Navigating the Commercialization Journey: Insights from Science to Market

Welcome back to Cut the Chat: Life Science Insider Podcast, Season 2 Episode 2, hosted by Seuss+ CEO and co-founder Sabine Hutchison. Cut the Chat promises to facilitate the conversations you've been dying to hear and tackle the real crux of our industry's challenges.

Let's get today's episode started. Let's get to it. Let's cut the chat.

Kirsten Detrick is a biotech and pharma leader who's known for commercializing new therapeutics and shaping drug pipelines for major firms like Amgen, Bristol-Myers Squibb, and Takeda. She's led or launched four blockbuster therapeutics, including Entyvio, Enbrel, Prolia, and Plavix, and when added together, these drugs delivered over 26 billion in total peak sales to their respective companies.
Currently, she's a global partner at Scilentia, where she leverages her strategic and technical expertise on behalf of emerging biotechs preparing for commercialization and launch. In addition to all this, she's an adjunct professor at the Dartmouth College Tuck School of Business, she serves as a trade representative who helps companies expand to Switzerland, and she's the CEO of two stealth biotech startups.
And that's where she and I first met — she's a former recipient of the Healthcare Businesswomen's Association (HBA) Rising Star Award, and is a sought-after public speaker and adviser. I'm thrilled to have the dynamic Kirsten with me today. It's such a pleasure to have you on the podcast today, so thanks for coming — I have to think, as I was reading through your bio, about how we first met, when you were in...

Hello.

Austria, actually — right? That's right, yeah. And you were with the HBA. I'm so happy about the HBA, because it's led to me meeting you, plus so many other fantastic people. It's such a great networking opportunity, isn't it, the wonderful HBA.

It really is. The HBA is just a fantastic group, and I've had the benefit, since I've lived and worked both in Europe and in the United States, to see the organization on both sides of the pond. So it's a great pleasure to be invited — thank you for the kind invitation, and I'm thrilled to be on...

Cut the Chat with you today. We've had lots of conversations, and I'm glad today we're finally able to record some of the ideas and topics that we've discussed over coffee. So now we're just going to share some of these thoughts and ideas for the biotech industry, which we support obviously at Seuss+, as do you. And today we're going to focus on the commercialization side of biotech, aren't we? Although many biotechs think, "Oh, I don't need to focus on this aspect of the business, because I'm going to sell my asset, or potentially partner with another organization to commercialize the project." But we want to take a bit of a different look at that, and I'm really happy to have you here today to do that. And I guess that leads us into the first question: why is it so crucial that biotechs actually think about prioritizing commercialization strategy and energies, really from the beginning — the early stages into their entire product development pipeline?

Yeah, it's so funny you say that — you hear from biotech, whether they're founders or leaders, "Oh, I don't have to worry about this." I've been in so many meetings where the head of discovery or development literally says those exact words: "I'm going to exit, I don't need to worry about commercialization," or "I'm going to find a great partner who's going to do that for me." And the thing about that approach is it suboptimizes all of the blood, sweat, and tears that the scientists have put into developing a particular asset. It sort of makes me a bit sad, because what a company is setting itself up for, if they haven't properly prepared for the commercialization stages, is leaving themselves open — they don't have the sophistication, they don't have the understanding, they don't have the depth of knowledge it takes to negotiate for the highest value for the asset that's currently being discussed for a possible out-licensing or acquisition.
It's funny, I think of scientific discovery, development, and commercialization as a relay race — somebody's in the starting blocks with the molecule, they start racing, then they hand it off to development, and development hands it off to the next person in line, and so on. The point is to get across the finish line, and everybody, the whole team, has to get across the finish line of commercialization. If commercialization isn't included in the team, you're not going to stick the landing, you're not going to win the race — you sort of run halfway around the track and then completely lose steam. And I think that's a real dangerous place for biotech startups to be, quite frankly.

Yeah, absolutely. You've already mentioned some of the risks associated with that. Maybe you can bring some of the experiences you've seen, and even some examples, where companies haven't — I think it's also so important to look at commercialization, because there's so much more to it than the one dynamic we often think about. It would be great if you have any examples, or have had any discussions or experiences with some of the biotechs, or even some of the organizations you worked for that have actually purchased assets — what are the dynamics around that?

Well, what really happens, I think, is that you have incredibly brilliant scientific minds that come together, and they kind of don't understand what commercialization is. There's sort of two views of commercialization: it's either "this is just a black box, nobody understands it, it's super complicated, and that's not my area of expertise," or "oh, that's so easy, commercialization — I've created an incredible molecule, this thing is just going to sell itself, and everybody around the world is going to recognize how important this is." Which couldn't be further from the truth. Unfortunately, biotech is a hyper-competitive industry, and I've worked with organizations where, in one example, a company didn't even have a TPP — a target product profile, which is the full list of every attribute and benefit that comes with those attributes or features of the drug. They didn't really understand beyond, "Well, we've got a great mechanism of action, our mechanism of action is completely different than anything else on the market." But nobody's going to prescribe a therapeutic just because it has a different mechanism — they'll prescribe it because it's got better efficacy, as defined by: it works faster, it lasts longer, it delivers higher safety benefits. There are lots of differentiating benefits, but unless you actually write them down and then test them with the various stakeholders who will be exposed to your drug, you're really running the race blind. It's not a relay race anymore — you're literally tying a blindfold around your eyes and running down the track, and you don't even know if you're still on the track.

And the TPP you mentioned — that's a key piece, I think, when you're in large pharma. That's kind of the Bible, isn't it? That document is taken very seriously, and completed and worked on throughout the life cycle of the development of the molecule. And I think so often in the biotech space, they maybe just cut out certain pieces of that that they think potentially are going to be beneficial or needed. And if they do that — which I can understand a bit — what pieces are the most crucial? If you were to look at a TPP and say, "All right, they definitely need to focus on these areas," what would you suggest?

I think the most important thing with building a TPP is you've really got to be comprehensive — it's critical to get it complete, and go well beyond what you, as a scientific leader, might think is necessary. For example, I hear all the time from development pros, "Oh, we have a better delivery system, we're oral instead of injectable," and those are certainly important convenience benefits. But quite frankly, what's being lost in the conversation is that payers really don't pay for convenience — that's not something they're interested in. So I think this is something most startups have blinders on — they think it's only about what they see from their view, and they're not able to necessarily open themselves up to the view of their stakeholders, and that's what's so critical.
The company I mentioned, that I'm a global partner in, Scilentia — we work to align stakeholder views, and see, even before we do the alignment, are they aligned at all? For example, if there's an incentive in the United States for physicians to be infusing a therapeutic, and a more convenient oral comes along that's maybe more convenient for the patient but loses that incentive for the physician, there might not be aligned incentives in the marketplace. Understanding all of that needs to be done well, well earlier than phase three — you need to be really taking a commercialization view at phase one, and starting to shape your target product profile comprehensively at that point.

Yeah, absolutely, so agree, because again, this goes to — I think in one of our previous conversations as well, we were talking about asset value, and that's really the goal of this, isn't it, regardless of commercializing a product yourself, or with a partner, or a potential exit?

Great. Completely agree with that, and I think that's the thing we, as small startup biotechs, can forget — we sort of say, well, as I said earlier, "the science sells itself." It doesn't. And the value, the way I think about it as a commercialization expert, is: I stand on the shoulders of years and years of contributions from incredible scientists, and my job is to optimize the value of the molecule I'm working on, because it reflects the value they put into developing and discovering that molecule. The challenge is, if you don't have a commercialization person on your team, you're probably going to leave yourself open to a situation where you're going into a negotiation with a large pharma who knows a lot more about the category than you do, who may actually have a view on your commercialization expertise, or lack thereof, that reduces the value they're willing to pay you for your exit. Or, if you're out-licensing, you want to be in a sophisticated position — you want to know everything around the whole chain of contributions, all the way through to, not just that the science is great, but why will physicians use this, why would patients like this, how will payers view this. Having that view optimizes the value you'll get out of any out-licensing opportunity, because that's part of what you can sell to your future partner.

So, kind of going back to the TPP — if you were to give advice to a biotech, either that's starting or has potentially already started, say phase one or phase two, what would you suggest for them to do around that, and around the creation of it?

The first thing to do is get your entire team to sit down and make contributions — there's an actual format you can use, and you write in, for every single component of the TPP: what are the efficacy endpoints, what are the secondary endpoints, what are the safety parameters, how is it delivered, do you have any value components in terms of payer value — will this therapeutic actually enable payers to remove another therapeutic from a patient's total drug load. Every single possible benefit gets literally written down in that format, and then the next thing you do is take it out to the various stakeholders and test it, and say, "What's the response to this?"
I worked with an organization recently that was working in the space, and something popped on their TPP with physicians that they completely didn't expect would be a real benefit. What they heard from physicians was, "This is a critical component of me knowing that, long term, this therapeutic is going to resolve" — in this case, a downstream sequela of a disease — and that healing benefit was really, really important to physicians. The company had been thinking, "What's really important is that we're 40% better at this particular endpoint than our competitors," when in fact it was actually more of a secondary endpoint that got the attention. So testing from the very beginning — not just what you have, but what you want to build. If you're in phase one, the word "target" is intentional — it's what do you want to deliver, not necessarily what you've already got in the "in the can" product profile. You want to be building and designing your therapeutic toward a specific target. In the big pharma space, theoretically, if a product doesn't deliver on that target product profile, the therapeutic gets shelved, because that's what you're trying to achieve — that's the target.

Absolutely. And also, I think the key piece — I was speaking with someone from J&J some time ago, and they were talking about how important this TPP is for their products as well, and also looking at the competition — what's going on. This is also something that happens during the life cycle. You don't just do it in the beginning and look at what's out there — it's so crucial to look at that through the entire product development phase as well.

It's happening. In fact, what's best practice is building a feed for your competitive therapies that are already in the space, but also the ones that are in the pipeline, and getting a sense of, okay, where is this market going to go in the next two to five years, and how does my product position itself in that future market? That's a pretty sophisticated way to see how your product is going to fare in the real world.

And do you see that also as being beneficial — so, for instance, when you're in the clinical trial phase as well? Again, we hear a lot — we have companies come to us struggling with patient recruitment. So I'm also assuming that can help, when you're looking at going into the clinic, to see, okay, who's out there, and who am I competing against for patients in clinical trials?

Yeah, absolutely. One of the toughest things today in development is getting patient enrollment and delivering on your target patient enrollment from a clinical operations perspective — understanding, are patients going to be interested in this during your trial? That's really a cogent point, because it can help you understand: are my estimates of clinical trial enrollment overestimated, are they underestimated? You can get a sense of how vibrant and interested patients are in your product by exposing them to a TPP.

Okay. Super critical piece in the development process. We talk a lot about asset value, and how crucial it is to think about commercialization early on. And I'm really curious to understand, because you've obviously worked for large pharmaceutical companies who've acquired assets from biotechs — I'd love to hear what that process looks like. When you're evaluating potential assets to acquire, what are some of the criteria for the asset or the molecule, and how much of the commercialization potential is evaluated during that process?

I'd argue that that process is all about the commercialization. I think what happens is, if you're a startup and you don't have anybody who's got experience in, let's say, big pharma, you might have a perception that the way this works is you go to the business development leadership of a company, you talk to them about the science, and they make a decision. That couldn't be further from the truth. The way it actually works is that business development individual is the figurehead, the tip of the spear — they convene a cross-functional team of people internally at the pharmaceutical organization, which includes development scientists, CMC experts, toxicology experts, but they're also adding in commercial people, which include experts in physician marketing capabilities, payer experts on what kind of price this asset will be able to command in the marketplace, and market research people. So you really have a big team on the pharma side — that can be up to 10 or 12 people. And those 10 or 12 people coalesce around, "What's our view of this molecule?" And if their view is that the commercialization value is aligned and worth the investment they're thinking about, then you have to go up the next level and convince everybody, up to potentially the CEO, depending on how big the opportunity might be.
All the while, big pharma's team is also assessing potentially other assets in your same space. So if you show up and you don't have a sophisticated view that matches the level of understanding of the people you're at the negotiating table with, you are absolutely undervaluing your asset — you will not command the value you really should be commanding, because you're going in a little bit naive, or maybe a little blind, and getting help is critical to making sure you're generating the kind of upfront and longer-term payout you're looking for, the milestones that are advantageous to you. All of those things are contingent on how the commercialization group sees the potential. So getting through the development team is the first hurdle — that's not the last hurdle.

Can you give some examples? I'm curious to hear some of the success stories of some of the companies — what did they display, what did they do, that took them to the top and increased their potential multiple compared to others? Do you have anything you can share there?

Yeah, I mean, I can't go into confidential stuff, but there was a company I worked with — a team internally, myself and our development leader, I was the commercialization leader, and we led a group to assess a really, really exciting approach to dealing with a pretty severe GI illness. That's one of my areas of specialty, GI, and quite honestly the science was incredibly compelling, but there was a huge concern about the distribution capabilities of a drug that had a 24-hour shelf life — how do you actually make this work in the real world? So we brought in our manufacturing experts, who drilled in hard on how this was actually going to work, and the startup was pretty sophisticated — more importantly, they had mapped out how this was going to work. They didn't just wave their hands, they were very specific about this component of the commercialization process, and that really helped them generate a better value for their asset. I think that's one example.
I've also been on the pharma side, where you've had a fairly unsophisticated group come in, and internally we look at each other and think, "This is actually pretty good science, but they don't really understand what they've got here, so we don't have to give them the kind of valuation they might actually deserve — they just don't even know how good it is."

Of course, that can be devastating for an organization as well, if it doesn't go their way. And would you say that the companies that — maybe going back to this idea of the target product profile, since we're focusing on that a bit today — did the organizations that got better outcomes also have a very comprehensive TPP completed?

Or, not their TPP — you can tell the ones that have actually done the work. They don't necessarily show it, they don't necessarily bring it to the meeting, but you can tell the way they talk about their asset, in a truly 360°

Right, right, you can.

way — you can tell they've done the homework, and they show up to the table ready, ready to have a really, truly engaging conversation, not just with the clinical development group, but with every cross-functional member of a commercialization team. They show up ready to play.

Nice, wow. We've hit on a lot of topics today that are crucial for biotechs specifically to think about when they're putting their commercialization hat on, and their development hat. Could you share with us — if you were to put together a list of the top three areas they should focus on, how would you prioritize those?

Terrific question. I think there's probably — I'll give you a bonus, I have four actually.
The first is really understanding how your product differentiates itself in the market, what is the benefit that your therapeutic offers to the marketplace — how well anchored is that, how well understood is that, how is that valued or not in the marketplace. Here's an example: I was recently advising a company, and I was looking at their website — it was a new engagement — and their website is really... it's kind of slick, it grabs you visually, except all they discuss is the mechanism of action of their therapeutic. They don't tell me why should I care — what is this going to do for me, as a physician?

The "so what"?

The "so what" — getting to what is the benefit, I think this is one of the things biotechs can miss often: they jumble up a feature with a benefit. I guess the best way — I don't know if I can come up with a good example, but the feature is: my mechanism of action works in a certain way. Well, okay, that's great, that's the "what," you know, the "how." Tell me the "what" I want to know: what are you going to do for me? Oh, you're going to work faster, you're going to work twice as fast as the competition, or you're going to last longer, or you're going to increase the rate of remission — all of those markers that are meaningful, that's the benefit, that's what you're looking for. And I think that's tough for biotechs, because they get wrapped up in the science and don't simplify and just bring it up a level: say, why should I care?

And communicate it clearly as well.

And communicate it clearly.

And that's so true for so many organizations, isn't it — we know what we do well, but it's the communication piece that a lot of us struggle with. It's a good point.

Yeah, yeah. And I think it's all about the "what's in it for me" — if I use this therapeutic, what's it going to do for me, whether I am the payer, the physician, or the patient? So I think differentiation, anchored in a meaningful benefit, is the first topic on my list. The second would be: what is your profile, and how appealing is it to payers? And by the way, payers — there's a huge difference between payers in the US and payers in the rest of the world, but in either case, no matter what geography you're located in, that payer access question and balance is critical. Just because you think this is a better mousetrap doesn't mean that a large payer — or the government, for example, when I was working in Austria, the federal government in Austria — is going to think this is a high-value therapeutic. And I think it's such a foreign concept to many early-stage biotechs, even mid-stage, that they kind of want to learn, but they're almost afraid to learn — it's like, "Wow, this is scary, I don't understand it, it's completely outside my realm of understanding." Bringing in somebody who can help teach you what this is about is going to drive up the value of your asset, because when you're asked the question from a big pharma — what's the price your therapeutic is going to command in the marketplace, and why do you think that's the price, and beyond the price, why do you think a payer is going to be willing to carve out a certain portion of their budget to allocate to you — these are all questions you have to answer if you want to be competitive at the negotiating table.
And number three would be competitiveness — I think every biotech working in any particular category is looking to see what the competitors are doing in the pipeline, but really understanding and gaming out what they could do, what their moves might be, what strategies the competition might take — not just monitoring their activity, but actually predicting it, working out the possibilities, the probability of those moves, and then what you would do about it, what answer you'd give to a potential partner or someone looking to in-license your therapy.
And then the fourth thing is that I'm not sure every company is thinking on a global scale. They often think, "I'm going to keep the rights in the US and give the rights away everywhere else, and I don't have to think about that." No — you've got to think about the whole world, and how this product will play everywhere, even if you're not going to be the one responsible for that geography. You need to have enough knowledge about what's going on there so you can capably command the right price for your offering, so you can build a value proposition that appeals in every geography. What I see often is that this global mindset is sort of, "Well, we're just going to worry about this geography right now, and we're not going to worry about another geography, that's just not our bailiwick." So those would be the three, or four, that I'd list.

Fantastic — that last one was really interesting, because we're seeing that with a couple of companies we're working with, because they're also thinking about commercializing themselves in one geography and then passing it on. But it's such a valid point that you do need to think about it as a holistic global approach.

Absolutely.

Yeah. Fantastic. Thank you so much, as always. I love having conversations with you, and I could go on forever and ever.

Delightful, really delighted to have a chat with you today, Sabine.

Yeah. Thanks for letting us record it, and I'm excited to share your insights also with the broader world. Great, and I look forward also to looking at how we can potentially collaborate together also in the future. So I'm really excited about that.

That would be great. Alright, well, thanks so much. I guess — I guess we've cut the chat, huh? Thanks.

We cut the chat, and have a fabulous weekend coming up!

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