2026, Future PharmaFut - Keynote Fireside Chat_ Embedding Commercial Insight Early_ Re-Engineering Pre-Launch For Predictable Launch Success

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): We didn't talk about where we were gonna sit, but I think we've got it covered. All righty. Farrell, why don't you tell everybody a little bit about yourself?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah. Allison, thank you for inviting me to this. So my name is Farrell Simon. I'm chief commercial officer of Trevy Therapeutics. We're a Phase III company in respiratory and chronic cough, single asset company, and I've been there six years.

So been on a journey with the company across different indications and really being thoughtful about how do we look at sequencing of indications, but also how do we look at integration of commercial insights hence the talk today.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): This guy is fascinating. I loved my panel prep call with him.

I literally could have went at least another hour. He has so much amazing information to share. Let's get started talking about early commercial integration and when does commercial actually belong in the room. If you've been in pre-commercialization, I think there's probably different opinions on when and how that should be done and also what good looks like.

So Farrell, a lot of biotech still treat commercial as something you turn on in Phase III. But you've said the real shift is cultural, moving from a purely scientific mindset to a commercial one over time. When do you think commercial insight meaningfully needs to show up? And what does that look like in the early conversations with the development team that might be laser-focused on proof of concept?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: So I think it looks different in a biotech than it does in a multinational large cap pharma. And I've been in both. My career spans both Pfizer, where I spent most of my career, as well as biotech, and I've seen both, both ends of it, and I think they, they struggle with the same exact challenges, which is you have a development team, which is normally R&D led, normally scientific founders in biotech or scientific PhDs in a big pharma, that think they know everything.

And there's always friction between the R&D organization and the commercial organization on what does that mean. And so where we usually start off in, in any of those conversations is what is the target product profile? And we also use something that is what is the minimally acceptable commercial profile?

And that sets the guardrails on what do we expect to see success when we get to market and labeling and when we what is the lowest common denominator of success because there is a, a viability bar that needs to be met in order to commercialize or compete within the market. And so I think early in- insight when you're looking at that is all about how do you help the cultural shift of the company in understanding value drivers? And I say value drivers, and it's such a wide term-

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Yeah ...

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: but it means so many different things to so many different people, and it can mean whether that's clinical outcomes payer endpoints within the trial. How do you bring that story together so that when you go through development, you're not changing things as you progress?

And that's a key piece of it because the biggest risk is a Phase II to Phase III conversion. And you want to minimize the risk within that time period as much as possible. The challenge is most companies don't start thinking about commercial until Phase III. Especially in a biotech world, last four years have been very capital constrained. Companies they can't invest in a full-time, person internally. But there's plenty of consultant models, board of directors, advisory roles, and ways in which you can integrate it across the company in different ways.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): That's really interesting. I love what your comment about the the value drivers. I feel like that typically comes up even more in the brand planning process, and people are like, "What does that actually mean?" And you have to educate everybody on that. But I think just establishing roles and responsibilities and who's going to take advantage of managing that and watching out for the company is incredibly important because you do wanna minimize that risk. There's so much involved. There's so much financial backing that goes into these launches. And so I think your points are well taken. Has anybody ever experienced what he's described? Got a hand over here. Got a nod over here. All right. Very good.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: And I think one of the, the unspoken things is the sequencing of indications- even within a brand. And that's where if you truly don't understand the commercial end game, you can sacrifice the end value, and that can be pricing because you go out with an indication that is a larger population, lower pricing dynamics, less executable by a company versus starting with probably a more specialty indication and then expanding over time into larger indications, potentially taking your price point into those indications as well. So but if you have no line of sight, you're already in phase two, phase three, and you can really detrimentally destroy value.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): It's too late at that point.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Way too late.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): You mentioned the target pro- the target product profile and MACP. You described the target product profile as more than a clinical document. It's truly- ... commercial discipline.

So if you could share with us how you use the target product profile and the minimally acceptable commercial profile to force alignment across clinical development and commercial teams. And maybe you can share an example of where the target pro- profile decision changed a development choice, whether at your current role at Trevy or maybe another organization.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah. So we I'll just use TPP and MACP to make this conversation easy.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Acronyms, write it down.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah. So when you look at the, the TPP it align... It is almost an alignment document prior to you doing work such as labelist driver. And for those not familiar with that, is as you progress through development, you're really pretty much writing your entire label- and trying to say, "What do I need to generate in order to have this label that, that I want?" So the TPP is a single page representation of the clinical data safety, efficacy and safety, the trial design. And the way I've used that in the past is to align on what the endpoints need to be. So what are we looking for in terms of clinical efficacy, the separation versus placebo, but even at times, the other secondary endpoints that are most valuable to physicians and to patients.

And we test that through research. We test that through our... We have a patient ad board that we talk to- ... and really get their input along the way. Because in a lot of conditions that we're seeing now is sometimes there's an objective measure, and sometimes there's not. But when there's an objective measure, the agency wants you to see a patient-reported outcome that supports your objective measure.

And how do you create that confirmatory result? And that's normally pretty straightforward. But then there's a whole litany of other secondary endpoints that you can say and I'll give a, a specific example. In our phase three program, we are looking at chronic cough and idiopathic pulmonary fibrosis.

Primary endpoint of the pro- trial is an objective cough monitor. So it's all about reducing the number of coughs of the patient, and the patient-reported outcome is a cough severity numerical rating score. How do you feel? Both measuring the same thing. One of the more important things is quality of life to these patients.

And so what other quality-of-life PRO did we need to integrate to really measure their experience- not just the outcome. And that was driven by alignment on the TPP, which we take into research to value the product, the prescribing shares, the challenges behind it, and really understand what what patients think about it and what physicians and payers think.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Quality of life, so important, right? Our patients are our North Star. So I think it's- ... it's really fascinating to see how that's being pulled through from so early on into such large decisions like this. I wanna shift gears for a moment and talk about access strategy. So you guys can just shout it out from wherever you are, but when we say the word access, what does that actually mean?

How would you define that? Just shout that out. What, what comes to mind when you- when we say access? Value prop.

Affordability. Thank you. Timely Payer rebates. Okay. Patient care. Any others? All right. We've asked some of these folks in the room what- ... payer ac- what access means to them, because it means very different things depending upon who you ask, as we just saw. So from your perspective, Farrell what does it take to bring payer and patient evidence needs into phase two design in a meaningful way? And where do you see biotechs cli- chronically underinvesting or misunderstanding what access really means?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: So ac- access, in my mind, really gets down into the patient, right? I think you said it. Patient is our North Star. Everything revolves around them, and if we can't get our therapy into their hands, they don't therefore have access- in my mind. So it starts at a very early stage of understanding. I think, there was a really good analogy of which I grew up on Procter & Gamble, which was talking about their construct. It was assess the landscape, the who, what, how. You first have to understand where you're competing, and is this a category with high unmet need?

What's the competition look like? What are the value drive- what's your differ- point of differentiation to them? And then from there, you can really develop, all right here's our story to payers, and how do we then build the suite of services, and it looks different for every brand. The suite of services to ensure that the right patient gets the right therapy in their hands.

The patient support services and specialty products is of utmost importance so that you help them navigate potential payer utilization management, whether that's prior authorizations or step edits, whatever that may be, because in more competitive categories, if you don't have access, you need to think about what your commercial plan is.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Yeah.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Your where you're deploying reps, where you're creating demand in the States is very much dependent on an access model. And if you don't have the open gate to even talk to payers or get it approved on formulary or get it pretty much reimbursed- ... in some way, 'cause it doesn't have to be on formulary, then you've created challenges, and you need to understand those barriers, which is really helpful in patient journey work.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): I feel put a hand up if you're dealing with administrative burden on the product that you're working on. Yeah. I think there are so many challenges that we need to overcome, where you could have that positive patient-provider conversation where a drug is ch- chosen, and then you're not able-

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): To get it in the, the hands of the patient. And so it's just delaying the impact on their quality of life and the ability for the, the drug to perform the way that you anticipated it would. From a, a pre-commercialization perspective. I failed to say earlier that there is a QR code if you wanna submit questions for Farrell.

Please feel free to do so. We'll see them come up here, so apologize for not mentioning that earlier. Would love to move on and talk about stage gating and just balancing discipline with realities of being in a small biotech. I've worked in a small biotech myself. Will not be discussing any of those details today.

Stage gating sounds clean on paper, but in small biotech you're juggling, capital constraints, timelines, M&A value. How do you apply stage-gated commercial planning without slowing the organization down? And maybe there's a framework or approach that you've seen be successful in the real world.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah, I think it gets formalized in multinationals a little bit too much, that there's ... We used to have this construct of DP1, DP2, DP3 once you get to the decision point.

Then this tranche of funding gets released. And it's similar in biotech, but every- In biotech you're all competing for the same dollars, 'cause every dollar that you use is a dollar away from clinical trials and a dollar away from getting that, that therapy into patients' hands.

So it's a little bit more intense in a biotech, especially a single asset company like Trevy. Where we only have 40 people and limited funds. It ... you have to think creatively about ... I think it in two ways, is the resourcing aspect as well as the work product. The resourcing aspect is how do you cr- You don't need to build organizations.

This is all my viewpoints, not representative of Trevy, but I'm not an empire builder. We're a phase three-ready company. I'm the only commercial colleague, and that's not my only job. So it is thinking about different models to use your funds most effectively. I have expert consultants in payer access, pa- pricing reimbursement and market access.

I use them on a fractional basis. I get the best thinkers, but I don't have a full-time employee that I need to pay. I'll eventually need to bring that in-house, but that's not until a later time point. That's across a lot of aspects that I do. And then there's the work product. What work truly needs to be done at different stages, and what are you trying to solve for?

Are you solving for investors to get them excited about it? We just held an analyst and investor day and I did some work prior to that so that we can tell a more compelling and justified commercial proposition to the street. Is it to strategics so that if a strategic comes in and wants to take a look at your company, we're a publicly traded company, so we have a fiduciary obligation to our stakeholders and our shareholders to entertain those conversations.

Do we have the right data to justify the enterprise value of the company? Or is it to help your better internal forecasting of what the, the right next step is? And you really have to think hard about what can you push out in a meaningful way that is not gonna jeopardize the launch. And that's where I put it too.

So we've pushed out things along the way, but we've done the right physician demand research, payer research, and pricing research to make sure we have the key pieces here that helps us progress against really investors and strategics without sacrificing the go-to-market launch plans.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): As being the only person who does what you do- in this company can you talk about how you are leading with this influence and maybe motivating people who may not agree or share your point of view? Because I think oftentimes, when faced with challenges at work, we might rely on other colleagues, in our area of expertise.

Obviously, you play the role you play for a reason. Yeah. But just curious about, that influence and maybe sometimes when there's friction, how you navigate that.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: So it's taking people on a journey. It's an education journey. Internally nobody had any commercial expertise other than myself. And so it's educating them along the way- ... so that when you go to that "Look, we want to set up X project. It's out of budget, but we really need it for these reasons." They are supportive of that recommendation.

And it's bringing them along the journey. So I'll bring them into some of the consultant conversations- that I'm having on prep calls or data readouts or discussion guides to say, "Hey, I just wanna get your thoughts in this because I wanna make sure we're aligned on what we're solving against. Here's what we're solving against. Take a look through this eye. This is with this type of physician, and this is why we're doing this work."

And then they understand the work product that comes out of it. And the next time I go back to the well to ask for funds that may be in or out of budget- ... they're like, "Okay. Yeah, we're gonna progress this work, and this is what it's gonna deliver."

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Thank you for sharing that. I have one more question for you, and then we're gonna jump to two questions in the chat.

So thank you for submitting for Farrell. So what it takes to thrive in early-stage biotech. More commercial leaders are joining clinical stage companies earlier in their careers than ever before. So what's the one mindset or capability you think that they need to build for now if they wanna be effective in a pre-launch CCO role, especially in an environment where you're expected to be, what, as I called him, a jack-of-all-trades?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Yeah. Don't be scared to do strategy and execution. Someone asks you to salt the streets. That's what my job entails and that's what my journey has been throughout small biotech is You come in, you have a predefined type role, and that role is in biotech loosely defined.

And then you come in and areas of opportunity, and you say ... I came into Trevy, I was US marketing, and I was like, you know that, you go back to what people don't understand about commercial. I was like, US marketing is this thin on the grand scheme of things. I was like, it's commercial.

And then bi- and then business development. Nobody was doing BD. And I said, "Do you care if I take over BD?" "No problem." Corporate comms is not working effectively. You care if I take on corporate comms?" "Great." So you just you get ... And there's something that somebody in our company used to say is, "You get paid bigger dollars to solve bigger problems."

Solve big problems, and, but don't be scared to execute, and roll up your sleeves to get the work done- to help the company at all costs. And with that mindset I think it takes a special mindset to make the shift. I've been really lucky and fortunate. I come from a scientific background. I'm a pharmacist by training, so I can get deep in the science as well as the business side- and play both of those roles. And at times that ... I was a problem solver. It was, "We're having problems in CMC." I led CMC for the company for a year. I'm not a CMC expert, but I can lead the group, make sure we get, we source it correctly, we got the right people in there, and that we're on the path there. Same with project management, did the same thing there. Same with clinical development for a period of time. So you just have to go with a problem-solving mindset- and collaboration.

I mean, it's key. You work in a cross-functional matrix environment in large pharma, it's the same. Small biotech's no more efficient. It's just as delinquent. Like I'm not telling anybody anything new. It all depends on the players and if you have a good leadership team and a good management team then things go smoother than not.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): I think that Swiss Army knife approach that- ... that you take to your work is something that's valuable at every level- in every organization. And thank you for setting a fine example for all of us. Thank you to folks who've submitted their questions in the chat. We'll see if we can get through them all. Maybe we'll take it as a little bit of a lightning round. Sounds good. We'll see if we can get it done. Looking back on your past launches, what's the most common pre-launch assumption companies get wrong too early in development?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: Access. They assume they're gonna get access on day one, and they set that expectation. And then depending on when you launch, you, you really have to understand the mix of your product. If you are a Medicare product, the Medicare review cycle is of ul- utmost importance. And if you don't hit that timing properly, your reimbursement is going to lag, and therefore your access is going to lag.

And people, I don't think, put enough early thought or into... you can't always control when you launch. You kinda get the date and it's like, "Hey, commercial, you deal with this." But it's setting the expectation because if you overpromise and underdeliver, that's where people get caught.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): When bringing in fractional consultants, how ... Oh, there we go. Thank you. I didn't know it was gonna move. How do you ensure providing a space where they can truly provide their expert opinions versus agreeing with you?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: So I think that's trust. And building that trustful relationship with them. Not seeing them as necessarily consultants, but seeing them as partners.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): Absolutely.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: And talking to them as truly integrated as part of the team. And that's where, as I talk about this, this group that I use for pricing and market access, in meetings, we just had a management meeting a couple weeks ago to discuss our pricing strategy and really understand if we were truly aligned on that.

And I go, "I'm not gonna talk. This is my workshop. I am not going to talk as part of this. And they are gonna lead the conversation." And that, that way it feels, whether, genuine to the rest of the team of how they're positioning this, why they're positioning this, why we feel the way we feel, and I can truly be a participant- in the process, not driving the process at every step, which feels sometimes a little forced to, especially those who don't know commercial.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): That's a tremendous signal of trust when the person that you're partnering with gives you the floor. In your current role, single asset firm, what's the one critical success factor to drive value to overcome all clinical issues to get to market?

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: All clinical issues. That was a key word within that.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): I don't know if we have the time.

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: I don't know if you can ... Yeah, I don't know if you can conquer all clinical issues. It is ... we're at this stage now, is I use the line chart. You can use it for any chart, is over time, one goes up, one goes down, and making the transition.

We're at the point where clinical and commercial transition needs to occur. And it's met with friction. It is, because clinical doesn't wanna concede that we're now becoming a commercial company. I'm not conceding that we're l- no longer a development company. And it, we have to start changing our mindset and changing the culture of the organization so that we can be prepared commercially.

It is execution for development, and they're gonna do a great job on that, hopefully. But now the mindset of the company has to make that shift. And so if you do that too late, and you don't align to when you're gonna start building those commercial building blocks- ... and shaping the market- Then you can be late.

We're a first-to-market product. We're hoping to be best in class and first in class in our indications. We need to shape the market. We need to educate, and we need to do that early, and I think some people educate the market a little bit too late or they don't educate it well, that it leaves them in a, a position of weakness.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): All right. Last question, and Farrell's gonna get his flower, so I wanna make sure we get to it. It says, "You've had an impressive career," which is true, "with some of the world's largest organizations, like Pfizer and P&G. What do you like most about a startup biotech?"

Farrell Simon, Chief Commercial Officer, Trevi Therapeutics: I'll say thank you for the question. A lot has come from luck. I will be the first to admit that. I love a small environment. I've been entrepreneurial since day one. I love the aspect of doing strategy and execution because you're never too far away from the patient, and that is ... That's what I love about biotech. I am so much closer to the patient today, patient advocacy organizations patients themselves.

We have a patient ad board, and we talk to them frequently across our indications. Hearing what they say, the urgency in their voices, and bringing that type of environment to our town halls, to everything that we do, it's exciting. It's invigorating. It's a big honor to try to progress a therapy on their behalf and really improve their lives.

Facilitated by Alison Tapia, Consultant, Digital Innovation & Omnichannel Performance, Sun Pharma (2): It's been a privilege to share the stage with you today. Thank you. Thank you so much for your time, Farrell. Thank you. A round of applause for Farrell.