The Rise and Future of Pharma Cold Chain Resiliency

The following edited excerpts are from a panel discussion hosted by the ELPRO Leading Minds Network as part of its Temperature Control Tuesdays™ programming in partnership with Biocom California. The session included Jim Bacon, Director of Technical Operations, Marken; Scott Masiella, Director of Product Management, Stirling Ultracold a part of Biolife Solutions; and Mark Taylor, Strategy Director at UPS Healthcare.

Martin Davis – Moderator:
Welcome everyone. Tell us about your company and a little bit about what you do in your company. Jim, let's start with you.

Jim Bacon:
My name's Jim Bacon, I am director of technical operations here at Marken, focused in temperature-controlled solutions including tracking and temperature devices.

Mark Taylor:
My name is Mark Taylor. I am a strategy director at UPS Healthcare, the newly formed division within UPS that focuses exclusively on healthcare.

Scott Masiella:
My name is Scott Masiella, I'm a director of product management at Stirling Ultracold, and I'm responsible for freezer platforms. We're a part of Biolife Solutions, a leader in cell and gene therapy.

Martin Davis:
Okay. Thank you. We really appreciate your time and I know that all of our attendees do as well. We're all aware of these sweeping changes that have been taking place in the temperature control supply chain over the past year. When you think about the pandemic, looking at it optimistically, it's highlighted new opportunities in our existing cold chain networks and accelerated the birth of this better, more resilient, global infrastructure. In particular, one that can sustain medicines and therapies that require ultra-low temperatures.
So today we're going take a look at that, what that future network might look like, what's being done now, what it could hold for the future. Also, some of the challenges we might face as companies and organizations build out this more resilient global infrastructure. Talking a little bit about personalized medicines, cell and gene therapies, they've shown tremendous and amazing growth over the past several years. It's expected to be a $15.5 billion market by 2025. I was reading a statement by the FDA commissioner recently predicting that they'll be approving 10 to 20 new CGT products a year by the year 2025, which is just phenomenal. That's based on the current pipeline and also the clinical success rate that they're having right now with these products. And so, thinking about the rise in CGTs and biologics in recent years, what are your thoughts on how this surge will impact the cold chain? Not only now, but also in the future.

• Jim Bacon:
  Yeah, I will take that question, Marty. Thank you and I appreciate Biocom and ELPRO including me on this Leading Minds panel. What we have seen in the cell and gene therapy arena is that the products have intensified the need for product integrity and patient safety. Whether they're autologous solutions or allergenic treatments, there's a heightened level of strict time and temperature requirements, as well as the chain of custody and, end-to-end transparency and visibility.
  Ultra-cold temperature solutions or real-time monitoring requires close coordination for success and requires a high level of mitigation and contingency planning. These treatments are unique. They're one of a kind. Generally very small volumes and extremely high value, not only in cost, but the very essence of life and death for a patient. I believe the major impact to the cold chain for cell and gene therapy is compliance and discipline, not only in process, but the proactive steps that we'll take to ensure a successful shipment.
• Martin Davis:
  Okay, great. Mark, what are your thoughts on that?

Mark Taylor:
You know, I was just going to add that a lot of these temperature ranges, especially when you get into things like deep frozen, and of course cryo, are very, very new. Therefore, you start thinking about what is out there today, as far as infrastructure and shipping solutions. Is it ready for what's coming in the next five years as you just stated? There are some very solid players in this space, but I think that there are a lot of 3PLs, forwarders, and carriers that are deciding what their infrastructure should look like. What their solution set and value prop should look like to serve their customers.
And that could be anything from the right shipping container to how do we think about things like re-icing and charging stations and contingency planning? So the next few years will be pretty exciting. I think you are going to see certain players start to invest and scale very rapidly to keep up with the growth. And then it'll probably be a more concentrated set of participants than with something like two to eight that you have today... for all the reasons that you mentioned.

Martin Davis:
Yes, those are good points. There's a lot of work that's been done, but there's also a lot more to be done. Right? And so you have to get ready for that surge. So, Jim mentioned the unique nature of these products. I'd like to explore that a little bit. Given the timing requirements of the manufacturing and the therapy delivery process, which is highly specific, how can we work to ensure safe and efficient product in transit and align the timing of the product creation and the delivery with a patient's treatment schedule?

Jim Bacon:
That's another great question, Marty. In the clinical trial industry where Marken participates, we really only get one chance to get it right, because a lot of these drugs and solutions are one of a kind. At Marken, we have done lane and risk assessments, and these are critical to a successful shipment. When we go through these lane assessments, understanding the weak links in the supply chain, mitigating steps is key. Therefore, pre-planning and scenario planning, as we call it, can help us identify these weak links and they will help us define assumptions and potential alternatives. We want to assess the impact and consequences of any potential interruptions or issues that might occur along the way. We then try to use this information to identify any warning signs and triggers that will help us initiate a proactive response.

There were multiple layers of technology and command centers and visibility systems… but you do need very well thought out SOPs. Those need to be created together by actual humans talking to each other.

Mark Taylor

Martin Davis:
Mark, what are your thoughts on that?

Mark Taylor:
You said something in the question that caught my attention and that was the word manufacturing. I think that you have to start looking more holistically at the supply chain, and this starts a lot further upstream. I am going to go back to Operation Warp Speed. I believe that was a blueprint for what is possible when you have very deep collaboration among all of the participants.
Certainly, never in my career, have I ever seen an instance where there was so much humility, transparency, and cooperation. When each participant recognized that they cannot rely just on themselves, but also on the other parties, to make it all work. Now you might not need all of the features that were part of Operation Warp Speed. There were multiple layers of technology and command centers and visibility systems… but you do need very well thought out SOPs. Those need to be created together by actual humans talking to each other. Again, it starts by looking way further upstream in the manufacturing process.

Martin Davis:
Yeah. So I hear what you both are saying. It's all about maintaining the state of readiness, right? Being prepared and having a good plan in place. So another question that I had as we walk through this… before the pandemic, pharma supply chain professionals saw technology as the primary driver of the biggest supply chain trends. I personally believe that is still true today. However, if COVID taught us anything, it taught us that there is much more to think about in the cold supply chain, including infrastructure for temperature-controlled storage and distribution.
So, a question for Scott: what have been some of the challenges faced with global storage and shipment of products in recent years? As a follow-up to that, can you share any specific examples or stories about how your companies are meeting those challenges today?

Scott Masiella:
Yeah, sure. The most difficult thing for us–right off the bat–is the level of response that we've had to have in order to deliver products like freezers to the end users. As we have been talking about, the distribution of vaccines and treatments, the final place where they might need to be stored for some period has been a big challenge, right? Between using dry ice in those locations–with users that haven't touched dry ice before or may not be familiar with deep frozen–and the FDA's recent emergency authorization to use it with the COVID vaccines (which have to be stored at -70 or -20), those are two temperatures that aren't readily experienced by end users. Because CO2 is renewable, it is also more of a consumable. Finding supply for that, getting it in, replenishing dry ice, customers (or end users) start to look at it as a way of maintaining something like a beach cooler. The worst-case scenario of the beach cooler is that maybe your drinks get a little warm. However, in our case, we have to maintain those temperatures at all cost. Technology is being driven by freezers that are local in those areas to be able to maintain temperatures. So you receive the shipments, you place the treatments inside these freezers, and hold those for use later. Those are the biggest challenges we have faced. Not only delivering to those users, but also teaching the users how to handle materials and operate in a space that is 100 degrees colder than what they are currently working with–and in the outside world. We've had challenges that we've met with the U.S. government, with the National Guard, to deliver vaccines all throughout the U.S. and globally, as we work with delivering vaccines to areas with developing infrastructure.

Martin Davis:
Mark, Jim, any thoughts on that?

Mark Taylor:
You're spot on. You can have all the groovy technology in the world, but it doesn't make a difference if there isn't some degree of infrastructure at the destination. As a carrier, we can get a product to the far-flung corners of the world, but how do you ensure that very last mile and that storage is taken care of? Solutions around leasing, rental, and purchase programs for freezers need to scale up and scale down. It can enable a tiny village in a developing world to have a solution. The other area where I saw some interesting innovation was around shipping containers around the actual box. Again, when you are going to the far-flung corners, obviously you are going to need a VIP PCM type solution. You are going to need 120 to 140 hours of duration. That's traditionally a pretty expensive box and the return logistics are difficult, if they are even possible. It can sometimes make the economics challenging. However, there's been a lot of innovation in that space to create something a little more cost-effective that can still get you to the Malawis, the Indonesias, the Bolivias of the world, holding that product at temp the entire way.

Martin Davis:
Yeah, that's a great point. The Gartner Group calls this idea of supply chain “resiliency” the ability to adapt to structural changes by modifying supply chain strategies, products or technologies. They call supply chain “agility” the ability to sense and respond to unanticipated changes and challenges, in demand or supply, and to do that quickly and reliably without sacrificing cost or quality. So, can you share any stories or instances where COVID has given birth to more agile processes and operations within your organizations and how it's helped you meet those future supply chain challenges for customers?

Jim Bacon:
Yeah, I'll take that one, Marty. At Marken, when we think back to the beginning of the pandemic, we offered what we refer to as a “high touch” approach. We use many reusable solutions. We needed to go back in and pick these up, but we realized that we could not really do that anymore. During the pandemic, we wanted to create more of a “touchless” approach. We also knew that we wanted to maintain the same level of on-time delivery and performance, including protecting the drivers and also the patients and the clients. We decided early on to (temporarily) convert to single use solutions. We worked with suppliers that offered both reusable and single use solutions.
We converted to the single use solutions and then looked at some monitoring technologies that required less human intervention as well. Of course, we also had an increased use of the UPS Network. It provided the right kind of footprint for us to provide these solutions around the globe. Therefore, in the short-term, that really helped to reshape our offerings. We were able to maintain the same high level of service for our clients. We use reusable solutions because we have a sustainability approach and we are very conscious of our carbon footprint. This caused us to take a closer look at some sustainable and environmentally friendly options for the future.
As we prepare for these kind of situations or pandemics in the future, we want to create that agility within our organizations to pivot when we need to. All the while maintaining the same level of service for our clients.

Martin Davis:
Absolutely. Let's move on to some of the questions that are coming in. The current supply chain scenario is really bad in LAX, SFO ports. Do you see manufacturing now shifting their strategy and shipping their supplies or goods via air cargo and/or passenger? How does it affect the dynamics and space availability to ship temperature-controlled shipments?

Mark Taylor:
Everyone knows what is going on right now off the port of Long Beach and Los Angeles. As the airline industry rebounds–and it hasn't quite come back to where it was before–you're stuck with these capacity constraints. It is a very, very valid point about prioritization and capacity. And if there ends up being a further shift to air, what is that going to do to supply chains in general? Now, I think what remains to be seen is whether this is just a blip or is this a trend. Is this going to be resolved in a few months or is this going to take a year or two? Your guess is as good as mine on that one.

Scott Masiella:
And Marty, we've seen a lot of requests recently on leveraging our portable freezers for use in air transport. So it used to be that we would get requests like, "Can you ship your freezers via air to an end destination?" It's now turning into, "Can we use your freezers in air, to transfer our therapies?" We're seeing a big uptake those types of the request as well.

Martin Davis:
Excellent. Jim, any thoughts to add?

Jim Bacon:
Anecdotally, I was reading an article recently that some of the larger manufacturing organizations are chartering ships as a possible workaround to these bottlenecks in Los Angeles and other ports. Unfortunately, not every company can do that. So long-term, we need to take a closer look at where products are being manufactured and start to embrace domestic manufacturing.

Martin Davis:
Absolutely. Here's an interesting question: “What do you think about a virtual cold chain, a virtual cold chain as a digital twin of your supply chain to make risk assessments more realistic?” And I assume faster.

Jim Bacon:
Marty, at Marken, we have started to look at the virtual supply chain. I think it is a great opportunity to test out and look for vulnerabilities in your existing supply chain. I think the virtual supply chain really allows you to look at your existing solutions and determine if you have over-engineered or potentially even under-engineered your solutions. It's a very valuable approach because we're operating in a global economy where we're shipping products out of branches like Dublin Ireland--where it can be all four seasons in one day--and we're also shipping out of branches like Sao Paulo and Singapore, where they're close to the equator. So, there is tremendous humidity and high temperature most of the time. We have to have a balanced approach. I think a virtual review of solutions and lanes can be quite attractive and very appealing to create that right solution.

Martin Davis:
Great, great. Any other thoughts on that Mark or Scott?

Mark Taylor:
I agree. He used the word digital twin, and I think that is where it can really add value. So in addition to traditional PQ and DQ testing, this is a technology driven way to do it is potentially quite a bit faster, and to model different simulations that you wouldn't necessarily capture when you're doing traditional PQ and DQ. You can change the confidence intervals. You can change what that temperature profile might look like and get results almost instantly. Its super interesting technology that I think will continue to take hold.

Martin Davis:
Great. Okay. Let's move on. What is UPS Healthcare's relationship with Marken?

Mark Taylor:
Back in 2016, UPS was looking at getting more aggressive in the clinical trials logistics space. We were exploring ways to invest in build new capabilities. That's when Marken came up for sale and UPS acquired Marken. Marken serves as the clinical trials logistics arm of UPS Healthcare. Anything that comes in to UPS Healthcare that is clinical trials gets pushed out to Marken. There is starting to be more and more overlap in the work we do with Marken and vice versa, especially when we talk about things like cell and gene and cold chain packaging, and cold chain infrastructure. We're leveraging each other more and more.

Jim Bacon:
Yes, and the nice thing here is that we really bridge that clinical trial to commercial. We have the same network and as Mark indicated at the beginning of the session, our teams work closely together. So, UPS Healthcare with commercial and Marken with clinical can create that efficient flow as our clients transfer from the clinical trial phase to the commercial phase.

Martin Davis:
Jim mentioned reusable solutions. Please share what your experience has been with the same in terms of number of round trips or the systems being returned in a timely manner.

WATCH THE PANEL DISCUSSION

Jim Bacon:
That's a great question and it requires a very disciplined, reverse logistics strategy. That's one component. I think the more important component is the number of uses. Generally speaking, our reusable solutions are vacuum insulated panels (VIP) technology. There are also phase change materials, one being the insulator and one being the control for the heat transfer. Careful cleaning, inspection, and preparation of these products creates the longevity. Many of the solutions we have seen out there generally have a five-year lifespan, some of them even more. In addition, we have been able to use the solutions up to two or three times a month over the course of five years. You can really get some good use out of them but as I stated, cleaning and inspection is critical to that process and helps drive the cost down when done correctly.

Martin Davis:
Yeah. Any thoughts on that Mark or Scott?

Mark Taylor:
I agree. A lot of it just depends on the wear and tear. We have some VIP boxes that we have turned 50, 60 times. They have been moving around our network for years. We have others that, after a turn or two, blow a panel and we have to replace that piece. You just inspect, refurbish and then you start the process over again. Generally speaking, being able to turn them at least once a month and have them last a couple of years is not unreasonable.

Martin Davis:
Here's a question that came in the chat: how do you foresee reusable solutions versus single use solutions as cold chain resilience surges in the next five years?

Mark Taylor:
I'll share my thoughts. One of the data points that I saw recently is that reusable packaging in the U.S. –this is actually a pre-COVID number–was growing four times faster than one-time use disposable. We've seen this anecdotally. We've seen some of our very largest customers make some pretty wholesale changes. It's taken the U.S. a little bit longer. I think Europe was a good five to 10 years ahead of the curve on this. The GDP requirements were a little more stringent and I think their sentiment towards environmental sustainability was ahead of the U.S., but we're certainly seeing very strong demand in the U.S. for it. The different operating models have evolved and the economics have gotten better. Obviously, the performance is just flat out better. VIP PCM is much more robust than traditional EPS and water-based phase change materials.

Scott Masiella:
And we've seen something very similar as well, Marty from the freezer side. Not only are our customers looking for us to help support their PCM, VIP PCM type solutions over a consumable, like a dry ice, they find it to be much more usable, especially as you start to get farther and farther away from those sources of one-time single use type solutions. So having a freezer on hand to condition those PCMs is a lot easier for customers to use than continue to have a dry ice supply.

Martin Davis:
Okay. Another question coming in, do you see this trend of ultra-low or deep frozen, continuing to grow as more clinical trials initiate? What percentage of clinical therapies are stable at 2 to 8° C? Why do you see the need for the frozen infrastructures?

Mark Taylor:
I'll go first then maybe Jim can tell you what he sees. The advantage of working with Jim is he is seeing products that are a few years out because they work on clinical trials. We do see this growth continuing. We always say that the freezer farms that we built; we were not just building the church for Sunday. It was not just for COVID, it's because we believe that more and more of the medicines, the future, and you recited some facts around cell and gene therapy, and there's others around mRNA technology, will continue. Do I have an exact number? I don't, but we see it continue to grow and we're continuing to invest to be ready for it.

Jim Bacon:
What we've seen Marty in the cell and gene therapy space is the need for extremely ultra-cold, which would be cryogenic or liquid nitrogen temperatures. I would say that probably more than 90% of the cell and gene therapy treatments that are in a clinical trial phase of some sort are at these cryogenic temperatures. The reasoning behind that is the incredible stability of the human tissue at those temperatures. We have talked to companies that are in long-term stability programs where they're attempting to recalibrate the temperature range of those, potentially from cryogenic to dry ice temperatures and then from frozen to refrigerated.

I would say that probably more than 90% of the cell and gene therapy treatments that are in a clinical trial phase of some sort are at these cryogenic temperatures.

Jim Bacon 

As we stated earlier, that 20 to 30 cell and gene therapy solutions will be approved per year in the coming years. However, there is probably more than 2,000 different clinical trials going right now for various treatments, mainly cancer. All of them are using liquid nitrogen to store and ship, so we're starting to see our offerings in those areas increase tremendously and with those solutions comes the need for visibility as well. This is why I mentioned earlier that's how we think. We see supply chain changing because of these new personalized medicines that are introduced through cell and gene therapy.

Martin Davis:
Yes. Good point.

Scott Masiella:
And Jim, piggybacking off of that, we're seeing pharmacies and clinics also stocking up to have freezers in their sites to receive these shipments coming in so that they can store and administer these treatments. Where in the past they might've had a deli type refrigerator at 2 to 8° C, they're now adding small portable freezers. They don't need a full-size upright freezer, ULT freezer or a giant cryo tank, but having the ability to have a smaller type freezer where they can store 10, 20, 30 personalized medicines. It has been a tremendous growth trend in the industry for us, for sure.

Martin Davis:
Interesting. Okay, here's a question: thinking of business and drug development, sometimes great therapies and great businesses come from the discovery of an unintended use in the development process. Have you found an off-label use for any of the cold chain technologies you work with, or have developed that have allowed you to expand your addressable market for that solution?

Scott Masiella:
I could probably spend an entire webinar talking about some of these things. Some of the areas where we have found interesting adaptations for our freezers have been manufacturing, where you have cold fusing parts or you are blast freezing bulk materials. COVID has generated a lot of awareness for our type of product. They come up with a lot of different, interesting ways of using ULT freezers and cryogenic freezers that we've never seen before.

Martin Davis:
Interesting. All right. Another question: since many frozen solutions require dry ice, what are you all seeing or experiencing with issues around dry ice availability in the U.S. and abroad? Still an issue?

Mark Taylor:
We made some investments in our own dry ice manufacturing capabilities. We brought in some of the equipment into our warehousing and distribution footprint in a few parts of the world. I've read about some of these pinch points in the supply chain for dry ice. We have not experienced that, between what we make and what we procure. We've been able to get everything that we've needed.

Jim Bacon:
I'll just take a different spin on that by suggesting that, as we look at solutions for dry ice packaging we want to transition away from (some of these traditional EPS type of solutions), take a look at alternatives like VIP panels or even some other types of solutions like expanded polystyrene versus VIP panels. Typically, one inch of VIP panel provides the same insulating factor as almost 12 inches of Styrofoam. So, looking for technologies that will better insulate means less dry ice in solutions and that works twofold; it addresses the supply chain issues around the globe for dry ice supply and the weight and size of the shipment can be much smaller as well. Therefore, this can create a win-win situation, by looking at some of these new technologies.

Martin Davis:
That's a great point. Okay, let's look at another question around technology. What specific technologies will be necessary to ensure products are stored and delivered safely and effectively in the future?

Mark Taylor:
I'll take that one Marty, because this is something I'm pretty passionate about. Obviously, you need robust monitoring technology across the entire supply chain. I mean, in the question you said, stored and delivered, which means start to finish. In addition, it needs to leverage all kinds of different communication frequencies to ensure that there is minimal downtime. Sometimes in these transportation networks, you get in buildings with a lot of concrete and a lot of steel and you can lose connectivity. However, more importantly, I really believe that there needs to be better ways to bring it all together. You can have milestone tracking over here, and temperature monitoring there, and GPS location in one spot, and then the customer still wants--throughout this technology--some kind of a clear pathway for customer service and intervention when it's needed.
There are more dashboards and portals out there that I can count, and they're very, very good at their respective pieces of the puzzle. However, I haven't seen a lot of solutions that really bring it all together in one place. Now that begs a different question, which is, is there a willingness among all the participants to work together to share their data? To share their APIs? So that there can be places where everything is one spot for customers.

Martin Davis:
That's the big question, right? Ok let's move on, this is an interesting question. Can you speak to which global health organizations you are all working with to get the vaccines to the masses?

Scott Masiella:
We've done a lot of work recently with the U.S. government flying vaccines all over the globe and administering them. We also have the usual suspects, WHO and UNICEF, who are driving a lot of requirements towards end user receipt of vaccines. So after receiving the vaccines, how do we get them to far-flung areas away from infrastructure? And what does that look like? Are there requirements that are centered around power grid and power grid stability. Can your freezers operate in those areas? We know getting dry ice into those areas is going to be extremely difficult. Having a solar panel and generators, how do we make sure that freezers can withstand in those areas too?               

Many of the technical requirements are less focused on temperature and more focused on the function of the freezer itself in these more challenging environments… it's taking our freezers from the lab into the field.

Scott Masiella     

Therefore, many of the technical requirements are less focused on temperature and more focused on the function of the freezer itself in these more challenging environments. Going back to that earlier question of “where you have seen some of those new applications,” it's taking our freezers from the lab into the field. It's the biggest new application where these agencies are really focusing, from the U.S. government to UNICEF and WHO.

Martin Davis:
All right. Next question. What new processes, capabilities or infrastructure are being developed (or are already in place today) to create or facilitate faster launches of critical frozen medications and therapies?

Mark Taylor:
At UPS we've been growing our cold chain footprint rapidly. We've made announcements recently about facilities in Rome, Germany and just recently the Czech Republic, all of which are going to have cold chain infrastructure. We're continually expanding our flagship campuses in Louisville, and Roermond, Netherlands. On top of our warehousing and distribution business, we've been deploying a lot of investment in our core small package services with a lot of new technology. We have the new UPS Premier service, which gives customers a lot more visibility and control. Part of that has been investment in smaller walk-in coolers and freezers around the world. Especially in our major air hubs.
Another area of focus for us has been around cold chain packaging and how we can work with suppliers to make sure our customers can always safely ship their products with UPS from point A to point B. So we've made some investment and deepened our relationships with some of these top shelf providers to make sure, again, that customers always have what they need to ship cold chain with UPS.

Jim Bacon:
At Marken, our focus has been on visibility. Our clients are demanding more and more visibility into the shipment, so we are designing processes and solutions that allow visibility from start to finish from end to end. We have also created some infrastructure as well. We have created control towers in the U.S. and Europe that will operate 24/7 and will provide Marken the visibility to track those shipments, and the ability to respond at a moment's notice to our clients regarding any issues that might be happening with particular shipments.
Providing extensive visibility to shipments, customers can see what is happening to the shipments at the same time that we are. We have built in proactive and mitigating steps to ensure that when we see a particular event—or we see a trigger—we can project what needs to happen to get that shipment back on track.

Martin Davis:
Very good. I think we have time for one or two more questions. What controlled environmental data monitoring technology will be necessary to meet future supply chain challenges? As a follow up question, what are the true benefits of end-to-end supply chain visibility and real-time data monitoring? We hear a lot about that today.

Mark Taylor:
Some of it is exactly what Jim just described. Once upon a time, if you were a logistics manager and you were responsible for the supply chain of a temp-controlled product—and you shipped a package with UPS—you may have gotten a UPS notification alert on your phone that there had been an exception. There's been an aircraft mechanical, there's been a weather event, whatever it might be. Traditionally you would get an alert and that was where the communication would end. That's just not good enough anymore. That logistics manager needs to know more. He or she needs to know a lot more. Where exactly is that package? What's going on around it? Is it sitting on the tarmac in Saudi Arabia in July? Is it sitting in a field in Minnesota in January? Is it in any kind of distress, and if so, how can it be routed to the right level of customer care? As Jim said, it could be nothing. It could be a situation where you have a 96-hour pack-out and you're only on hour 15. It could be that these environmental conditions are well outside of that 95-99% confidence interval that we used when the performance qualification was completed. It could be that we should watch this closely all the way or we need to intervene right now. Temperature aside, there could be a life at stake and this product needs to keep moving. That's where contingency planning and control towers and SOPs would kick in. So I guess, long story short, data and visibility is great, but it needs to be accurate, timely, relevant and, most importantly, actionable.

WATCH THE PANEL DISCUSSION