TRANSCRIPT

[0:05] Intro: Welcome to Measuring Up – Thinking Out Loud, featuring news and information from Testo, your consultative resource for precision measurement technology and digital solutions, serving the pharmaceutical, industrial, and allied industries worldwide.

[0:22] Bill White: On the Testo Network today, we're with Major General Chris Sharpsten. General Sharpsten is a retired US Army logistics leader whose experience spans many years of global missions and crisis response. He served as the deputy director of supply production and distribution for Operation Warp Speed at the request of the White House at the onset of the COVID pandemic. There, his job was to ensure that this new generation of critical vaccines reached all of us safely and efficiently, and I think he did. So General Sharpsten, welcome to Measuring Up. We're honored to have you today.

[01:07] Major General Chris Sharpsten (Ret.): Thanks very much, Bill. I'm glad to be here today.

[01:09] Bill White: Thank you so much. Could you tell us a little bit about your background and how you got into this position that you're in today?

[01:17] Chris Sharpsten: It’s definitely a roundabout story. I didn't start off as a pharmaceutical expert in any way, but I found early on in my military career that I really enjoyed the aspect of logistics – just throughput distribution, the ability to provide critical materials to those who need it. That could be soldiers on the front line, aviators flying across the battle space, civilians operating in our area, as well as down to the American people, where I concluded my career at Operation Warp Speed. Throughout my military career, and I, I did, I started as an infantry officer, but quickly found that logistics was my passion.

[01:58] Chris Sharpsten: And so, since the early times as a lieutenant, transferring into the logistics corps, I was able to do operations in the Pacific, the Middle East, Europe, the continental United States, as well as some of the more far-flung regions of Africa. Through it all, none of it, I'll say none of it was easy. Rarely does the military give you a mission that's easy, but the bottom line is I always felt we were being effective.

[02:25] Chris Sharpsten: When it came to later on in my career, and Operation Warp Speed, the White House was calling, it was an area that I, I'll frankly admit, I'm not quite sure I was prepared for. The biomedical, pharmaceutical industry was not something that I'd spent a lot of time studying, but I knew it was something that needed to be done. It was the nation's number one priority. So, I got as smart as I could in the shortest amount of time to make sure that I could contribute.

[02:55] Chris Sharpsten: Looking forward to the discussion today. I think it should be enlightening.

[02:58] Bill White: Well, and we got to watch it, you know, through TV and the news, and you were busy behind the scenes. When you took on this job, you were working under some intense pressure, a lot of national security, it was a global pandemic that was merging a lot of, nobody really knew what was going on, and you must have been in the middle of a real firestorm.

[03:23] Chris Sharpsten: Yeah, at the time I got the call, I was actually operating out of MacDill Air Force Base down in Tampa, Florida. And my day-to-day job down there was responsible for the logistics and engineering of the 20 countries of the Middle East region, supporting the Department of State, Department of Defense activities. That was a time when the Iranians were throwing ballistic missiles at us.

[03:46] Chris Sharpsten: So, I was extremely busy putting high altitude air defense things into place, radars into place, and at the time when I received the call from, at the time, General Gus [Gustave] Perna, who was just coming out of the Rose Garden Ceremony at the White House. I really couldn't imagine a more important mission at the time, because I was actually safeguarding the lives of service members and State Department employees overseas. But when he described the challenge that the nation was facing, and I was aware of it from the media, but actually telling me, ‘Hey, I need you in D.C. next week, so we can solve this.’ That quickly led to a series of questions that which I knew there were no answers for: Do we have a vaccine? Do you have a distribution channel? Do we have administrators on the end who can provide these vaccines to the American people? And General Perna was pretty quick and easy to answer those questions for me. He said no to all of them. And so, you talk about chaos and not knowing what you're getting into.

[04:54] Chris Sharpsten: He's like, ‘That's why I need you in D.C., Chris. You need to be here to help me figure this out and get the system in place to make it happen.’ It was pleasing for General Perna to, you know, say that in the words of, ‘hey, just make it happen,’ because that's what we all aspire to do.

[05:13] Bill White: Well, you were at the right place at the right time, or maybe the wrong time. That's kind of up to you, but it got done, I think it cleared through the cold chain, for example, and these Moderna and Pfizer vaccines needed to be protected from point A to point B. A lot of folks were suddenly required to pay attention to the condition of pharmaceuticals and other materials in transit, and how to receive them and how to deal with them on what we call the end of the cold chain. Ah, how did that work out for you?

[05:52] Chris Sharpsten: So, I would say, you know, in the beginning, where we had an optimal relationship with everybody participating in the effort, we could see things happening from the research and development front to the production line, to the distribution channel, to the administration sites. And if you could tie together that entire supply chain from start to finish in a unified effort, it made things a lot easier. Well, what we found was that people, organizations were still operating under the old mindsets, and I won't even say epidemic relief, let alone rising to the pandemic level. Pfizer is a good example, love Pfizer.

[06:35] Chris Sharpsten: And you know, we threw a little, the US government threw a little bit of money at them to get after messenger RNA vaccine technology, and they took it to the finish line, which would not have happened, I'm convinced without, you know, government support in terms of funding and FDA support. And Pfizer came up with the best vaccine in the world, you know, typically in the past, the US was shooting for a flu vaccine efficacy that was around 65% or better.

[07:04] Chris Sharpsten: That, you know, that was a passing grade. When Pfizer developed their vaccine and the initial efficacy results came out, they were 95% effective. That became the new standard for vaccines, which is great.

[07:17] Chris Sharpsten: But Pfizer did what they were good at. Their core competency is developing these drugs. Their core competency is not distribution. So, they created a wonderful, wonderful vaccine, a very effective product, but it had to be shipped at -80°C, and it only came in shipments of 1000 vials.

[07:38] Chris Sharpsten: And it's only good for a few days once you open it. So that created a distribution and administration nightmare that had to be overcome by leveraging other strengths from other partners in the distribution administration chain. Thank goodness, Moderna came on board with a little bit more of a user-friendly vaccine.

[07:59] Chris Sharpsten: And then Johnson and Johnson was not far behind them with an even different type of vaccine, where distribution was a whole lot easier.

[08:08] Chris Sharpsten: We found that by optimizing what vaccine went to what location, we could optimize delivery effects and administration effects using the other partners. The Pfizer vaccine is a very effective vaccine that could be used in congregate settings, so where we have a lot of people, you know, hospitals, universities, prisons, where there's a bunch of people we need to vaccinate at one time. FEMA, when they set up the sites in the big cities, loved the Pfizer vaccine.

[08:42] Chris Sharpsten: Because they could receive shipments of 1000 and do increments of 1000 very easily as they flowed people through.

[08:50] Chris Sharpsten: But when you're dealing with a small tribal clinic in the middle of North Dakota or in Alaska, and you've only got 150 people that need to be vaccinated, a shipment of Pfizer vaccine was a tremendous waste and loss. We just couldn't afford to lose vaccines when we had to vaccinate all 300 million plus Americans globally. So, we started to use the Moderna vaccine and Johnson and Johnson's vaccine to take care of some of those lower, smaller density locations, but that would not have been able to be achieved if we didn't have a unifying Operation Warp Speed effort that tied together both the government effects and the industry partner effects working in harmony.

[09:36] Bill White: General Sharpsen, it's a chain, a cold chain, but nonetheless, a chain of custody. What did you find was the weakest link in this chain?

[09:46] Chris Sharpsten: The weakest link that we found is that entities within the chain attempted to optimize effects within their small segment. When they did that, that put the other elements in the supply chain at risk, or they had to operate inefficiently to do that. And so, what we found is that by providing a unified data system where everyone could track the overall efficiency of the channel, we were able to bring the strongest capabilities of all the partners acting in a unified action.

[10:20] Chris Sharpsten: So, Bill, to get the essence of your question, what was the weakest point? It was really the lack of teamwork because most of the companies that we had to partner with operated with profit and cost reduction as the prime incentive. And while that's good during normal days of business, pandemic relief is not the time when we have to worry about that as the first and foremost incentive.

[10:45] Bill White: Nicely said. I think that there were so many people impacted by COVID. We know that there are enormous repositories of clinical specimens, both from people who survived and people who didn't, but those specimens remain in storage and bio repositories, for we would hope, further research down the road. Those specimens must be protected in a uniform way. Do you think we're prepared as a nation to do that?

[11:22] Chris Sharpsten: What I found very early on, as you recall, I mentioned, I had very little experience in the pharma or biomedical business when I started. By the time I got into my second set of 30 days to 60 days on the job, the realization hit me. The American industrial sector had let so many medical capabilities be moved offshore that we were at risk. That's why to this day I continue to work with members of Congress who are reshoring and onshoring multiple industrial capabilities that affect our national security back to the United States and to our partners and allies. We found, as an example, just a very simple example in the cold chain and in needle production, we did not have sufficient capability in the United States to receive or even to distribute in major hubs across the United States. We emptied out all of the American manufacturing capability for the next 9 months' worth of production capacity, and we had to actually go to South Korea to buy their production capacity over the next 9 months to bring us up to the sufficient standards for cold chain distribution. 

[11:38] Chris Sharpsten: Today, I think we're in a much better position. But we're still not there, yet. I think continued congressional action and investment are still necessary, and I do see that coming. It's just taking some time to get there.

[12:54] Bill White: So, in a sense, we may be ready for the next one, and there probably will be one. We certainly don't hope for that, but nonetheless, the complex has been experienced, more experienced than ever, and the infrastructure is in place to make things happen, but not from scratch like you had to do, but where did you leave it when you finally concluded your work with Warp Speed?

[13:24] Chris Sharpsten: I think if there's a silver lining to the pandemic, it was that wake-up call that we needed to bring more medical health care capability back to the United States. When we left and finished, I won't say finished, but when we came to a one-year conclusion on the first year of pandemic relief, I think many of our big medical centers of the universe in the United States, Chicago, Raleigh Durham, areas of Texas, California, I think they were in a much better position for research and development, distribution, and administration. The cold chain capability, the onset of messenger RNA vaccines, I think that set us up for success. As you know, everything operates on a sinewave, so I think we came out of the pandemic in a much better position, but as you know, heads cool down and traction is lost in the media, I think there's a potential where we could slip back if we don't maintain constant pressure on onshoring and reshoring capability back to the United States.

[14:37] Bill White: OK, we're on the Testo Network today with Major General Chris Sharpsten, director of Operation Warp Speed. We'll be back after this.

[14:50] Intermission: You're listening to Measuring Up – Thinking Out Loud, news and information from Testo.

[14:58] Bill White: We're back with Major General Chris Sharpsten, retired US Army logistics leader and someone who's very experienced in the cold chain and the technologies that go into protecting the materials that are being stored and moved about the country. General Sharpsten, what kind of technologies can we expect to make a difference in knowing how these specimens are stored and where they're located, and what the security profiles look like going forward?

[15:34] Chris Sharpsten: Bill, if I could just tell a little story about when we were working on trust and efficacy of the system, during Warp Speed. Each of the states was basically responsible for its own marketing campaign to get after trust in the vaccine out there, and get vaccinated. We found that some states were very successful and others were less. They all had a different approach. What we found most is that the states that had the best results were ones that were directly supporting their local healthcare providers. Nationally, we could come up with campaigns on trust and efficacy. States could do the same thing, but what we found most is that people on the street, they trust their local healthcare provider. They trust their nurse, they trust their dentist, they trust their doctor. And so, we did everything we could to take the data we had available on cold chain security and trust in the efficacy and distribution channel, and we made that data available to local healthcare providers because if they had strong confidence that everything was working from research and development to production to distribution and they got the best of the best product in their offices, their sense of trust that conveyed directly to patients. And so, we did everything we could to take the cold chain validation data and provide that straight to the healthcare providers, so they had visibility on it, complete transparency. And in some cases, the overly cautious ones would take a batch; they'd quarantine a batch because it came within one degree of the lower threshold. And in my mind, that's OK because if that's wastage of a shipment, then that's OK as long as complete trust is maintained. So that's why I think, you know, cold chain validation and the sharing of data is extremely helpful, not just for the executives, but for the people that are actually handling the vaccine and medications that are going to the patients.

[17:36] Bill White: So, you are powering the last mile of the cold chain, where everything gets done. Does that kind of a mindset remain in place today?

[17:46] Chris Sharpsten: I hope so. I think that's a completely valid assumption, and it should be held. Too often, though, when we're talking with large companies that do, you know, distribution of pharmaceutical products, whether it's a company that makes it or a company that actually delivers it in the chain, they only want to use that data for internal purposes only, to check on their costs, minimize wastage, and provide validity for the people who check on their systems. But if we're going to make this an effective tool, we need to make sure that that data is also shared with the end users, the offices, the hospitals, the universities, so that they can then lend that credit to the final user. I mean, ultimately, it's all for naught if that final pharmaceutical product does not go into the body of a patient.

[18:34] Bill White: So, it's important for the last mile in the cold chain to have the confidence that comes from above or outside the area, something that is so difficult to ascertain. There has to be a great deal of accountability at every point in the cold chain, and that requires the technology, the sensors, the data aggregators, the cloud-based solutions to be at the fingertips of those people who are responsible for compliance, correct?

[19:02] Chris Sharpsten: That's correct. 

[19:04] Bill White: General Sharpsten, you've mentioned a couple of times the concept of teamwork and where it wasn't, and perhaps where it's evolved for the benefit of all of us, in a contemporary sense. What did you learn there?

[19:17] Chris Sharpsten: As we discussed, everyone optimizing their segment of the supply chain is good, but it doesn't lead to overall efficiency and effectiveness. I think what we need is a team effort that entails the entire supply chain, which requires a certain degree of trust and accountability across organizational boundaries. So that's point number 1. Point number 2 is for people who operate a segment within the supply chain. I think it's very helpful to ensure that they understand their piece and what the end result of their efforts would be, and that again goes down to, you know, the last tactical mile of delivery to a patient. 

[19:55] Chris Sharpsten: You know, starting early in my military career, one of the things I realized is that people don't often, they can't envision in their own mind what they do is important or why it's important. As a lieutenant, I led one platoon that had 30 trucks in it with 30 drivers, and all these truck drivers would do was go to a location, load their truck, drive it somewhere, unload their truck, and then it was just endless, endless back and forth. And what I found in terms of giving them some incentives and some understanding and some motivation as to what they're doing and why it's important is I'd regularly take those truck drivers out of their daily duty, and I would take them to the front. I'd take them to an exercise and I'd show them how those artillery rounds they loaded two days ago, those missiles that they put on their truck, the tanks that they moved across state lines were actually being employed. And when those soldiers saw the effects that artillery does or tanks do, I mean, they got excited. They got motivated. And then their next mission, where they're picking up artillery rounds, they had a sense of purpose. I did the same thing when we were at Operation Warp Speed. We had VPs, executive vice presidents from distribution companies, big companies like FedEx, UPS. We had VPs from CVS, Walgreens. I had colonels who had been in the Pentagon for years doing distribution operations. I had government lawyers and, you know, we all love lawyers, and government lawyers in particular.

[21:23] Chris Sharpsten: But they don't, they didn't, they were working in an operation center that we ran every day at the Health and Human Services building. They just didn't see how it was all coming together. They would do the daily coordination meetings, but not until they actually got out and saw it. So, I would organize these essentially field trips, and I take 4 or 5 of them with me on any, any one of these trips, but we just visited the FEMA field vaccination sites in Houston and D.C. We went to the US Federal Penitentiary [Federal Correctional Institution (FCI)] at New Cumberland, Maryland. We visited the Chickasaw Nation Health Clinic in Norman, Oklahoma [Chickasaw Nation Medical Center in Ada], where we saw these vaccines actually going into arms. And I tell you, you know, the person that really resonated most when we came back, I had one Air Force lawyer who had been doing contracts and other things to kind of help us move along. She saw this, she got very excited about doing her job, and now she understood and had a sense of purpose to really get after things. The other ones, and I didn't expect them to go on the trips, but they asked me to go with the actual VPs from the big commercial companies.

[22:32] Chris Sharpsten: Because they wanted to be part of this. They wanted to get the excitement in their teams as well. And so, I would take these VPs out on these field trips, and they came back and became champions that they would go back to their organization and say, ‘Hey, profits – tremendously important. Cost reduction is tremendously important. However, pandemic relief for the nation is tremendous. It's super important,’ and they became the champions who made the companies even more effective in making the mission happen.

[23:03] Bill White: So, you were able to put what they were doing into context with the big picture, which always helps. It's like putting yourself on a map to see where you are and why you come to work, very important. 

[22:13] Chris Sharpsten: Right.

[23:14] Bill White: We're with Major General Chris Sharpsten on the Testo Network right now.  We've talked about cold chain logistics and all that goes into it, and boy, there's a lot. So, we have to ask right now, General, what's next for all of us in the United States with respect to things like potential pandemics and other threats that may involve similar marshaling of resources.

[23:40] Chris Sharpsten: I think, like any nation in the world, the United States is not alone in facing national security threats, and that's national security in terms of other governments taking action against us. That's criminal networks, that's terrorists, non-state actors, and it's also epidemics and pandemics. You can do a Google search history of the United States in terms of understanding, you know, what are the deadliest events that have happened in American history, and I just pulled up the top 10 when I was at Warp Speed because I just kind of want to understand, and you know, coming up from a military mind, I was expecting, OK, Civil War, World War 2, World War 1, you know, they just, they had to be the biggest killers of Americans. But what I found is that the top 10 were epidemics and pandemics. So, I don't want to be a naysayer, but I will say they're going to happen again, and we have to be prepared, and we have to be able to respond and understand that an immediate response is important. We need to recognize it's coming. And act. And at times, we're going to have to bring government resources and commercial partners together to go after unified effects. We should expect that that's going to happen in the future, and we should be prepared and have organizations that can rapidly do that.

[25:00] Chris Sharpsten: Some parts of our US government are not postured or ready to do just that. Department of Homeland Security, FEMA, Health and Human Services, they have, you know, organizations that get after that, but they're not necessarily prepared or funded well to do that when the time is nearby. The Department of Defense is built to go after our nation's adversaries. We're not built to support epidemics and pandemics. However, it is a tool that should be leveraged if necessary, and that's what we attempted to do during Operation Warp Speed. I think the time may come again when we do that. My suggestion is not that you have to have, you know, a bunch of trucks and planes and railroad cars staged outside the Pentagon to deliver supplies and materials, but our ability to provide thinking power, organizational power, planning power to help the whole of government achieve an effect is something that we will always do. So, looking forward to the future, what do I recommend? I recommend a robust and ongoing dialogue between industry and the US government to maintain adequate resources to ensure that we can respond when the time of crisis approaches.

[26:10] Bill White: We've been talking with Major General Chris Sharpsten, who directed Warp Speed during the COVID crisis. General, what are you doing now out of the military?

[26:20] Chris Sharpsten: So, since I've retired, I've continued to work with the medical and pharmaceutical markets. Cold chain is one that's intrigued me since my Warp Speed days, so I try to stay very tight and informed on that one. In addition to that, I also work with several companies that are attempting to onshore and reshore capability back to the United States. Some are Department Of Defense-related, some are energy-related. I think those are all going to be critical sectors for us to ensure that we remain a safe and secure nation.

[26:49] Bill White: Best wishes as you go forward, and if it happens again, I'm sure you'll get the call. 

[26:53] Chris Sharpsten: Hopefully, I'll be a little bit more prepared this time.

[26:56] Bill White: Very good. Thank you so much. We've been on the line today with Major General Chris Sharpsten. Thanks so much for being with us.

[27:08] Outro: You've been listening to Measuring Up – Thinking Out Loud, news and information from Testo, your resource for precision measurement technology and digital solutions for pharmaceutical, industrial, and allied industries worldwide.