Why Drug Launches Are Won Years Before Approval with Ana Bozas

Drug launches don’t succeed at the finish line. They succeed or fail years earlier, when teams decide what evidence they’ll generate, how they’ll publish it, and which assumptions they’ll pressure-test before it’s too late. In this episode of Pharma Sessions, host Jonathan Kaskey is joined by Ana Bozas, Director of Clinical Evidence Strategy and Scientific Communications at Vera Therapeutics, to dive into what launch readiness really means from the medical side.

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Transcript

SPEAKER_00 0:01

From my perspective, is to always question assumptions and make sure that you understand everything and then retest again right the day before kind of stuff. But with time, so that's the scientist, me, that's the me who works in isolation and just chugs along. But with time, I've noticed that it's the team that makes the whole thing. It's make sure that you know what your colleagues know, that they know what you know, that you talk to each other, and that you care about what they care. It's a mind shift. When you depend on yourself, you have a measure of control, and obviously I'm a control freak. When you depend on others, you have to cede control and you have to give up your part so that everybody can be successful. So it's a harder part.

SPEAKER_01 0:42

Hello, hello, and welcome to Pharma Sessions, a place for pharmaceutical leaders to come and learn from each other. I'm your host, Jonathan Kaskey. 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. On today's episode of Pharma Sessions, I'm excited to welcome Anna Bozas, a medical affairs and scientific communications leader with deep experience across rare diseases and biopharma. Anna currently serves as director of clinical science at Vera Therapeutics, supporting clinical strategy and kidney disease as the organization prepares for pivotal regulatory moment. Previously, Anna led scientific publications and medcoms at Ibsen with other roles at Pair Therapeutics, Ionis, Sinofi, and Acabia, giving her a unique perspective across startups and established organizations during high-stakes launch periods. Anna, welcome to the show.

SPEAKER_00 1:52

Thank you, Jonathan.

SPEAKER_01 1:54

Excellent. All right, so before we get into it, I always like to do a quick warm-up, a quick get to know each other. We're in the end of January now, but was there any music or albums that you were listening to on repeat last year? What did you find yourself playing when you were in the mood for that type of thing?

SPEAKER_00 2:10

This is one of those questions that seems easy to warm up, but it isn't because I'm a working mom with teenagers, so I have no hobbies, no life. I used to have a personality and like music, mostly Pink Floyd, but lately I'm just putting electronic music for work. So it's like coding music on YouTube. I'm not coding, but it's essentially be productive all your day.

SPEAKER_01 2:31

So I played from Pink Floyd the song, I think it was Pigs or something from the Animals album for my 12-year-old daughter, and she thought it was the most boring song that she had ever heard. She's like, this thing is seven, eight minutes long. What are you doing?

SPEAKER_00 2:46

It is seven, eight minutes. Long, I don't know, with the current attention span. I um tried the karaoke night with my girls, and they told me I'm tone deaf, and that my music choices, which happened to be the 80s, were completely too old and unfashionable. So yeah.

SPEAKER_01 3:02

Oh no, you gotta stand your ground on that one. They're the ones that need to come around.

SPEAKER_00 3:05

So it's fine. I love them anyway. How about that?

SPEAKER_01 3:10

There you go. So let's start a bit with your journey. So you grew up in Romania, moved to North America through Canada, Utah for your PhD, eventually landed in Boston. How do you think that unconventional path shaped who you are today?

SPEAKER_00 3:24

Yeah, I don't know. For me, it seems very conventional. I will say that uh you don't know what normal is because normal is normal to you, kind of thing. So uh I will say that me in biotech and pharma, very few people have one set past. Most of my colleagues uh do weird um circumventions and uh go in loops. Typically, the degrees that I see most around me, obviously being in medical, is MD, PhD, and PharmD. And very few of us think that we'd be working for pharma in the future. Nobody says when you're seven years old, what are you gonna do? And you're gonna say, I'm gonna work for a big corporation making medications, okay? Even if you do want to hear all the world, the others or whatever, okay? Passive pharma and biotech are very rarely straightforward. I think there used to be straightforward 25 years ago, or maybe, you know, my parents' generation, but certainly not this generation, but whatever's coming after us.

SPEAKER_01 4:16

That's interesting, right? Because it kind of brings like a diversity of thought, we'll call it, as people have their own experiences and their own interests before they get into pharma. And you've described yourself not necessarily as an innovator, but as a collage artist. So what do you mean by that? And how does that mindset show up and how you approach, you know, medcoms, launch strategy, etc.?

SPEAKER_00 4:39

That's a good uh characterization. I essentially the the the reason I gave myself that label is because we in biotech, at least, we say all the time, and pharma for that matter, uh, we say all the time we're innovators. And yes, in a way, we are innovating because we're bringing medicines that didn't exist before to life and all of that. But I think it's less about innovation and more about learning what works for you and applying that in a way that is successful. So that's why I'm saying it's a collage artist. I took, I try to take the things that I admire best about the various things I encounter in my uh work life and my personal life, to be honest. Okay, I don't keep it all that all that separate, and try to bring that collage of uh best practices and uh great ideas together to sort of shape the current vision. And it's it's always a different vision. We kind of all aim for the same thing. We're always all patient state-centric, we always want to sort of serve the patients and save the world, but we do it differently at different organizations.

SPEAKER_01 5:39

So I think I understand what you're saying, but you have an example of what that actually looks like.

SPEAKER_00 5:43

I've been for the most of my career in publications and scientific communications, right? And publications, in a way, it's a very templated thing. So you have research, you have to put it in a paper, you submit it to a journal which has been there for a hundred years, so they have a way of doing things, and then it goes out and people read it. So it's a very standard thing. And the printing press has been around for 600 years, and before that, quill and whatever. So this is pretty standard in some ways. But how you express your ideas, what kind of idea you do, how you disseminate in this uh technology world, what makes your specific drug special or that particular disease that needs attention, all of these are things that vary quite a lot. So that's the stuff that changes from for me from company to company. It may be the same thing that I have to do, but I do it relatively differently depending on where I am and what is needed.

SPEAKER_01 6:35

I'm just curious about this. Like, how much does right now you're at a kidney company, right? If you are at someplace else, you might have a completely different set of doctors and patients and caregivers that you're trying to get messaging to. How much of it is the same, regardless of who the specialty or the demographics of who the patient set is, and how much of it is legitimately different around different channels and different types of communications that you're trying to put together?

SPEAKER_00 7:03

So I will say the thing that doesn't change is the fact it's a medication, it's heavily regulated. It has to do with the health of patients. You cannot treat this lightly. Medicine is medicine, and uh you cannot start embellishing stuff out of the blue. It has to be based in science. And of course, I heavily believe in science, so I would do that even if I didn't have a regulation, but it helps to point to a regulation. That's the steady and constant part. The things are changed on what is your, you know, it may sound a little light-hearted to say audience, because the what we have as audience are, of course, the patients themselves, and all of us are patients at some point in time uh or other. And you know, I'm approaching middle age, I've been a patient more frequently these years. I mean, it's a little closer to my heart than before. And you also have the doctors, and the doctors are not all alike. I mean, from the outside, perhaps, you know, it's like the teachers, all the teachers are the same, but they're not, okay? You can have a specialist doctor who's been there and doing that particular area for years and years and knows all about it, but that particular organ, or even sub-organ, depending on the case. You can have generalists, you know, you have the general practitioners who will refer. You could have somewhere in between, because some diseases, depending on where they are, may not manifest as their final thing. There were rare diseases that were basically your organism is missing an enzyme, and because you don't have that enzyme, you go into a slow spin to end the decay, of course, which is never pretty, no matter which disease. But my point is with all of this, is that go through stages. You could have maybe neuromuscular degeneration, you could have kidney involvement, you could have digestive things. There were some diseases of uh pediatric diseases that are absolutely heartbreaking that have to do with bone growth, where you fall down and you bone drones instead. But depending on what that disease presents, it involves different specialties. So some of these, like this stuff with the bone disease, it might not be caught by a general practitioner and it might not get yet to the specialist. It might be caught by somebody who gets referred to physiotherapy, and the physiotherapist says, that's not a normal lump. Maybe you should check it out. So depending on the pathway of the disease, you have different people who touch it, and that's where you have to figure out who needs to know what. And again, we don't even stop with the doctors, you also have nurses and physician assistants, you also have the reimbursement field and so on. It's an involvement process, but we're all people who this is it matters to all of us.

SPEAKER_01 9:23

That's what I think is always so fascinating about medical, is you do have all of those different audiences that you need to tailor your communications to. So, in that, you may have a parent who's dealing with this tragic situation that's and there's so much emotions involved. The doctors, I'm sure, are attached, but they must be they almost have to be a little bit more emotionally removed in order to keep functioning. And then you have the payers, and it's like, okay, well, how do you quantify the value of being able to brush your teeth or walk down the stairs or something like that?

SPEAKER_00 9:57

I will say some of my colleagues almost went the payer out or went the payer out and came back. So, you know, I see that perspective too. I used to be like it's all about the money. It's not even all about the money. From a payer's perspective, is I have this group of people and I need to keep them all healthy. How do I best use my resources so that everybody gets maximum health? They're not like trying to, there were conversations a few years ago when uh youth and Asia got approved in Canada about death panels, you know, because you're gonna try to kill your most expensive customers, whatever you want to call it. It's not about death panels. It's not about trying to deny people the cutting edge uh um, you know, advancement. It's about is that proven that it does what it does? And if it proves that it does what it does, what's the maximum benefit I can do with this amount of money that I have? It's having a budget.

SPEAKER_01 10:44

Right. And what and correct me if I'm wrong, but that kind of gets into formulary status and the like, is essentially where that comes into fruition. And so, I mean, that is part of pharma's always arguing that we should be on a higher formulary than others. So it's still a competitive space. That's where it gets tricky, right? Because there's there's that distinction between marketing and medical, but they sort of like if you don't get on formulary, no patients get your drugs, and then your drug fails, your launch fails.

SPEAKER_00 11:19

We always have this thing of, you know, if a tree falls in the forest, does it even make a sound? You know, if there's nobody around to hear it. So that happens to medical when if we don't publish, we could have all the data. If it's not published, nobody sees it. That happens to commercial if nobody buys, what does it matter if the drug exists? You know, so we all we all suffer from that tree falling in the forest. Problem.

SPEAKER_01 11:41

Yeah. So let's talk about that a little bit more. I've already used the phrase marketing is optimistic and medical deals in reality. So from your perspective, Metafairs and Scicoms, where does that tension between commercial ambition and medical responsibility show up most clearly during a launch?

SPEAKER_00 11:58

I will say that the reason I said this is because I think marketing needs to be optimistic. They need to have a vision of what they want. And when you have a vision, by default, is you have to forge a thing that doesn't exist. So you have to be optimistic. If you start with the catastrophe, you're not going anywhere, okay? So I think that's a good thing. But what medical does and what we do best is keep things anchored in the reality and with evidence. So that's the tension, you know. Like you want to say, you know, I'm perfect, but you can't say perfect. Medical will be always with the limitation that, and with the explanation that you can do this and only that. We only have evidence for this. You might potentially be doing a third thing, but there is no evidence yet. And we have to always, you know, have that limit. I do think that it's great to work with commercial partners because they're very energetic and motivated. Because they're so optimistic, they're like, oh, we're gonna win, we're gonna be great. I don't know who wants to be on a team that's not winning. I want to be on the winning team. So that enthusiasm makes me come to work happily, okay? But sometimes you have to pull them back from the brink and say, I know you want to make this statement, but let me explain to you how I would say it because the way you see it now, it's not backed by evidence.

SPEAKER_01 13:14

Also, like the optimism is good, but it also like I always think of that at one point a couple years ago when that book Demon Copperhead came out. I got really into it, and then I reread David Copperfield, and there's this sad sack character, I think his name's McCaubber, in there who's always in debt, and he's going to debtor's prison. And he has a quote where he says something like annual income 20 pounds, annual expenditure 19 pounds, result is happiness, annual income 20 pounds, annual expenditure 21, and the result is misery. And I feel like that's the same thing with a drug launch, where if you set the expectation that it's gonna be a $800 million product and it's an $850 million product, everybody's happy and everything's great. And vice versa, right? If you say it's gonna be a billion and you're at 900, then you're a failure and the stock suffers and everything else. So how much does medical, if at all, factor into that, or how do you deal with that? Because like there's so many things that when people are like, oh, it was a successful drug launch, it's often about meeting, did we meet expectations or not?

SPEAKER_00 14:22

I think that you you've put your uh your finger on the right uh question. I will say that you know what makes a successful launch is highly valuable. In a launch, that's when you prove that your company is able to do what it says, what it does. You know, I was listening, I forget now which entrepreneur was saying the difference between tech and biotech. So in tech, you have to have a prototype from day one. In biotech, you don't see anything for 10 years, and then you win. So basically, you have to launch is when you tell your investors, listen, this you haven't seen anything for 10 years. Let me show you now what we can do. That thing of, you know, of the money pressure certainly is large. And uh commercial does make uh these projections about how many of the product they're gonna sell, and then they estimate a price. And there's always the competition. What is the competition selling it? What are they gonna do? So it's a whole model that they're building. So I've seen people where the situations launches where the drug was selling, it was available, the patients were taking, they were compliant. So you worry about whether or not not that the drug works. Usually the efficacy is proven in phase two and phase three. But you worry about that maybe compliance as in um people not don't stay on the drug is ideal, or you worry about side effects that didn't happen in the clinical trials, but now with bigger populations or populations that you weren't aiming for, maybe it's off-label for some things happen or whatever. So there are things that happen in real life that you can't plan for, you do your best, but in the end they happen. So these are things that could more or less muzzle a drug or take it off the market. FDA definitely takes it and DMA, the regulatory authorities take it for safety, number one. But you could be that it doesn't gain market share because it's not easy to administer or not easy to stay on the very due to various issues.

SPEAKER_01 16:09

And what is RedCall's role? I mean, you have a lot of times a lot of MSLs out there having these conversations. So, what's your role in finding these early while there's still time to adjust strategy or or refocus, you know, the types of data that you're publishing?

SPEAKER_00 16:25

So I will remind you that I'm a scientist, so I'm very biased towards the research side, okay, you ask? But I will say from for me, it's always about the data, the research. You know, what's the basis of doing something? And the thing with research, that the reason why, you know, a biotech is different from tech, and it takes 10 years to get there is because you need to research it and you need to research it in humans, and humans have takes a long time for a human to do something. You could do it in flies a lot faster, you could do it in mice a lot faster, but they're not human. And in fact, that's why you do the preclinical research initially in smaller organisms or directly in the dishes. It goes fast, answer all the questions that you can, and then you move to the human. Once you move to the human, it becomes expensive and slow. So you have to choose what kind of questions you're gonna make that are absolutely necessary to establish, not with unquestionable clarity, but to the best of your ability for that aim, okay? To establish to get the most out of that research question with as little, the most bang for the back, okay? And those are the phase one, two, and three studies. Phase one is making sure that it doesn't do anything weird to healthy humans. Phase two is making sure it works in the patients with your disease, but you're testing typically different um doses to make sure you have the ideal dose, one where you get the maximal benefit but the least amount of side effects. And then phase three, you're doing whatever worked best in phase two with the most amount of people to make sure that you even if it wasn't a lucky shot basically in phase two, because if you work with small numbers, you could just get lucky, okay? So in phase three, you increase the numbers to say, do I see the same effect? If you do, you didn't get lucky, it's really effective. So that's the typic, typical question. So medical wants to have that plan basically when the company is 10 people, if it's a biotech. It's a big pharma five years uh ahead, okay? That's very early. Nobody else is thinking about that question, okay? And so we have to think very early about what the things could be happening five years ahead, and then line up a research plan in advance as things move forward. If something works, then what would be the next step? What other question should they be asking and answering? That's the medical question. You know, what do you want to think about? You want to think about way ahead of everybody, and you want to think ahead with like a whole contingent of uh research questions and answers that you could be setting up.

SPEAKER_01 18:48

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SPEAKER_00 20:01

I would say that metaphairs and psychomes generally should think about the data being published. That's the number one thing, is the the tree falling in the forest. If your data is not out there in the minds of the audience that you're trying to reach, it doesn't exist. It doesn't matter how many years you spend. Science is merciless sometimes. So with this metaphairs and psychomes, you first think about if I'm at launch point, what would I want to say about the drug? What kind of evidence needs to back this up? Do I have it set it up? When is it panning out? When is the results of my research coming out? And then do I have enough time to publish? And publication takes, if you're reasonable and you're not trying to kill yourself, about a year for a manuscript. You can do it faster. Absolutely, you can do it faster. You just it consumes. You there for everything, there's a price. So to be honest and to not have uh surprises, you say it's gonna be a year, and then you do your best to get there. It might be less, it might be more, you do your best. But you have to think in in these increments, in yearly increments essentially, or more.

SPEAKER_01 21:03

And have you seen, because you've been involved in a number of drug launches, I'm sure not everything goes perfectly, right? So let's say Metafairs is brought in too late, I guess to make it useful. What's some indications that that might be happening? And then how can you adjust? If you are not, if it's not a perfect scenario, you're not doing this long-term planning from the beginning.

SPEAKER_00 21:22

So, in some things you can make up the time, in some others you can. So if it's a drug that has already been on the market and you're doing a new indication, you may use previous research and say expect similar results. Okay. If it's a new drug, nobody has seen it, new mechanism, new administration, the disease hasn't been researched, and you come at the 11th hour, good luck. The only time you might get grace there is if there's no other competitors, nobody has worked in the field, and usually the need is so big that the patients and the FDA will work with you. But it has to be a desperate case. And I've seen those desperate cases happen, and there's a reason, you know, that nobody else has done it. When you arrive at the 11 Tower. Let's say we're at the 11th hour scenario. Usually you have like that proverb where it says the best time to plant a tree is 20 years ago. The next best time is today. Okay, so now you're with the tree planting today, okay? What can you do? It's rarely about getting data at that point. It's about looking what is it that you have that you can publish right away, obviously, if you already have something. If not, it's working as a team with whoever's left in the company to at least support their needs. Ask them what do you need and see, can I at least meet that need? There are some things that they're gonna say, well, I want real-world evidence for 500 people on this drug. And if you haven't launched, you can't get that evidence. They first have to have the drug to test it. So you're gonna say that's a very nice theoretical thing. I'll see you in three years. But sometimes they're gonna say something like, I want to know if it has digestive side effects. And then you can look in your clinical trials, which you've had to do at least one or two, and you can say, This is what we've seen. You might not be able to say in all people everywhere, but you can at least go to a subset and say this is what it had. So being realistic is the when you're at the 11th hour. You know, ask everybody what do you need, and you can say, This is what they where I can meet you. Let's work on that. That's the low-hanging fruit. And then we can work on the more difficult stuff with time. Sometimes, you know, that's enough. Sometimes it isn't. Again, you do the best with what you've got.

SPEAKER_01 23:20

At one point in my career, I worked for a company that did a lot of advisory boards. And what I always thought was very fascinating was that some companies had very some of the pharma manufacturers had really different takes on when do we engage advisors. And it always made so much sense to me, the ones who did it. I guess maybe I was biased because I was like working putting on these ad boards, but it's like, well, if you do it early and you're talking to them about what endpoints do you need to see while you're still designing the protocol, that to me made a lot of sense, right? Because that's kind of the type of planning that you're talking about, where you are you are spending all of this time and money marching up towards hopefully a drug launch. And you want to make sure that when you do launch, are you going to be the first line treatment? Are you going to be the second line treatment? What are they more concerned about this, that, or the other thing, safety, whatever? And having those conversations early just seems like it will help you so that you're not in that scenario where, okay, that data is great, but it doesn't actually answer my primary question.

SPEAKER_00 24:22

I fully, fully agree with you. I couldn't say this, like couldn't endorse it any harder, okay? And it's not just not just prescribers, or not just your doctors or even nurses and uh PAs, which should be taken into account, but it's even patients. So depending on the drug and disease, you might have symptoms. It's not that the doctor don't hear about symptoms, it's that some symptoms are very generic. There are some disease areas where you can have extreme fatigue. And when you tell your doctor I'm tired, they're reasonable people, they've seen all sorts of diseases. For them, if you're bleeding on the floor, that's clear in emergency. If you're tired, you probably can wait. We will find a solution. We'll give you coffee or something like that. But there are diseases when you're tired, as in you go to the grocery store and you need to sit on a chair, just having entered the store because you're tired. And then you move two more aisles and you have to sit on a chair again. Okay, it's that tired. It's really hard to quantify that medically. So then you you need the patient to have to express how that interferes with your life, and then to say, well, when you're looking for your drug, try to look for this benefit too. That matters. If your drug not only makes your disease better, but the symptoms too. I mean, a patient is like, I'm in heaven, I can now go grocery shop. Maybe that's not their dream ambition, but not to sit on a chair every two steps. It's something that makes a difference, okay? Alongside, I mean, I wouldn't say to replace the main efficacy. Of course, you want the drug to work on the disease, but if it has additional benefits, why not? So that's sort of the reason why you have to talk early to basically your stakeholders, which are the patients, the doctors, the nurses, the physician assistants for sure. I will say that I've seen some things, of course, you have to talk early to regulatory authorities, and that's I think every company does well, because for them, that's the go-no-go decision, what the regulatory body says. But I've seen some companies fail to have their drug approved for things like they didn't understand what is the correct endpoint. But these trials take five years sometimes, they give in 10 years. Depends on which disease you are. Sometimes you're lucky that they take only two years, okay? But either like longer years. Things can change during that stuff. You can learn about the disease. There are new investments that say, oh, well, it's not this mechanism of action, this is other, it's not this pathway, this other pathway, it's not this molecule that you think was affecting, it's this other molecule. So everything that you thought was going through molecule one is now invalid. It could be technological changes. Just because something is done standard for a particular organ may or may not apply. And you may find out at the 11th hour, and that's really the sad part. So I would pressure test all of these assumptions as early as possible with everyone.

SPEAKER_01 27:00

That's wonderful. All right, Anna, let's wrap up here with one final question. So let's say these episodes generally get published on a Thursday. If you could give one piece of advice for somebody listening who's in Metafairs, in Scicoms, to take in and implement on a Friday, right? Like this is the one thing you need to do differently tomorrow. This is a very on-the-spot question, but they're preparing for launch. What's your advice to them?

SPEAKER_00 27:26

It's a good question. I tend to think, from my perspective, is to always question assumptions and make sure that you understand everything and then retest again the day before kind of stuff. But with time, so that's the scientist, me. That's the the the me who works in isolation and just chugs along. But with time, I've noticed that uh it's the team that makes the whole thing. It's make sure that uh you know what your colleagues know, that they know what you know, that you talk to each other, and that you care about what they care. I'm sad to say that I've become a people person. It's a mind shift. When you depend on yourself, you have a measure of control, and obviously I'm a control freak. When you depend on others, you have to cede control and you have to give up your part so that everybody can be successful. So it's a harder path. That's basically where I am. It's easy to be by yourself and say I can do it and work alone. It's harder to work in a team because you have to chug and be motivated and interact. It's uh it's more, in my opinion, there are extroverts who will say for them that's how it is. I'm obviously not an extrovert.

SPEAKER_01 28:31

I love that. That's a great answer. So you heard it here first directly from Anna. She's approved you to take your team out, send the expenses her way, and have a nice Friday lunch. Get to know what motivates each other. I think that's a fantastic answer. And uh yeah, let's leave it there. Anna, thank you so much for joining me today.

SPEAKER_00 28:48

Thank you, Jonathan. It was a wonderful conversation.

SPEAKER_01 28:51

Absolutely. 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.