Two Questions, Zero Prep: What We’d Ask Each Other (If We Were the Guests)

Yeah, they have been.

Kieran @ Seuss+ (00:47)
So this season we're bringing a new format — a video-first approach. We're actually going to show what we do — it's going to get even more real, because you'll be able to see who's saying the words they're saying. So today, to kick it off, we're not interviewing a guest — we're interviewing each other. And on top of that, it's unscripted, so I'll be interviewing Sabine, and Sabine will be interviewing me.

We've spent over a decade in the biotech trenches — actually, we're getting up to a decade and a half with Seuss, but we're probably going on two decades of being in this industry. And even today we had meetings together where we were in those trenches, dealing with the challenges we have — navigating vendor selections, scaling clinical development strategies, identifying how to best achieve timelines, and fixing issues caused during setup.

So today we're going unscripted, as I said — zero prep, all on cue, which is probably why this is a little more nerve-wracking than normal, because I don't know whether I'm going to bumble through my answers. But we're going to give you the real, which is what this podcast is all about. So let's start with some brief introductions — Sabine, do you want to go first?

I'll introduce myself, for some of you out there who may know me — I'm Sabine Hutchison, and for the others who may not: some of you may have known me when I was an employee at a company, others know me as starting Seuss with Kieran. Today, what we're doing at Seuss, and what I'm doing — what I love — is actually partnering with fantastic biotechs, which we really enjoy. If I think about that, and about myself and my career, it's all about reinvention, and changing, and trying new things. That's what we're doing with Seuss too, and what I do every day, and what I love every day. Nothing fits into a nice, neat little box — and that's what I'm about, and what we're going to talk about today too: not fitting into a nice, neat little box.

Kieran @ Seuss+ (02:56)
Thanks, Sabine. I think, over the last — we're actually on our 20th year anniversary of being friends this year.

Holy cow, that's incredible. Yeah, when you actually think about it, like 20 years.

Kieran @ Seuss+ (03:22)
Crazy, isn't it? And in that time we've been, at least for me, immediate besties, and immediately tight within the supplier world, really trying to figure out how to maneuver and build relationships with pharma, and build relationships and understand from the vendor side — that was our world, that's what we had. But we also came to see there's a better way to do this — there are real issues in the selection process, issues in the way these relationships are built, managed, overseen, and contracted, that are fixable. It's almost a shame we're dealing with problems that are actually avoidable, because most of what we do in clinical development—

Yeah, true.

Kieran @ Seuss+ (03:52)
—there's a big chance it doesn't happen just because the science isn't achieving what it needs to. It's a shame when things go wrong because of organizational execution, or contract mismatch, relationship issues, or financial limitations. So — I'm Kieran Canisius, part owner of Seuss. I'm in the biotech trenches with our biotechs, as well as with their investors, all focused on bringing life-saving treatments to market. But what gets me up in the morning is really achieving those goals — how do we get there, what's in our way, how do we fix those problems. So, exactly as Sabine said, there's never a single approach to everything — there are consistent issues, things to fix at a larger scale, but every asset is unique, every team is unique, and every vendor is a good fit, or not. So our work is never boring, that's for sure.

That is for sure — every day is an adventure.

Kieran @ Seuss+ (04:57)
Every day is fun and games, at least if you love doing what you do, like we do, and our team does too. So let's get into — for me — the scary bit. What kind of questions?

I've never been asked a question on our podcast before — I'm always asking the questions. So I don't know if I'm ready for this. This is my first time.

Kieran @ Seuss+ (05:14)
Look at that — well, we're tearing it up. So before I put you in the hot seat, I want to do a quick reality check for our listeners. You might both know us as the co-CEOs of Seuss, but behind the scenes we've navigated many biotech rollercoasters. As I was saying this morning, we were both in a meeting that was definitely on some exciting, exhilarating part of that rollercoaster. And we've been doing that for many years, through vendor chaos and calls. This is a chance for us to share some of that with you, which we normally only get to share one-on-one when you ask us questions. So this is a really exciting thing for us. So, Sabine — you ready?

I think so.

Kieran @ Seuss+ (06:07)
So one of the things I hugely value is your dedication and your focus on the reality of the vendor side of the table. I think we've always talked about this — that Seuss doesn't live in either camp. If you think about our biotech and pharma sponsors and our vendors, they live in two different worlds — we've talked about having different shirts on, and all of those types of things — and that we stand in the middle, a hundred percent focused on making sure that what they've agreed to achieve together actually gets achieved. Well, one of the things you definitely do better than I do is really understanding and navigating and seeing what's going on with the vendor side of the business. Probably because you've also had more years of experience on the vendor side, and a more diverse experience across different types of vendors, which gives you that holistic view. So — after that long intro — my question is: what are you seeing currently in terms of trends within vendor selection? How are things changing, how are vendors doing things differently in order to attract and connect with biotech companies, with sponsors in general? And how have you seen that change over the last few years, from the very typical standard RFP selection process?

Yeah, if I think back too — when I first started, I was on the vendor side of that coin, and thinking about how we presented ourselves, what we did. I definitely think things are changing, and it's interesting, because we're of course very connected with the biotechs, working with them and with the vendors on that side. But we also know what's happening in the industry — we have friends who work in the industry, friends who work with large pharma, who are also from vendors, and it's interesting to hear the dynamics that happen in that space too. When these large pharmaceutical companies and CROs work together, it's very process-driven, financial-driven — there's a different kind of dynamic when a vendor or CRO works with a large pharmaceutical company than when they work with a biotech. It's a different world — they're talking to different people, at different levels, and it's a much more structured process. When you're dealing with biotechs, it's — whew — different. Every day is different, we experience that too. But that's what we love about it, because that's their world, and we have to embrace that, and go with it. That's life, and it's part of living in this space, where everything is so agile.

I was thinking about this a couple of days ago, having this conversation about what a challenge it is for a vendor to actually do that — because you have to balance having that way of presenting, that way of working within processes for the large pharma side, but also be able to adapt and work in a more agile way with biotechs. So it's a challenging space, and you can see it often at partnership meetings — that interaction — where they'll often want to bring in the super senior levels to these meetings. Those are important, but the dynamic is different, because the biotechs want to see who they're actually going to be working with. They want that engagement, that personal contact — how am I going to connect?

The one client we were talking about, that we were in the meeting with this morning — they were very much about, who is the project manager I'm going to be working with. They're less focused on whether they have a connection with the CEO of the company, and more on what my team is going to do, how my team is going to engage with the partners at the biotech. So if you look at how things are changing, I think how vendors are showing up to biotech meetings is — we see them trying to get more real, and wanting to connect more. Sometimes it's a challenge, because they're still boxed into having to present a bit differently, having to switch hats. So it's a challenge, and I think the ones who are successful are bringing more of that human touch, that connection, and getting really real with the biotechs. Did I answer that question?

Kieran @ Seuss+ (10:45)
Yeah, yeah — I'm with you, I see that as well. One of the things I'm hearing more now, back from different vendors, is executive-level people saying, we need to stop sharing what our standard process is in a bid defense or partnership meeting, and instead actually say what we are going to do. I think the whole selection process is, generally, I'd say, broken in a certain way — we have a standard process to follow, but at the end of the day, what every biotech is looking for is a partner who actually has the knowledge and is going to get in the trenches with them. And at the moment of selection — the way it works, if you win one out of five bid defenses, or one out of three — you can't allocate all your best people to every single one, to really understand what's going on, because you'd go bankrupt. And I think that balance between the two is really important — it's good to highlight that empathy we also need to have for the vendor side, and to understand what we're actually asking for when we add a sixth, seventh, or eighth CDMO, lab, or CRO into a process. What does that mean in terms of the weight it puts on the other side? And I'm intrigued, because you said — sorry.

Yeah — and also, go ahead — I was just going to follow up on that, because you're so right, because we come back a lot and say, can we have one more call, can we just have one more call, we need to discuss one more bit — because that flexibility is just so important, especially with these smaller clients. So it is true — we do come back a lot more, there's a lot more discussion, when you think, oh, this is done and dusted. Not necessarily.

Kieran @ Seuss+ (12:31)
Yeah. And I'm really intrigued by what you said about the bigger companies — big pharma, together with big CRO, big CDMO, big everything — trying to make it management-controlled, especially with the additional regulatory burden and compliance burden that we're — I said the wrong word, "burden" probably isn't how we want to describe it — it's a good thing that the selection process, management, and oversight is much more scrutinized, because — yeah, it's what we said 14 years ago, there's a problem here that needs to be fixed. And I feel like the industry is starting to see that, on the back of the regulations too. But what I think I'm seeing with these bigger pharma and big biotechs is that they're trying to force something very complex into a very fixed process, whereas we're moving into an agile environment, which requires agility — even more so for smaller companies, where a significant, unexpected change order can bankrupt, or stop, the study. The allocation of insufficient staff, or inexperienced staff, actually makes the process near impossible. I think that's — clinical development is such a human thing — every piece of data is touched, by a human, multiple times. Which means that's where the interaction is — and I'm a little afraid we're evolving toward two different ways of selecting, and one might be detrimental, because we've eliminated the human interaction from it. But we'll see. The other thing I want—

—yeah, for sure, because we see it in some of the proposals as well, where someone's allocated like 0.0111 of an FTE, and we know that just doesn't work. I think — yeah, have a coffee and keep going. But, back to your question about what we're seeing — the vendors who are successful are the ones saying, listen, you need this, and here's why you need this.

Kieran @ Seuss+ (14:23)
You can wink at the sponsor — that's what you do.

We need to have more FTEs on this — not necessarily chop, chop, chop those crucial people out, but provide a rationale as to why this is going to help the trial be successful, maybe shorten it, or think differently, rather than just, wait a minute, I've got this many FTEs, this is all I can allocate. We all understand that RFPs are mapped, and there are reasons for that. But sometimes, maybe take a look at that too, when you're working with a smaller biotech — do you need to rethink how you're mapping and allocating FTEs for the study? So it's something to think about too.

Kieran @ Seuss+ (15:18)
Yeah, I mean, that's a whole other podcast, just that question. I think there's a lot of talk, a lot of meetings, a lot of time spent on the outside of it, rather than — give me a minute, let me go fix the problem, it was a problem, we created the problem, we fixed it, and now this is how we're moving forward. But we tend to have all these processes and procedures kind of getting in the way of — just very simple elbow grease. And that makes it sound like a very small-company mindset, but I know, a hundred percent, that the success of a clinical trial — or any study, whatever it is — is related to the clarity of what needs to be delivered, and the elbow grease, the team, and the expertise added, which is just as important as the process, the procedures, the organizational structure behind it.

So, those are my questions — I could keep going and ask you for 600 hours, but—

Well, I know what those are like — we could loop around on this for a really long time, couldn't we?

Kieran @ Seuss+ (16:27)
But otherwise they'd have to listen to us for hours, Sabine, so — that's why.

Well, I know. Let's see — it's true, what time do we have? All right — well, what I wanted to ask you about is your connection — you're talking a lot with investors now, and also with the biotechs, so founders and biotechs. Do you also see, in that dynamic and in that relationship — are there disconnects, and do you see things that need to be adjusted or changed in those relationships too?

Kieran @ Seuss+ (17:01)
It's so funny you say that, because that's one of the things I didn't actually expect at all, ten years ago. I'd had this idea — because at that moment we were definitely functioning at leadership level in the biotech, but we weren't looking at all at the interaction with their funding, with the investors, the background of that — we were purely in execution.

Over the last few years, one of the things I definitely see as a disconnect is that the exact same playing field we see between a sponsor and all of their vendors also plays out between an executive or a CEO and the CFO, the leadership team, and all of their investors. And that's also a distraction, also a stressor — and all the good it does, without the finance there would be nothing to execute, right — but it also adds complexity, and conversations. I actually have two things that come to mind, and I'm struggling to choose one, so I'll say two. But let me start with the one thing that, if I could pick out of a hat, would fix so many issues: this additional milestone, or pressure, to get to first patient in.

So many problems are caused during selection, during contract negotiation, and mainly during setup — because everyone is rushing. If you think about how long it takes to get the syndicate agreements behind the biotech financing signed, and then, boom, it's like a race, and we're off — everyone just starts doing, even though they've been thinking beforehand—

You're right.

Kieran @ Seuss+ (18:49)
—the moment you have the money, and things need to happen — that's the moment you actually get the capacity from the vendor. As generous as many vendors are, in order to, in essence, buy their way into having the confidence that you'll work with them, you don't actually have access to all of their capacity until you sign the contract. It wouldn't be fair any other way, but that's the reality of it. So then everyone starts running around, standard procedures roll out, and everyone starts doing — and it's this craziness, because a few months later, everyone goes, yeah, we did that because we needed to rush, we needed to get first patient in, we signed up one site even though the systems weren't quite ready, but we got our first patient in. Everyone gets a gold star, the board is happy, investors are happy. And for me, the moment I hear that, I think, well, let's wait for all the issues to come out. And I think that's a shame — especially compounded by the increase in regulations around data integrity, and the increased risk that the portfolio companies, from the investors' side, and our biotech clients themselves, face by not ensuring they're aware of how their clinical systems work, and how their data is collected. So if I could pick one thing, it would be to expand that moment between fundraising, funding signed, and execution — to actually keep that same feeling of go, go, but build into it the time to do the things we need to do, like patient recruitment. Being behind on patient recruitment starts even before we sign the contract, and it's just something people aren't aware of. So that's my one wish.

The other one is — and I got laughed at, two weeks ago, by an investor, when I said this — I would love if risk management was actually something connected at board level, from the start of a syndicate, to say, what risks are you guys seeing, facing, and so on. Not because I think a biotech — in many cases — shouldn't be left to do what it needs to do, but because it could relieve some of the interaction and pressure, and give confidence and alignment, by saying upfront: what are the risks we're going to mitigate, what are we going to pay for, and what are we not — rather than trying to be perfect in every way, because we're on an unknown path with clinical development. We don't know what we don't know, and there will be risks along the way. If we could align on that, at that layer — I've promised myself that in a few years, I hope that'll happen. So that would be my wish. It's not something I want to change, it's something I wish for — that somehow we find a way, even though they're often different teams, to align on that risk. Did I answer your question?

Yep, you did, you did, you did. Yeah, that's so true, so true. And there — we could just take each of our questions and have totally different sessions on these. We should actually have people come and ask us questions. Maybe that's something — then we'd both be in the hot seat, like totally.

Kieran @ Seuss+ (21:55)
Oh dear, I'm less stressed now that I'm just chatting with you, but before this morning I was like, oh my goodness, what's she going to ask, am I going to sound like I know what I'm talking about? But yeah — this is what we do, right? Yeah, go ahead.

Well — yeah, exactly, this is what we do every day. I have another question — you recently wrote an article, talking about the vendor selection process, and you made a statement. I'm going to read it, because I want to make sure I quote you properly — you said that vendor selection can quietly unravel everything a biotech is built on. Which feeds a little into what you were just saying. I think it could be interesting for some of the listeners to hear — can you share a story, confidentially of course, where you've potentially seen this happen?

Kieran @ Seuss+ (22:49)
Sadly, more than one. One of the reasons Seuss is built the way it is, is because we know the importance of centering everything around risk. We know the importance of being very clear on scope and needs. We know the importance of identifying, before we fall in love — with our heads, not just our hearts — why the data we're collecting is going to help us choose the best vendor. That sits very deeply in us, in how we think and what we do.

We have many examples where the process has gone through, like, a checklist — we sent out an RFP to five CROs, it was a document, it looked great — sometimes it even came from my past company, not this one, but that's the example — the paperwork is beautiful, and then they get to a decision, and the decision is made, and it just doesn't have any real foundation. So we ask questions like, tell me why — what's the added value of working with this vendor, what risks is this going to help you fix? Or, worse, a board or an investor comes in and says, hey, this is my partner, sign up with them, we'll have better control — when, at the end of the day, the complexity of what's being outsourced is substantial, and it's never fixed by only having the ability to escalate, it's never fixed by only having experience in the area — that helps you know at least some of the challenges, but it's never fixed by one thing. It's the whole of those things together. There's a reason our process is the way it is, and why it emphasizes certain parts, because all of those things matter.

I don't actually know many really bad vendors at all — I really don't. In Dutch, we say, for every jar there's a lid — people usually mean that about marriage, about love — but I think it applies here too. You need to achieve something, and so you go to a certain partner, even if you don't especially like them. That's not the point. The point is that they're going to deliver what you need, even if it's uncomfortable — they're going to do it.

So when it unravels — so easily, so quietly — in vendor selection, it's when we go through a tick-list process, when we go through a decent process and then let something very left-field influence us, and then struggle later to identify why it went wrong. I think it unravels silently, because we get a nagging feeling early on that maybe this wasn't the right choice, but we're not quite sure how to grab onto it. And there's a kind of momentum — if you think just about CROs — it's a huge amount of work, they come in with an army. Suddenly you've got 25, 50 people working for you as a biotech, when maybe you had 10 — you've basically quadrupled your company overnight. And you get overwhelmed with meetings, emails, everything that comes with it.

It's about how you take control of that moment. It unravels quietly at vendor selection, but it explodes quite quickly in setup — even though we feel like we're treading water, running, getting it all done, the real problems actually surface during execution. That's past the phase when — our colleague Anne-Marie always says to me, once we start signaling that we're behind on patient recruitment numbers, that problem actually started months and months and months earlier. The fact that we're signaling it now doesn't mean that's where it started. And I think that's maybe what inspired "unravels at vendor selection" — because that's how I see it too.

Yeah, so true, so true. It's not just a huge tick-list you go down — it's so much more complex. It's interesting, when people are like, wait, you're going to do all of that? And we're like, yep, we are — so buckle up, because you're going on a ride with us, and we promise the outcome is going to be really good.

Well, thanks, KC — that was nice. No, tomorrow — we're having a nice long Easter weekend, so, no, but we'll definitely do it again. And thanks to everyone listening, and to everyone who's listened to us in the past — we hope you got a couple of nice insights. So that's it for season two, episode one — season two, I think it is. So, thanks for joining.

Kieran @ Seuss+ (27:18)
Thank you, this was so fun — can we do it tomorrow again? ...Mmm, no.

And follow — obviously, follow us on LinkedIn, you can connect with Kieran or myself if you have any questions, or anything else you'd like to discuss, feel free to do that. And you can also follow the Life Science Insider — Spot— Spotcast podcast, on Spotify — I'm making up new words — and Apple, and YouTube, of course. So let us know if there's anything you'd like to hear, anyone you think could be interesting for us to interview — we're happy to take the lead on that too. Look forward to seeing you next time. Take care. Bye.

Kieran @ Seuss+ (28:17)
Me too. Bye.