Coronavirus: Clinical trials and the future of breast cancer research

Breast Cancer News
May 1, 2020

The coronavirus has affected healthcare in many ways, some that we see and experience every day and others that will impact the system in the coming months and years. As medical centers have limited in-person visits and elective procedures, many wonder what COVID-19 means for breast cancer research.

Living Beyond Breast Cancer CEO Jean Sachs, MSS, MLSP, spoke with Christian Nguyen, PharmD, MBA, MS, global brand development leader for Eli Lilly and Company, about how prevention efforts are affecting clinical trials now and what this means for research over the next few years.

We’re here to help you with trusted information and support throughout the coronavirus outbreak. Learn more about how breast cancer care is continuing during this time and ways to care for your mental health on our COVID-19 resources page.

Christian Nguyen, PharmD, MBA, MS
Christian leads the clinical development of abemaciclib (Verzenio) as global brand development leader for Eli Lilly and Company. She has launched more than a dozen medicines and has expertise in multiple phases of drug development and commercialization. She has volunteered her time over many years to serve on internal and external diversity and inclusion initiatives, including gender parity and allyship. Read more. 

 

Jean A. Sachs, MSS, MLSP
Chief Executive Officer, Living Beyond Breast Cancer
Jean began her work with LBBC in 1996 when she became the organization’s first executive director; she was named CEO in 2008. Jean brings a lifetime of women’s advocacy experience to her role as CEO. She lives LBBC’s mission everyday by speaking with newly diagnosed women about their needs and gaps in support. Read more.

 

Jean Sachs (00:00):

Hi, everyone. It's Jean Sachs. I'm the CEO of Living Beyond Breast Cancer. First and foremost, I hope you're all safe and well and healthy. Today we are talking about the impact of COVID-19 on clinical research and clinical trials and I'm honored to have as my guest today, Christian Nguyen from Eli Lilly. Hi, Christian.

Christian Nguyen (00:24):

Hi, Jean. Thank you so much for having me today.

Jean Sachs (00:27):

We're very happy to have you.

She is going to talk about breast cancer research and clinical development. She oversees this part of Lilly's work, and I just want to say before we get started that Lilly has been a really strong, loyal and consistent partner of Living Beyond Breast Cancer and also incredibly flexible during these uncertain times. We are so grateful for your support and your understanding of what it's like to be a nonprofit during these challenging times.

Christian Nguyen (00:59):

If I may, I also want to commend the work that Living Beyond Breast Cancer does. It's amazing. It's inspiring. I know you represent a community that has a lot of questions but also has a lot of strength and resilience. And I'm hoping our conversation today will answer many of those questions around the state of clinical trials in the age of COVID-19.

Jean Sachs (01:25):

Thank you. And that is true. Our community has a lot of questions and we've been working hard to try to answer them.

Let's start right there because we know that Lilly is a global company, so we knew you saw the impacts of the coronavirus before it really hit the United States. What was Lilly's response both internally and externally?

Christian Nguyen (01:46):

Let me start out by saying that we all know that cancer does not stop because of COVID-19 and the take-home message you should have is that we're not stopping either.

To start, Lilly's purpose is to make life better for people around the world through our medicines. That purpose has never been clearer to us. We're bringing to bear the full force of our scientific and medical expertise to attack the coronavirus pandemic all around the world. We're focused on ensuring, first and foremost, a reliable supply of our medicines, keeping our employees safe, and pushing scientific efforts at top speed to defeat the virus. We have a great sense of urgency.

We're also committed to supporting our communities and keeping our business moving during what I know are very uncertain and challenging times for us. In terms of, internally, from the very start of the outbreak, one of our top priorities has been to keep our employees safe and to care for them. They are vital to our purpose.

As the virus spread around the world, Lilly moved very quickly to protect our employees by restricting travel and practicing social distancing. Additionally, we moved very early to a work from home policy for almost everyone but those who manufacture and maintain the supply of our medicines. This was done yes, to reduce the risk of spreading the virus, yes, to protect our employees, but also to ensure that the millions of patients who rely on Lilly medicines every day continue to have access to them.

Externally, Lilly is confronting this pandemic with everything that we have. We redirected so many scientific efforts to help solve critical issues, including potential therapeutics and diagnostics and testing.

I'm going to share some very specific examples with you that we're really proud of.

One, we're co-developing antibodies for the potential treatment and prevention of COVID-19 with AbCellera, which is a therapeutic antibody discovery company.

We're teaming up with the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, in the fight against the pandemic. Specifically, one of our medicines will be studied as an arm in their adaptive COVID- 19 treatment trial to investigate its efficacy and safety as a potential treatment for hospitalized patients diagnosed with COVID-19.

Thirdly, we launched and are continuing to support a drive-through testing facility at our corporate headquarters in Indiana, at no cost, for frontline healthcare workers, first responders, as well as high risk individuals, including immunocompromised patients like those undergoing cancer treatment.

And lastly, we're also enabling our employees to volunteer their time in the care of patients, which we have many employees doing.

In sum, we're really proud of all that we're doing to ensure a continuous supply of medicines to keep our employees and their families safe and to drive scientific efforts to help end this virus or this crisis.

Jean Sachs (05:13):

That is so reassuring. I think we've all felt incredibly grateful for companies like Lilly who, you know how to do this, you have the personnel, and the amount that you have done to move things forward.

It's great to hear that you're working on all ends from the antibody testing to the vaccine and the treatment because everything we're all reading says we need to cover all the bases to get this under control. And we have heard about your testing efforts, which are really incredible for your community. Thank you for, for doing that.

Let's move to what is so critical to Living Beyond Breast Cancer's community, which is the impact on clinical trials and particularly in breast cancer clinical trials. Are they being stopped? What's being done to make sure that we don't lose pace in finding new treatments?

Christian Nguyen (06:13):

We are doing a lot to combat the COVID-19 crisis, but rest assured that's not all that we're doing. The work that we otherwise would be doing as a company in many ways continues. Lilly is working with institutions globally to minimize the impact of the pandemic on ongoing research efforts.

We have taken proactive steps to ensure patient safety and minimizing further stress on healthcare systems including delaying initiation of new studies and pausing enrollment of new patients and most ongoing studies.

It's important to point out that not all studies have been paused and any kind of pause is considered temporary by us. Our goal is to get as many studies enrolling again as soon as possible for patients that are already enrolled in trials. We recognize the importance of keeping them engaged. Discontinuation would disrupt their treatment and also potentially diminish the value of the research information that could help patients in the future, and we don't want to do that. Therefore, in line with [U.S. Food and Drug Administration] guidance and regulatory guidance from other countries, we're actively assessing trials on a study-by-study basis and [putting] mitigation plans in place to maintain integrity of these studies while protecting patients and investigators, and I can share with you some specific examples of what Lilly's doing in this area.

We really care about the health and safety of clinical trial participants, their healthcare providers, and support staff, but we also want to make their life as easy as possible. Some of the flexibility that we've put into our protocols include leveraging virtual visits when and where possible, using telemedicine, for example, permitting required lab work to be done locally instead of centrally, minimizing travel and other inconveniences, and providing alternate methods of getting medicines to patients — for example, by delivering directly to their homes. As you said, we know this is a top question and it's something that we're thinking about every single day.

Jean Sachs (08:30):

It's good to know that not all clinical trials have stopped and we certainly are trying to pay a lot of attention to how that's happening. We also understand that you have to put safety first. How do you think this will impact the pace of results for clinical trials? We know, for breast cancer, we're always looking for updates at the two big meetings, ASCO and San Antonio. Do you think there'll be a delay in the research that's ongoing?

Christian Nguyen (09:02):

In the long run, I don't think so. There's a couple ways to think about this.

One, scientific meetings and medical meetings are still taking place. They may be a little bit delayed, or in most cases, they're going virtual. We're having one this week in fact. That venue being open allows the scientific community to continue to connect and share information, which in the long run is better for patients.

Here at Lilly. We are not delaying the data that we're disclosing. We're just finding new and creative ways to share them with the broader community.

Jean Sachs (09:48):

Great. It's amazing what we've been able to do virtually. Hopefully we'll want to leave our homes when this is over.

Christian Nguyen (09:57):

I also think that down the road, some of the practices we're putting in place as mitigation strategies could become best practices. I mean, I think there's going to be a lot that comes out of this that could potentially be, in the long run, new ways for us to do things. The examples I shared with you on how we're being flexible. I would love to see some of those become standard options.

Jean Sachs (10:24):

Yes, I'm hoping we all come through this learning things and the flexibility has been amazing and the fast rollout of telemedicine has just made such a big difference. It's been quite impressive.

Is there anything else you want our community to know about clinical trials before we end?

Christian Nguyen (10:47):

Yes, first and foremost, I want you to know that for us working from home does not mean the work has stopped at all. We continue to do very important work. There are literally hundreds, if not thousands, of employees within our company, across the whole industry who are still planning for and preparing for new trials. We're still writing protocols. We're still putting things in place such that when we do come back we're ready to do it as soon as possible, because we know people are waiting.

Here at Lilly, as I said, our purpose is to make life better for people around the world, through our medicines. We continue to focus on that as our core reason for being. We've been in the business of discovering and innovating new medicines for the past 140 plus years, and in cancer alone for more than half a century.

We also recognize that these are very challenging times, and we will get through these challenging times, but what keeps us going is one, advancing new therapies for people living with diseases such as cancer. That never leaves us, that's super important. Breast cancer research and the development programs that we are engaged in remain critical to bring new therapies to those patients. Once we get past this phase of making sure people stay safe within the context of the pandemic we are going to get back up and running as soon as possible.

If I may, I'd like to personally thank all of you who are living with breast cancer, who continue to fight the good fight, who show your humanity and your resilience and your beauty. You inspire us. Just know that we're not stopping work. We're not giving up. If anything, coming out of this, just know that we're going to continue to work harder and faster so that these therapies will be made available to patients living with cancer, especially breast cancer. So thank you, Jean.

Jean Sachs (13:01):

Thank you so much and we are so happy to have Lilly on our team and I really mean that. I'm all for the employees that work for you and all the highly trained scientists and doctors. We really do appreciate all you're doing. Thank you for your time, I'm sure you're about to jump on another virtual call.

To everyone out there, I just want to remind you that Living Beyond Breast Cancer is here for you for both information and support. So keep checking out our website for new information. If some of you want to connect with other women, we do have closed Facebook groups, just log onto our page and we will add you to those groups. There's a lot of immediate support that you can get 24/7.

Thank you again and most importantly, stay healthy, stay strong, and stay connected. Thank you.

 

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