Sam Tarantino 0:02

Welcome to The Pharma podcast, conversations with industry experts and business leaders about important and current topics in Canadian pharma, biotech, and Med Tech. I'm your host, Sam Tarantino. Today I'm speaking with Deborah Brown , managing partner at Accelera Canada. Accelera Canada is Canada's premier consulting firm offering end-to-end advice and services to emerging companies wanting to bring their new medical innovation to Canada. Deborah is one of Canada's most experienced general managers with close to three decades of industry experience, both domestic and international. And she's an amazing person overall. In this episode, Deb will share her insights on how to optimize one's approach to planning a market entry in Canada and the commercial options that emerge from that analysis -- and the pitfalls to avoid. Welcome to the podcast. Deb, for the audience, tell us , briefly about yourself and the professional journey that led you to where you are today.

Deborah Brown 1:05

I went directly into a pharmaceutical career from my scientific studies and I started in the technical area of the industry. So I was analyzing clinical trial data in a little cubicle when I started. And then I moved on to domestic and international regulatory. I worked with local R and D and it was when I was doing that, I got a lot of exposure to the other functions in the company. I decided that I was interested in the commercial side of the business. I did an MBA and subsequently moved into marketing business unit management, general management. And, then I held some international or regional VP or executive VP positions around the world. And from there , after about two and a half decades of working in the industry , I wanted to do something new and I wanted to parlay my experience, leverage my experience and understanding a lot of the breadth of the functions in the company. And then as a general manager having oversight of those functions as well. I wanted to parlay that into working with new companies that wanted to come to Canada and help them bring, you know, new medical innovation into the space as, as efficiently and as effectively as I could.

Sam Tarantino 2:22

Deborah what would you say is the first thing, the most fundamental thing a company should consider, before entering the Canadian market? Well, I'm talking first and foremost about international companies here. So not a large multinationals that have an affiliate in Canada. So if we're thinking about, you know, US, European, Asian international companies who are coming first for the first time to Canada, my most important piece of advice I think would have to be, don't be penny wise and pound foolish. As my grandmother used to say. Um, a lot of incredible rigor goes into working on and developing their primary market like the U S like Europe or Japan for example. But it's amazing to me how often , companies can fall down in terms of their approach to the Canadian market. So I really believe that, and I know that an early investment in a rigorous analysis of the landscape, doing a market evaluation, really thinking out your Strat plan and the different ways you could approach the market will save you so much money in the longterm and really predict your longterm success in the market. Deb, can you elaborate what do you mean by a Penny wise Pound foolish.

Deborah Brown 3:43

What I mean by that is Canada is a top 10 pharmaceutical market. It's number 10 in the world. It's worth billions of dollars in the market. It's a sophisticated and complex market, that requires the rigor, the same kind of level of rigor that you would approach the European market with the Japanese market or the U S market as examples. And u h, and it's worth really applying that rigor because although it's a complex and relatively small market, as I said, it's a top 10 market and it presses above its weight in terms of international medical practice and in terms of how lucrative it can be. U m, so we always say to people, it's really important to invest early to make sure that you scope out your approach to the market and the market evaluation before you actually start doing things.

Sam Tarantino 4:35

There's a real desire to start doing things, you know, because people procrastinate and, and it , it time starts going by and then they panic and think, Oh my God, the first thing I need to do is hire a general manager because I don't know how to approach the market. And that can be absolutely the worst thing to do. What about the infamous , uh , the one 10th rule? Yeah, well a lot of, so there's a lot of approaches that people take if they're, in my opinion, sort of cutting corners and that is okay. We've done a lot of research, for example, in the U S market divided by 10 as a rule of thumb because of the population size and you'll have an estimate of the market. I think that falls apart almost right away when you're looking at the pricing disparity , uh, in a lot of products between the U S and Canada. So in my experience, only rarely does the rule of one in 10, 10 apply. The other approaches are , um, you know, we have some, we have , uh, people in our analytics team that have done some work or know a bit about the Canadian markets. They'll , they'll , they'll work up numbers using either an international plug and play model or their own forecast model and try to come up with some very high level numbers. And what I've seen when that happens and people think, Oh, we've got something reasonable. They , they're feeling pretty good about it and still they till they bring it to the executive committee and they have to defend their approach and their investments in Canada and it pretty, it becomes pretty clear very quickly that , um, they don't ha they haven't got all the information they need to underpin the analysis. Deb, why do you think so few firms are willing to invest in a , in a comprehensive market analysis?

Deborah Brown 6:15

That's a great question, Sam. Um, I , I really think that with the companies that we primarily deal with, I understand it very much. I've worked in the U S market, it's the or, or the European market. Your primary market is so overwhelming and the focus is so critical when you first launched that most of the cutting edge companies that we're working with bringing new innovation , uh , have a skeletal infrastructure at this point. So the resources that they have are largely focused on their primary market, wherever that is. And there's, there's , um, you know, they're, they're struggling, they've only got so much financing and they're, they're focusing on their primary market and it's, it's a difficult decision , uh, to make an investment in yet another market that they know little about at the beginning. Anyway.

Sam Tarantino 7:03

What about the , uh, the conundrum that , uh, that we all face - affiliate versus a strategic partner versus just an outright out licensing? What do you think of that?

Deborah Brown 7:13

Well, that's one of the reasons why we say Pennywise and pound foolish. It is a , where I say it at that is I think the most important thing you can do is to two things is is do the landscape analysis, really get a a depth of understanding of what's going in the market on in the marketplace and put in all the inputs that you have to for market access, regulatory, et cetera, to come up with a market evaluation and based on that market evaluation, there's a number of different ways that you can come into the market and we're seeing a lot more creativity in the last, you know, 10 20 years than we used to see in the old days it was a, I have a product, I'm going to set up an affiliate in Canada and I'm going to carry on that way it's going to be a branch or an affiliate of a multinational or a branch office.

Sam Tarantino 7:57

And now we see, especially since there's a lot more rare disease drug coming in, niche drugs coming in, that there might be some gap before the next product in the pipeline. And it's a relatively small product, although a great product and those rules don't necessarily apply because the infrastructure costs of running that niche product. Um, you know, even a skeleton team is two and a half million, let's say probably 3 million. And so people are starting to look at the options of should I partner with somebody locally in Canada? Should I take on a strategic partner? Should I fully out license? Uh, or sometimes when they partner, they partner for three years and take the brand back or three to five years or set up an affiliate. There's, there's a lot more options and creativity being applied today than there used to be. And which I think is great because there's a lot of, there's a lot of implications to that choice. Um, tax implications, revenue implications , um , your whole P andL is a ffected by that first decision. And if you jump in and hire a GM before you've thought that through a , that's going to be a very expensive mistake. Do you think there's a, there's there a rule of thumb that you , uh, that you follow?

Deborah Brown 9:09

Uh, well, I, it's my own very personal rule of thumb. I think everybody's number would be a bit different, but I always look at it and I know those of us who have been general managers in the business, both for smaller products and large products in Canada, you pretty much can very quickly know this is how much it would cost for a basic infrastructure or a more substantial infrastructure. So even if you have a small product, if your revenues aren't peaking at at least $10 million, and many companies would say it should be 20 at least, but I've run things in a frugal way, in a creative way. So I understand that you could do it for 10 million, you really should be looking at other, other , um, you know, alternatives then setting up your own shop, unless you've got a whole portfolio coming before behind it. And it's an investment. It's strategic investment to build your corporate brand up front .

Sam Tarantino 9:56

Yeah, I would imagine if you partner with a , with an existing , uh , you know, pharma company, a local partner here, you're, you're, you're going to be splitting your profits. Uh, which would , uh , dilute the investment overall. Do you have any thoughts on that?

Deborah Brown 10:09

Well, I haven't, I'm not the biggest fan of that option. Um, I have either helped companies look for that or been in that situation myself when I was in the corporate world. And , uh , another rule of thumb that we use is if you're partnering with somebody, so you're both actively involved, whether it's a co-promotion or co-marketing or whatever your arrangement is, is that it takes 40% more management time to manage that collaboration. And of course your profit sharing. So, you know, probably best case, you know, the , the originator is ending up with 60, maybe 70% , uh, and giving up a good chunk of the profit for some, for some shared investment in all the rest of it. But it's also taking a ton of management time. And if you're a small company already that's struggling with infrastructure and then you have to manage a partnership that can add a lot of complexity.

Sam Tarantino 11:00

Do you , um, do you have any examples of any , uh , of a creative partnership with a smaller niche company that you've , uh, you've seen?

Deborah Brown 11:09

Well, I could think of several examples. I probably, I won't share those because I was involved with those that who , who the, who the people involved are. But I can certainly think of a , of a few examples, as I said, of companies that had a product or a small basket of products that was worth five to $10 million who looked at, Oh, can I look at a contract sales force ? How should I do this? Should I give it to a big pharma company and found an arrangement where they could , uh , launch and then carry a, in their basket, another company's product for three to five years to, you know, to bolster their sales force. So they had more things to talk about. Some of the cost was shared and then at five years, that company comes into the market with their second product. They hand it back. Everybody's had a good arrangement that that can work quite well. If you hand over, in my opinion, hand over the reins to a really good partner in the , in the market.

Sam Tarantino 12:07

Yeah . I imagine that's why you need both a , uh , an upfront market analysis, but also tie that in with a business plan so that that transition, that longterm transition is, is laid out that you have, you have a beacon to follow.

Deborah Brown 12:22

We really think that there , especially if when you're new to the market, doing a brand plan is completely insufficient. You need a corporate plan. You're absolutely right Sam. I mean it's what is your longterm vision for this company? I mean globally and locally, what are you trying to achieve? And based on, we ask a lot of questions when we work with clients, what is that you want to achieve in five years and in 10 years? And based on that, that will help to just direct , uh , not that market evaluation, but maybe some of the decisions that they in recommendations we would make related to that management preference is still an enormous thing in, in the industry. You'd be surprised, even despite the amount of rigor we put , uh , against analysis, there's strong management preferences in the cultures of the country

Sam Tarantino 13:06

There's so much more to consider as well when investing right. H ave your tax liability, your employment liability. There's, there's a lot to, to, to consider. So what would you say, u m, how should someone put this comprehensive market analysis together and what advice can you, can you give the audience? Well,

Deborah Brown 13:27

I actually like to touch on some of the ways people do approach it and perhaps how I would recommend they do instead. Um, so as I said earlier, some firms do in house projections and they come up with a very, you know, raw number. They discuss it in their commercial operations team, they bring it forward and they move forward. They hire a GM in Canada who then turns around and hires a VP of marketing or a head of marketing and a commercial operations person and an men . And then they turn around and hire all the consultants they need to actually answer the questions. And before you know it, you're in for two or two and a half million dollars and you still haven't answered the question, you're six months. What is this market worth and what is our plan? So I would not recommend that in at least in that order. Um, alternatively, they might hire a U S or international provider that's not based in Canada. Do one of those plug and play models that um, that is used. And I think that could be very helpful at the front end, high level when companies are making clinical trial decisions and investment decisions. But not when you're talking about how should we actually enter a market. Um, you know, the old rule of, you know, one in 10 that's, that's developed internally as we talked about already. And then the one that bothers me probably the most is when people say, well, we need some expertise, so we're going to hire a lot of different people from Canada. Somebody in our office knows somebody in regulatory in Canada, someone else knows somebody who runs a legal firm or works in legal , uh , communications, market access, 3PL, HR, you name it. And then you take a team, let's say they're European based who's already very stretched, just launched their product potentially in Europe. They have very little management bandwidth and then they're trying to manage like seven or eight different agencies in Canada. It's a nightmare. It's a nightmare for management. But more importantly it can be very difficult because then you have all these different pieces of advice is advice that aren't being woven together and particularly put into the corporate plan, the brand plan and , and the market evaluation in a cohesive way. Like we , we work cheek to jowl and we put together a market evaluation where our market access people and our advocacy people and everyone is feeding information into that plan and those numbers.

Sam Tarantino 15:44

Yeah, you need that, that uh, the, the conductor to , to , to bring every , uh, every , um, every discipline together because if not , um, things get missed. Right. And the individual components just don't jive together as part of a cohesive strategy.

Deborah Brown 16:00

That is why I've always been a fan. Uh, you know, I , I sound like I'm dissing the idea of hiring a general manager. Not at all. You absolutely. If you set up in Canada would want a general manager, if you run your own subsidiary, the general manager is that conductor. If you're hiring a firm to help you prepare for, you know, those investment decisions in Canada, you need a conductor in that case too . Um, and I think that's the person who brings it all together and, and, and make sure that you're putting all the right elements in and they're basically defacto your eyes on ears on the ground to make sure that things that are happening you're informed of. So we really think that's important. And the reason I want to stress that it's important to have an integrated advisory group up front is that the prelaunch period is so critical. Um, I Q V I A did a study years ago that showed that your longterm success in the market can be easily predicted , uh, by your first three months performance, which, which tells you something very clearly. It's all in your prelaunch decisions and preparation. That's where the secret sauce is. It's not the great talent that you hired and what they do after you launch. Of course that's important. But it's that upfront planning and having the right integrated approach to make the right decisions and then everything falls into place very well.

Sam Tarantino 17:19

So how could a model like Accelera help , uh, help clients?

Deborah Brown 17:24

Well, we think, you know, this is the reason when I, when I left the corporate world and wanted to do something like this, I really didn't even for a minute consider hanging up my own shingle. Uh, because I'd seen so many people do that who would become, who had been presidents and then hung up a shingle and were sort of a GM for hire, which a GM for hire . It can be very helpful, but they're only as good as the, as the experts they're working with. And I think it's, you know, we built Accelera around the model of saying that you need the conductor but the conductors , nothing without, without the orchestra, right? So you need, you need everybody to be working together and to provide the best product overall that you can. So that's why we developed a model where we have, you know, A to Z in house, commercial functional experts, market access, communications, advocacy , uh, you know, everybody's lined up all the market insights and analytics. And then we have former presidents and general managers who are conducting that orchestra basically for clients.

Sam Tarantino 18:26

Yeah, I find my experience that , uh, the , uh, the GMs that come from big pharma aren't necessarily the , the ones best suited to run a small startup. Uh, and I say that because when they're with big pharma, they have huge billion dollar infrastructure behind them. Someone's taking care of regulatory. It just happens. Someone takes care of a quality. It just happens right now. It's you, right ? You're on your own and there's a shoe string budget and you need to have those competencies to understand that it's not just sales and marketing, right? It's, there's a huge infrastructure that's behind you that makes it all work.

Deborah Brown 19:06

In fact, we , we often advise clients, we say to them, number one, we're happy to help you , uh, find people in Canada because it's, it's a pretty small market and we tend to across our team, have a , have a pretty big Rolodex. We understand who's who and where they've worked. And we know there's a, there's a fantastic roster of talent in Canada that is ready to move up into general management or president positions. And in most cases, I highly recommended that. I recommend that because they're eager. They've got a fire in their belly to do it. They've come straight out of, you know, hopefully multiple functional areas. So they've been right up at the rock face recently. Um, and they're not afraid to roll up their sleeves. As you say, Sam, you know, if you say you've got a $3 million budget, they're okay, I'm going to move mountains with this $3 million budget. I'm going gonna , I'm going to make it happen. And this is a legacy building from my career and I'm particularly delighted that I meet quite frequently for coffees or lunches. I could go every day if I wanted. Uh , with , uh, women , uh, younger women that are coming up in the industry who have been commercial operations directors, marketing directors, you name it. And uh, they're ready, they're ready to move up. And I see a lot of hires of a very talented young women now and I'm , I'm excited about that.

Sam Tarantino 20:23

Couldn't agree more. So what are some of the common mistakes that you've seen?

Deborah Brown 20:28

Well , uh , we already talked about the higher, the higher the GM right away without due diligence. Um, so try to avoid that , uh, situation because the costs Mount quickly. And before you know it, you're , you're , the decision is almost taken out of your hand and you're spiraling into a fed a complete in terms of what you're going to do. I would, I feel the same way about a hiring , uh , purely a 3 PL agency up front or hiring a regulatory agency in isolation of anybody else. I mean, not so much regulatory. Sometimes you've got to do that work early and get some early advice, but it's amazing how many people panic because they need, they've heard they need a drug establishment license and they go to find a 3 PL provider and next thing you know, they've sort of committed all of their, the work or some of the services with a, with a company there and they haven't stepped back and done really a full commercial analysis of what they need to do.

Sam Tarantino 21:20

Do you find there's a, there's like a panic that sets in? Yes, Canada, right ? All of a sudden DEL hire GM.

Deborah Brown 21:30

you know what Sam, I understand it because people, you know, sometimes people in the Canadian market can say, I don't understand. I sent them an email, you know, three weeks ago and nobody's responded from the U S team or the European team. And, and yet when I worked in the U S I worked in Boston and I oversaw the Canadian business at the same time, I was so preoccupied and consumed with this, this huge thing that was this opportunity in the U S that literally what I did for Canada, I did between 11:00 PM and 11:15 PM at night, you know, that's how much energy I had left. So it happens very organically. They don't intend to do that. But these decisions get pushed forward as things happen in the U S and then all of a sudden it's like we've had several cases where people have called us and said, Oh my God, we're going to have approval and you know, three months and what are we going to do? And it's like, Oh well, you know, we can, we can, we can work with that. But there's such a missed opportunity in that in terms of market preparation. So I think that to me, one of the key things that I would say a common mistake is, is that the panic is , you said, Sam, they, they decisions are procrastinated and then made late. And made with inaccurate data or in, in um, insufficient data. And then you miss this prelaunch period. And the reason why it's so critical, I mean it's critical in all markets, but in the Canadian market, especially with a lot of the small specialty products that we work with, you know, we have a center of excellence model for those specialty areas in Canada, the way we operate very like a European model. And, and so you often have situations where, you know, 20 to 30% of the key thought leaders or clinicians are prescribing for 70 to 80% of the patients in , in a complex chronic disease model. And so getting to know those, that that market, those people, the allied health professionals that all support that is so critical to making the right decisions. And it's really about listening and learning and understanding. And you can't do that after you launch very effectively. You really need to do that up front . So doing your analysis, figuring out what you're doing and whoever is going to be handling the market for you, whether it's yourself or somebody else getting those feet on the street, you know, a year and a half before you're launching will cement your market afterwards.

Sam Tarantino 23:47

So, Deb, can you touch on why , um, it would be so important to have clinical trials in Canada?

Deborah Brown 23:55

Well, when I first started in the industry, we were, we were lucky. Canada definitely pressed above its weight . It had a sophisticated infrastructure to do clinical trials. So defacto we got, you know, way more than our two point something percent that we should have of world , uh , you know, population in terms of clinical trial participation. Uh, but that has shifted tremendously in the last 20 to 25 years and fairly, I think as you know, the BRIC countries have come onto the scene and other pharmaceutical markets have grown. As I said, Canada is still top 10 and participation in clinical trials is enormously important. It just, you don't always have that leverage , uh, as much as you used to is what I guess what I'm saying. So when you have it, that they're the first people you go to and listen and learn from , uh , if you don't have, if you haven't benefited from the clinical trial was also done in Canada for the last five to 10 years, then even more so you've got to focus on your prelaunch period and really , uh , get out there, meet the key thought leaders and understand what they're thinking and how your product might fit into that.

Sam Tarantino 25:01

So it's not just the prelaunch, you know, post , uh , you know, preapproval, but it's, it's thinking about Canada in the development stage, getting key opinion leaders engaged fairly early on in your product. Right . So that , uh, that we can tap into those into their expertise and uh, and become a , and have them become really your, your champions down the road.

Deborah Brown 25:27

Absolutely. It's one of the first things that I would ask a company when I work with them. Do you have any cadence meetings , a Canadians on your global advisory board? Do you have a global advisory board? Uh, you know, which studies were done in Canada and how many people and how many patients and how disparate in terms of geography, where there you just, that's part of the landscape analysis, you know, where do you already have some uptake and sometimes it's not clinical trials, sometimes some amazing work has been done in Canada on pharmaco epidemiology in terms of your brand , uh , there's other ways, radiology for example. So we look for those pockets of people who've had experience with the early development of your product and can speak with some authority about it.

Sam Tarantino 26:10

Yeah, I find , uh , you know, when we talk about centers of excellence, KOL centers of excellence in Canada , uh, sometimes we get pigeonholed into the U S model and that's, that doesn't apply. The Canadian model for center of excellence is very different.

Deborah Brown 26:25

Uh, yeah, I've, I've seen, I've seen both. I , you know, in, I worked in multiple sclerosis for many, many years and for decades actually, and I worked in both the U S and Canada , uh, working in that area. And I saw , uh, I saw a lot of overlap there in terms of the what was offered in a core center. But the difference was more what I pointed out that, you know, 70% of the patients in the U S were being treated by community neurologist in Canada. 70% were being treated by clinics where they had integrated expertise, physios, OTs, et cetera. It's a very different model and you have to, you have to approach that with a different level of sophistication and a different kind of, you know, account representative. You really have to think that through. So Deb, in a , you know, as we wrap this up, what , what tips can you, can you offer someone considering a, a market entry in Canada? The thing that comes to mind right away is , um, things like, you know, your talent is absolutely critical. We've already talked a lot about market preparation, so I don't have to reiterate that, but then we move on to the people and um , just be aware, be aware if you're coming from Europe or the U S that employment legislation is different in Canada. Don't assume it's the same. Um, it certainly was a wake up call for me when I worked in the U S at first that severance packages are totally different. The expectation that you can remove someone quite easily is, is prevalent in the U S but certainly doesn't apply in Canada. And it's not something to be afraid of. It's just something to be aware of. Work with , uh , someone who's going to develop good employment contracts for you and be aware of what your obligations are around that. So , um, so yeah, be aware that that's different. And similarly, the compliance world is different in Canada. And uh , I'll give you one or two minor, you know, specific examples. A lot of people are familiar with the direct to consumer differences in promotion, whereas in the US you can have ads for your drug and people magazine and certainly you're not able to do that in Canada. There's very strong restrictions in terms of, you know, your drug and its price and its name. Basically. There's a combination of things that you can put into the consumer world, but , um, but certain combinations aren't allowed. So it's very restricted in Canada. Um, and in terms of let's say advocacy , um, advocacy is, there's a lot of similarities between the U S and Canada, but I know I'm in the U S it's devolved really, at least by the time I left when we wanted to work with a patient association, it was becoming much more that we were getting a folder that said, here's the eight things you can sponsor this year. You choose and send us a check or dote. And um, the opportunity to really collaborate with them based on compliance rules had really changed over the years that I was there. Uh, in Canada of course we have lots of , uh, regulations around that and guidelines, but we still have more of a collaborative culture here. I think in terms of being able to work multiple companies appropriately with patient organizations, enlight groups. And it's particularly important in Canada because public reimbursement in some therapeutic spaces is an essential element of your product mix. And you need, you need patient advocacy in order the voices from the patients in order to make sure that that actually happens. There has to be a , a strong voice out there. So be aware of employment, legislation, differences, the compliance environment. I tell people when they come, be aware of the different options that are available for you in terms of the self regulated market, in terms of compliance and decide who you are and who you want to be in five to 10 years and then conduct yourself accordingly. So that's an important decision to make up front . Um, I also said earlier that in terms of your hires, a lot of people think because they're not hearing Canada, it's so far away, they have to get executive recruiters and there's offering good, you know, that's a can be a good choice. But there's a lot of other ways to , to recruit good talent in Canada that are cost effective. And I would suggest you lean on the advisors that you do have in Canada because as I said, they have a great Rolodex and they can help you. It's essentially no cost. Um, at least introduce you to some really good people that you can talk to.

Sam Tarantino 30:48

Deb , thank you so much for your advice. You're welcome. I can , you know, we could talk forever I think, but uh , but we do have to, we do have to keep this podcast somewhat short. So how , um, how can, how can our audience connect with you Deb. well , uh, you can uh, check us out a wwwdotAcceleracanada .com or our LinkedIn page, which is also Accelera Canada. Uh, you can reach out to me personally. I'm always happy to hear from anyone at Deborah.Brown@Acceleracanada.com uh, or drop into our office in Toronto at two 19 Dufferin we're always happy we did three village people to in Liberty village every village right off the , uh , exhibition stadium. That's right. All right , thanks. Uh, thanks a lot Deb. Uh, I should also mention contact details for Deb are also available on our website at thepharmapodcast.ca. Thank you for listening. Please subscribe and follow me on LinkedIn to stay up to date on future podcasts . This podcast along with the transcript of the show can be found on our website at thepharmapodcast.ca. Thank you to our sound engineer, Errol Francis and the town of Oakville for providing the studio. If you'd like to be a guest on this podcast or if there is a topic we should cover in future episodes, please connect with me via LinkedIn.