Protecting Pharmaceuticals: The Logistics of Saving Lives Transcript

[00:05] 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.

[00:23] Bill White: This is Bill White for Testo, and I'm here with Patrick Girten. He retired after 19 years in the pharmaceutical industry, and Patrick has some valuable insight into high-stakes logistics in the pharma business. Patrick, welcome.

[00:39] Patrick Girten: Thank you for having me.

[00:40] Bill White: Let's talk about how you got to be in this business in the first place.

[00:46] Patrick Girten: My background is in aviation. I started out in aeronautic technology and worked as an airplane mechanic for a number of years. But with a growing family, it didn’t pay as well as I had hoped. My father worked for Mead Johnson and then Bristol-Myers Squibb for 33 years. At one point, he said, "Hey, they’re hiring," so I started in the pharmaceutical industry at the base level in the compounding area. We made products like Excedrin and aspirin, then I transitioned into the prescription side of the drugs. So, I just kind of started out by chance because it paid better.

[01:29] Bill White: In the pharmaceutical industry, everything is done for a reason, with a purpose, under controlled conditions. The decisions you made in your earliest jobs in the pharmaceutical industry were all based on quality and critical pathways. Tell us about that.

[01:52] Patrick Girten: It’s interesting. I used to make a joke. Somebody would say, “How did you end up in pharma from aviation?” I’d say, “Well, there’s really only one letter difference between the FAA and FDA.” The regulations read the same. You have ‘done by,’ ‘checked by.’ There’s, in a way, life-and-death situations that you’re making. Your signature means something. So, if you sign something, that’s saying, ‘I certify.” In aviation, my criteria was not “Would I get on the airplane if I sign this thing off?” but “Would I put my family on this airplane?” I got on a lot of airplanes that I probably shouldn’t have, you know, that I wouldn’t put my kids on, and so I looked at it the same way in the pharma industry.  Not, “Would I take the drug that I’m making? Would I give it to my child?”

[02:46] Bill White: Let’s talk about your experience in the cold chain as it evolved in your career.

[02:53] Patrick Girten: Cold chain was something that evolved after I did some time in the manufacturing process. I started out at the ground floor and was making product, then I moved into quality compliance, where I had interactions with health authorities, you know, actual audits when they would come in and we would audit against procedures. It’s a very detailed, somewhat arduous process, looking at what you say you’re doing, and then how you’re holding up to that. From that, I moved to the distribution and logistics side of the business. When I would talk to people, I’d say, ‘This is still kind of the wild west.’ The U.S. does not have the FDA oversight, the regulations, the depth of regulations that they do for the manufacturing side. So, a lot of times, it was difficult to get a vendor to do something that you wanted them to do when there wasn’t a regulation driving it. If you could open up one of the regulations and say, “Here it is in black and white. You need to do this or that.” Then, OK, yeah, they’ll follow that. But when it comes to distribution logistics, it took a little more than a regulation. There just weren’t regulations; there’s guidance, but there are no federal regulations. Europe doesn’t have that problem so much. We did here. Getting your vendors to do something for you was tricky sometimes. And especially in the cold chain because in the cold chain process, they want data from start to finish, or they want knowledge from start to finish. You have to have a guarantee that your product is going to leave and arrive as expected. So, you either have to monitor that the entire time and have data to prove that, or you have to have some sort of technical assessment—a qualification to show that this container is going get it from A to B as expected.

[04:54] Bill White: Isn’t that a component of FDA 21 CFR?

[04:58] Patrick Girten: Yes, but if you look at the distribution and logistics segment of all of that, I think I could go back and look, but I think it's like 121 words, that's it. You know, in Europe, they have an entire section on it. So since we did ship globally, one of the keys is you have to know your destination, who's the customer at the destination, because your receiving market is the one sometimes that says, this is how we want it received, this is how we want it packaged, this is, you know, it has to have temperature monitors, or sometimes they would say it cannot have temperature monitors in it. You have to know your receiving market and how they want it, especially when you're doing global stuff.

[05:46] Bill White: From point A, where it’s manufactured, to point B, C, or D, where the product is actually deployed at the end of the cold chain, there are a lot of points in between. Ultimately, though, a pharmaceutical is typically going to be used for a treatment of some sort, and that treatment is going to be for a human being, and there comes a time when you get to understand just why you come to work in the morning.

[06:18] Patrick Girten: Uh, huh. Yes. Number one – know your product. If you're a manufacturer, you need to know your product. Then you need to know that supply chain. Then you need to know what your vendors are capable of, and then you have to have all of the procedures around it. Then you have to try not to become complacent. Trying to get a vendor to do something that there's not a regulation for, and trying to keep everyone motivated and knowing that every single shipment, there is a person at the end of this thing. Whenever I would go out on an audit, when I was talking to a subcontractor or vendor or whoever, one of the things I tried to do was instill in them that they are a key link in the chain. I can make whatever I want to make – the best life-saving drugs in the world – but if they don't do their job correctly, it doesn't matter. And so, one of the things that I would do is, there's a couple of things. One of them was, if you're familiar with the Stand Up To Cancer, at the baseball games where they have everybody sign a loved one's name, or someone they know, who is fighting cancer. Well, I would do the same thing. I would, I would hand out just, you know, a little card and say, “Put anybody you know that's taking life-saving drugs,” they put their names down on there; that's who they are working for. And this really drove home to me one time. I would tell this story, and it was difficult to get through sometimes myself, still is. I still get choked up thinking about it, but I would tell this story to my vendors, and I would watch their faces, and I would ideally, I would want to see a tear. I would want to see them wipe their eyes, cause then I knew I hit their heart, and that was the only thing that I had to leverage them doing something to spend the money to go that extra mile when the regulation wasn't there. 

[08:04] Bill White: So, you put the faces to the end result here. We’re talking with Patrick Girten, who is a pharmaceutical logistics expert. Patrick, we’ll be back right after this.

[08:17] Intermission: You’re listening to Measuring Up—Thinking Out Loud, news and information from Testo.

[08:28] Bill White: We’re with Patrick Girten, a pharmaceutical logistics expert. We’ve talked about compliance and the care taken to produce quality pharmaceuticals. But then, once they’re done, they have to be delivered, meaning that there are other people in the loop, and the absence of some regulations can make that difficult. Patrick, you moved over from production to the logistics. Tell us about your experiences there.

[08:58] Patrick Girten: The scale is one of the first things that hits you. In manufacturing, you’re doing with batch sizes and you have issues associated with that scale. When you move into a large distribution center, you’re now talking truckloads. You’re moving stuff in the thousands and tens of thousands. All of a sudden, you’re faced with losing perspective, you could say. And you can get into very quickly [the mindset] that these are just orders. And, like we were talking about, you, you forget that there's a patient at every single one of these is a patient at the end of it.

[09:40] Bill White: You have a story there that apparently means a lot to you. Tell us about that.

[09:46] Patrick Girten: Yeah, so thankfully it was early on in my distribution and logistics career. We had a last-minute order for a last-chance cancer treatment come in. The treatment was not yet approved in Canada, so we had to have a special process in order to get our product into Canada. And they were in the far reaches of Canada, and this just happened to be right before Christmas break, and my family was actually at home waiting on me to open Christmas presents, and I was at work waiting for my final approval in this process to get this product to the far reaches of Canada. And like I said, it was a last-chance type of cancer treatment at the time.

[10:36] Patrick Girten: And so, it required a lot of coordination. When my step of the process finally came through, I distinctly remember hitting “approved” and slapping the lid of my laptop closed, and that thought went through my head: finally, I’m out of here. I distinctly remember that piece. And then that was the last I thought of it. I went home, opened presents with my kids, everything was fine. Well, the following year, I was in Canada and a coworker came up to me and said, “Do you remember that Christmas Eve shipment?” And I said, “Yeah, I remember that.” And she said, “Well, it was for a 16-year-old girl, and she’s doing well.” So that forever changed my view of these shipments that we’re making. I have six kids, and instantly it hit me—that could have been one of my kids.

[11:29] Bill White: Patrick, tell us a little bit about the technology available to us today that runs parallel to the cold chain logistics world, the business of transport from production to the end of the cold chain.

[11:43] Patrick Girten: So, the technology—that’s an interesting question. There’s a couple of different ways you can do it. You can either monitor the entire time, or you can qualify the route, and that’s basically you test it a number of times and then ensure that the packaging that you’re going to use is adequate. A lot of it depends on, again, the scale of your operation. If you have a small distribution and logistics operation, you might want to monitor every shipment, and if you have a large one, you’re probably going to go more for the qualification of the packaging. The problem is more is not always better, and one of the things that I think is a trap we fall into is metrics and wanting to overanalyze. The more that you ask of a person, the less they’re going to be able to do in some other area. You know, set up your process, have your procedures, and then let it ride. 

[11:48] Patrick Girten: One of the things that KPIs—key performance indicators—something is key. You don’t have a million key performance indicators. One of the things from aviation that I think about sometimes is when you’re flying, you could get by on three instruments: your engine, airspeed, and altitude. But that’s a highly complex aircraft, you’re doing a lot of things. Those are your three go-to’s. And so, have a few key performance indicators and, again, more is not always better.

[13:20] Bill White: So how do you describe a critical material shipment? What parameters are you trying to document and corroborate for the end user?

[13:32] Patrick Girten: That starts with the manufacturer’s stability data. They create a stability profile that says if the product remains within these parameters, it will be efficacious. Anything outside of that, you have to go back and speak to the stability people and find out if the product is acceptable or adulterated. So, you have a box, so to speak, that you’re playing within.

[14:02] Patrick Girten: And you have to figure out in the distribution and logistics world how to stay within that box, and box meaning the stability data. So, you can either, like we were saying earlier, monitor the entire way and have actual data that you can compare to the stability data, or you can qualify a lane using a pack-out that you think will work. And you do that a number of times and ensure that, and then from then on you set that in stone and that can’t be changed. And that’s one of the things I say: when you write procedures around this stuff, you’re writing procedures for the person who’s packing this product out at 3 a.m. in a freezer. You’re not writing a procedure for your boss to show him how eloquent you can speak and write. This is technical writing; this is not creative writing. So, know your process, every step of the process, know where those handoffs are and where the risks are, write your procedures around that, and then audit to that on some frequency.

[15:14] Bill White: Patrick, what did we learn during COVID about pharmaceutical manufacturers having to deliver medicine, vaccines to the endpoint on the cold chain—in many cases, retail pharmacies where they were ill-prepared to accept and manage vaccines at ultra-low temperatures?

[15:36] Patrick Girten: Yeah, so my experience was in what I would call room temperature or the cold chain. I didn’t have a whole lot of experience in the ultra-cold. But one of the things that was interesting—you had your, never did like the term, but “essential” and “non-essential” workers, right—and you had a certain number of people that did go into work every day. A lot of my work could be done from home because I was in quality oversight of a process. But one of the things that was interesting was how some vendors leveraged COVID to keep us out of their process. We had vendors on a yearly schedule to be audited, and basically, they said, “No, we’re closed, we can’t have anybody in here,” and so we lost some oversight abilities. That didn’t do us any favors. And then one thing that happened was these vendors realized how much power they had and didn’t have. It used to be that if the manufacturer said, “We’re going to come audit you,” they just said OK. All of a sudden, they said, “No, our COVID policy says you can’t come in here,” and there was nothing we could do about it. So, it was detrimental, for sure, to pharmaceutical manufacturers when it came to the oversight of vendors. That’s one point where I think you have to have a good relationship with your vendors. Your vendors have to be in good faith with you and working together in this whole thing, because when something like that happens, you’re trusting these vendors that they’re on the same wavelength as you are, trying to get this product to a customer—it’s not just about money to them. So, it was extremely difficult.

[17:37] Bill White: So, Patrick, where are we today? What’s the state of pharmaceutical logistics as it stands right now in 2025, 2026, where we have learned, what we hope, lessons from the COVID experience?

[17:52] Patrick Girten: Yeah, so that’s going to be difficult for me to answer. I’ve been out of the industry for about three years, and one of the things that I told all the new people that came in was, “Stay here for three to five years, and you’re going to be the expert.” It changes that rapidly. I sat in the same chair for eight years, and I didn’t want to move because I wanted to be that SME. Things changed so rapidly. So, I wouldn’t want to go out on a limb and speculate where we are right now because the industry was moving rapidly in the technology area—real-time monitoring and stuff like that. So, I don’t know exactly where we are right now. I would say, things are changing yearly, and being out three years, I think I’d probably be speculating.

[18:38] Bill White: We’re with Patrick Girten. Patrick, what’s your advice to somebody just getting into this industry who’s been brought on board to manage logistics for a pharma company, or even somebody responsible for receiving products on the end of the cold chain?

[18:55] Patrick Girten: Yeah, so someone needs to understand temperature, whether that’s, if you’re new into this space or if you are managing this space. Learn temperature, learn temperature mappings, learn the process, go to each one of the handoff points and see for yourself. See what your vendor tells you it’s like, and then actually see it for yourself. And stay more than two or three years and become the SME in this thing. It’s an exciting area to be in because it does change rapidly, it keeps you on your feet, but it’s also challenging in that it’s not as highly regulated as manufacturing. It takes a little bit of imagination and creativity sometimes to make it all work, I think.

[19:54] Bill White: Would you advocate for more regulation going forth?

[19:58] Patrick Girten: Yes and no. I would, yes, in that it would help the manufacturers drive consistency in the distribution and logistics world, but at the same time, if it’s not thought out, I think it can do more harm than good. It depends.

[20:21] Patrick Girten: We had situations arise where they started talking—not us, but the Canadian authorities—about humidity controlling every shipment. We’ve seen some of the laws coming out of California with sterilization and what that drives into the industry. It’s a double-edged sword. I would say things are working right now. What we did was rely on a lot of the European regulations. They have very good temperature mapping guidance, and so when we were shipping into those areas, we would basically just say, “We’ve adopted those as our own,” and that’s what we would use.

[21:03] Bill White: OK, any final thoughts?

[21:06] Patrick Girten: I would say looking back, and if this was too upper-level leadership, as it impacted my job: measure wisely and frugally. Don’t over-KPI the process. Metrics don’t save lives. People filling the orders, following that pack-out diagram—that saves lives. So, get the metrics correct. And finally, how many times on your CV or LinkedIn profile do you mention money—whether it’s profit or cost savings—and then go back and reread it and see how many times you mention the word “patient.” We can never forget who we’re working for and why we do what we do.

[21:50] Bill White: Well said, Patrick Girten, a pharmaceutical industry logistics expert. We appreciate your time today for Testo’s Measuring Up podcast. Patrick, thank you.

[22:01] Patrick Girten: Thank you very much for having me.

[22:05] 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.