw materials at the same time so that they could deliver them as fast as possible in a sufficiently large quantity. The next step was then making the active ingredient at multiple sites that were dependent on these starting materials.

I think the hardest thing about working remotely with these partners was that we truly were fully remote on key things where in the past we could actually fly out, see, touch, and feel their instruments as they’re running.

We couldn’t do that.

And so, we really had to get...think of it in a new way. How could we visualize what they’re doing? How could we get them to be more specific on their description?

How could we be more specific? It was what really enabled a lot of this to get done.

You know, we compressed down our timelines that we’d normally do for development by literally years–things that we’d do in years we did in months. So, most people said, oh, I don’t know if that’s possible. But we really challenged the team to say, don’t tell me if it’s possible; tell me if it’s impossible. If it’s impossible, okay, then we can’t do it. But even then, I'm certainly going to question you why it’s impossible.

There's a lot of things about the team that impressed me. They didn’t miss a beat.

They found ways to overcome all the distractions that are out there.

I don’t know if I have my proudest moment. I'm really proud of the team. That a lot of people really bought into that saying, hey, we could make a difference, let’s see what we can do.

I think, just the sort of level of dedication, teamwork and sacrifice was, it was impressive.

Closing Card – Gilead Logo

“We need to make more and we
need to make it faster.”

– Laura Bauer, Research Scientist II

Expanding Production

As the COVID-19 pandemic brought the world to a halt, Gilead employees worked diligently to advance the company’s then-investigational antiviral. Laura Bauer, scientist in the Formulation and Process Development group, collaborated with her team, colleagues and partners across a wide manufacturing and supply chain network to increase production.

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I’m Laura Bauer and I’m a scientist in the Formulation and Process Development group at Gilead.

What our group is responsible for is taking the active ingredient and turning it into a drug product.

Earlier this year when we found out a respiratory virus was quickly spreading across the world, we immediately thought of our investigational medicine.

I got a call from my manager towards the end of January. He was asking, “How much investigational medicine do we have in stock?” And then it was, “How quickly could we make another batch?” And then the next day it was, “No, that’s not good enough. We need to make more and we need to make it faster.”

The project was just rapidly evolving every day. It just started to snowball.

We had these daily strategy meetings where the whole project team, basically, came together and thought of how we could make this investigational medicine faster.

And to further complicate matters, we all had to begin working remotely from home.

So, basically, we had to change the way we did things. Change our interactions with the manufacturing sites and use the remote tools that were available to us.

To scale up the manufacturing of this product, we focused on two areas. The first one, we reduced the cycle time to make the product. And then, for manufacturing more, we transferred from one manufacturing site to seven different sites with over 13 lines manufacturing our product.

And this allowed us to exponentially grow the amount of product that we were making.

Bringing this investigational drug to patients as quickly as we could, and manufacturing it at a scale in order to meet the global pandemic, was such a big responsibility.

I think everybody was just so focused and dedicated to bringing this medicine to patients that it just kept that whole collaboration and that whole feeling of urgency.

I don’t ever think we thought we couldn’t do it. We always knew we could, just one step at a time.

2020 was such a different year. Kids were off of school. People were off of work or working differently. And we couldn’t do the normal things that we normally do, like travel and go see our family.

For me, personally, to then have worked on a potential response for this global pandemic, I was so proud to have been a part of it.

Green Chemistry Reduces Environmental Impact

Even as we worked to advance Veklury rapidly, we remained focused on decreasing our environmental footprint. The principles of green chemistry – designing chemical products and processes that reduce or eliminate the generation of hazardous substances – are a day-to-day discipline. We improved the total Process Mass Intensity (PMI) score of Veklury by 40% through a reduction of solvents, reagents, reactants and consumables. This innovation led us to use fewer resources while enabling us to produce more, faster. For details on how we advance green chemistry, download the full report.

Rising Beyond Barriers for
People in Need

Employees conquered challenges globally to ensure continuity of supply of all medicines.

Gilead Kite Cleanroom

Ensuring Continuity of Cell Delivery for Patients

A top priority was to safeguard and minimize any potential impact of the pandemic on access to Kite’s cancer-treating cell therapies. Because cell therapies represent a truly personalized medicine – they are made using a patient’s own T cells – transportation plays an integral role in getting therapy to patients. Patients who receive cell therapy are often very sick and don’t have time to wait for treatment, so potential delays can have serious consequences. Amid global travel restrictions and the threat of supply chain disruptions, our employees worked tirelessly to ensure the timely manufacture, supply and delivery of lifesaving therapies to eligible patients around the world.

To ensure continuity of treatment, the Kite team deployed a highly coordinated effort to navigate potential supply chain disruptions and find alternatives to transportation challenges, such as canceled flights and border closures. This required extra care as we shipped patients’ cells to and from manufacturing locations around the world – monitoring flights, tracking hospital capacity, working closely with our authorized treatment centers and establishing mitigation plans.

WE’RE JUST
GETTING STARTED

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