This month Utah Business, in partnership with Holland & Hart, hosted a roundtable event featuring leaders in the life sciences space to discuss COVID testing, federal regulations, and innovation. Moderated by Kelvyn Cullimore, president and CEO of BioUtah, here are a few highlights from the event. 

How has COVID-19 affected your business and how are you responding to it?

Fred Lampropoulos | CEO | Merit Medical

We’ve had to do furloughs and we’ve had to cut headcount. We’ve had to do a lot of things that are unpleasant, but we have had portions of our business, like our critical care business that has been very, very busy. Our critical care business, which is based out of Singapore, is up about 25 percent for the year. Overall we’re down about 25, but our business is coming back [because] we started producing COVID-19 test kits. We started that on April 5th and here we are today, in the middle of July, and we’ve produced over 3 million swabs and hundreds of thousands of test kits. We, as a business, adapted by filling the needs that were out there and making sure that we assize the inputs.

Andrea Kendell | Acting CEO | BioFire Diagnostics

As part of a global in-vitro diagnostics company, BioFire is part of Biomerieux. Our development teams responded to [the pandemic] by adding a COVID target to our current respiratory panel and getting that FDA EUA in 40 days, [which]  is unprecedented.  For some time we’ve been in the molecular diagnostics space focused on many different infectious disease targets, but our upper and lower respiratory panel has really come into play. We have basically had to pivot and figure out how to keep our products safe while manufacturing. [We also moved] all of the non-essential employees off-site to really control contamination to our products. We’ve gone from a position of being able to fully manage our customer requirements, to being in a place where we are in allocation, managing customer demand that far exceeds our capacities.

Since March, we’ve not been able to keep up with demand and we foresee that this challenge is just going to get greater as we reintroduce. All of the other bugs have really been laying low because of quarantining and we’re starting to see them come back as the economy has reopened and people are out there socializing in ways that are really creating problems. We are in a fortunate place here where we have not had to furlough people.

Guochun Liao | President & CEO | IDbyDNA

IDbyDNA is another Utah company involved in COVID-19 testing. We’re using the sequencing technology for infectious disease diagnostics and we were actually one of the early responders to COVID-19. We have our Explify Respiratory test that can potentially detect over 900 different pathogens at the same time. 

In April, we worked with Illumina to launch this viral panel against COVID-19. We are working on a much larger panel in the coming flu season with a potential second wave or a continuation of first wave COVID-19 in the US. 

Brad Brown | Founder & CEO | ATL Technology

We have a facility in China, so it impacted us much earlier than the United States. We had people getting respiratory illnesses but no way to test them to find out if they had COVID, so ATL, even though it was against the law back then, set up a lab and started testing our own people. Ultimately, that lab was bought by Silicon Slopes and then ultimately the state of Utah, but being early and setting up that lab enabled us to supply test kits. We now supply test kits to many states across the US and so that’s been a big boost to our business. Plus, we’re involved in the manufacture of patient circuits for respirators, so that business has gone up. 

Adam Brown | CEO | Quansys Bioscience

We’ve developed an antibody test that detects antibodies against COVID, as a response to the pandemic. We’ve had a lot of interest in that. We’re actually working right now with the FDA to get an EUA approved on an at-home collection for that test and we’re really excited to move that out as quickly as possible, we’ve had a lot of interest in that. Then we also have a lab test. We developed this test to measure both the S1 and S2 spike proteins and it’s proven to be incredibly accurate because of that.

What is your take on the path forward against COVID-19 as well as preparing to respond to future similar pandemics?

Brad Brown | Founder & CEO | ATL Technology

I view the key to this, and the future, is to test and trace, and I think the current privacy rules surrounding the medical field is hindering our ability to kind of educate the populace as to where and how this is spreading and who’s getting it. I lived and worked in China during the SARS epidemic, we were much more easily able to pinpoint exactly where the infections were, which companies had them, which neighborhoods had them and from that, people were able to make decisions to keep themselves clear of it.

Rob Etherington | President & CEO | Clene Nanomedicine

The big challenge is that the US pharmaceutical industry, and one could even argue the global pharmaceutical industry, has not been appropriately focused on antivirals for decades. In fact, I read an interesting statistic that since the 1960s, we’ve seen only about 90 antivirals approved in this country, half of them for HIV. We are not prepared at all for pandemics. Even when we have a vaccine, the question I think remains, how successful will we be able to vaccinate most of the world? We need a much more concerted national strategy for a national stockpile for pandemics. 

One of the reasons the pharmaceutical industry has steered clear of antiviral development is, in a normal world there’s not a lot of value proposition there. Most of us don’t care that much, but I think that this pandemic has clearly proven that the pharmaceutical industry needs to focus on vaccine development most definitely, but be in parallel work on antiviral development also.

Guochun Liao | President & CEO | IDbyDNA

It’s very important to respond to a future similar pandemic [with] early detection and prevention, right? We working on using the sequencing paste technology, not only we can provide a broader diagnostics, which is important for a co-infection and antimicrobial resistance at the same time, detect them at the same time, but also we can monitor those kinds of emerging virus or pathogens that was not monitored by current testing measures. This is one of the advantages of using the sequencing approach, because it can detect pretty much anything. 

How do we get the public more educated, careful, and comfortable with these processes? 

Andrea Kendell | ActingCEO | BioFire Diagnostics

The moment you have a positive in the corporate environment, you start to have these dialogues with the employees to do a bit of contact tracing for two purposes. One, to figure out their association with other people, but also, you need to have a way of sharing that positive in a protective way, but yet in a way that tells other people that they’ve been in contact with someone who has tested positive. This has proven to be really challenging for companies and for HR teams in organizations. 

One of the things that we find challenging here at BioFire is, we test our employees who make product. And with the new immunity statute that has just come out in Utah, we’re trying to figure out how to balance that appropriately with testing. It’s proving quite challenging to manage both of those aspects and also be a manufacturer of a test that, in theory, our employees ask us every day, “Why can’t you just tell us if we have COVID?” And the answer is because we’re not allowed.” So, this has been a really challenging topic to navigate. Personal health information used to be very easy. And now with COVID it seems like the legal implications and the legal flexibility is moving under our feet, and trying to keep up with how to manage that is not easy.

What would you ask the state legislature to do to help catalyze our industry? What are the primary barriers you see to growth here?

Rob Etherington | President & CEO | Clene Nanomedicine

Many of these other life science sectors in Cambridge,San Diego, and in the Bay area have been facilitated by tax breaks and incentives. And Amazon very famously ran this process a couple of years back, to place their second headquarters and had states and counties all across the country play for that. If we were able to get Pfizer, Merck, Sanofi, or Johnson & Johnson, and have them place a major R&D center here, I think that act alone could go far to helping us keep recruit and grow talent in the life science sector in this area. And the state needs to help facilitate that by [creating] tax incentives and an economic recruit, much like they did for the movie industry, for example.

Beth Hoberg | CEO | Majelco Medical

From a startup standpoint, I think refunding USTAR would be a great start. My colleagues who also are in early-stage startups, it’s very difficult to find funding when you are pre-product and you need that initial funding. So when you’re a very high risk still, you can get some angel investing, but many times that’s not enough investment when you are in the life sciences. It’s not an IT startup, where it’s quite inexpensive to get up and running relatively speaking. So having more funding for people who are still in that stage, who are very high risk, more non-diluted funding.

How much does regulation add to the cost of medical products today?

Kristy Kimball | Partner | Holland & Hart

[I’m] a life sciences and regulatory healthcare attorney. With COVID-19, the federal agencies have tried to waive as many laws as they could, or they’ve said that they are going to be exercising enforcement discretion. But with the FDA having created their emergency use authorization (EUA) process, what’s been interesting is just even a few months down the road, you would think that in this situation, it’s like, okay, well we all need to play nice right now to make sure that we can get the testing that we need. But on the backend, there are issues and liabilities being created because these federal agencies, their guidance is not sometimes not clear and sometimes contradicts.

Now that things are a little bit calmer, I am seeing some significant issues. And unfortunately, that’s a significant, not just financial costs to my clients that are involved, but it’s also the amount of administrative and employee time that it’s been hundreds and hundreds of hours that have had to be spent trying to deal with these issues on the backend that are really unnecessary. And it’s really frustrating seeing some of these federal agencies or state agencies causing this incredible burden when right now, we should be solely focused on increasing testing, making this more available, and getting out of the way.

Brad Brown | Founder & CEO | ATL Technology

From where I sit in the industry, it’s a double-edged sword. The regulation has created the safety that has allowed this industry to flourish, but as new innovative procedures and products come on the market, it can cost hundreds of millions of dollars to get that product into the market. They aren’t simply allowed to come into the market because the regulators don’t understand them. 

Some would say that innovation and medical technology is a major driver of healthcare costs. How do you respond to that? 

Jared Bauer | CEO | Cibus Biotechnologies

Innovation is our greatest opportunity to lower the cost of healthcare. We talk about the healthcare process or the entire medical world as though it was one large factory. And that’s the analogy that I give to my staff all the time. We have a finite number of personnel in the factory. So now we’re looking at the number of man-minutes that we have in a day. What can we develop that will minimize the amount of time that they need to spend on any certain tasks while increasing the hours or improving the outcome?

What you end up with is a team that is focusing on innovations that are going to improve that process. If we can get the answer earlier, if we can get it more rapidly, then we can begin to treat the patient more effectively more quickly. And that is where we should be innovating.