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Rely on Roche Point of View

Perspectives on the Pandemic: What we’ve learned and why that matters to you

The past many months have been both trying and transformational for labs worldwide and the organizations like Roche, working to serve them. We’ve gathered six global leaders to get their insights on what Roche has learned so far during the pandemic and why that matters to you moving forward.

 

 

Ann Costello


Ann Costello
Global Head
Roche Diagnostics Solutions

Alexandra Valsamakis


Alexandra Valsamakis
Head of Clinical Development & Medical Affairs
Roche Diagnostics Solutions

Cindy Perettie


Cindy Perettie
Head of Molecular Lab
Roche Diagnostics Solutions

Lance Little


Lance Little
Head of Region
Roche Diagnostics Asia Pacific

Whitney Green


Whitney Green
Sr. VP, Molecular & Pathology Lab
Roche Diagnostics Corporation US

Christian Paetzke


Christian Paetzke

General Manager
Roche Diagnostics Deutschland GmbH

Insighs from six Roche global leaders

Part 1: The power to prevent, prepare and prevail

Let’s start our discussion by acknowledging that the pandemic is clearly not over and new challenges are arising even as old ones continue. But what have you heard from customers-in particular, the labs you serve-as they have faced the challenges of the last 18-24 months?

 

Alexandra Valsamakis: Having been a lab director, I understand how extraordinarily frustrating this time has been for our customers. As much as they were trying to address everything coming their way, it felt like an inferno out of control. The scale up. The inability to access the depth of testing resources needed. The lack of available consumables and reagents. All were an unprecedented challenge.

Through this time, they depended on Roche and other suppliers to deliver highly reliable answers to “Am I positive or not? Do I need to quarantine or not?” And all had to be done at the volume needed to combat the unrelenting waves.

 

What did customers tell you they value most in a partner during this time?

 

Ann Costello: Customers told us that transparency and consistency were very important to them. We were very clear about the allocation we could provide and what each customer could expect… from the tests, to the accessories and the instrument, itself.

 

Lance Little: I’d like to echo that. We have had very difficult discussions with governments, labs and healthcare institutions-all imploring us and any other assay provider for help. But globally, we only commit to what we can actually do. There were times in the past months when that wasn’t nearly enough, but we are always transparent about what and when we can deliver… all at our standard pricing.

 

Ann Costello: Those transparent, ongoing dialogues have been essential.  Throughout the pandemic, we have interacted with customers and governments globally-often daily. Because we had the relationships in place, we had earned the trust that our information was accurate and reliable.

Many customers have invested in instrumentation to keep pace with the COVID testing demand in their labs. What is your advice for how to effectively use those systems to prevail moving forward?

 

Alexandra Valsamakis: You need a simple system that is highly reliable with a long meantime to failure. Identify systems that are easy to train on and have a useful, extensive menu. This is how you can consolidate the number of platforms in the lab so you don’t have to train people on a plethora of systems.

 

What strategic role can Roche’s highly automated Molecular Work Area system play in helping prevent or at least prepare for future uncertainty, such as another pandemic?

 

Christian Paetzke: Perhaps more than ever, our global society recognizes how important labs are to enabling clinical decisions for the patient’s benefit. Patients want and need to trust that their samples are handled in the most automatic way to reduce error and variability and ensure reproducibility. And the answers are needed quickly, even in the face of overwhelming volume. This is where increased automation drives enhanced certainty. The pandemic has shown that the labs and countries that have invested in past automation have fared better than those seeking to build capacity under duress.

 

Whitney Green: In fact, that’s what our cobas® 5800*/6800/8800 Systems have been designed for: flexibility in the face of a pandemic to facilitate 24/7 testing if needed; matched with the ability to shift seamlessly to routine population screening to help clinicians keep people healthy.

 

What role does assay design play in helping physicians (and their patients) be confident about their test results?

 

Cindy Perettie: We designed our COVID-19 assay and got it into labs in just six weeks, confident that the assay would perform well even though the initial design was developed with knowledge from seven sequences in the COVID-19 databases. Our scientists and assay designers had to make quick decisions but they were able to apply the methodology proven in developing assays for Ebola, Zika, HIV and other global threats. As variants emerged, we were happy to see our assay design was robust.

 

Alexandra Valsamakis: Yes, in developing the COVID-19 assay, we focused on areas that were critical for viral replications. Our long-term commitment to virologic diagnostics and virology was extraordinarily powerful because it made for an incredibly robust product.

 

What’s the significance of introducing new non-COVID assays during the pandemic?

 

Cindy Perettie: We were able to continue to support customer needs beyond COVID by introducing new testing for respiratory infections, transplant care, HIV, Hepatitis B, Hepatitis C diagnostics and sexual health throughout 2020 and 2021 by capitalizing on our global presence. As one team ended their day, another was just starting. By passing that baton around the globe day after day, we leverage our global sites to continue innovating diagnostics.

 

Alexandra Valsamakis: The need for current diagnostics doesn’t go away because a new one arises. Those patients are still there. Answering that unmet need and devoting the resources to get those solutions through regulatory approval is our obligation as part of the healthcare ecosystem.

 

Cindy Perettie:  It’s worth noting that most companies invest 10-13% in diagnostics and pharma R&D. We have never invested less than 15-18%, and that commitment has driven so much of our innovation, from our ability to deliver a COVID-19 assay quickly to the new comprehensive transplant assay portfolio.

Coronavirus
Part 2: What it means to be reliable in a pandemic

The discussion continues as we look at the value of reliability in extreme uncertainty. Customers told us they value accuracy and throughput during the pandemic. What examples can you share that speak to Roche’s differentiation in those areas and overall reliability and transparency?

 

Lance Little: I have heard from customers that we stand for reliability. We were the ones that told customers what was possible and what was not possible. Irrespective of the overwhelming need, there was a limit to what we could do. Roche’s guiding principles are to be open, honest and transparent-even when that meant that customers had to look to alternate sources to meet their needs. We value a consultative partnership approach beyond our own commercial interests.

 

Cindy Perettie: Reliability extends to the ongoing variant evolution as well. Our experienced assay designers applied what they’d learned with Ebola, Zika, HIV and more, and they strategically selected conserved regions to cover-and continue to cover**-the variants. We leverage our global scientific expertise from California to Switzerland to deliver the reliability our customers need at a consistent price. We will always do what’s right for society.

 

Christian Paetzke: I echo all this and want to emphasize that point about consistency of our pricing. I had many customers say, “Christian, I need more consumables, reagents, everything.” Everyone was in the same situation. But if reliability and consistency are the driving themes, then it is a logical, strategic consequence that you are not trying to make a quick buck during a societal crisis.

 


How is Roche building capacity to further enable control and consistent delivery?

 

Alexandra Valsamakis: We have been aggressively building the infrastructure required to facilitate the ability to quickly scale up as needed. That took 9-12 months and it’s in place now. Today, the challenge for us as a company is what to do with that infrastructure when demand for direct COVID-related products declines. 

Now that the base business is growing again, the enhanced capacity allows us to manufacture a broader portfolio of diagnostics for the world. Then should COVID or a new threat spike-and using the lessons learned about what we need for consumables and what that pace of production needs to be-we can just as quickly scale down the less used reagents and scale up whatever new reagent is needed.


What were some of Roche’s challenges during the pandemic and how were they resolved?

 

Lance Little: Like our partners in the labs, we held many strategy sessions to determine how to address the rapidly changing landscape as the pandemic evolved. How to get tests to the labs-including chartering planes. How to get instruments into countries where they never existed and had no experience in setting them up. How to make sure our engineers and installation teams would be safe with PPE.

 

I want to share one example of the sacrifices made to support those heroes in the lab: We needed to get an installation into New Zealand, but that meant someone had to go there for the better part of a month, factoring in quarantine time. A team member from Australia did just that. So many people did whatever they could do-whether hands on or virtually through online installations. Our pre-planning and remote capabilities served us well when we couldn’t safely move people from country A to country B.

 

What should a lab be thinking about in determining what to do with newly acquired platforms … how to make the most effective use of disparate or niche systems?

 

Whitney Green:  Depending on the lab’s geography, some of the systems may be used more than others at this point. There is an increase in routine molecular testing and there will be COVID testing for the foreseeable future. As we move from pandemic to endemic, the key is to have a system robust enough to deliver the diagnostic solutions in highly controlled environments with the accuracy and confidence a lab can trust.

 

COV variant
Part 3: Why a strategic choice matters more than ever?

So much has been learned that can better prepare all stakeholders for the future. In what ways has the pandemic challenged labs with regard to efficiency and how can those challenges inform strategy moving forward?

 

Christian Paetzke: Through the pandemic, labs gained even more recognition for their ability to enable clinical decisions. At the same time, they’ve been under great duress whenever there was a shortage in testing capacity or delay in turnaround time—greatly affecting their efficiency. These enormous stress levels have certainly taken a toll on lab staff, much like the patient-facing healthcare workers.

 

Lance Little: The pandemic took everything into firefighting emergency mode. Labs had to employ every means possible to keep up. At the beginning, any supplier delivering a half-decent test was in demand to relieve the pressure. Now that supply has evened out more, labs have the luxury of choice.

 

Credibility becomes a key factor as does a demonstrated ability to drive efficiency. Labs are now considering who they want to continue working with—and which primary platforms will best serve them.

 

Ann Costello:  We saw this firsthand: Customers who may have been reluctant to invest in the Roche platform and previously sent their testing out have since realized how cost effective it was to have a system that is easy, fast and reliable—and would be delivered when promised.

 

What role did training challenges and staffing shortages play in this issue? Is it likely those factors will improve?

 

Alexandra Valsamakis: The labor crunch was bad before the pandemic. The crunch is surely even more severe now. When you have a lot of turnover, you look for turnkey solutions that are easy to train on and easy to use. You need scalable throughput and a large menu to accommodate your lab’s needs beyond COVID-19 testing. You also consider what offers scalable throughput, from smaller to larger runs so you can operate efficiently with minimal hands-on time. It’s all about making the workflow easy for the technologist, which could mean scaling back the number of platforms currently in place.

 

Cindy Perettie: Also, in the last 20 months, few have felt comfortable bringing the full workforce back, so having a highly automated system really makes a difference. That’s why we designed the cobas® suite of instruments to be run with very limited personnel—a compelling advantage as hiring and staffing constraints remain.

 

Christian Paetzke: In terms of the future, if we look at the macrotrends, healthcare will be increasingly more important globally. However, across a lot of economies there is growing lack of skilled labor. I hear that often from lab leadership—and they also talk about the generation shift as they approach retirement age. Moving forward, automation is essential as these factors intensify.

 

How would the Roche Molecular Work Area approach to automation, consolidation, integration and standardization have helped during the pandemic?

 

Christian Paetzke: Customers told me they wanted to put as much of their work onto the Roche platform as possible because their lab technicians were burning out. Roche simply gave them more hands-off time. By driving more volume with less manual interaction, we could help make the lab team’s work—and lives—more manageable.

 

Cindy Perettie: It just makes sense, really: labs that run the cobas® 5800*/6800/8800 Systems can have as few as one person in the room to load and walk away.

 

Christian Paetzke: Yes, and if high-quality, timely diagnostics are valued, the only way to achieve it with labor shortages is through automation, consolidation, integration and standardization. It’s not the IVD industry pushing this model. It’s the increasing fact that there may not be enough skilled staff to meet the demand.

 

Alexandra Valsamakis: Truly, one of the key lessons of the pandemic is recognizing the power a model like the Molecular Work Area in any combination can bring to all labs. Getting automated instruments into labs of all sizes—not just the large labs— will be key to this new era in diagnostics. 

 

How is Roche thinking about diagnostics overall?

Whitney Green:  Between core lab, molecular lab, point of care, pathology lab, sequencing and more, we have a very broad solution for diagnostic testing. As first to enable fully automated PCR on a high-throughput system and now our reinforced ability to quickly adapt to changes in market demands, we are purpose-driven to do now what patients need next.

 

Cindy Perettie: That adaptability is important because the pandemic is training people to think differently about screening—putting a priority on finding out their status as early as possible. “Can I fly? Can I attend an event?” All diagnostics are now even more valuable to everyday life.

 

Christian Paetzke: So true, Cindy. All have seen the incredible value diagnostics brings to people … the comfort in certainty. This paradigm shift has also put our customer, the lab, in an elevated position of authority. The pandemic has revealed that diagnostics are a necessity for an open and free society.

 

Coronavirus
Part 4: How to feel confident even as COVID continues?

At every point, labs have urgently needed more just to survive. Now it’s time to prevail with a partner that can confidently deliver more to help them thrive. Let’s close with a look at what helps make decision makers confident moving forward.


What are examples of Roche’s solution development (COVID and non-COVID) during the pandemic?

 

Ann Costello: Beyond creating more than 20 COVID-related solutions during the pandemic, we developed non-COVID assays as part of our transplant portfolio and we increased our offering in transplant care, HIV, Hepatitis B, Hepatitis C diagnostics and sexual health.

 

Cindy Perettie: The need is great for routine testing even during a pandemic. Healthcare providers are recognizing the value of early detection through screening. Non-COVID testing has increased significantly as providers seek a way to get in front of HIV, HPV, transplant and other health issues that benefit from screening.

 

Ann Costello: I think some customers were surprised at the number of new solutions we delivered in this challenging time. It’s all thanks to our teams working from home when they could and putting themselves at risk when needed. I’m so grateful for their extraordinary effort in the midst of a pandemic.

 

How can Roche be confident that the assay performance won’t be affected by variants?

 

Alexandra Valsamakis: Our long history in and commitment to diagnostic virology enabled us to create an incredibly robust product. Now, we are armed with a depth and breadth of information about the variants themselves and whether our tests detect them - they do!  We make this information available to our affiliates and customers through regular reports. This differentiated outreach reassures affiliates and customers and provides everyone with distilled, actionable information on the variants as they emerge.

 

Why does Roche invest so much in R&D?

 

Cindy Perettie:  Family owned, we are able to invest 15-18% - significantly more than others. This commitment has proven invaluable in enabling us to see and go after the full need. That means delivering a COVID-19 assay in 6 weeks and bringing new non-COVID solutions to market in such a disruptive time.  We don’t just dabble in diagnostics; the power of our investment means we consistently deliver.

 

Christian Paetzke: By creating other assays and solutions in parallel with the COVID portfolio, we can support labs when pandemic volumes decrease and they can use capacity for other tests. That’s why it’s been important to continue research beyond the urgent COVID development.


What is Roche focusing on to help labs, governments and health systems be confident moving forward?

 

Whitney Green: More than ever, we intend to help ensure labs of all sizes can get the ease of use, broad menu, high-quality results and high throughput they need. By focusing on flexibility, Roche can be the partner to count on now and for what’s to come.

 

Ann Costello: It’s humbling to realize our families are now or may soon be patients. Why have them or anyone wait for tests that have to be sent out? People need an answer now so their healthcare provider can take action. Toward that end, we are further building out our offering with the cobas® 5800 System* and our robust menu to continue delivering instruments and assays where and when needed. Customers can rely on Roche to continue investing in capacity building to ensure pandemic readiness for the future.

 

 

 

 

*In development, not commercially available

**Subject to ongoing testing of variants and mutations.

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