Supply Chain
Technology Podcast

SUMMARY KEYWORDS

Vaccine distribution, supply chain, COVID-19, temperature control, clinical trials, less developed countries, logistics, GXP advisor, regulatory compliance, direct patient delivery, depots, sea freight, customs clearance, global supply chain, pharma logistics.

SPEAKERS

Sue Lee, Premsai Sainathan

Premsai Sainathan  00:08

Welcome to the supply chain tech podcast with Roambee. In this episode, we speak with Sue Lee, the director of hexagon supply chain, a consultancy dedicated to empowering all actors in the pharma logistics chain of custody with effective education, planning and procedures. Sue shares some of the challenges in the industry faces as it ramps up to distribute the COVID 19 vaccines in the new novel at an unprecedented scale and velocity. Sue. Welcome to the only supply chain tech podcast today in context of everything that the world is seeing during the pandemic, there is a huge challenge for the pharmaceutical sector, which is to get across the COVID 19 vaccines that are largely the clinical trial faces today out to the population is at large. Now this is not a challenge that has ever been of such a big magnitude, simply because of the fact that most of the other vaccines till date have been to very targeted individuals. It could be either the elderly or it could be children, but for the first time, we are actually looking to vaccinate the world, and obviously that is a huge, huge, huge challenge in terms of distributing this vaccine and getting it out to every patient who needs it and who needs it on time soon. So with your experience with the healthcare industry and as a GXP advisor, I have a few questions around around this whole topic, but I would like to begin with a very simple question, why is it so big of a challenge? Because you always had pharmaceutical companies who are shipping across the world. There were trade lanes, there was there is vaccines going out into every country. Why is this so unique in your opinion?

Sue Lee  02:12

It’s the sheer scale of what’s going on, is the sheer requirement to go into getting on for 200 countries across the world. And that’s clearly going to end up being a rather staged approach. But what we don’t want to do as an industry, I think, is to disenfranchise some of the less developed countries in the world, to concentrate on Western Europe, North America, which is where traditionally, large amounts of clinical trials have gone on, and indeed, where some of the COVID trials are going on at the moment, so that there’s, there’s a lot of scope to be going out into some less developed areas which have their challenges in terms of setting up supply lanes, actually physically moving material, whether that ends up being sent on aircraft, whether it ends up being sent by ship, it will have temperature control requirements, as all vaccines do, and at the moment, we don’t know what any of those requirements are going to be. We don’t know how it’s going to end up, because there are so many vaccines on trial at the moment that they will probably be two or three that come out as being the ones which go into mass production. We don’t know where they’re going to be produced, or where the Gates Foundation has put a huge amount of time and resources into supporting the industry in terms of getting vaccine trials up and running, and is committed to providing physical infrastructure to be able to manufacture vaccine. But we still don’t know exactly where that’s going to be, which is going to happen, and how we’re going to be able to transport temperature control material at whatever temperature, it turns out to be into some very challenging locations which have not typically been used as part of clinical trials. They will clearly be getting some level of commercial drug supply chain into them, but it’s probably going to be going to be very limited number. When you start looking at very small places, if you are looking at islands, if you’re going out into India, then there’s huge challenges going up into the mountain areas, somewhere, like going into the Himalayas, into Nepal. You know, these are places that we don’t regularly send drug and vaccine to, and that’s before you start getting into the more remote areas in South America, in Africa, all of these places do not traditionally take part in big clinical trials or in big commercial supply. And so we’re going to have to relearn all of that in a situation that we’re at now where there are not so many commercial aircraft flying, and a lot of commercial aircraft that are passenger aircraft have been repositioned into being cargo aircraft. So it’s all there are too many unanswered questions at the moment for us to be really clear, to be able to say, well, we’re going to do it like this, and that’s only. Going to evolve over probably the next year or so.

Premsai Sainathan  05:03

So in that context, all of these last challenges you’re talking about, is any of them actually visible in the clinical trials phase, because a lot of companies are actually already shipping out vaccines to conduct these clinical trials.

Sue Lee  05:22

Well, a lot of the clinical trials, you have to remember, there are global clinical trials going on, but a huge amount of what’s being done is still being happening the traditional places in North America, Western Europe, a bit into Eastern Europe. And so a lot of clinical trial is concentrated on there at the moment, because it’s a relatively straightforward population and market to be able to serve in terms of supply chain, but also in terms of having well educated and well motivated investigators, having infrastructure in place in order clinical trials take place, having full GXP in place, using things like the European clinical trials directive in order to conduct trials, which gives a regulatory framework for that to happen. And everywhere in the world is going to need to be serviced, ultimately, and that may include places which have not taken part in the clinical trials at all, and so the infrastructure won’t have been set up in order for that material to go in straight away. So that infrastructure is going to have to be built, the supply chain, routes are going to have to be investigated to work out things like replenishment. Whether it turns out we end up with a vaccine that’s moving on liquid nitrogen, or we end up with one which is on dry ice, or on two to eight. If you’re going to go into a small airport somewhere and have to wait for customers to clear it, who are not used to clearing drug supplies. They’re not used to the pharma chain and all the requirements around it. There aren’t going to be fridges and freezers set up in place for you to be storing boxes whilst you wait for the customs process to go through, necessarily. And what we do end up with is a situation where we’re more likely to have temperature excursions because of well meaning people putting boxes into fridges and freezers while they wait for the whole paperwork process to go through. And I think one of the things that supply chain has to get on board with is being really well prepared and dealing with and talking to people who know what they’re doing, about going into remote locations. You’ve had experience of doing that, in order to be able to set up paperwork in advance, to have everything possible pre arranged, to reduce the clearance time and to retain control of what’s going on with shipments as they’re moving. And that’s going to be a really key component of how we make sure that vaccines get in, so that they can still be used, so there’s no temperature excursions, no issues around how they’ve been controlled.

Premsai Sainathan  07:51

So Sue, I think you’re touching upon a lot of things that actually could go wrong in the supply chain or the chain of custody, right, from the time that it’s manufactured to the time that it that it.

Sue Lee  08:06

It is the nature of having worked in quality and risk management for a number of years, is that I am always looking for what are going to be the problems, and how are we going to try and control those.

Premsai Sainathan  08:17

Absolutely and in that context, you are actually a GXP expert and an advisor. So what is GXP? What are these good distribution practices about? Could you kind of walk us through what needs to be followed at every step in the chain of specific question that is manufactured till the point that it actually reaches the patient.

Sue Lee  08:48

So there are a lot of components to GXP. Includes good distribution practice, really crucially, but it also requires us to consider good data practice, good storage practice, good clinical practice. There’s a whole lot of regulations that all come together, and one of the key parts of being able to physically get things to move in a compliant way is to be clear about what applies at each step of the transport, whether it’s as it’s being stored, choosing what kind of boxes it’s going to go into, temperature monitoring along the way, also around making sure that temperature data is moved in a regulatory compliant fashion. And so all of these things, storage and premises, how you temperature map fridges that you’re going to precondition gel packs and things like that in there’s, there’s hundreds of different factors which all need to be applied, the correct ones need to be applied to actually physically moving a box from point A to point B. What’s happened in the manufacturing process will make a huge difference about how the shipment is going to move. But it’s not necessarily the thing that you are looking at and considering. You’re picking up a package and taking it and delivering it. So you need to be clear about which parts of the regulations apply when a shipment is actually physically in transit, but also at the point it’s being dispatched, at the point it’s being unpacked, when it gets to the pharmacy, what we want to be really clear about is that shipments move in such a way they are expedited through customs clearance, where it’s possible to do so, so you don’t have them sitting around with the potential for a temperature excursion. But also, it’s really critical that we have things like the pharmacist, who’s going to receive it at the hospital actually knows it’s coming and allocate space for it in the fridge or the freezer when it’s there. And that can be a really, really challenging thing. I’ve heard pharmacists describe Tuesdays as being like Christmas, that they’re going to come in, there’ll be lots of packages, and they’ve got no idea what’s in any of them, because a whole lot of material has just been sent out by drug companies arrived with them, and so making sure that they know what’s going on, that the site location has an idea. But also, if you’re going to be sending a shipment that’s going through and is being delivered directly to patient, because that then brings in a whole raft of extra requirements around data control, about being clear about who knows who the patient is under the circumstances where you’re making delivery. And one of the things that COVID has brought about is a really big change in the way that we look at making deliveries in so before, there were a very small number of companies who were just beginning to try out doing direct patient deliveries. Now, because of the additional requirements of being able to just get drug into patients so that they can use it. There’s a whole raft of people who have now decided that they are going to use direct patient as a methodology for getting shipments through. And that could be that it’s being transferred from the site, so it could be pick up from the site that goes straight into the patient, but then you open up whole new set of complications around who knows who the patient is, how the delivery is going to take place. How do you make sure the patient’s there in order to take their delivery? You can’t have them sign for things, because that could be an issue around patient confidentiality. You can’t have their relatives signed for things because they might have the same surname, that could be a data breach. Also, you don’t want to leave patients who potentially are very ill with a huge, thermally controlled box that you just sit outside their door. Step back two meters, ring the doorbell and go there are your drugs, because that’s unfair to patients to give them that additional burden of being able to take the materials in, and then they’ve got all of this temperature control material that presumably they’ve got to do something with temperature monitors as well. So all of that. So there’s a complexity that’s been added, in addition to all the complexity of physically getting things to move on an aircraft, which is a challenge in of itself, to certain routes these days because of the restriction and other passengers that are traveling.

Premsai Sainathan  13:07

Yeah. So what is Compounding the problem is really that it’s not just the unprecedented scale of things, but also the fact that you know the carrier capacity and all of that is actually low because of the pandemic. So the pandemic actually impacted your normal supply chain. So you’re actually working a limited supply chain today, and in addition to that, you are now looking to distribute an enormous amount of of vaccines and millions of doses, exactly, and that context, Sue, you talked about customs, you talked about the last mile delivery. I’m just curious as to how many touch points or Change of Hands exist in a typical vaccine supply chain. Is it like five, six, ten, fifteen?

Sue Lee  14:00

Potentially hundreds, quite literally hundreds, because of the number of people that it will go through from the point where you have it collected from the manufacturer in the process of being manufactured, it’s going to go through potentially dozens of different places, different points where additional parts of the manufacturing process to take place once it actually gets collected. So you’ll have a driver who comes to take it. It’ll go to a depot. It will then go across to an airport. It’s going to go through potentially dozens of hands moving across the airport, people physically driving it, people interacting with the paperwork to go with it. Then it will physically travel on the aircraft, get to the other end, then it can go through dozens of different hands as it goes through individual airports, until the point where it gets handed to a driver and then gets taken to actually make delivery at the consignee. Now there are ways to cut down that. So if you go with an. Airport that’s gone through the IATA pharmaceutical certification process, and they will potentially have a specific pharma control area where material is taken and stored, and they have very stringent requirements about how they move material inside the airport and how many people actually take physical control of it or documentary control of it, and those that can make a massive difference. I also have worked incredibly hard with airlines and with individual airports to try and make these kind of havens of pharmaceutical moves, and they’re definitely their increased compliance makes a huge difference, particularly if you’re going out to somewhere in the less developed world and choosing the airports that you’re going to go through along the way, so somewhere like Brussels, for example, has worked really hard on being a fully certificated airport, and also has a lot of flights going out into places like Africa, so that you can use them that as a transfer point, and you’re much more likely to get a successful shipment taking place because of the certification work that’s been done. So that can make a massive difference to how you’re moving things.

Premsai Sainathan  16:12

Interesting. So when you’re talking about all of these certified airports and the care that a vaccine needs to go through. Is it largely from the temperature perspective, or are there more factors to consider in the chain of custody?

Sue Lee  16:33

That’s a good question. Temperature is absolutely critical. It absolutely is going to be the thing that is most likely to cause a problem with actually making a successful delivery because part of that is because it’s one of the things that’s very straightforward to monitor, and so therefore you use one of the available commercial temperature monitors. There are lots of different options to do that, but it means that you can see when it gets into the site location. You take the temperature monitor out of the box, and it’s really simple for you to be able to go it’s got an alarm on it, or it hasn’t, it’s got a cross or it’s got a tick, whereas some of the other things people are not monitoring for. So some of the things which might affect the efficacy of a vaccine aren’t always a standard monitoring option so people don’t generally check for humidity, vibration, light sensitivity, all those kind of things because they’re much more challenging. To be able to monitor humid is probably the least difficult of them. You can buy monitors that also have humidity sensors if you want to start doing vibration, or whether it’s in a dry ship, or if it’s been tilted, things like that, there are less options being able to easily see that information when you get to a site location, so people don’t generally monitor for them, whereas there’s still things that can affect the efficacy of the vaccine when it gets there.

Premsai Sainathan  18:01

That’s interesting. So how are companies preparing for this challenge? Because with hundreds of touch points in the chain of custody, and you’re relying on people in the chain of custody to actually tell you whether the vaccine arrived in the right condition or not, it’s a task. So how do you see companies are approaching this problem, especially at the scale that you’re talking about, and shipping regions that they’re not familiar with, like the less developed world, parts of Asia and parts of Africa and South America?

Sue Lee  18:40

I think actually good companies are not, don’t, other than the increase in scale, are already perfectly well prepared for this, because it’s been a requirement for all of the drug supplies that have been being moved for such a long time that people have developed really sophisticated supply chain processes in order to be really clear about the people that they’re using in order to ship material, which airlines things are going in, which airports they’re going through, how is the packaging going to work? What temperature monitoring options are going to be used? All of those things, people have got it set up at a really well managed level. And a huge amount of work has been done by the big pharmaceutical companies, who are the people who are really working on vaccines, to be able to say that they have very good supplier agreements in place. They are monitoring everything that’s going on with shipments that they’re moving. So if you are looking at a particular box supply, they will know where it is and who’s got their hands on it. Most of the time, certainly at all the major touch points, they will know where it is. Lots of people are using things like GPS tracking now so that you can see where a shipment is at a particular time as it’s moving through. And those the options doing that have massively evolved. Come down in price a lot, and so that’s being used a lot of the time. And I think. Certainly for the initial COVID vaccine supplies, those are going to be such high profile things that people will be putting all their time and energy as you would want for every shipment, to make sure that there are no possibilities of things going wrong, or that those possibilities are reduced absolutely as far as possible, because this is going to make all the difference as to how everybody in the world, all of our lives, evolve over the next few years.

Premsai Sainathan  20:28

So in your experience, and looking at this challenge of vaccine distribution today, how long do you think it is actually going to take for us to vaccinate the whole world?

Sue Lee  20:45

That’s a really big question, isn’t it, and one that we really want to know. It’s interesting when you talk to people, because everybody now has read so much across the news, so everybody is so well educated, or hopes that they’re so well educated on what’s going on and how it’s going to be everything’s got massive opinions on how old this should be. And the problem is that we have no concrete answers at this stage. We don’t know when we’re going to get a vaccine, we don’t know how it’s going to do, what it’s going to do, we don’t know how it’s going to be transported, where it’s going to be going, all of those things. So I was training some people are working on a vaccine last week who were saying that, you know, it’s going to be well into next year. There’s no possibility of having anything until at least part way through next year, and at that point, we’ve got to hit the ground running. I know that there are lots of people are already planning now for how they’re going to be shipping things, even not knowing how they’re going to be shipping things, and looking at all of the potential options, trying to see what kind of materials they’re going to use to keep things at the right temperature, to see how they’re going to box them, how they’re going to monitor them, all of that stuff we’ve already talked about, and so being ahead of the game at the point in which vaccines are actually released, and they will be able to basically hit the ground running, they will have some level of supplies in order to be able to get the first shipments out straight away. And that’s going to be really crucial for us to make sure that that’s going to work in an international context, that we can actually physically move things in place, but it’s going to get to some of these more remote locations, it’s going to take a while, so my finger in there is going to be about 18 months to two years before We’ve got everybody vaccinated, which fits in with previous issues with epidemics and pandemics. If you look at the Spanish Flu of 1918 that was about two years before things began to get settled down. So I’m expecting we’re going to be operating on the same kind of timescale. The drive is there, the push is there. Also the money is there, because pharma have money to be able to spend on making this thing happen, and they’ve got support of people like the Gates Foundation, who all of these international agencies that are going to be really making sure that the vaccine is not combined into Western Europe and North America, that it goes out and it goes out across the world, so that everybody gets the advantage of having it when we get to a point where we’ve got a vaccine which worked.

Premsai Sainathan  23:25

And thankfully, I think we live in a world today which has a lot more technology, horsepower, a lot of a global perspective, and hopefully we should be able to Get this vaccine out to a lot the larger population, much, much more quicker. I have a question.

Sue Lee  23:45

I really hope so. I really hope so, because, you know, I love my family, but really I want to get out, as everybody else does, into the same world. I want to go and enjoy life as we had it before, whereas now we’re just pretty much confined. So we’re all in the same boat. Everybody is pushing in the same direction at this stage.

Premsai Sainathan  24:05

Absolutely, absolutely. So Sue. If you were to tell me with your experience the trainings and workshops that you had, with, with with with the vaccine manufacturing companies, what are the three tips that they need to most definitely consider at this point while they are planning for the big distribution?

Sue Lee  24:33

I think the crucial one is going to be making sure that they’ve got huge flexibility and how they’re going to make everything happen. So talking to lots of different transport suppliers, lots of different routing options, don’t rule out sending things via different transport modes. So a lot of the time, people’s automatic belief when they are shipping is going to be that it’s going to go on a flight. So. That that isn’t always necessarily the best way to do things. There’s a lot of really good options at the moment on sending sea freight, and a lot of work has been done in order to make sure that we can maintain temperature if things are being shipped by sea. And it will take for longer, clearly, to send something by sea. But I think everybody is going to be pushing together in order to make sure that these vaccine deliveries happen. And so exploring how the sea freight companies are going to be able to move things in, temperature control, briefers and things like that, is going to be really useful in order to try and get to some of the more challenging places. So temperature is really crucial and critical. Being really clear about the documentation that’s going to be required. So that is a really good planning point that can be done now, regardless of where we’re going to building up a database of what we’re going to need in terms of import licenses, import permits, what kind of certification is going to be required, how many temperature monitors to put in boxes, all of those kind of things, is all stuff that can be prepared for in well now in advance, and also being really clear about using things like depots in order to be able to get vaccine in to be looking at depots now who can handle multiple levels of temperature control, to be able to give a really flexible regime of getting supplies out at the right time. So if we can get stuff into depots and then start distributing out from there, then using depots can be really good way of controlling the flow of materials in and out, and being very flexible in terms of getting things into the ultimate location. If you’ve got stuff in a country and you’ve already done all the customer experience and all those things, then being able to do domestic moves in order to make the last bit of it happen is a lot simpler than trying to do an entire move. So using depots is going to be a really important strategy for people moving things around.

Premsai Sainathan  27:01

So what essentially you are proposing is that it’s time now for the companies to think how they are going to get control over the the end to end supply chain, rather than just the last mile or pieces of it, so that if that is in place, then you know you are better off with knowing which lanes you’re going to use. You will be able to assess your new transport partners better and all of that stuff.

Sue Lee  27:33

having all of those options talked about, set up risk managed, so risk assessments across the board for everything, so that we can be prepared for because we the world has changed so much, and the world is changing and evolving continuously at the moment. So the things that we think are the way that the world works may not be the way the world works in six months time or a year’s time when we start really moving things, because we don’t know how flights are going to be operating, we don’t know. We could be almost back to normal, or we could be in a much worse situation than we are now. And nobody knows. And that’s all going to depend on how the virus evolves, if it shifts. We don’t want to be in a place where we have no people to be able to physically move things about and that is a very significant possibility. So we’ve got to be flexible and adaptable and agile, all of those words that you read on logistics, supply chains. This is how you know we should be doing everything, and they all apply. In this case, we’ve got to be able to plan ahead so that we can do whatever needs to be done depending on what conditions are at that point, and none of us know what they’re going to be, which is the real crucial challenge.

Premsai Sainathan  28:47

And what would be your tips to the logistic service providers who are gearing up for this challenge?

Sue Lee  28:59

Talk to lots and lots of people, because everybody’s got an opinion on what’s going on. But we need to take all of those into account, and we need to be able to flex as logistics service providers need to be able to flex to what pharma needs them to do in order to make this happen. At the same it applies the other way as well. So pharma have got to be able to flex to what’s available and what ultimately, the supply chains that we’re in operation, the methodology that we’re going to have, we may turn to using doing everything electronically. We may end up going back to using physical paper, because we’re going into all of these kind of these kind of places, and we will be getting into these places where they are not used to having farmer shipments. It may be they’re not geared up for having electronic transfer data, things like that, looking that’s another very good thought, is looking for importance of record now that you’re going to be able to get your materials in, because some of those are going. To take a long time to put in place, and so being clear about who’s going to take responsibility for tax, for documentation, for record keeping in whatever countries you’re going to be going into, because some of these will be Uncharted and are going to be challenging to make that be set up. So if we start on that now, if that hasn’t started already, then that’s going to be a really crucial and critical point to be able to not have to start that process when shipments are moving, but to be prepared for shipments to move in advance. I think preparation is absolutely the most significant important thing that we can be ooing.

Premsai Sainathan  30:39

Great. Sue, so if I was to summarize everything that you talked about in this podcast, the first thing is that the enormity of this challenge, especially because we are shipping vaccines to many parts of the world, which have never been the Traditional large vaccines. So you are actually now working with unknown regions. You’re working with new lanes. You’re working with new transport modes to these lanes, which actually make this a challenge at an unprecedented scale.

Sue Lee  31:17

Just to add to that, they’re not used to doing lots of farm shipments. These are places where things will be moving in and out, but they may be things which have no temperature control, but they have no specific time constraints on them. And so that’s going to bring about a much added complexity which there, which may not be prepared for. If you’re going into a small island somewhere. They probably never had to deal with the temperature control farmers.

Premsai Sainathan  31:46

Absolutely so with that in context, because you don’t have that kind of first world infrastructure at all the places that you would be shipping to, which really means that the second point that you said to us in this podcast was, plan really well. Map out the map out the roots. Map out the way to get your racks in there, but also the people involved in the chain of custody and their roles. And last but not the least was, I think your point to all the supply chain professionals is, expect the unexpected, be prepared for it, and ensure that you are able to visualize everything that you have from the point you dispatch your vaccine till it reaches your final patient, in terms in terms of temperature records, in terms of Your maybe even your shipment location, and last, but not the least, is all your regulatory paperwork.

Sue Lee  32:46

Absolutely there’s one more thing that I want to add to that, which is there has never been a better time for us to have people who are physically doing the job understanding why they are doing the job, because almost everybody will have known somebody, everybody’s lives have been impacted by COVID. And so making sure that people understand the real value and the importance of their part of what’s going on will empower them to do the job in such a way that we get really good compliance, we get really good shipments going ahead, that people care about what they’re doing. And by giving people the opportunity to make a difference and for their all of their actions, to really do something very important, you’re giving them much more of a reason to do their jobs well and to understand why that’s so critical. And we get a better world out of that. And you know, you I defy anybody to come up with a better reason to do what they’re doing for.

Premsai Sainathan  33:46

I think that’s a wonderful point Sue, because, you know, the awareness, you know, educating everybody in the chain of custody is not just going to help us to address this challenge, but it’s also going to help us upskill the people who are pharmaceutical cold chain so that in the future, we are better geared to face and better navigate these kinds of challenges. So much. It was a pleasure speaking with you, I think we learned a lot of insights today, lot of which needs to be applied very quickly to this, this challenge that we have, hope so to the students that we have.

Sue Lee  34:36

Vaccine comes soon. Thank you so much for having me. Thank you, sir.

Scott Mears  34:43

Hi, my name is Scott Mears, and I’m one of the hosts of the Supply Chain Tech Podcast with Roambee. On this podcast we talk to supply chain heroes from around the world about everything, ranging from the disruptions related to supply chains, their personal experiences with tracking technologies, strategies to build resilience, and much, much more. We already have some recommended videos for you to the side of me, and if any of this sounds interesting to you, do subscribe to our Youtube channel and hit the bell icon so you don’t miss another Roambee video. I’ll see you next time.