S01 E07

Pharma's New Navigational Rules for the Age of Covid

Robin Hunter

General Manager

Mallinckrodt Pharmaceuticals

In our seventh episode, Peter Brenders, Founder & President of Kontollo Health, talks with Robin Hunter, General Manager of Mallinckrodt Pharmaceuticals, about supplying products for Covid patients in and outside of Canada during lockdown.

LIONA SANGFROID:

Thank you for downloading episode number seven of the NPC podcast from the National Pharmaceutical Congress. This is a program that's all about discussing and considering the purpose, process, and people of the pharma industry during 2020, the year of Covid. Today we're continuing the healthcare conversation by answering questions sent to us by listeners like you.

This program is presented in cooperation with Impres, Impres best in class commercial solutions drive top line and bottom line growth with maximum salesforce, flexibility, speed, and efficiency. You can learn more about their next generation commercial model at www.impres.com.

On today's podcast for August 19, 2020, our guest is Robin Hunter, General Manager of Mallinckrodt Pharmaceuticals, your host for today's podcast is Peter Brenders of Kontollo Health, coming to us from Fredericton, New Brunswick.

But first, here's Mitch Shannon of Chronicle companies. Take it from here, Mitch.

 

MITCH SHANNON (MS):

Thanks, Liona.

We're back again to talk about all those questions we have regarding the life sciences business, and how Covid continues to shake up the world we all knew.

We're ready to take your questions anytime, 24/7, just call our comment line at 647-875-9011.

You can always tell when this week's guest is about to arrive. You just need to listen patiently for his theme music. I think I hear it now.

*MUSIC PLAYS*

That, of course, is the distant sound of the hunter. Every company has faced its own challenges during the Covid pandemic. Robin Hunter's company Mallinckrodt was in a slightly different position. They have a hospital product that is said to help Covid patients. That should be an opportunity, but it was also a challenge.

Robin describes it all to Peter in this interview.

 

PETER BRENDERS (PB):

Welcome to the NPC podcast. I'm Peter Brenders, your host.

Joining me today is Robin Hunter, Canadian General Manager of Mallinckrodt Pharmaceuticals. On the NPC podcast series, we've spent some time exploring the patient and physician views of the evolving pharma world in these Covid times, and we've heard from several Canadian leaders about how their business is evolving and changing. Today, we dive into a Covid example of how pharma and its in-market products are actually making a difference for patient care in Canada today.

So welcome, Robin. Let's start with how is Covid affected your business?

 

ROBIN HUNTER (RH):

That's a good question. That's one you get most often when you're talking to somebody for the first time since Covid started and my answer is half the business was impacted negatively. Like I think most other people were, procedures being cancelled, patients couldn't get into hospitals, reps couldn't go and see the physicians.

But the other half of our business, which is the biggest part of my business, what I've been working on the last seven years, there was a time where our business tripled in one month, and we weren't certain if we were going to still be able to supply patients. We had to figure out how to get in and out of hospitals. We weren't closing our offices, we were getting people into the office, because I guess that's different, right? When you have a drug that's being used in the ICU for ventilated patients who have COVID. And then you're getting questions about research and the safety and all of these things.

I should say this is where my legal counsel and compliance officer will chime in with some sort of disclaimer that this product is only to be used in newborns by 34 weeks of gestational age and above and anything to do with Covid is off label and should be sent to medical information.

 

PB:

Take us through how Mallinckrodt has been helping Covid patients today. What's been the clamor and the requests of your company?

 

RH:

So, the product is, to my knowledge, the only pharmaceutical that comes in a gaseous form, so it's inhaled nitric oxide. That's the drug it has a bin and it's subject to every other pharmaceutical rule and regulation like everybody else has, and on label, and on off label. Comes in a cylinder though. So it's not in a vial. It's not cold chain, but it is dangerous goods.

So even your supply chain has a lot more regulations and outliers with it. A lot of the companies that typically do supply chain in Canada can't handle our product wouldn't want to put on the dangerous goods, SOPs, in order to ship our product back and forth. So there's that.

The other problem is this is a drug that can be toxic in the wrong doses so it comes with a class three medical device. And that's a completely different regulatory pathway, completely different supply chain. And it all comes with a very interesting business model. We were prepared, when Covid hit that we were likely going to see an increased demand.

So I remember when there was an email from about 40 general managers in Canada and one person started to ask "What are you all thinking about closing your offices? Are you going to do it? When are you going to do it? What do you think is your plan?" And it's good to have that network of people so we can bounce these ideas. We're only 11 people in Canada, six in the office. So it never even dawned on me that we were going to close the office other than to me, really, I was the only person going in there. And if you ask any of the staff there, they don't see me there that often anyway. So I guess there's nothing new for them.

But I had to find out a way how do you keep your office a safe place where people are going, who are working on the maintenance of your medical device and your supply chain, because without that, you can't get it to patients and we knew that the Covid accounts were going to start calling us as the pandemic hit, because they were going to try to use this product. And we've seen that in other countries and we were starting to get prepared for it.

 

PB:

So, you have a product that's going to be high demand, it's going to be needed, and it's going to bring benefit to patients and you got a system that's a bit of a struggle. What needs to change?

If you were to go back four or five months before this started, and you're going to say this system, "Hey, you need to put some different approaches in place" to help address what you guys want. What would you like to see change?

 

RH:

A lot of things from Health Canada perspective, I remember getting a call from them. They're contacting a lot of companies about drug shortages, typical drugs, you know those high volumes, we only have 40 accounts in the country, all academic teaching centers and children's hospitals.

It's not a high-volume product. It's a pretty rare disease that we're treating. They're looking to mostly the generic companies and anybody else who are high volumes and hospitals and other things like that. But they called me and I said that "yea, the drug you're probably not going to have to worry about and think I'm feeling pretty confident about that, because that supply we can always make more. Our medical device though, which is critical to getting that drug, that you can't use the drug without the medical device. We have a finite supply of those we can't just manufacture a bunch more, ship them into Canada and start selling them. There's a lot of things that need to happen. So we run out of medical devices. We also run out of drugs."

What Health Canada did is then they thank you for the information. So check mark on the drug, no drug shortage there from Mallinckrodt inhaled nitric oxide, but then they flip you over to a different department and start to talk to you about the device and what I wish that they have just had one person talk to you, right? We hate to talk to two people about the same product. So that's nothing that I could change. But perhaps when we see our health care authorities starting to do, what can we do differently? I think this might be one thing that they could have done differently.

Although I'd have to say that I've never seen government as responsive or proactive. And that's all levels, provincial and federal, as they were in this. You could get somebody on the phone the same day, by just an email in every province and federally if you needed to so. They clearly knew that they needed to be responsive to industry. So that was good. From my standpoint, changing.

Here's an interesting lesson. I don't know if anybody else had this. So, we had to start to think about disinfecting our premises. I think everybody did. And we have a cleaning company that comes in there. But I needed to get somebody that could do real industrial disinfection of our warehouse, of our device technician shop, where we do the devices, even the crates and everything that are coming back and forth from hospitals. You can imagine employees and they were asking me questions, "Robin, if we get a device that's come back from one of the hospitals and it was used on a Covid patient, what do we do with that device?" One of the questions I literally got was, "Are we supposed to burn it? Or do we just throw it out? Or is there some sort of dangerous goods?" No. So we have to answer all those questions. And there were things that, you know, some cases we had SOPs in place for, but in this case, nobody had an SOP for Covid.

So, we had to adapt some of the old ones, be ready for that. We hired a, what I thought was a professional sanitation company, I thought I'd do an upgrade on our regular cleaning company. And they came in without any masks, any PPEs, any proper equipment. We all left, they hung around for about 40 minutes, and then they left without doing anything.

Now luckily, we have cameras and we were able to spot that, so we ended up having to fire them and then source another company to do this. And we were probably about three weeks late on our disinfecting that we wanted to do and again, my employees were worried "Can we come into that office? Is it going to be safe?" and without those four people I had working, we had no devices that we can deliver to these hospitals. So a lot of learnings and things that I'll do differently. I'll have all these things ready to go by the next wave if there is one, but stuff that you didn't think about before.

 

PB:

You're listening to the NPC podcast. Our guest today is Robin Hunter, Canadian General Manager of Mallinckrodt Pharmaceuticals.

Let me ask you another question. You talked about sort of the potential challenge you could have in medical devices. And it's nice to hear that the regulator is listening and is trying to be responsive in that space. But it must be a challenge as well within your own corporation.

How do you keep Canada on the radar and a priority in that space when the world is increasing demand? Do you have any stories you can share in that space?

 

RH:

The US, as you know, is getting hit a lot harder than we are. So, they got probably hit in the northeast earlier than we got hit here in Canada. So, there was a point where they were struggling to meet demand. And our demand hadn't quite started at the peak here in Canada yet, so we had to make a decision. I remember I was actually on the phone call with, I think was another group of GMs for a different topic, but similar to this and I got another text come in and we had an account in Canada that wanted us to set them up so it's difficult to set up an account because Health Canada requires that we do face to face training of everybody that might use this device. We had to figure out ways obviously we couldn't do that we have to figure out virtual videos to do this.

But the bigger issue was if I sent a couple of devices to this small account in not rural Ontario, but rural enough, would I have enough to then supply Vancouver Calgary, Toronto, Montreal, Halifax, etc. And all of our existing customers in the children's hospitals because babies weren't stopping being born sick. So, we had to make sure that they had that. At the same time that I got a request from the US because they were hit and saying, "Rob, you have extra devices in Canada that you're not using, can you ship them back to us? Because we need them in the US." And so I found myself having to make decisions on who's going to get this product and who's not because we couldn't supply everybody. And one of those customers I had was my own company in the US who luckily as of April 1, I don't report into them anymore, I report into International, so that made my decision a little easier. I actually had to make those decisions.

I know I was losing a ton of sleep probably all of April into the middle of May trying to make decisions like that, where you would go, we managed to ship some of our devices to the US, some that we couldn't use here, actually. So, they did some remanufacturing and were able to use some there, they did some work for us and sent them back. So, we actually ended up finding a different way from the supply chain that might help us in the future and efficiency there. We had to say no to some accounts. So, some accounts that wanted to set them up. We said no to them, other ones that we said yes to have yet to use our products. So, it was a waste of money and time setting them up.

So, a lot of learnings, tough decision makings, decisions I didn't like to have to make, I guess that's why I get paid the small bucks. It's one of those things that you hope we won't have to go through. But we're going to have to go through it again the next time. And what I had done is reached out to the Ontario government I didn't get a real good response on this was, I knew they were starting to designate Covid centers. But I thought well, if I knew who those were, then I could probably proactively ship our product or at least direct our product to those places that need it in advance, so that's what we're going to try to do for, let's say, November to March. Where outside the big teaching centers will be the Covid centers, and let's make sure that they have the product because we're only being used in the sickest of the sick.

So, some of the more community or rural hospitals, those patients are going to get shipped to the bigger places anyway, so we didn't need to set them up. So that was learning there. It'll help me with my decision making.

Like most people don't know that we exist, or what we do, right, they were reaching out the ventilator companies, PPE companies, anybody else that had a drug that was in the news that could potentially be used to treat Covid patients. So, all of those types of things they were looking for, but nobody was reaching out to us because they didn't know that we were probably going to be used there. And there were some hospitals who never did use us because they didn't think the evidence was there. And then there were some hospitals who were super users. And we'll see those results are going to get published. Well, time will tell if it made a difference or not.

But it was very interesting in the time so yeah, but maybe because it's just me, I don't have a Government Affairs Department. And as you know, Peter, you've had this when you're a GM of a smaller company and in somewhat early stages, you do a lot of different things yourself. And I particularly, I would say, I don't do any of them particularly well anymore. And I guess that's the definition of general in General Manager, you do a lot of things and nothing particularly well. So I probably need to do a bit better than the government affairs side of the job.

 

PB:

You're listening to the NPC podcast. I'm your host, Peter Brenders.

What advice do you have for your peer companies that are gearing up to bring a Covid-19 related treatment to Canada? What counsel are you giving them?

 

RH:

You know what? My guess is that they know better than I do right now, because we had one that was in market.

If you're one of those companies that is going to have some sort of treatment device or drug then you might want to reach out to the government now, not just Health Canada for your approval pathways, but the provincial governments so that there's some way that you can expedite if you have supply issues, like we almost ran into is to make sure that you're directing products to the places that need it the most and also letting people know that you actually have something that could be of use. Like anything else, and you need your clinical support.

And what I thought you were going to ask is, what are some of the leadership lessons that you have in the time of Covid? Because

 

PB:

That was my next question!

 

RH:

There's some podcasts that have already talked about this. I've seen articles, you've seen articles all over social media, in the paper, right? Just this is a worldwide issue. So, everybody's telling me “No, how do you lead? What are the best leaders doing?”

I found, at least for that six weeks, I was too busy to do any leadership at all. My sleeves were rolled up and I was doing work, different work from what other people were doing. But I was in less communication with my team. We weren't having town halls, I mean, I had some touch base on supply chain and a lot of calls with internal organization just to make sure that supply chain was happening and the critical business was going forward and the non-critical business was on hold. So, I was doing a ton of that.

But I think the test of leadership became in what you did beforehand that when you're in a crisis, by definition, you're probably too busy, maybe to be leading. You got to pitch in and help, there is just too much work to be done. I mean, if I was having to pack crates or tape up things or load boxes on a truck, now I didn't, they didn't want me in the office. But I would have had to have done that. But there were other things I needed to do.

So, I think, you know, when people are starting to talk about working from home or remote working, or this new culture that's happening, we always had that. Everybody in my company was allowed to work from home or from wherever they want, I can't stand working from home anymore.

So, I like to use the term work remotely from a coffee shop, or your gym or a restaurant or somewhere that's not home where the dogs and kids aren't maybe running around. But if you have that culture in advance, and if you have to put policies around them, I always wonder if you have the right culture anyway, so you’ve got to trust your employees. And then within that six weeks to three months, where I had the least interaction with my team that I had to trust them the most.

And so back to that supplier example, who obviously I couldn't trust. My team, not only could I trust they were actually stepping up, but they were finding out ways to do virtual education. They have to get into some of these hospitals to help do what we call a device switch out or some routine maintenance. And so, they have to take, at the time they didn't know, but they were taking personal risks to their health and to their family and asking themselves. They weren't asking me for permission, I put a little bit of guideline, but I said, "Look, you guys can make this choice. Here's what we have to have happen, here's what would be nice to be happening. But you already know what needs to be done here. And if you're willing to do it, then that's great. If not, we'll figure out a way around it."

And so, the team was just so self sufficient, able to make decisions on their own in the moment and do their job and other jobs at a higher level that I didn't need to lead them during that time. Maybe that's what we're trying to strive for. Right?

 

PB:

Any little hiccups in terms of trying to help patients in Canada today?

 

RH:

Yeah, two words: Donald Trump. Every time that he tweeted or anything like that we had troubles. We were worried about whether a product was going to make it across the border. So, I mentioned about those devices being shipped into the US for their use. And then they were going to Madison, Wisconsin where our big manufacturing plant is, they did some relabeling, re-manufacturing and shipping them back to us and they got stuck at the border.

And then you would think anything that says medical supplies or medical this was going across. But remember, trade wasn't working that easily. It was supposed to be. Some things were coming across in 24 hours that we were expecting in two weeks. But in this case, one shipment didn't make it across the border.

Now, luckily, that one wasn't urgent. But it was an example because usually all of the shipping we were doing was between a different area. In the US, this was the first time they were shipping something directly out of that area in Wisconsin and they didn't label it the way, because they had just labeled it the way they usually do. They didn't think about it. And they only distribute in the US, that was the first time they were distributing to Canada.

So, there's an example of "Oh my goodness, thank God, we didn't need those things right away, because that could have been catastrophic." You don't think of everything? We'll think about that the next time for sure.

 

PB:

You've been listening to Robin Hunter, Canadian General Manager of Mallinckrodt Pharmaceuticals, giving us some real time lessons on how pharma is today making a difference in the lives of Canadians with new products.

 

MS:

That was Robin and Peter and by the way, the unedited version of that conversation continued on for about another 17 hours.

If you enjoy listening to industry experts who are passionate about the pharma business, you'll want to hear every episode of this series. So, make a point of downloading the NPC podcast from Google Podcasts, Apple iTunes, Stitcher, and other leading sources. Better yet, subscribe at pharmacongress.info and never miss an episode.

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The NPC podcast was presented in cooperation with Impres, Canada's next generation commercial partner. Learn more at www.impres.com.

In Toronto, I'm Mitch Shannon of Chronicle companies. Jeremy Visser produced this episode. The announcer was Liona Sangfroid.

Have a great week and stay safe.

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