TRANSCRIPT

[0:00] 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: This is Bill White for Testo. I’m on the phone here with Jim Bacon, who is an industry expert in supply chain and cold chain logistics, mostly in the pharmaceutical industry. Good morning, Jim. 

[0:36] Jim Bacon:  Hello, Bill. Good morning to you. 

[0:37] Bill White: Thanks for being with us, and tell us a little bit about yourself and your background as it applies to this subject today.

[0:45] Jim Bacon: Yeah, absolutely. Thanks, Bill. Well, Bill, you know, I’ve been in the industry, in the pharma biopharma supply chain business for about 35 years. The most recent 25 years of that, I’ve had a cold chain focus. I’ve had a number of different roles in cold chain. I’ve been a decision maker at a manufacturing supply chain position. I’ve been a sales and operations strategist for Cold Chain Solutions when I was marketing a cold chain solution. And most recently, I’ve been a technical subject matter expert for Cold Chain Solutions. My objective has been really to discuss and teach best practices, to improve cold chain acumen across the entire industry, and that’s what I’ll help do today.

[01:26] Bill White: Jim, boy, we sure got a lot of exposure to the concept of cold chain during COVID, especially when manufacturers were trying to get these vaccines from production to distribution and the last mile. Tell us about your experience during that time. 

[01:44] Jim Bacon:  Yeah, so, I was involved as a technical operations subject matter expert in my previous organization. I was really responsible for making sure that we brought solutions to the table, shipping solutions and tracking and monitoring systems, that would protect these clinical vaccines as they were going through clinical trials and getting ready for commercial approval and wider distribution. So it was very important, as we carried out these clinical trials, that we maintained the labeled temperature of these products, because that’s really the one nuance between clinical drugs and commercial drugs is that there’s really no room for error. You know, once a product becomes commercial, there’s a lot of stability work that’s been performed, and so, there’s a little bit of leeway when shipping these products, but for clinical drugs, it was absolutely important to maintain these temperatures to control the efficacy of these drugs.

[02:43] Bill White: Jim, all of this effort is brought to bear on making sure these pharmaceuticals are safe, and it all boils down to people, children, you know, parents, you know, us. Your entire efforts are focused on making sure that safety is there and that you are confident in your patients and the producers are confident in the viability of these drugs. Tell us how you do that.

[03:04] Jim Bacon: Well, for me, it boils down to some personal experience. When I got started in the Cold chain, prior to that, I have 2 children who were type 1 diabetics. I understood early on what product integrity meant in regards to temperature control. It was so important to maintain that safety, the integrity of the product, to ensure that the product, the insulin that was being injected into my children, was safe and that it would work. And so, that really became a driving force for me in cold chain compliance. Regarding the safety in delivering these products, I was involved early on in my career with the distribution of our products up in Canada. We contracted out to a third-party distributor. About every 6 months, I provided a basic orientation for this contracted distributor staff, all the way from the pickers, the packers, the quality folks, and the management team, and really talked to them a little bit about how our drugs worked. Given the nature of these drugs, many of these folks knew of friends or relatives who had taken these drugs. And so, really, this simple exercise really drove home the result that the medicine, if it didn’t work because of a broken cold chain, or if something wasn’t done correctly, then it could have some devastating effect.

[04:40] Bill White: OK. You’ve had those experiences of going home on a Friday and hoping things are OK on a Monday. That’s the fear factor. Tell us about how you felt about when you left work, and how confident were you that things were going to be OK?

[05:04] Jim Bacon: Well, exactly right. Early on in my career, we had a situation where it was deemed quite catastrophic. Unfortunately, you know, we encountered this situation where the warehouse that was storing the product had an environmental monitoring system. After hours on Friday, it malfunctioned. The temperature sensor malfunctioned, and the cooling continued to occur throughout the weekend on Saturday and Sunday, because there were no automatic alerts during the weekend. And so, the product went from a +5°C controlled temperature to -5°C, so basically, frozen.

[05:56] Jim Bacon: At that point, all the product was immediately quarantined. The good news in this case was that it was a commercial product, and so, we did have some stability data handy, and we were able to perform some, what we call, accelerated characterization work to demonstrate that the product was OK. And we were able to release the product, fortunately, before the next scheduled ship out of the product. In this particular case, the client was, was informed and we provided a complete investigation report to them. But as an immediate remedy, we worked with the distributor to install 24-hour alert monitoring. Now, in the beginning, that was as simple as putting a body in the warehouse for 24 hours and monitoring that system, but, you know, that ultimately led to more automated alert systems for this product.

[06:55] Bill White: It’s best to have layers of monitoring, both local and others that will tell you if there’s a problem. 

[07:04] Jim Bacon: Absolutely. 

[07:07] Bill White: Is the technology today sufficient to make sure that’s deployable, in a practical sense?

[07:14] Jim Bacon: Yeah, I think we’ve come a long way.  This particular example that I provided was over 25 years ago. I would say today, you know, Testo and other organizations have provided, you know, redundant systems for alerts, and so, personnel are informed via text and other emails and phone calls, but as well, there are, you know, systems that will make corrections to the temperature, if something goes wrong.  I think, you know, your notion earlier on about redundant systems, I think there, you know, there’s a lot of those built into the systems that we have today that we certainly didn’t have 25 years ago.

[07:58] Bill White: OK. Jim, what about the concept of predictive performance? Can you tell when something’s going to go wrong?

[08:06] Jim Bacon: Yeah, I mean, so, we’ve done some work, or I’ve worked with some companies in the, in the last few years where, you know, we’ve kind of called it, it’s, you know, predictive analysis or, you know, what we would call machine learning, where systems recognize or identify patterns that they’ve encountered before. And so, you can build these corrections into the system so they can take some proactive measures, you know, in order to correct the situation. I would say that this is still, you know, a lot in development, but, I would say over the past 5 years or less, we’ve come a long way and really recognize that is a need for all systems for environmental monitoring.

[08:54] Bill White: OK, we’re on the line with Jim Bacon, who’s an industry expert in supply chain and cold chain logistics and a lot of experience in the pharmaceutical industry. We’ll be right back after this.

[09:10] Intermission: You’re listening to Measuring Up, Thinking Out Loud, news and information from Testo.

[09:22] Bill White: We’re with Jim Bacon. Jim, the products are sophisticated, robust, and the monitoring systems are very well thought out. We know that Testo has a kind of a triple-layer data accumulation from whatever parameters that they might be measuring, that’s both with the local sensor, with the aggregator there on site. Is there any additional type of oversight that needs to be done on a regular basis?

[10:02] Jim Bacon: Well, if you think back to the initial installation of this equipment, I think some of the best companies out there, including Testo, operate through demonstrated qualification validation of these solutions. What that really means is going through a number of compliance checks to ensure that the system or solution is doing, you know, what it’s supposed to do. I’ve really found that in the better solutions out there, an independent verification of these systems through a qualification or validation is necessary to provide that extra proof about evidence of compliance. 

[10:41] Jim Bacon: I think that when we take a look at other systems that are out there, you know, we want to make sure that people aren’t just checking boxes, right? This is really where this qualification and validation plan is really key. From a time perspective, I think that reevaluation, revalidation of these systems on a routine basis is key. You know, whether that’s every 6 months or annually, because in a warehouse, you know, the configuration of that warehouse changes from time to time.  It’s very important that the system keep up with those changes in order to make sure that it’s protecting that product adequately and measuring the right temperatures in the right places, in the warehouse.

[11:27] Bill White: In addition to the hardware and the software, we also have the need to understand best practices on how to do what these folks are doing in order to get these pharmaceuticals to the market. What are some of the best practices?

[11:43] Jim Bacon: Yeah, I think in a word, Bill, you know, it’s training, training, training, orientation and understanding of the compliance and quality, and a quality-driven culture is, is key. You know, it’s not just the system, it’s the people behind the system. You know, staff and management need to embrace this quality approach. It’s really not just words on a company website when you think about compliance. Constant communication within the teams is really essential when you’re having any kind of issues. And for me, from some past experience, I think that the idea about, from a personnel perspective, an idea about team huddles at a frequent pace where you’re talking and communicating about what’s about to happen, what has happened, some of the issues that have come up, what corrective actions have taken place, what kind of training might be needed to re-educate, you know, staff on, on how the system is working. And all of these things relate to outcomes. Right, the actions that we take along the way all lead to positive outcomes.

[12:45] Bill White: Well, we’re all affected by those efforts that lead to the quality and the viability of whatever medicines we may be taking. You’re an industry veteran, professional. What kind of advice can you give to some people who are getting into the business of, say, bio repositories, or either local storage or bulk or even off-site?

[13:10] Jim Bacon: Well, for me, people who are getting into this industry, I think communication is really the key. From my perspective, we need to embrace diversity of thought. We need to practice transparency. All of these traits really exemplify, you know, a learning mentality. I think that they also contribute to what, you know, I refer to as a compliance mindset, where we’re, where as I said earlier, we’re understanding the effects of our actions for people that are just getting into this industry, hopefully they don’t have this closed mindset and just talked about earlier, just checking the boxes that they really get involved and that the organization has a culture that embraces these, these ideas as well.

[13:49] Bill White: Safety first everywhere. Jim, talk to us about what kind of parameters you are monitoring in these processes or storage functions.

[14:00] Jim Bacon: Well, what we’re doing is we’re monitoring the climate, the environment of the facility. We want to make sure that the product that’s stored in the top corner of a warehouse is at the same temperature as the product in the middle of a rack in the middle of the warehouse.  We’re monitoring, we can be monitoring humidity, we can be monitoring temperature, we can be monitoring light, you know, all of these things, as well as some of the systems contribute to inventory accuracy as well. When I think about systems that are monitoring, they’re also usually integrated into warehouse management systems as well so it’s all related.

[14:35] Bill White: OK, and in the testo Saveris model, all of these data points are then recorded, transmitted, and then analyzed in a way that yields some useful information, as well as compliance for the client.

[14:52] Jim Bacon: Yes, it’s going to, it’s going to provide a history, an environmental chain of custody, really, if you will. And there’s a lot of movement in that, in that arena now, where we want to be able to, if there is an excursion in the last mile, or let’s say, somewhere along the supply chain route that we’re able to track this right back to the original product. Or if there’s an, you know, efficacy issue with the product, you know, that can be tracked as well, and the temperature data that is being collected and supported through these Testo systems can support investigating those investigations if necessary.

[15:32] Bill White: Well, this is one of those parts of life where the technology meets the humanity. And what we do here is for a reason, and that’s to make our lives better. Fortunately, the technology is evolving, will continue to evolve. Let me ask you one final question. What do you think about the concept of artificial intelligence as it analyzes and interprets the information that we’re getting from the sensors that Testo makes?

[16:04] Jim Bacon: Well, it’s a new concept that’s being looked at in the area of temperature control and cold chain, you’ve got, you’ve got organizations out there that try to create what we call digital twins, and this is where we’re able to create an environment where we can test out theories and situations to best incorporate any kind of changes that are required, or that help us determine what could happen if temperatures fluctuate one way or the other.  I think it’s a science that’s really evolving almost daily at this point. And we’ve got to be careful, of course, how this evolves, but I think it’s, it’s going to be quite positive for this industry.

[16:50] Bill White: All right, safety first and last, through the cold chain from production, warehousing, distribution, last mile, and certainly we’ve all been sensitized to it now with our COVID experiences and watching these vaccines deployed not only the vaccines but all sorts of medical products. Jim, what about other industries outside of the direct pharma? Like in the biotech, life science, and clinical, what kind of considerations do we have to apply there? 

[17:27] Jim Bacon: Well, I spent part of my career in the biotech industry in cold chain and also most recently in the clinical trial space for biotech, so, here’s a situation where you’ve got product that is literally priceless. From the perspective that it’s, you know, the products are, are quite expensive. They’re either personalized or small batch volumes. They cannot easily be replaced. Here is where it’s absolutely critical, you know, all the work that we’ve done over the last few years, kind of leads up to, you know, what we’re encountering today, because you incorporate, you know, what I spoke about earlier, this chain of custody, along with the fact that the product can’t easily be replaced. So, any problems in the cold chain or any breaks can result in an immediate impact, potentially for the patient.

[18:27] Bill White: Certainly. Jim, tell us briefly about your experience with Testo.

[18:32] Jim Bacon: Testo is pretty new for me. I’ve had a recent discussion with the technical folks there, and I think what they’re doing is leading edge. They’re embracing a lot of the things I’ve spoken about so, I’ve been quite impressed so far with what they’ve accomplished and trying to provide some input to them in the area of not only environmental monitoring, but shipping logistics as well.

[18:57] Bill White: Jim, before we finish, let me ask you this. What’s next in the industry?

[19:02] Jim Bacon: Well, yeah, it’s, you know, if I think about my career, you know, and I think about temperature, temperature monitoring, temperature monitoring early on to me meant that it was an insurance policy, right? It provided checks and balances for the things that we were, we were doing. And unfortunately, over the years, it’s proven to be a good insurance policy because it helps detect breaks in the supply chain. I think that, you know, moving forward, you know, ensuring that this technology continues to advance, but also pulls, you know, the compliance and training of personnel along with it, because really together, those two things will give us the assurance of product integrity and patient safety.

[19:50] Bill White: Jim, this podcast is called Measuring Up. What does that mean?

[19:56] Jim Bacon: Well, Bill, for me, measuring up really means stepping up to our cold chain responsibilities. We want to be able to ensure that we have best practices that drive quality and compliance in everything that we do. And, you know, these things will help protect patient safety, and that’s really what it’s all about at the end of the day.

[20:15] Bill White: Jim Bacon, an industry expert, supply chain expert, cold chain expert with lots of experience. Jim, thanks so much for your time today and your insight. We look forward to talking with you again because we know the industry is evolving so quickly, and there will be other things we can talk about in the future. Thank you so much.

[20:37] Jim Bacon: Absolutely, you’re welcome, Bill. Have a great day.

[20:40] Bill White: Thank you.

[20:42] 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.