2020 was an extraordinary year – unlike most of us have ever seen before. Throughout the COVID-19 pandemic, many of us have faced both professional and personal challenges in adapting to our new reality. We’re looking beyond the science with two of Takeda’s leaders, Julie Kim, President of the Plasma-Derived Therapies Business Unit, and Rajeev Venkayya, President of the Vaccine Business Unit, to explore how Takeda adapted to this new normal while continuing to deliver for patients.
Amy Atwood, Head of Vaccine Communications at Takeda, sat down for a conversation with Julie and Rajeev at the start of the new year to discuss how COVID-19 evolved their day to day work, reflect on how the CoVIg-19 Plasma Alliance and Takeda’s COVID-19 vaccine partnerships came to be, and learn about their key mantras for 2021.
Julie Kim: I am responsible for the Plasma-Derived Therapies Business Unit; it is a new business for Takeda that came as part of the acquisition of Shire. From a COVID-19 perspective, we are in the process of developing a hyperimmune, which is a potential treatment for COVID-19 in an Alliance with other plasma manufacturers. That's currently underway with the Phase 3 clinical trial in progress. On the personal side, I am based in Zurich, Switzerland. I'm married. I have one son, one daughter, one dog and one cat.
Rajeev Venkayya: By way of introduction, I'm running the Vaccine Business here at Takeda. We have a global organization that is a vertically integrated business unit that is managing R&D and manufacturing and commercial strategy for our vaccine programs. I, prior to this, have worked in the global health space and my most relevant experience to the current pandemic is that I worked in the U.S. government for some time overseeing biodefense strategy, which then became pandemic strategy when H5N1 influenza became a threat and was a concern from a pandemic potential standpoint. On the personal side, I'm based here in Boston. I'm married and I have two small children that you might hear running around the house while we're talking here today. I'm looking forward to things getting better at some point in 2021 later this year and getting back into the office with the rest of our team.
Julie: From the professional side, we have formed an Alliance to address the public health crisis that we're currently in. What that taught me was that the power of purpose is extremely strong, and it can help bring together a group of people that normally would not work together; and that has been really fantastic to see. I would say on the personal side that we've been very fortunate that we've remained healthy. I'm in a role that I love and with a company that I love, but all of that can be taken away at any moment by something like COVID and so it's really about being grateful, being consciously grateful for what we do have.
Rajeev: On the professional side, I learned a lot at the beginning of last year as the pandemic was emerging when the Takeda Executive Team (TET) under Christophe’s [Weber, Takeda president and chief executive officer] leadership made the decision to delegate leadership of Takeda's pandemic response to the Global Crisis Management Committee (GCMC), which was to be co-led by myself and Takako Ohyabu, who is our Chief Global Corporate Affairs Officer. That was a really instructive moment for me because I found the delegation to be extremely powerful. It allowed Takako and I, and the GCMC team, to quickly assess and monitor the situation and take decisions and actions to ensure that our employees were protected and that we could continue to supply our medicines, hopefully, without interruption and then execute on those decisions very quickly. That streamlining of the decision-making and execution process was extremely valuable and I think that is part of the reason that we had what I think was a lot of success and in moving quickly to respond to the pandemic threat. On the personal side, I've found that working away from the office, and I do feel fortunate that I'm one of the people in the organization that can work remotely, did come with some challenges because being at home with family and having this spillover of family life into work life and vice versa – as well as the, let's say, erosion of boundaries, both in terms of space and time – has been pretty challenging. For myself and my family, we found creating some structure to help to keep things in check, manageable and to create time for ourselves has been really important and valuable for all of us.
Rajeev: I found during the pandemic that there were a lot of things that I learned when I was at the White House developing the US pandemic plan some years ago s that I could share with others that could help put things into perspective as we navigated this pandemic. Both in terms of policy, but also science and strategy and product development. Twitter has turned out to be a pretty useful platform to do that. I am also on the board of CEPI, the Coalition for Epidemic Preparedness Innovations, and so that gives me a perspective on COVID vaccine development and information that I think is useful for people to have, and I've enjoyed using Twitter and LinkedIn to do that.
Julie: Like Rajeev, I'm fortunate enough to be able to work from home, but I would say it has caused me to experiment a lot more. The things that we typically rely on to maintain engagement, or to keep things moving along, we don't necessarily have the ability to do when we are isolated in our homes and separated from our teams and our key stakeholders, whether they're internal or external stakeholders. Really, it was about experimenting and not being afraid to experiment and try different things; and if something doesn't work, it's okay, learn from it and try something else. We talk about being a learning organization and it's something that I espoused in general, but the COVID situation and working from home has definitely kicked that into high gear.
Rajeev: Like Julie, I've had to experiment and figure out what's going to work best for our leadership team as well as the entire organization. I, along with our leadership team, have tried to find new ways of managing our processes and our approaches to things that make it easier for people to get things done and don't create new barriers for people. We've actually taken on a challenge as a leadership team to try to figure out how to give back time to our people, and we're playing around with the idea of, say, giving people an hour a day back by changing the way that we do things – whether it be processes or policies or the way we manage our meetings – just as a way to help them decompress and manage what is a very significant workload for everybody.
Julie: I think that piece is really important, in terms of creating the different boundaries to help manage your time and your schedule. Most people use their commute as a natural boundary for their working day. I'm sure people would still work sometimes in the evening, but when you're working from home and you don't have those natural boundaries, myself as I'm sure many others, you found that it just bled into a non-stop schedule. And unless you re-teach yourself how to put in those boundaries and manage your life accordingly, it can take over. Because everything you do now, you need to set up a meeting to talk to someone, whereas before you may have just reached over and said, "Hey, what about blah, blah, blah, blah," and it would have been done in a few seconds. But now, I need to find time in someone's schedule, book the call; so, it does take a little bit longer. To everyone's credit, I think it's been fantastic that we have not let down our patients and we've not let critical things fall, but it does take a toll on people. Because this has dragged on for such a long time, and we're still not out of it entirely, it's important that we look at how to prioritize and how to give back some of that time so that this is something that is sustainable in terms of how we're working now; because it's not going to end next week unfortunately.
Rajeev: I think that's a really important point and I have found that this issue of losing the boundaries affects everybody in a household if people are living with others, family, or friends.
Julie: Our team immediately recognized the value that we could contribute to a hyperimmune program, because of our expertise in plasma; and hyperimmunes had also been used in the past to treat other pandemics. But given that the collection of convalescent plasma is the rate-limiting factor for hyperimmunes, I also quickly realized that we could do more by partnering with other plasma companies, because we could combine our resources to accelerate the development of a hyperimmune and potentially make more supply. What do I mean by this? Let me give you an example: Let’s say that three different companies want to make a hyperimmune; each need maybe 5,000 liters of convalescent plasma for a manufacturing run. Each company would need to wait until they have collected enough plasma. So maybe it takes company A 45 days to collect 5,000 liters, so that’s when the first manufacturing run could occur. Now imagine that all three companies pool their collection infrastructure and provided plasma to a single designated company. Now it maybe only takes 15 days to collect 5,000 liters; and so, the first manufacturing run can happen 30 days faster. And because I sit on the Plasma Industry Association board, I put out a call to action to create a coalition and shared that Takeda would stop our internal development program to pursue a joint development through a coalition. That’s how Takeda and CSL Behring formed the CoVIg-19 Plasma Alliance, and then a number of other companies joined. This type of partnership between industry competitors has never happened before, and it was the believe that we could be stronger together in fighting this global health crisis that made it happen.
Rajeev: One of the issues that I think Julie and her team faced – and by the way, I think it's incredible what's been accomplished with this unprecedented consortium that has been created under Julie's leadership – is that, when you're facing an emergency like this, and you take on a program to respond to that emergency, it can consume the entire organization's efforts and/or capacity, and can really undercut your ability to do other very important things. We learned this from Ebola and then Zika and applied those lessons to COVID-19. By that I mean that we, during the Ebola outbreak, when it happened a few years ago in West Africa, we thought about whether we should begin an Ebola program. We decided that we didn't have special capabilities to apply to Ebola, on one hand, and, on the other hand, if we were to take that on, it would really consume the organization and we would almost have to put other programs on hold. When it came to Zika, we took that program on because we were able to bring in support from the U.S. government and additional capacity. When it came to COVID 19, this came at a time when we were in the midst of our Phase 3 program for dengue. We knew that there were over 150 other organizations developing COVID-19 vaccines, when in fact, we were basically the only entity developing a late-stage or near to filing a dengue vaccine. We made the call that we should ensure that we don't sacrifice anything on dengue because we believe the world is really counting on us to bring that vaccine to the people that need it, but that we also shouldn't turn away from COVID-19 vaccine opportunities. We felt the best balance was to partner with another company or companies, as it turned out, to manufacture and/or distribute vaccines for the Japanese population and potentially beyond. So, leveraging our capabilities, but not consuming our R&D organization to actually do the development work, leaving that to the partner. We think in retrospect that was exactly the right decision for the organization. Dengue is still on track; the world has its first COVID vaccines; it's going to have more and we're going to be a part of that, bringing those vaccines to the people that need them.
Rajeev: I think the urgency is something that we've seen before, but we've never been as successful in addressing it in vaccines. When we look back at Ebola and Zika, we were working with approaches and platforms and, frankly, an evolving situation that didn't have all of the crisis attributes that this pandemic does – where the entire world is threatened and you have many, many people everywhere getting infected and hospitalized and dying from the disease. That urgency has really unlocked tremendous innovation across the entire product development spectrum and nowhere has it been more apparent than in vaccines. I think everyone's probably heard by now that it typically takes eight to 15 years to develop a vaccine and we've actually been able to compress all of that into one year; of course, building upon several years of research into these vaccine platforms. We have found creative ways to, without compromising on safety and efficacy evaluations, do product development in parallel, to do manufacturing scale up in parallel, to do clinical trials in places where there is a lot of virus transmission happening so that you could quickly accrue cases and demonstrate that vaccine candidates work; and all of those things done together along with a lot of support from the public sector, from governments, has allowed us to do things that have never happened in history. I like to call it, effectively, a moonshot. In the course of this last year, we basically, in my view, did the equivalent of landing a man on the moon while we were responding to this pandemic. I think that's extraordinarily exciting, and it holds a lot of promise for where we're going to go in the future with vaccine development as well as development of other products.
Julie: Donating plasma is a simple and safe way to help other people. You are literally providing the source of life for some individuals. As you've mentioned, we treat many rare and chronic diseases with plasma-derived medicines, and they don't have other alternatives. By providing plasma to make the precious medicines that either sustain or save people's lives, you can literally be a hero.
Julie: Absolutely! As we've been talking about the development of the hyperimmune, the plasma that would come from an individual who has recovered from COVID-19 is what we refer to as COVID-19 convalescent plasma and that is the plasma that we need to make the hyperimmune. So absolutely, they can donate and contribute to saving lives.
Rajeev: My first response is that this is very, very common. I've received this question countless times, as I'm sure many other colleagues in Takeda have, because it's natural to wonder whether corners have been cut when you shrink the timelines for vaccine development, as much as I've said. I do take the time to talk about what has changed to make that possible, but most importantly, what has not changed in terms of the rigor of the safety and efficacy assessments. For example, the size of the Phase 3 clinical trials that are being conducted for COVID-19 vaccines are really no different from the size of the trials that we do for any vaccine that's going through Phase 3. I found that walking people through the reasons why we believe the standards for safety and efficacy are essentially what we have in normal vaccine development is an important part of it, and then also explaining to them how I would approach COVID vaccines. Now that we have some data, and we have authorization of the first vaccines in several countries, I can tell people, having looked at that data very carefully as I have, that there is zero hesitation on my part to take the vaccine myself when it's my turn.
Julie: From my perspective, it's the fact that we didn't have a single effort. We had a number of different efforts across multiple groups to try to address the global pandemic. To me, it's just another demonstration of how Takeda lives our values. These aren't just words on a page; they drive our actions very clearly, not just when it's an internal program, but also externally as well. I think this is further underscored by the fact that the hyperimmune that we've been discussing, that's being manufactured as an Alliance, we're going to be providing that as a donation.
Rajeev: I too am very proud of the way Takeda has responded, both in the ways that Julie explained, but also in the way that we responded as a company to the crisis itself and the impact it can have on our people and the important work that we're doing. From the very beginning of this crisis, there have been two priorities for the crisis response committee and the company. Number one, to protect our people. Number two, to ensure that we can continue to supply important medicines to people that need them. Those were not just words that were written down somewhere. Those were guiding principles for every decision that we made in the crisis response committee and as the Takeda Executive Team. They were very clear to everybody, and they were also perfectly aligned with our corporate philosophy and our values. I thought that the way we responded to the pandemic in terms of protecting our people and what we are here to do, was a great embodiment of everything that we said we aspire to be.
Julie: Someone once told me that, when you figure out how to let go, you create space for better things to enter in your life. I think this is a year where we have to figure out what we're going to let go, what we're going to stop doing, whether it's from a work perspective or a personal perspective, so that you can create that space for better things to enter. This is a year, I think, where we all need better things to enter into our lives.
Rajeev: I certainly agree with that. I think it's been an extraordinarily difficult year for everybody and the challenges that people have faced have spanned the spectrum, but we all share the fact that it's been difficult for all of us. We're ending the year, or I should say we're starting the year, with this news of a new variant or variants that may create another set of problems for us, that could make it tougher to get this virus under control. Still, I am entering this year with a sense of huge hope and optimism because we saw in 2020 that science can prevail. We did things that we never thought were possible and we ultimately came up with the most precious tool, and tools, in vaccines to protect people. We made huge progress in treatments, and in diagnostics, and in other areas. The fact that we were able to do everything we did with science in 2020, gives me absolute confidence that we will get this virus under control, even as it evolves, and that we will be well on the way for people's lives returning to normal; and most importantly, the most vulnerable amongst us, everywhere in the world, being protected as we hope they will be. I, again, go into the year with a lot of hope.