ChalkTalkJim: Breaking Down the Game - A Guide to the Future of Healthcare

From Startups to Success: Navigating Rare Disease Drug Commercialization

March 08, 2023 James Jordan Episode 3
From Startups to Success: Navigating Rare Disease Drug Commercialization
ChalkTalkJim: Breaking Down the Game - A Guide to the Future of Healthcare
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ChalkTalkJim: Breaking Down the Game - A Guide to the Future of Healthcare
From Startups to Success: Navigating Rare Disease Drug Commercialization
Mar 08, 2023 Episode 3
James Jordan

Launching a successful drug takes more than just a brilliant idea - it takes a village of experts. 

In this episode, Peter Shadday, Chief Commercial Officer US and Global Head of Marketing Specialties at Zambon shares his insights on the commercialization of rare disease pharmaceutical products in the startup space. Peter knows firsthand the importance of patient support and health economics to develop a successful market access strategy. He also sheds light on the challenges in the rare disease field, from navigating the complexities of clinical trials to overcoming regulatory hurdles.

Tune in to this episode to learn from Peter's experiences and gain valuable insights on drug commercialization in rare diseases. 

See More ChalkTalkJim Episodes

Get more information on Healthcare Data Center.

Show Notes Transcript

Launching a successful drug takes more than just a brilliant idea - it takes a village of experts. 

In this episode, Peter Shadday, Chief Commercial Officer US and Global Head of Marketing Specialties at Zambon shares his insights on the commercialization of rare disease pharmaceutical products in the startup space. Peter knows firsthand the importance of patient support and health economics to develop a successful market access strategy. He also sheds light on the challenges in the rare disease field, from navigating the complexities of clinical trials to overcoming regulatory hurdles.

Tune in to this episode to learn from Peter's experiences and gain valuable insights on drug commercialization in rare diseases. 

See More ChalkTalkJim Episodes

Get more information on Healthcare Data Center.

Jim Jordan Peter Shadday


Welcome to the Chalk Talk Jim Podcast, where we explore insights into healthcare that help uncover new opportunities for growth and success. I'm your host, Jim Jordan.


Our guest today is Peter Shadday. Peter is a chief commercialization officer with global experience and he has both large company and startup company experience, but I'll let him tell us these details. Peter, welcome. Tell us a little bit about yourself.


First of all, a pleasure to speak with you today. And I'm Peter Shadday, I'm a Chief Commercial Officer, someone with a long experience in commercialization of pharmaceutical products across several different therapy areas. In addition to this, I have worked in the US, but also in many markets ... US, all around Europe, Latin America.


So as it relates to where you fit into the healthcare continuum, your experience is in biotech and drug companies. Peter, what therapeutic areas have you worked in?


And I would say that in the last couple of years, I have worked more in the rare disease space, particularly in respiratory disease products as well as drug-device combinations. But my first steps were in large companies, like many people, I did my schooling at Novartis and various countries and various marketing and sales roles and then progressively moved into biotech at Gilead Sciences, Lundbeck, Vertex, and then was attracted by the startup world and decided to roll up my sleeves and join a startup as the first commercial employee, which then led to a very successful acquisition by Zambon, an Italian family-owned business. And I think that is really kind of the area that I enjoy the most, is this kind of early commercial opportunity to come into organizations to build a commercial vision, and then also to bring in a cross-functional commercial team, and to really prepare products for launch from a commercial standpoint, which is very often, I think, once you look at the development risk of a company, or of an asset, the commercial risk is probably the second largest risk that companies face, particularly when they're launching for the first time.


Peter, we've spoken in the past about how writing a book avails messages that you might not have anticipated when you started out writing. So my first book on startups, I realized that large companies, you have the opportunity to focus solely on the customer because they actually get the money. However, in startups, you have this simultaneous equation of balancing customer, investors, and attracting an acquirer. So can I get your initial impression on your first startup experience? What were the differences? What were the behaviors in terms of how you had to operate that were different from a big company?


I was extremely lucky in the sense that the CEO of the company I joined, Breath Therapeutics was, already had a thrilling idea that he needed to have a commercial person join his team to be able to value the asset that was in development. At the time, the product was about to enter phase three and there was a very, very nice clinical story behind the asset in terms of what it could bring in terms of an improvement for patients, but there really had not been any kind of business case that had really been built around the product. So the market potential, the market access, pricing, corridors for this product had not really been explored as well as what might be the desired commercial footprint in terms of organization ... He really needed someone to bring that in, in view of future funding or in view of engaging with strategic partners or other companies. So he was very much on board, I think where there was more and more pushback or just more education that had to be done, and now I would say education, was more with the investors, with the funds, that have supported Breath Therapeutics, as well as some other members of the team that were more on the clinical and the development side where they didn't necessarily see a need early on to have a commercial person on board. So they weren't opposed to it but I think you just had to overtime educate why you needed to have a commercial vision, why you need, asking certain commercial questions around the development of product was actually quite relevant, and exposed sometimes areas where we didn't know what we should be knowing by now or we needed to do more work. So I would say that in many cases in development stage organizations, you have, you often have a founder who's a scientist who is very much in love with his or her science, they forget in some way to look at what might be the commercial implications of launching a product down the road. And so you have to educate and you have to ask the right questions, I think, in the beginning, so that they realize that there's a whole other aspect of launching a drug that they don't necessarily consider.


So since some of our audience members are from the payer side and some from the retail and some from the provider side, let me just pause for a second and just make sure we have some clear definitions for these. So what you call development is a period of time where the company is sort of taking their product through proof of concept, through ensuring that they have a product. And then commercialization is the concept of getting the product approved and then out in the market, am I correct in those definitions, or would you define it differently?


Yeah, I mean, I think it's a little bit more fluid than that, right? In a way, yes, your development goes all the way through to the end of phase three and a successful pivotal trial that will enable you to register a drug and hopefully successfully launch it down the road. But already in phase two, you should start having a commercial vision for your product. And it never ceases to amaze me how late companies develop a positioning or a value proposition for their product. You have companies that, you know, and you go on their websites and they will talk for pages about their science, but trying to actually position the drug or trying to summarize what the value of this drug will bring in a market compared to drugs or technologies that are already existing in this market and what benefit it might bring to a payer, to a patient, to a physician, those arguments are not always very well developed. So it is, I think it's more fluid than these kind of hard milestones, this is when it becomes commercialization. I think it takes a village to launch a drug. And it is, I think, important that you bring in commercial folks, access experts, as well as marketing experts to be able to really ask the questions from a commercial standpoint and to ask the questions around what's going to be important, what is the value you're going to want to communicate or you need to communicate to be successful in the market when you launch?


So when you were, you said you were the first commercial person in this startup. How many other people were there in development?


So this was a small startup, so I was employee number ten in the organization. By the time we were acquired, we had grown to a staggering size of 25.


But nonetheless, there was one of you and nine of them, and so was part of your job, part of your role in the organization is not only getting things done, but educating the development folks on why these commercialization activities were necessary.


It is, I mean, I think it is really in the design of a trial, really making sure that the populations that they're studying or are going to be well defined so that you can describe them to a payer, for example, so that they know exactly what they're reimbursing a drug for and for which type of patient. So sometimes, particularly in rare disease, patient definitions aren't always very clear. The ability to be able to describe how many patients suffer from a disease is a bit fuzzy because the epidemiology isn't always there. So that's one aspect, is really being clear as best as you can, all the patients you're going to be recruiting. The other element is often in rare diseases you don't really always have very hard endpoints that have been defined with regulatory authorities, and the same thing with payers. You might not have endpoints that payers recognize or they might recognize a different endpoint than a regulatory body. So you have to kind of be able to combine both and sometimes make sure that yes, you have a regulatory endpoint that will secure an approval, but make sure you've got a couple of secondary endpoints that maybe are talking about quality of life or more relevant patient-related endpoints that are going to be important when you go into peer negotiations and discussions. And the challenge, Jim, as you know, is that in a small organization, resources are pretty strapped, right, are constrained, so you're not always going to be able to do everything. So you have to have these hard discussions sometimes on what is really, really going to be important, right? And what is it that you absolutely need not just for regulatory approval, but then down the road for a successful reimbursement and access to the drug?


So what's next to you? So for our audience, you know, one of the things in a startup, as I said earlier, it's a project, right? And when you're done with it, you take your reward and you move on to the next thing. And so you've been, talked about the success of your last company. What do you want to do next? What interests you? What areas are you targeting?


So I, you know, I love the commercial leadership role, particularly if it's a cross-functional role. I love being able to see, as you mentioned before, how these different aspects come together. I enjoy and learn a tremendous amount too, working also with development folks and scientific folks as an organization. I do think that these folks are brilliant and they teach you so much. So I love that kind of stimulation of learning about new diseases, learning about new treatments, technologies. So I look forward to doing this again, right, and, and I love the startup space, too, because I think it is a space where you truly test it in terms of rolling up your sleeves, being sometimes exposed to new challenges, new problems, and trying to find solutions, right, based on what you've learned in the past, but also talking to different folks and doing this really kind of for the first time. And because you're in a situation where your resources are a little bit more constrained, you have to make the right choices. You might have to do less, but do it really well, so focus on what really is going to make a difference. So I look forward to doing this and I think I've worked a lot in rare disease space, there's certainly a huge unmet need, and in so many rare diseases, the people you met, you meet in these organizations and the patient advocacy groups, the patients themselves, the care, the caregivers who care for these patients, they're all tremendous folks. So that's, it's very, very kind of rewarding to work with these folks.


So you got into rare disease. What are the challenges of rare disease compared to, say, other more mainstream products?


Well, I think, I mean, in many, many rare diseases, and in a sense, this is not what I face, so I'm quite fortunate. But I think in many rare diseases you do not know, you don't even have a strong estimate of how many patients are afflicted by the disease, right?

Because there is no epidemiology. Sometimes it fits a, you know, the diagnostic testing is incomplete. If it's a pediatric rare disease, you actually don't really have a strong sense of what is the true burden of this disease, and that's complicated to get. The, I think, the direct application to this is you don't necessarily know where to find the patients. I mean, you have some companies that are in these ultra-rare disease spaces where in each country you might have 50 patients with this disease. How and when are you going to be able to diagnose and get these patients under treatment is a tremendous challenge. So I think that the whole patient identification and targeting is really difficult, and then basically it's really hard to actually know what might be the true potential in, for a treatment in this disease.


Is it fair to say that you couldn't get a investor interested if you didn't take a rare disease global? And if I recall, you speak five languages, if I recall?


Yes, I was lucky to have parents who lived abroad and took me along and decide to completely confuse me. So I'm half American, half French, and I grew up in Germany and then I obviously got the international bug. So I worked for several years in South America, both in Brazil and Argentina, so I'm fluent in five languages. And I think going back to your question, Jim, if you're are in this kind of very rare disease setting where patients are, there's a limited amount of patients around, you are going to want to have a global view pretty quickly because you're going to want to identify patients across different markets. So very quickly, your expansion plans have to include your international expansion.


Can you define what a market access person background is and what they do?


Yeah, so at an earlier stage, what you really want is someone who can define your market access strategy. So someone who can understand how are you going to develop a strategy to attain a certain price? What are going to be the types of patient populations you're going to highlight? What is going to be the type of burden of illness that you need to describe to show that right now with this disease is untreated, it is costing X amount to society too, or X amount to the system to care for patients that have no treatment. So you want to, you're going to have someone who's going to build the argumentation and a strategy to really focus where you're trying to obtain reimbursement. Later down the road, you're going to have market access folks that are going to be working really much more with payers, and in a sense, they're your natural account managers, they're going to be the ones who are going to go out and really try to obtain reimbursement to get on the formularies and to actually obtain access. Someone that is going out and really kind of selling the strategy, if you'd like, and obtaining access. In addition to those folks, so I think what you're going to be building too is two other functions. One is health economics, so that's kind of more the scientific arm of an access organization. They're going to be responsible for generating the market access relevant type of data. So many times they might be generating epidemiology type of data or they might be generating other types of data that helps fill in evidence gap. I think the, in many organizations, what comes in a little bit later is the entire kind of patient support and patient hub type of organization. So how are you going to help patients not only have access to the medication if they're not able to pay for it, but secondly, how are you going to make sure that they take the medication appropriately, that they're reminded to take their medication and support it through their compliance and their drugs?


Peter, I just want to pause here and make sure the audience can get a summary of all this information that you just shared with us. So the first is just the challenges of rare disease itself, that there's often no epidemiology, there's potentially incomplete diagnostic testing, the picture of the true disease burden is not always well known. And the other challenge is to make a viable business, it needs to be global in nature due to the small patient population. So those are the challenges of the rare disease. But you talk about the importance of having a team, so you need someone from market access that can develop a strategy, find the target, make sure that there's a goal on the target market in the reimbursement, and that needs to be supported with health economics, where you get scientists together to be able to find the supporting scientific data that makes sure that this product is delivering its value. And finally, the fourth issue is patient support, where you aid the patients in getting access to the drug and helping them pay for the drug. So with that, I'll ask the next question. I don't know if you can answer this question, but could you give the audience a sense of how healthcare operates differently in some of these countries and the implications that that has on your commercialization?


Right, well, I think the huge difference in the provision of healthcare between the US and many international countries is that, a healthcare insurance system in most European countries, it is a single-payer system. So it's a very binary type of approach where you, before you have reimbursement, your product is likely never going to be used, or in a very, very small proportion. Once you have reimbursement, your reimbursement is, you know, is across the board for all citizens of a given country. So that I think is the big challenge. In the US, the healthcare system is much more complex, it's much more fragmented. So your access to medications in the US is kind of given over time, but you never have a situation, I think, where you will have absolutely no coverage. In most European countries and in many, many Asian countries, if you're not a cash-paying market, you are going to have to go through this national reimbursement system.


So can you share a story? Tell us a time when you had to quickly adapt or shift your strategy in any organization that you've been working with.


Sure, well, I think it actually goes back to regulatory aspects. You know, I think the really nice element, if you're a commercial lead and, you know, you're kind of always having the, you know, the launch in mind, the kind of the end result in mind, you're able to go back into the organization saying we need this, this and this, or we know we need to, we need to consider these elements. So in one situation, I was in an organization in charge of a launch of their next-generation antidepressant drug, and I had joined the organization in phase two. It was a larger organization, so already quite commercially developed, but it turned out, as we were looking at the work with the project team, that our regulatory organization was really adopting a very, very sequential approach to submitting for registration. So they were going to be submitting in Europe first, then they were going to submit in the US, then going on to Canada and a few other markets that have their own regulatory process. And the end result of that is that you were going to have some very staggered and delayed approvals across markets, whereas if you were able to bring these submissions in parallel, you were gaining anywhere to six, from six months to a year of revenue ..., assuming you would be able to launch and have an earlier reimbursement. So one of the elements here that we did very quickly in the first three months that I joined that organization was saying, what would it take for us to beef up the regulatory organizations to be able to support these simultaneous submissions? What's the level of risk that you're willing to accept for this? And at the end of the day, what is the estimated gain? You start looking at the estimated revenue that you could generate ... earlier, obviously, I mean, I think everything else kind of falls into place. So we were able to submit near simultaneously in our markets and obtain approval in a much earlier time frame that it would have initially been planned. So sometimes it goes back to asking the right questions or kind of looking at the end in mind, looking at what are you going to generate in revenue, how are you going to launch these products, and then coming back into the organization and seeing if there's ways to optimize.


So how do you keep current on the changes in the healthcare system? Where is it that you go? What do you read?


So I think the first, I always like to do is, whenever I have the time, is to listen to various podcasts that come up. So there's always podcasts from different vendors that are on different topics. So I think it's a good way, and, you know, in half an hour or 45 minutes to get a kind of an overview on a new aspect of the market or an aspect of technology that you're not always as familiar with. I think another area that I've found very useful is obviously to join industry lunches and meet colleagues and talk to them about what their challenges might be, or what, or offer all sorts of insight. And then I very much also joined some benchmarking services where, again, you're hearing from peers how they would build up a commercial organization. What are their first commercial hires? So listening to peers, chief commercial officers who are giving their perspective of how things are done in the organization and they're a little bit ahead of you in terms of their launch plans, it's tremendously helpful to kind of have some of those perspectives. So either steer you in the same direction or sometimes say, no, we need to do things a bit differently in some way. So let's say those are different sources that I use to keep current.


Are there specific people you follow?


Not necessarily, I think there's just different organizations possibly that I would follow, but not a specific person that comes to mind.


Okay, it's such a hard decision. I have a daughter and she asked me this question on my last birthday. What is the one thing at this age of your life that you learned? My commentary was patience is sometimes the fastest path to get what you want. And the minute I've met you, it seems like that you learned that at least 25 years earlier than me. So how do you, and I have a friend that works for you and has validated this about you, that you're very good at pulling the pieces together and trying to get the organization, you see the power of the organization versus the force of yourself as a leader. Can you explain how you develop that? Where it came from? Is that a European thing? Is it just always how you've been?


I think it's, again, you learn it, right? I mean, you've been in organizations that have been incredibly siloed where people do not work as easily together, and you realize that that doesn't really make much sense. And then I think you have a lot, if you want, sometimes to come into organizations where personalities and professional expertise come well together, and people naturally involve each other in their projects, they basically really collaborate, work very well together. And I find that in those organizations, what you're really doing is everyone's working for the same goal, everyone's working for the same product. So maybe it's also the fact that I had a chance to work in Scandinavia for a couple of years, which is a very consensus-oriented society where everybody has an opinion, whether it's the right or wrong one, you do have to listen to everyone and you do have to make sure that there is a certain consensus of alignment. It doesn't mean that once you made a decision, people can still question it. I mean, you do come to the decisions and move forward, but there is a certain amount of time where everyone can express their feelings, but also their opinion and their viewpoint, which I think very often you might have a viewpoint that is incomplete. So you're able to kind of learn from other folks as well. So I do firmly believe that as a leader, your role is to establish that vision, to establish that story. I think there's a model that you're probably really familiar with, Jim, called the 6C model, where.


I'm not, explain it.


Yeah, the 6C model is a model of teams where you move from coexistence, which is kind of the caveman version of the model where you just coexist and your different functions, even though you have a common product or a common goal that you need to achieve all the way to co-ownership and you kind of look at yourself as an organization and take a temperature check at given points with your teams and you're honest with yourself, you can kind of say, well, where are you on this continuum? Are there folks that are truly co-owning a project? We'll step in sometimes in an area that's not nearly necessarily their area of expertise, but could offer some support or offer perspective. Or are you more in an area where you collaborate but nothing more? And I do think that when you go to this kind of more towards the co-ownership, that's when the, really, that's when you've achieved your goal really and you've got that entire power of an organization behind a product.


That's excellent, and I guess it also holds true when there's not alignment between your values, that it's important to recognize that in your company and it's time to move on, and that's equally a hard decision, I imagine.


Yes, it is. I mean, I think sometimes organizations very much struggle between their vision, where they would like to be and how they're going to get there. And that has so much to do with the culture, right? So you can read a number of reports out there around what makes for a successful launch? What have been the critical factors of it? They're always very concrete things that consultants will find or, they need their market preparation, right? Or you had very specific kind of commercial model that seemed to be very interesting. But I think very often when you peel back the layers, the other aspect that you have is you have an organization that was truly aligned that at some point was able to have different functions work together, have a common goal, and really be able to act on that. I think where organizations were not well aligned, where there was not good communication, good collaboration between functions, where people didn't feel that they were trusted and empowered, the organization is just not as successful.


I think those people who haven't done a startup do not know how personal it is. I can think of two of my startups where you knew every patient in your clinical trial, you knew their story, you might even know their spouses, and it becomes a very personal thing.


Yeah, I mean, I'll remember the day, without naming anyone, but the day that we worked in a rare respiratory disease and we had a patient advocacy group with a leader who was very charismatic and extremely supportive of what we were doing, and he called me one day to tell me that he actually had the disease that we were exploring a treatment for. He had actually just recently been diagnosed with it, and it is, as you say, it's a very personal thing. But I think in general, Jim, you're asking me about why people have a more patient-centric attitude. If you think back in your career, when is the time that you've usually stepped out of the meetings, dropped everything else that you were doing to help someone? It's usually when you get a call that, your switchboard somewhere doesn't know where to feel when it's the call from a patient and they just pass it on to you. Somewhere in the organization, it's usually 6:00 at night or kind of late, and that's why they don't always feel it. So you happen maybe out of sheer coincidence to suddenly have a patient online who has a question about their treatment or some other question that is related to their disease, and you will drop everything else to do something to help. I think at the end of the day, this is what kind of keeps you, to wake up in the morning and keeps you going because you know that somewhere in a small way you might have an impact on this patient and you're able to help them.


Yeah, that's beautiful, great. Peter, thank you for joining us, sharing your thoughts on culture, leadership, and the complexity of rare disease.


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