Pivoting a product launch during the pandemic – transcript

Conversations in Healthcare

Mike:    Hello everyone. I’m Mike Ward. Welcome to Conversations in Healthcare, a series brought to you by DRG, part of Clarivate. This is an opportunity for us to hear firsthand the challenges and opportunities that are facing the healthcare industry and how business leaders in the sector are managing them, particularly where events have forced a rethink in priorities or the company strategy. In line with this, I’m delighted to be joined by Bryan Witherbee, who is president and CEO of Adarza BioSystems. This is a private biosensor assay and instrument company, which is based in St. Louis, Missouri, which is servicing life science, research, drug development and in-vitro diagnostics clients.

Earlier this year, Adarza raised 25 million dollars in a series D round, and that was to support the full commercialization of an automated biological platform, Ziva. That platform exists to help academic and clinical researchers quickly identify inflammation, cardiovascular, and oncology biomarkers for disease profiling and drug development. Then obviously came along COVID-19 and disrupted that plan.

Bryan, I hope you and those that you care about are all keeping well. Thanks so much for joining me.

Bryan:   Mike, thanks. Delighted to be here with you. Likewise, I hope you and those that you care about have been able to remain safe.

Mike:    Yes, everything’s good given the circumstances. First, it would be helpful, I think, if you could describe the challenges researchers face that the Ziva platform actually addresses and how it can actually help them.

Bryan:   I think as a scientist or a researcher, our desire through our work is to help humankind and finding a solution to a problem. Really, our moon shot as scientists is helping to solve a disease, and that’s what really drives us.

With the Ziva platform, we can do our part to help researchers by providing this platform that delivers a comprehensive, high-definition protein biomarker profile of a disease. We then provide the ability to track changes that are happening, based on efforts to attenuate the disease–whether it’s by a therapeutic or a lifestyle change, such as diet or exercise.

I think that the genomics revolution, which was really led by high-throughput sequencing, helped provide large amounts of data about a person’s genetic makeup.

Biomarkers are the outcome of that. Biomarkers are how the body takes that genetic information and turns it around. The system’s biology part of that is when things don’t work, or things are broken, or things need help–those biomarkers are hints to tell us what’s happening. By identifying those different biomarkers, we can see how the disease has affected our body, and then how different treatments affect that. That’s extremely important to researchers.

I think, if we are going to deliver on personalized–or precision medicine as it’s defined–we have to take that genetic information and couple it with phenotype, which is the protein–the biomarker information. Once we can put together those combinations and look at the relationships between them, we are able to do a lot to help direct researchers on how to treat disease or to build different therapeutics to treat disease.

That is really where I think our part is at Adarza, in terms of where we see the Ziva platform, and hopefully continuing with some of that protein evolution and being able to put as much biomarker data and as much phenotype with genotype. That’s really where I see this being important for researchers. Then, as you get past the researchers, it’s clinicians–giving information to physicians to be able to make the best decisions for patients.

Mike:    There’s a plan that it actually would provide real time information so you can actually track how a particular therapeutic approach or some other intervention is actually helping improve the patient’s condition?

Bryan:   Yes, I think that’s the diagnostic part of this. Early on, there’s the research component of it. As researchers are looking for new drugs and looking for new therapeutics or new changes, we know a little bit about this disease in terms of how genetics happens, what’s happening once it’s in the body, and how different therapeutics or lifestyle changes affect it. We are able to measure that and understand whether or not it’s being effective or not.

Mike:    Looking at the company’s history, it looks like getting Ziva out of the door has not been an easy task, given the fact that there were plans in place for a 2012 launch and a 2015 launch. What were the hold ups then?

Bryan:   I think the interesting thing about Adarza’s technology is that it’s always been very promising. As in the earlier efforts, we really need to prove out this concept. The other part that’s important with any new technology, is that it’s got to be in a format that actually makes researchers lives easier, or delivers something that they can’t currently do. I think that the earlier effort wasn’t in a format that would allow researchers to really take advantage of where the technology is.

I joined Adarza in 2017 and we really wanted to build off of that core that was done with the things you had said in terms of 2012/2015. The founders had taken the technology to a certain point–in terms of proof of concept–but it was not in a format that users, researchers, clinicians, etc were going to be able to use and be able to use well.

A lot of the effort since 2017 is we had an opportunity to bring in a lot of talented people with experience in delivering these types of technologies. So we did a lot of listening to the customers, understanding what was lacking in terms of the current tools, and were able to build that into our design.

That’s what has been going on for the last couple of years, we basically took a technology that was extremely promising and interesting, and then put it into a package that was going to be readily usable by researchers, clinicians, etc.

The whole idea there is just what we talked about earlier, we want to deliver more data to the researchers and the clinicians. We want to do it so that it doesn’t take them much effort. We needed to make sure that the package that we’re delivering in terms of how the person took the biological sample, put it into our technology, and most importantly, get data back. That’s really been the effort for the last few years.

Delivering new technology is never easy. Part of it is taking a lot of the experience that the team that we’ve built had and being able to package this together so that we’re in a place where what we are delivering now to the scientific community is going to be well received.

Mike:    Right. You raised the 25 million dollars, as you say it was a series D investment. And essentially that was to support the launch of the platform and that was back in June that that was meant to take place. Could you outline what the commercialization plan would have looked like if you’d been able to do that, because obviously you are affected by COVID?

Bryan:   We had expectations of starting our early adopter program based on an introduction of the technology at a couple of key meetings in May and June. One was AAI which is the American Association of Immunology and then AACR, which is the American Association of Cancer Researchers. Both of those were key meetings where we were going to introduce the technology, show some of the earlier work, and really start to fill out our early adopter plan. Then with the idea that there’s some key meetings that were going to come up in the Fall where we could do our full launch.

We’ve had to delay that plan a little bit, obviously, because of COVID, and mainly because some of our partners had to close, and several of our potential early adopters were in shut-down or had to close their labs. The labs have begun to open up, though a lot of them are very focused on COVID-19. We’re still very wary of bringing everybody back into the workplace.

The same is true of labs. They’re bringing back people on different schedules and trying to get work done, but a lot of it is really focused on the current pandemic. I think we’re continuing to move forward with our plan, it’s just delayed.

Mike:    With COVID-19 being destructive, it’s clear that’s happened right away across the board. I was just thinking that when you saw what the potential of the pandemic was going to do and that disruption, what were the discussions that were taking place at the board level to actually respond to that challenge?

Brian:    This is interesting, because our board meetings bordered around the COVID piece. Our first one was in February before things had really gotten full blown. And we did have a discussion there–is this thing going to be big or not? At that time, a lot of people thought, this is going to be like the flu. It’ll be here and gone.

There were some of us that were really worried about it and we did talk a little bit about that, but we just didn’t have enough information at the time. I think as it did start to fully be present in the United States, one of the things we first had to do with the stay-at-home orders and everything else, our number one responsibility was to make sure that we kept everyone safe in terms of doing the things that we all had to do–minimize numbers in the lab. We tried to keep the work going by working shifts.

We also knew that there was an opportunity there–and opportunity and challenge is one of those things that as a start-up, it really excites your folks and it is something that drives us anyway. We knew we had an opportunity to use Ziva technology for COVID-19 research as well.

One of our co-founders, Ben Miller, who is a professor at the University of Rochester, had been using the air technology in the earlier iterations of this to look at flu serology. In 2019 at University of Rochester, his NIH group looked at the possibility of a flu pandemic, what resources as a nation do we have to go after, and really identify what the pandemic is and how we operate.

That exercise in 2019 was really an opening into how this could be used. We saw that and started to talk through that internally and just said, you know what, there’s an opportunity for us to help. One of the tough things about a pandemic like this is that sometimes it’s a passing freight train. It’s going through pretty quickly. Hopefully it comes and goes, but obviously in this case it’s not been the case. You start to weigh your opportunities and you have those discussions of what is the realistic ability of us to help.

Definitely not on the diagnostic side–we didn’t have enough platforms out there to help. With our tool, a lot of the early discussion was around serology and false negatives and stuff like that. We knew our high-definition approach could really help to rule those out. The ability to look across many different variants of the COVID-19 protein, to look at what someone’s response was to other circulating coronaviruses. We knew we had a strong tool. It’s just that we didn’t have the install base to really be effective and definitely not as diagnostic. We could have spent a lot of effort pushing and getting emergency use authorization, but I don’t think that’s where the value is.

Our board talked about it, and our value is more in demonstrating the technology and then being able to utilize it now. Especially now that the pandemic is going on and we’re learning more and more about the virus and its effect on the body. What we talked about earlier was, here’s this disease state–how do we know what’s going on? This is where researchers will want to start to not only track what’s going on in terms of COVID-19 infections, but I think it’s going to have longer implications in terms of drug trials and overall health, and understanding what your COVID status is or was, and then as we get a vaccines, how well protected are you.

We’ll start to understand more of that, but I do think that the value of our tool is going to be even more realized as we start to dig in and do more research around COVID. And then as we go on and understand questions like: Is going to be like the flu? Are we always going to need a COVID shot? What are the long term effects on cardiovascular disease?

We know inflammation from this disease is causing all kinds of problems in different areas. That’s where we think we have a lot of value for researchers and we’ll start to couple our COVID panel and our infectious disease panels with the ability we have four other biomarkers, particularly cytokines and chemokines around inflammation.

Mike:    You mentioned that you’re in the fortunate position that Dr. Miller had actually looked at a related area, so therefore you weren’t completely unprepared, even though you weren’t necessarily expecting to use that. What did you have to do though to reconfigure, to almost reposition Ziva as a platform that’s going to be able to help COVID-19 researchers?

Bryan:   Infectious disease was always on our product roadmap, but it wasn’t something we were going to start in earnest until 2021. We had done several proof-of-concept projects related to autoantibodies generated in oncology and other infectious diseases. We knew it was something that just wasn’t an area of focus because, quite honestly, the market wasn’t huge for that. The better introduction was going to be around some of these cytokines, chemokines, and inflammation.

In terms of reconfiguration for Ziva, luckily we had experience with this. We had done several proof-of-concept projects. We had actually even had a couple of collaborators that are looking at the mixture of cytokines, inflammation markers, biomarkers with autoantibodies generated during cancer, oncology drugs, et cetera. In terms of reconfiguration, the biggest challenge was getting the different proteins in to be able to apply to our platform.

One of the beauties of our technology is that we can quickly add new content onto our Ziva platform. It’s something that was really challenging–to be able to deliver something to customers that we’ve been working on for the last few years and to quickly adapt and add new content. We feel this is important for researchers because new things are being discovered all the time, and then we want to research them.

Being able to add that content quickly was really important to how we could differentiate ourselves from other technologies out there, the ability to quickly add new material. It really launched into our overall plan to quickly get the COVID proteins, so that we can apply this to our technology and see how quickly we can turn and get a serology test put in place.

Actually, the beauty of this is, after procuring the proteins–which was probably the longer part of this because everybody was after these–we were able to put together a chip that was working and giving us strong answers within a week.

This is really a testament to the team we have here. We fit it in, made it part of our workflow, added it during a time where we were low staff and other things, but we’re able to do it quickly. And as soon as we saw our first results, we saw we were definitely getting the response we expected.

We had COVID samples coming in that we were looking at compared to pre-COVID. We knew we had something right away that was working well, and it was just a matter of making sure we do all the other things we need to do, and then we need to have other people test it.

Mike:    Right. What has been the plan or the program to roll out that COVID-19 focused application of the Ziva platform?

Bryan:   Yes. So this is just like we fast-forwarded what is in our product pipeline and so we’re in the midst of it. We have researchers that are doing follow-up studies. They’ll put out peer-reviewed papers. At the same time, we’re launching the product with the instrument–it’s out. It will be released to the general public very quickly. Actually, this month we’re in the midst of getting this in place for the public to purchase and to start to see results from it.

We’ll continue to find good research projects with researchers out there that are studying this disease. I think our main thing, like I said earlier, is that as a scientist and as a technology developer, we want to be part of helping to solve these problems. COVID is definitely being looked at by everyone everywhere, and because of that effort, we’ll find solutions to this.

I think the other thing is that it’s the next phase of this that we feel like we can really be a big part of–doing everything that we can in terms of surveillance to prevent this from happening again, or to be well prepared for it.

The Ziva platform can very quickly be refocused. Part of what iss on our COVID panel is also influenza proteins. When the latest flu vaccine came out, we were able to quickly add those new flu proteins that they’re expecting to be part of the flu season this year. Now we can analyze not only the Coronavirus responses, but also for the new flu influenza A and B that is expected to hit the population here in the northern hemisphere in the next few months.

I think all of this is important–and it’s going to be refocused for a lot of the research community–is to be better prepared for when a pandemic does strike, that we have a good understanding of it, and that we’re prepared to battle better than what we did this time.

Mike:    What’s the commercial model? Is it that you sell instruments or is it that you make the money on the consumables that you would then put into those instruments depending on what your focus is?

Bryan:   It’s definitely the razor blade model. The instrument is a small part of it, but really it’s the content that comes out, in terms of the consumable that comes with the instrument, and those are what allows for the high-definition. Part of the technology allows us to look at hundreds of biomarkers at once.

As we start to roll this out, it’s really looking at a researcher, taking their biological samples, being able to apply it to that razor blade–our chip–the Ziva platform itself. Part of what I was saying, we wanted to make it very user-friendly. They have their samples, they add it to Ziva, Ziva gives the data out. That’s the most important part of this, that we wanted to make it easy on researchers to get their data, so they can hopefully make the bigger decisions on being effective in treatments, and seeing the progression of disease.

And as we add more content, the instrument won’t change. The beauty of the way we designed this is that it goes through that without what we described as the testing funnel for biomarkers–the biomarker continuum. In the early stages of drug or disease discovery, you want to look at a lot of biomarkers. And as your focus gets closer and closer to clinic with either treatment or disease, the number of biomarkers that you really need to look at gets less and less that are really pinpointing where your treatment is going.

I think one of the things that has plagued pharmaceutical developers in the past is that as they’ve gone through that continuum, they’ve had to change platforms. They do their bridging studies to show that this is the more effective way to do it, or the tool wouldn’t work in a diagnostic platform. Part of what we built into our design was the ability to go through that whole continuum.

We can be very high content, meaning lots of biomarkers with lots of samples at the early stages, and as the focus gets closer and closer to clinic for a treatment or a disease, then we can also do high numbers of samples–but with a fewer number of biomarkers–without having to change platforms, staying on the same system. I think that’s going to be really important for continuity for researchers as they move forward.

Mike:    Yeah, because there was the plan that Ziva was going to be launched as a biomarker discovery system. When it comes to those plans, where are you and what’s the expectation?

Bryan:   Our expectation is that–and honestly the COVID work is a biomarker in itself too–it is definitely something that’s going on in the body. Our main focus was to launch this as a biomarker discovery system. We’ve got the system out with early adopters. We’re continuing to build out researchers. We’re just going to be a little bit delayed on this. As labs start to open up, we’ll get more and more users going through and then we’re really pushing for a large 2021 where we can hopefully get out to different meetings and showcase the capabilities of Ziva.

In the meantime, we’re doing all the things that have to happen now as a company. I think that everyone’s learning to discover. How do I reach customers? How do I reach those researchers and demonstrate the tool?

It’s been a big push on us as a company to figure out the new ways to do this going forward. I think some of them are great. The necessity has driven us to find new ways to be innovative in terms of marketing and figuring out ways that are really outside of the way researchers and companies like us have reached people in the past, because it’s been more personal and face-to-face and stuff.

Finding ways to effectively do it with videos and demos and being able to count on emails and other things, and hopefully being able to reach people. I think we’ve found that, just like everyone else, that this is going to be a new way to go forward, and a lot of people like it. This has been incorporated into our plans, just like a lot of other companies have had to.

Mike:    If you’re thinking about reflecting what has actually happened this year, what as a company or as a management team are you doing differently than actually you think it’s going to help you manage the company going forward and actually it might be new behaviors that you’ve introduced that actually may become more permanent?

Bryan:   Yeah. I think like a lot of folks, this has been an interesting experiment. Not an experiment any of us all wanted, right? But one of the things always being a leader–communication is key. Being able to effectively communicate with a group that’s not all at the same place at the same time, and figuring out how to use the tools like we are today, has been important. Definitely, we identified critical areas that you need to have people well cross-trained, because you don’t know if people are going to be out of the office. It has definitely highlighted areas within our own workflows where we’ve got to do a better job of making sure we have people cross-trained or that we’re adequately staffed.

I think that’s been an interesting learning experience. I think the other side of this is that we did learn a large group of our people that can work effectively from home–and maybe even be even more effectively, because they’re not plagued with the drop in meetings and other things like that that happen in a bigger work environment. I think that’s been interesting to learn, and I think we’re trying to find ways now to facilitate that because it has worked out pretty well.

I think there’s the other side of it that I think a lot of companies are seeing too. Part of being an innovative company is a lot of those side conversations and a lot of those, let’s go through and draw on the wall and figure out if that’s going to work and ideas. As an early startup company or a company trying to deliver, those conversations are important. I think finding that balance of still having those, and using tools like Zoom and video conferences and other things to make sure that we’re getting the right people in the conversation.

I think one of the tougher things I’ve seen, and it’s something that we’ve tried to minimize, is that you have a lot of repeat conversations because you can’t just go and grab someone out of their office and say, “Hey, let’s go sit and talk about this.” You may have to schedule it and you may have to make sure that you have the tools there and stuff. I think it’s been interesting in terms of finding ways that we’re going to have to do that. There are definitely areas where we’re going to be able to take advantage of some of the things we’ve learned, and things where we know where we just have to be better at how we do them. I think that a lot of people are finding that out as they move forward.

Being a small company you really depend on your people and our people have been great. We’re committed to delivering this technology and with the challenge, I think we’ve all risen to it. I’ve been pretty excited about where we have gone as a company, and in future I know with the group I have, we’re going to be able to meet a lot of these challenges. I feel like we’ve been battle-tested as much as anyone now too. This has been a learning experience. It’s also been something where you find the best in people, and I feel that we found the best.

Mike:    It’s interesting what you say. In some of the other conversations I’ve had with business leaders, it’s clear that a lot of the activity, and we’ve seen that companies have been able to raise record sums of money, but it’s clear that a lot of that activity actually already existed pre-pandemic. There were relationships that were already there, and therefore I think it’s easy for people to have this attraction for having additional conversations.

But when you’re looking to create new relationships, not having those business trade shows, et cetera, that’s potentially more of a challenge. Is there anything specific you’re going to be able to do to ensure that you meet new people and have an alternative to these accidental or unexpected collisions that you would have had at those big industry meetings?

Bryan:   We’ve learned that we’ve got to use things like LinkedIn and other tools for expanding your networking. I think that’s paper networking. I think the thing that I’ve learned from the past relationships I’ve had with people and worked with people, it’s more effective calling those people and reaching out and saying, “Hey, we have an interesting tool. We’re looking for developers. Can I expand into your network? Is there someone that you can think of that might be able to help us or we might be able to work together?”

I think what I’ve learned in terms of my style now is that LinkedIn is great.  In the past you used LinkedIn to hopefully build up all your network and connections, but it’s actually utilizing it now, and utilizing it in terms of sending an email. I think very much like email, it gets drowned out a little bit. We took that for granted–the personal connections that we had prior to this are things that you lean on.

You go back to people that you’ve worked with in the past that know you, and then you ask them to look to their networks and dig and find people that you’re going to be able to work with or work together. I think that part of it in terms of, “I’m just not a LinkedIn connection. I’m actually going to call you and we’re going to have a relationship and a conversation.”

Those things seem to be even more important to me now, the past relationships I’ve had, not to take for granted, because something like this draws it into a need and a desire–an opportunity. Something where staying well-connected doesn’t just mean a LinkedIn or an email, it means reaching out and having that human contact, whether it’s a voice or conversation can really help propel a business. Really drawing on a lot of our team’s past and reaching out to those connections, finding out how they’re doing. How are you doing through all this? How can I help you? Then vice versa.

I’m hopeful that the idea that this is a research community, it’s a community of scientists and that we actually use that word community effectively, and reach out and hopefully that will help propel a lot of these advances that are happening. Because of this, people are being very innovative, working hard in the labs, hopefully coming up with new solutions and then they’re going to be able to use their networks in a different way–in a better way to reach out and get there. Maybe it makes these conferences and other things even more effective.

Mike:    I think you make a really good point there about not just having a passive relationship with those networks, but actually leveraging the value, the power of them. That’s an excellent point.

Bryan, thanks very much for taking the time to talk to me today. I’m sure the journey you shared with us is going to resonate with a lot of our audience. If after listening to this episode of Conversations in Healthcare you’d like to listen to future episodes, why not follow our LinkedIn page, which Bryan was already talking about, because that’s where we put out announcements for future episodes in this series.

In closing, I’d like to thank Bryan again for joining me, and I’d like to thank the listeners for tuning in. Until next time, stay safe and healthy. I’m Mike Ward and I look forward to seeing you in the next episode.