[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: This is Bill White again with Jim Bacon. Jim, welcome back to the Testo Network. We're glad to have you share your insights.

[0:32] Jim Bacon: Yeah, thank you, Bill. I'm glad to be here.

[0:34] Bill White: Jim, you've talked about the concept of a core team with respect to the cold chain and logistics. Could you expound on that somewhat? You know, you've given presentations on this throughout the years. It's important that we make sure we understand that.

[0:52] Jim Bacon: Yeah, absolutely. They, you know, the idea of a core team approach really started to surface early in my career when we started to work on cold chain processes, and really, it was a collaboration with a number of our partner suppliers. We came up with this idea of having a strong internal group of people working with a very strong external number of suppliers. And because of the complexity of the coal chain, it became apparent and critically important that all of these different characters and representatives work in unison. You know, collaborate and coordinate to develop a clear set of roles and responsibilities for the cold chain. So, really, you know, what we strive for is trying to leverage all of the knowledge and experience of those external providers and leverage that against the knowledge and desires, and needs of our internal stakeholders. 

[02:00] Bill White: Sure. You've got people on the inside, people on the outside. What do you, how do you define the difference between a vendor and a partner?

[02:08] Jim Bacon: Yeah, that's a great, that's a great question because, you know, I came up with this idea of, you know, supplier or strategic partner, and the word vendor is used a lot in the industry, not just our industry, but, uh, a number of industries. And to me, it points to a very transactional type of relationship, one that can start or stop in an instant and really takes out any personalities, where I believe the idea of a partner-supplier incorporates the competency of the people that work with the suppliers, or that are part of the suppliers, I should say. Really, at the end of the day, you're hiring a supplier for their technical know-how, but you have to be able to work with them. And so, understanding supplier personnel that you're working with really adds that trust factor in.

[03:00] Bill White: That makes sense. You certainly have criteria that you've used over the years to measure the potential benefit of working with someone. Can you tell us about how that developed?

[03:13] Jim Bacon: Yeah, absolutely. So, a couple things. What we decided early on was to create an internal process, because it was important to understand where we're coming from so that we could collectively as an organization determine what we need and to be able to assess it. So, we wanted to ensure that we included people inside the organization that were a representation of all of the requirements that a cold chain solution required. So, from you know, logistics and procurement, those are the kind of easy ones. How do we get, get it from point A to point B? You know, what's it gonna cost? But then from a quality perspective, you know, are we looking at temperature criteria from a regulatory point of view? Or do we want to make sure that we're staying within the guidelines of the regulatory agencies around the globe? From a validation point of view, you know, is the solution that we're looking at from a provider? Is it qualified to do what it says it's gonna do? And then from a risk management point of view, do we have the proper assessment in place from a financial point of view to identify any potential risks in the execution? 

[04:26] Bill White: OK. We're with Jim Bacon. Jim was um the founder of Stay Cool Logistical Consulting. Jim, how do, how do people know where to find you, and how does that process work?

[04:39] Jim Bacon: Yeah, well, thanks for asking that. Yeah, you know, I'm on LinkedIn, Bill. They can look me up on my profile, Jim Bacon. It's a rather low-key approach that I've taken. You know, I've created the organization or the company, Stay Cool Logistics Consulting. And so, I don't necessarily have a page for that, but I talk about the capabilities of what I can support and provide on my profile on LinkedIn. If you're interested, I can open up some communication, uh, with, uh, with potential parties and start from there.

[05:11] Bill White: Thanks, Jim. Your entire career appears to be related to pharmaceutical integrity and getting high-value materials from point A to point B safely and within the parameters. They have the documentation required to assure the safety of the public overall. Jim, how do you instill ownership at every step of the way? There are a lot of people involved in this chain, from the producer to the people that are gonna be actually using these products, and a lot of different disciplines. How do you keep everybody on the same page?

[05:50] Jim Bacon: Well, what we did early on, you know, as we developed the core team, we also developed the structure of a shared business review. And what I mean there is that um we not only had business reviews with the individual suppliers, we had a quarterly business review with all of the suppliers. And so we invited them all to the table at the same time. And what this tended to do was, number one, it introduced all the suppliers to each other, so they could benefit from the knowledge of knowing each other. We described those relationships as arms of our supply chain. So, in essence, there was a, there was responsibility to provide services for the proper transport of those products. And through a process that we called the mock shipment trial, we mapped out particular lanes that we wanted to create, and then we engaged with each of the suppliers to see how the cold chain worked. Each of the particular links. And so, there was, there was a number of handoffs. We wanted these suppliers to understand who they were handing off to, when the accountability transferred from one supplier to another, and what each one of them would do to ensure that the product remained intact and that they were supporting the uh positive outcome of that shipment.

[07:15] Bill White: Jim, we're all much more sensitive to the concept of cold chain in our post-COVID years here, at least I hope we're in the post-COVID years, but the idea of a success, I think was expressed nicely in many cases during the early parts of this decade, where we had to get these pharmaceuticals to the end user. Were we successful with that, Jim, in your opinion?

[07:43] Jim Bacon: I think so. I think that, you know, the pandemic and the ultimate response of providing life-saving vaccines to patients around the globe. Unfortunately, you know it happened later than we wanted it to because a lot of people perished along the way, but you know, the development of these vaccines happened at lightning speed, right? And what made it really, truly successful was when we rolled it out. There was a real coordinated effort. And, you know where I was involved in this process, we spoke to and engaged with partner providers and clients as well to execute this core chain concept. So, you know, number one in the success area is communication. You can never have too much communication. You know, we've developed best practices along the way. So benchmarking, you know, the particular process against best practices was, was absolutely key. Mapping out the process and agreeing to it, and engaging in the mock shipment trial that I mentioned earlier, was a definite success factor. And, you know, creating those clearly defined roles and responsibilities creates a win-win situation for everyone.

[09:01] Intermission: You're listening to Measuring Up: Thinking Out Loud, news and information from Testo.

[09:11] Bill White: Jim is a, is a consultant. Your business is to see the big picture, and you see it from many different points of view, working with many different companies and interest, those producers as well as shippers and people in the air and on the land and elsewhere. And how do you think we're doing? Are we ready for the next one?

[09:34] Jim Bacon: Well, the unfortunate thing is, I think, you know, complacency always sets in after some kind of disaster or pandemic. And so, we've seen ups and downs in the whole process over the last 20 or 30 years. You know, it's really, really relies heavily on the regulatory agencies, because they're kind of the gatekeepers, if you will, where they see what went wrong and what went right in terms of execution. There are a lot of companies out there that were not paying it complete attention. So, I would say that you know, we haven't hit a valley at this point, but we certainly need to ensure that a lot of the, a lot of the things that we did in terms of collaboration and communication, you know, remain in place. The whole idea of established communication and escalation channels is absolutely key. And that's really the concept behind the whole core team process: it’s to ensure that kind of higher-level engagement. And that's where the creation of these strategic partnerships, as opposed to these transactional vendor types of relationships, is really key.

[10:42] Bill White: Jim, you've certainly made tremendous contributions to the industry in terms of best practices, what to do, what not to do, how to build these teams. Does your work extend to the international market as well?

[10:57] Jim Bacon: Yeah, absolutely. You know, earlier in my career, when I was working in the commercial sector of biopharma and pharmaceuticals, my responsibilities were, in fact, international. And so, I had responsibility, even though I, you know, I had a role here in the United States, I was responsible for our business in Canada, and then I was responsible for our business in Europe from a logistics point of view. I also had responsibilities for trade compliance and international logistics globally for the organization I was working for. So, you know, when I speak about these relationships with suppliers, I'm not only talking about, you know, domestic, solution providers, I'm talking about international ones as well.

[11:42] Bill White: Jim, do we have the technology that we need right now to put these best practices into place and to give the continuity of service that the industry demands and that the public expects?

[11:56] Jim Bacon: Oh, absolutely we do Bill, but there has to be a, there has to be a will, you know, from the organizations to put these things into place. And so, this is where I spoke earlier about complacency. You need to have this structure in place at all times, so it's there when you least expect it, but most need it. So, you continue to develop those relationships with suppliers, and this is where the trust and competency come into play, because you have the trustworthiness with your supplier, you're working with them, they have the ability and the willingness to um deliver to your expectations, and then on the other side, you know, from a competency perspective, these organizations are continually looking at innovative ways to improve the process.

[12:48] Bill White: Jim Bacon, the last time we talked, I asked you the same question. What's next in this industry as far as compliance, safety, and best practices for getting critical products from point A to point B? What's next?

[13:04] Jim Bacon: Well, you know, Bill, there's a lot of talk about AI, right? And so, there's a lot of that that goes on in the cold chain today. There's this whole idea about digital twins so that you can create a process and map out a solution and test all of the the weak links and risk spots to ensure that you've answered all of those potential risk areas. But, you know, I think that when you think about the cold chain and success, you really have to talk and think about or engage in the whole idea behind risk. Because there's different risks in the process, financial risks, you know, strategic risks. There's the hazard, hazardous risks of the product itself, and there's operational risks. So, using AI, we can engage in what we refer to as predictive analytics, and we've seen a lot of that in some of the companies today with their, um, tracking devices, whether they're real-time, you know, Bluetooth or software as a service. And this, this is an area that I think continues to develop and expand and respond to these critical points.

[14:06] Bill White: That's great insight, Jim. I really look forward. We've talked before, we're talking now, and I hope we talk again, uh, next time on the Testo network about AI and how it's, uh, what we're learning as it evolves. It's just fascinating, but it's not everything, and we're gonna learn a lot along the way. I assume you'll agree with that.

[14:31] Jim Bacon: Absolutely, Bill. You know, it's interesting that you talk in mentioning that because at the end of the day, as well, data is critical, right? And so, you know, being able to collect and assess data, whether it's manually or electronically or potentially through AI is going to be a, you know, it's one of the big challenges. And ensuring that continuity is critical as well. Last week, I was looking at a blog on the Testo North America site, and they talked about, you know, data storage ownership. And here, you know, they really dove into a number of areas about who owns the data. So, you know, the manufacturer ultimately owns the data, but the supplier, and in this case, Testo, you know, adopts best practices as they develop solutions. When they're partnering with the client, they want to be able to demonstrate that they have the audit-proof capabilities and proper service agreements in place to create that continuity. I think that's where AI is gonna have its biggest advancements is because you're gonna be able to predict potentially, based on, you know, what we would call machine learning, identified situations that have happened in the past, you know, with known responses that work. And this is where organizations will be able to develop that strong compliance.

[15:51] Bill White: Jim Bacon, Stay Cool Logistics and Consulting. Jim, once again, thank you so much for your time, and we're gonna talk again. There's just too much here to explore, the industry is evolving so quickly, and much of it is due to you. So, we appreciate your time.

[16:11] Jim Bacon: Oh, hey, I appreciate the time today, Bill, and you know, what I really enjoy, and I've always enjoyed is sharing a lot of my experiences because I feel that, you know, I learned a lot along the way. If I can just share a small portion of what I've been able to experience, it really improves the acumen of people in this market space.

[16:30] Bill White: Clearly, you're an asset to the entire industry, and we appreciate it. Thank you, Jim Bacon. We'll talk again soon.

[16:38] Jim Bacon: You bet. Thanks, Bill.

[16:43] 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.