Pharma Sessions
Pharma Sessions
Why Pharma products win or lose years before launch
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When you looked at the competitive landscapes, there was a lot more competition in dermatology coming from the biologics, from oral therapies. It became a more crowded space. Pricing dynamics, value was going to be harder to prove out in that indication, where almost everything in chronic cough, even in our other indications, our life cycle management indications, fell to the wayside. There was nothing that was working. And we had a clear point of differentiation over those, which is we work centrally in the brain and peripherally in the lungs. That's something I think you we take a look at is what is the value? What is our key point of differentiation? And how can we service these patients differently while building shareholder value? And I think it was a really hard organizational decision to make that pivot and say we're going to become a Chronicle company. But then once we made that shift and once we made that decision, it was then alignment on what are the right patients in which we can help the most and how do we build the most value in these indications.
SPEAKER_01Hello, hello, and welcome to Pharma Sessions, a place for pharmaceutical leaders to come and learn from each other. I'm your host, Jonathan Kaske. Technology and market trends are bringing change at an ever accelerating rate, and no person, team, or company can afford to be left behind. Here, we dive into the strategies and tactics that our guests use to tackle these challenges and create new opportunities and how you can do the same in your own organization. This episode of Pharma Sessions is sponsored by Xunt, makers of the X1 reporting platform. On today's episode of Pharma Sessions, I'm thrilled to welcome Farrell Simon, Chief Commercial Officer at Trevi Therapeutics. Farrell brings a rare blend of scientific training and business leadership with a career spanning consumer health, big pharma, and now clinical stage biotech. I can't wait to discuss all that actually, because it's really interesting to see somebody go from a company like a Procter and Gamble to leading billion-dollar franchises to serving as chief of staff advisor and now building and scaling Trevi clinical and funding milestones. So really, Farrell has operated at every stage of the biopharma life cycle. And with that, I'm thrilled to get started. Welcome to the show. Thank you, Jonathan, for uh having me. Absolutely. All right. It is Monday morning. Snow is melting outside. Just as a little get to know you, what have you had to eat so far today?
SPEAKER_02Oh, great question. Start off every day with a cheese omelet and then clean up any scraps of waffle that my kids leave behind.
SPEAKER_01What's your omelet technique?
SPEAKER_02I'm just curious. It sounds crazy, but every morning, seven egg whites, one full one split between my wife and I, and uh, and then a banana for extra stuff. Absolutely.
SPEAKER_01That sounds delicious, actually. All right, so let's get going here. So you've built your career across consumer health, big pharma, now biotech. When you look back, what was the moment you realized you wanted to operate smaller and take broader ownership?
SPEAKER_02Great question. I would say I always wanted to work smaller. And a little bit of it was built the building blocks to get there. And so I always, even going back to college and education, I always looked at entrepreneurship. I tried to get an entrepreneurship concentration as part of my B school and MBA program. But working in even big companies, I always chose to work on the small brands for the most part and start my career there at Procter. I launched aligned probiotic nationally. And the reason being, you got to touch every aspect of it. It was a small team doing everything. You got to be agile, you got to test things out, and then you got to take those learnings into the bigger brands and apply those learnings. And so I've always had this entrepreneurial mindset. And I think when I had a great career at Pvisor, I got a lot of great experience across geographies, different stages of company. But in that chief of staff role, I got to see all the variety of learnings across the organization. And I knew that if I stayed there long enough, it would be hard to make that switch to a smaller biotech. And that the timer is right, the opportunity was right. And I decided to make that switch to a small uh emerging biotech at the time.
SPEAKER_01Very cool. So who were you chief of staff to? What position were you supporting?
SPEAKER_02So to the head of the biopharma business unit. So I was first chief of staff to John Young, who managed uh Pfizer Innovative Health, pretty much all on-brand assets. And then I was chief of staff to uh Angela Wong. So I created that transition as she came in as the biopharma group president and stayed with her for a couple of years and just it was a great learning experience. It was probably one of the biggest career pivots I had. So and this is across commercial, clinical, across everything for that business unit or commercial operations, uh, you know, looking at launch excellence work streams, looking at operating plans, portfolio prioritization from the commercial mindset, and then external facing earnings. How do we communicate those messages externally every quarter and in uh key earnings messages, which are really high stakes in a company like Pfizer?
SPEAKER_01Very cool. Well, you're now my third either current or former chief of staff guest. I did a full episode on it. You might actually find interesting. Steve Sorillo, um, who I met when he was at Decada, and he's done this job for a number of places. I think now he's at at Biogen, and then Martin McLaughlin was at Decada also, but now he's got a chief of staff role at Teva. And it's just it's a position I'm kind of fascinated about from a career growth. Actually, my wife had did it in a different industry for Santander Bank. It's a bit of an insane job, really, because it's like she when she was doing it, one she was did it before she was pregnant, but then she was pregnant, but she kept a suitcase and a change of clothes at the office in case she had to, you know, hop up hop a plane to, in her case, Santander, Spain. But it's not really a nine to five job. It's a very interesting job, I think.
SPEAKER_02But it is, I'd say it is one of the most valuable jobs because of the vantage point you get. You get to see all the organizations, all the business units, however, whatever your chief of staff to, but you also get to see the executive team and the executive presence and advisor of the ELT. I'm up to the CEO and sitting in those meetings and learning from those leaders, which I think has just tremendously helped me shape how I want to show up as a leader.
SPEAKER_01Oh, I'm sure. And now you get to apply some of that to your own, kind of following the entrepreneurial bent you talked about earlier. But let's stay in the commercial realm for a bit, just because that was, you know, what we're talking about at Pfizer. So when we're talking about commercial leadership, we're often thinking about launch, right? There's so much so much around launch. From your perspective, having seen this many times, when does a successful launch really begin?
SPEAKER_02A successful launch begins in phase two. And even prior to that, probably phase two A. And the reason is when you look at the drivers of a successful launch, a lot of them start with the right endpoints. And getting those endpoints into your proof of concept, your phase two B kind of confirmatory study and having the least amount of changes from your phase two B to your phase three transition de-risks the asset and really helps you understand where can this provide value, not only to the patient themselves, but also to the providers and also to the payers. So integrating that, I think the earlier the better. Not all companies, I think, share that mindset. No, definitely not. Not all companies can afford to integrate that at a full-time position, right? They can do it through advisory positions, but starting earlier, the earlier the better.
SPEAKER_01Yeah, for a bit, I worked for a company when we did a ton of virtual advisory boards, and somebody had to be pretty aggressive to be doing this at phase two B. It was really phase three when all that work started coming up. But what I thought was really cool was wouldn't you talk to, for example, your access folks earlier in the stage so that you know, hey, this is the endpoints we're designing for. Are these going to get us the formulary status we need, for example? Right? Like there's all sorts of questions that really are much greater value if you answer them earlier in the process. Exactly. So are you doing any of that work at Trevi?
SPEAKER_02I think the benefit of having the commercial leadership, and there was a CCO in before me, and he did a great job of integrating that commercial mindset throughout the organization. And I think we've done a great job of partnering across the organization from clinical development to commercial to make sure those value drivers, depending on the stakeholder, are integrated into the trial and that we truly understand and building that overall value story as we get closer to launch.
SPEAKER_01And one of the things you mentioned was if you could afford it, right? And I'm assuming that your budgets are very different if you're at a company like Pfizer versus at a company like Trevi. And honestly, a lot of people that listening to this aren't at the Pfizers of the world. There's a lot of people in in biotechs who are always saying, Oh, I wish I had that resource or this resource. So how do you think about launch preparedness? How does that differ when you're in this situation?
SPEAKER_02I don't know if it's different in resources, right? Between a large versus small. I think it's how the companies have grown up. There's always a trade-off of when do you spend what? What do you stage gate your spending off of? And I think that's the key metric is what are you looking to achieve? And how do you then have that inflection point of spending so that then you're ramping the organization at the right time point. In big pharma, you have new product planning groups that look across assets and are saying, all right, here's how we look at it, here's how we integrate that knowledge, probably before even a brand team is set up. And something like, oh, Trevi, when I joined a small 25-person organization, you're doing commercial, but you're also wearing so many other hats. Well, I was also very integrated in terms of business development and corporate communications. At times, I was leading CMC in project management. And so there you have a commercial mindset, but you also have to be open and agile to wearing the hats that are gonna, how do I contribute to the company today in what I'm doing and what I skill set is and what my strengths can provide that?
SPEAKER_01Yeah, this is all very interesting because so CMC was a world I knew nothing about. And then at one point I was like, oh my God, I have to have these conversations with CMC people, and it's like a whole different language, right? So how do you manage that as a leader where that might not be your strengths to the degree that it is the people that you're talking to and trying to lead in that organization?
SPEAKER_02I think it's really how do I help? Right? It's not necessarily the subject matter expertise because I didn't have that in CMC. I have a scientific background, I've dealt with that in the past, but I'm not I'm not a CMC leader. But it's how do I help out in the ways that I do? How do I actually hire the right people and get them into the spot so that they are educating and building out the organization they need to? And that's exactly what we did is at the right inflection point, once we got positive data in phase two B, we went out and hired a CMC leader who was fantastic in the organization. And then he brings that expertise. Or you have consultants, right? I think that's a merging or a small, we're no longer emerging. We're we've actually built up the company and we're over a billion dollar valuation, which is always great, great to see. But you leverage subject matter expertise through a consultant model. And so that you're not bringing a full-time hire on, but you're getting that knowledge integrated into the company in order to have the best final product that you can.
SPEAKER_01Right. So you're supporting, you're advancing the ball as much as possible and as much as makes sense given where you are with your clinical readouts, and then kind of preparing to move faster when you take that next step.
SPEAKER_02And they can do gap analysis, right? Tell you what you don't know. I think that's probably the the first step is assessing where this way back in the day at Procter and Gamble of first thing you do is assess the landscape. You have to understand what do I know and what may I might I not know? And that's where consultants who go deep, right? Mile deep inch wide can can really help you out.
SPEAKER_01So let's talk more about the Procter and Gamble background. Because when I think Proctor and Gamble, like I think probably one of the best marketing companies out there. You've talked about marketing starting long before commercialization. So what does good pre-commercial marketing actually look like for clinical stage biotech? And did any of your learnings coming from PG help you form that view?
SPEAKER_02I think Proctor and Gamble, as you said, great marketing powerhouse, also really great general management. And so you're thinking broader when you're there of not just what can I do to market the messages, the targets, how does it actually come through and communication plan choices, but how do I look at that in terms of a PL and how do I run a proper PL? So when I look at starting that early, it's I categorize it in terms of what type of launch are we working with at the most basic level. Are we building a category? Are we competing in a category? Are we changing a category and how it's operating? That helps lay the framework of what do we need to start doing. Something in chronic cough and IPF, which is our lead indication. There's nothing out there. Physicians know the high element need, there's no approved therapies in the space. We're building a category. And so that then helps shape the thinking of what we need to do in terms of market development work. And I think that's a key role is what do we need to do in market development in order to raise the burden of disease, in order to raise the urgency to treat once a therapy is hopefully approved in the space. But that's a very different model than if you were to compete and if there were existing therapies in the space. So I think Procter thought taught me to take a step back, look at a landscape, and then determine their model of who, what, and how, who, who is the right target for that message. And what are you going to say and how are you going to say it most effectively?
SPEAKER_01Just a hyper focus on some of the marketing fundamentals, right? Of and then if when you think about applying that, it's really not different at all from the work that you know we see all the time in pharma, which is who should my reps be seeing seeing? What should they what should they be saying? Uh, you know, how should they be delivering the message? How do you even reach some of these people, right? It all is the same or swap out reps for MSLs, and it's the same thing that that medical's thinking about.
SPEAKER_02It's all about personalization when it comes down to it. And I think with newer technologies, you can get more personalized in what you're doing. And I think AI is only going to help enhance that a hundred percent.
SPEAKER_01So then part of that, right, that landscape analysis, maybe not so much now, but in in your past, right? There's been times, I'm sure, where you've had to make some tough portfolio decisions, continuing development or stopping development. The data coming in and and the strength of that, I'm sure, is a huge part of it, but also that competitive landscape and what's likely to come out of it. So, how do how do leaders balance scientific promise with that commercial reality?
SPEAKER_02Difficult. I think it's almost an impossible question without using examples.
SPEAKER_01So, can you share an example?
SPEAKER_02Yeah, I think Trebi was right at that crux of that decision making a couple of years ago. We had a lead indication in dermatology and prigonodulares, and we had an early stage in chronic cough and IPF. And we got had a successful trial in dermatology. We had an even more successful early stage in chronic cough. And when you looked at the competitive landscapes, there was a lot more competition in dermatology coming from the biologics, from oral therapies. It became a more crowded space. Pricing dynamics, value was going to be harder to prove out in that indication, where almost everything in chronic cough, even in our other indications, our life cycle management indications, fell to the wayside. There was nothing that was working. And we had a clear point of differentiation over those, which is we work centrally in the brain and peripherally in the lungs. That's something I think you we take a look at is what is the value? What is our key point of differentiation? And how can we service these patients differently while building shareholder value? And I think it was a really hard organizational decision to make that pivot and say we're going to become a Chronickov company. But then once we made that shift and once we made that decision, it was then alignment on what are the right patients in which we can help the most and how do we build the most value and in these indications.
SPEAKER_01It's so interesting how much of what you're talking about is very universal in the startup world. So I took a role at a startup maybe six, seven months ago at this point. Some of the best advice I got when I was talking to various people who have mentored me throughout my career is focus, right? Like you cannot do everything. You need to make decisions with the best information you have and then double down, triple down on that particular path. And sometimes it's easier said than done when there's a number of things that look like they could be good options. But it sounds like you've taken this at a fundamental level of ceasing a somewhat promising clinical trial and saying this is the company that we're we're running at this stage.
SPEAKER_02That's a you know senior management discussion, right? Our CEO has done a great job leading the way there. It's a good partnership with clinical development on where can we be successful? Where do we think we can be successful? And where do the opportunities lie? And I always go back to almost like a rapid prototyping model. How do you test and learn? Like how do you be be agile? But once you make those changes and once you make the decision, then how do we mobilize quickly? That's sometimes hard for organizations to do because you have a lot of stakeholders. You you have a board, right, board who has um really great experience who give you ideas, you have investors who you know challenge, you know, why are you doing what you're doing? And also have seen the landscape across therapeutic areas. So you kind of take the nuggets from everybody and you have a nice discussion and then you try to make the right decision.
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SPEAKER_01So let's hang out on this topic for a little bit because it's something that is, I don't want to say it's been bugging me, but it's something I've been wanting to explore a little bit, where I think a lot of pharma folks, at least people that I'm talking to, have really bought into this sort of tech mindset of fail fast, test and learn, right? Adjust, pivot. We're a tank company, it's actually really easy. Like we can, especially now with AI, we're like, hey, I have an idea for a product thing. Our developers can spin it up ridiculously fast, not like the final product, but something good enough to talk about and to show and get feedback on. We can go have some conversations, we can come back. And if it's like, no, that was a dumb idea, don't do that. Worst thing is we've wasted, you know, four or five days of time. Pharma world is very different, right? So, so how in a world of like multi-year clinical trials, millions of dollars of investments, how do you actually test and learn and fail fast and do all that lean startup type stuff?
SPEAKER_02I don't know if you can fast, right, in pharma, but some of it, some of it is what are your decision points? And if we ran a trial on IP up chronic health and were successful, then what makes sense as the next indications? We took a hard look and we said, look, this sits in a broader category of interstitial lung disease. That is underpinned by similar biology. And it gives you somewhat of confidence on why is the drug working in one population and why does it have the potential to work in another? And I think that in pharma is probably the fail-fast mentality is how do you go back to the confidence in the drug and also the confidence in being able to run the right trial to prove out that success and have a market opportunity that's valuable? Those three three things rarely align. And I think it's finding the intersection of those three that provides the most value because what I have seen in other companies and earlier stage companies is you have a lot of a scientific founder mindset and they can run the right trial and they have the biological plausibility, but it may not lead to the best market opportunity. And it goes back to our prior prior conversation of unless you integrate that mindset early, you may launch in an indication with unfavorable pricing, and then you're stuck with it in an indication that's actually more valuable. So without understanding those commercial dynamics, it's hard to really set that favorable path forward.
SPEAKER_01Sometimes get launched, right? Where it's this balance of scientific promise versus commercial reality. But actually, without a commercial success, it's not sustainable, right? So it could be the drug won't actually get into human bodies and help people unless the commercial models are there to support it. So it is definitely a balancing act, but I do think it's that part is incredibly important because that is how your company continues to operate and how you continue to manufacture drugs and. ultimately hopefully help patients.
SPEAKER_02I do feel, you know, in terms of failing fast, it may not be on the clinical development side, but it could be in it will be in the commercial model. As as we do targeting, as we, you know, get closer to to launch and with sales reps, you're going to look at A B testing on messaging. You're going to look at who is responding to what types of messaging andor vehicles and channels. And you're going to be able to optimize that at a rapid pace, knowing the responses that come back. And so it it's more in the commercial model than it probably is in the clinical development side.
SPEAKER_01That makes a lot of sense, right? Because there's things like shifting from static targeting to dynamic targeting. There's, you know, digital twins for having mock conversations with doctors, right? And AI enabled like there's a lot of experimentation and play and you can get feedback and make adjustments much more quickly when you start to see even as something as simple as an A B test, right? Like that's a very, very easy experiment to run.
SPEAKER_02And you kind of know, you know, nowadays of what the digital affinity of many prescribers are, how easy they are to access. And so that that all plays into the targeting strategy to as you said the number one reason most of if not all of us are here is to get the right product in the right patient's hand to be able to help them. And I think is as long as we have that North as the North Star, then it helps us fill out the rest of the plan.
SPEAKER_01So let's talk about the North Star a little bit, right? So you're, I believe, looking at a 2029 launch potentially. How do you keep your teams focused and motivated when that big moment is still several years off?
SPEAKER_02Yeah. So one thing we did within the the last years and somebody on my team is leading a lot of this great effort is establish a patient advisory board. And it's putting patients into our day-to-day activities. And that is listening to them, hearing what they have to say, having along our clinical development path, having them respond to some of our stimuli in terms of what they may go through in terms of clinical trials, some of our messaging. We want to always keep them at the heart of what we do and we bring them in in various ways throughout all of our conversations. We have have a new patient testimonial campaign so that we able to share their voice and share their experience with others, which will hopefully launch you know later this year. And it gives us so much insight but it also gives us so much motivation bringing them into our town halls and having the team so it's not just the commercial team listening to them or medical affairs. This is the entire team listening to a patient probably on a quarterly basis able to ask them questions. And sometimes where we get stuck in a condition like IPF is the patient. This has widespread impact. Caregivers are a key piece of this as well. And so how do we bring in their viewpoint as well because they are part of that patient journey.
SPEAKER_01When I was at that advisory board company the patient advisory boards always carried a bit more emotion, right? Because these are people and depending on the disease it could be chronic it could be life altering. When you give patients the chance to communicate and to help it's very empowering for them. They feel like they're no longer just at the whims of this disease they're now engaged with people trying to formulate a cure. And so everything from hey here's our protocols for the clinical trial is this something you think you'd adhere to here's our ICF right do you understand what that means the mechanics of it and then the patient journey like what was your pathway to diagnosis? It was always tricky. Doctors it I won't say it was tricky. I mean we paid them an honoraria to compliment but sometimes still even so there they'd be you know maybe a little terse right patients it was never that they were like oh finally somebody understands what I'm going through. And then we would bring them into either the company event or at a conference and those I mean it's so emotional right these people talking about the burden that they've been living with so I can understand that being hugely motivating for for your team. That sound sounds like a fantastic initiative.
SPEAKER_02A lot of this is in partnership with our patient advocacy groups they do a great job of harmonizing the group and really motivating them and giving them a place to interact with each other and learn. They normally have a patient summit once a year in the US it's once every other year for this patient group. We attend those and we listen to how they want to be involved. Often enough they say we're involved too late or it's just a check the buck exercise. It's it's not just a fact of involving them, it's listening to them. And those are two very different things.
SPEAKER_01And it seems like nine times out of 10 a patient advocacy group is led by somebody who's been somehow touched personally by the disease, right? So they are looking for partnership they're brought they're oftentimes looking for resources to help to do some of the great programming that they're thinking of and it's a wonderful thing to see when you're able to make that connection and support those organizations. All right let's wrap up with just a couple maybe take a step back questions. But for people considering a move from big pharma to biotech, like a hard truth about that transition they should understand before making the leap I think you know if you asked that question probably a year ago, very different answer.
SPEAKER_02Biotech's been through a rough patch in the last four years 2020 to probably midway through 2025. Funding was challenging there were a lot of companies out there and everything was getting funded prior to that and it entered a consolidation phase. There's a risk in in the company I think some people think that there's stability in larger companies you have to be entrepreneurial. You have to be agile to be able to help and you have to be risk averse and figure out you know is this the right company that I want to take that risk with I think the other biggest thing of making that transition is the people. If you don't see yourself fitting into that culture on that dynamic, then that could be challenging staying in that smaller company for a longer period of time. So I think those are the two biggest considerations that people look at but for those that are ready for it, it's an exciting place and I I feel like you get closer to the patient being in a smaller company than you do at a large one.
SPEAKER_01And so then how do you suggest people make that risk tolerance decision? Because if a clinical trial goes bad at Pfizer, there's a bunch others in the hopper but often not the same I mean especially if you're joining you talked about joining this company at 25 people right that's a very very young single asset company. How do you suggest people take a take a look at that and and make an informed decision.
SPEAKER_02Some is looking at external experts. It's you evaluating what do you think the probability of success is some of it is do you archetyping the type of company you want to go to is it a single asset company is it a platform company that even if one may not work out you have three or four other avenues that can prove out biological method. But I can't give any guidance to anybody because that is such a personal choice I think in in your set of set of circumstances of how much risk do you want to take what type of personal situation are you in and location plays into it as well. Are you willing to move for these types of opportunities and are you ready for it like mentally family wise and you have to have a good family support system to do it.
SPEAKER_01Yeah absolutely it is a big decision but it's I can literally Farrell hear the excitement in your voice as you answer many of these questions. So I feel like that's maybe a reward that's not spoken about as much is as you say feeling closer to the patient feeling more ownership of the work because at the end of the day there's something very rewarding to looking and saying okay I didn't build this by myself but I had a pretty big big impact on something cool that was built.
SPEAKER_02And I think that that is a a really fulfilling at least for me aspect of all of this absolutely you're able to see the the marks that you make on the on the company and you're able to see the partnership you have at different levels in your organization.
SPEAKER_01Perfect well let's leave it there. I just want to thank you I thought that was a an excellent conversation and I've enjoyed getting to know you through this process. No thank you very much Jonathan really appreciate it. This episode of Pharma Sessions is sponsored by Xunt makers of the X1 reporting platform. And that's a wrap on today's episode of Pharma Sessions with me, Jonathan Kaske. If you enjoyed today's conversation don't forget to hit follow or subscribe and share it with someone else in the pharma world who might need to hear it. For more on pharma trends, career growth and business strategies, connect with me, Jonathan Kaske on LinkedIn. Until next time, thanks for listening