Building Biotech Teams That Can Execute: Ross Pettit on Clinical Development, Vendors & Trust

Hi everyone and welcome back. Today I have the privilege of talking with Ross Pettit. He is the Senior Vice President and Chief Development Officer at Kestrel Therapeutics and they are an oncology focused biotech company. Ross has been around the block. He's been over 30 years in clinical development and he's worked across various operations, roles in biotechs and pharmaceutical environments.

And he's built and scaled and navigated operations across all kinds of stages of organizations and life cycles of assets. And what really stands out for me about Ross is about how he thinks about things. He's a very practical person in the time that I've been able to engage and work with him. And he really looks at the connection between what's happening operationally and what leadership needs to know and to hear in order to make sound strategic decisions for organizations. That gap or the absence of it can make a real difference in how programs move forward. And so today we're going to get into the practical side of building a clinical development function, how you think about hiring, what capabilities to look at, being a sponsor organization. So Ross, I'm glad you're here. And although I've prefaced at what we're going to talk about today. Our conversations can be like those bouncy balls sometimes, right? So that's where we think we're going to go, but you never know. So thanks so much for joining me today.

Thank you Sabine, it's pleasure. Glad to be here, looking forward to it.

Yeah, I actually have, I started out with one page of questions, but I actually have two. So that again, I want to preface everyone because we could jump all over the place. But I guess one of the things that when we originally when I originally asked you to be part of the podcast, we talked about building biotechs and how you've seen other organizations build and grow their teams. And at times you can have a tendency to say, I need to hire this full scope of people. I need to have C this, C that. . all of these roles within the organization. And obviously that's some big runway dollars coming in when you make those kinds of decisions. And as you're building and growing in the dynamics of the organization, maybe that changes. And so that influences how you hire. So I'm curious, you've had lots of experience getting into this, getting into the space and also with Kestrel where you are now.

Maybe you can walk us through how all that experience has brought you where you are today and how you're making some of the decisions at Kestrel.

Yeah, sure. I think in early noughties, biotech, when it was sort of coming on the scene, every biotech company, every biotech leadership team had this aspiration of being a FIPCO, a fully integrated pharmaceutical company. That's where they wanted to go. And there wasn't really much discussion about other exit strategies such as acquisitions or M&A. So it was all about build, build, build. And to be honest, build very quickly. As you said, people wanted to put preclinical teams in place and then file their INDs and put clinical teams in place and then commercial teams and it just it continued it snowballed. I think as I've sort of witnessed biotech development become a little bit leaner we've had to take this sort of lean and mean approach whereby you can't invest in everything and your board of directors and management teams don't want you to invest in everything so the way I've seen it progress now is to the point where you're essentially controlling the critical path internally. You know what you need to do, you know how you need to get there, and you need to manage that resource as close to your chest as possible. But I think there's a couple of key pieces to that that you need to look at. The first is you've got to keep that strategy and the oversight and the interpretation of data and the interpretation of everything you're doing very close to the chest.

You don't outsource accountability. You outsource scale. So I think you're looking for the volume piece. We've all worked with CROs, as you know, for many, many years. And I think that hasn't really changed. mean, there's been different models to outsourcing between fully outsourced, functional outsourcing. But you're still going to outsource scale as a biotech. There's absolutely no real pressure anymore to build armies of people. you are accountable. And I think you know this better than I do Sabine, that the changes in regulations continue to emphasize how accountable you are. So I think that's the major shift in resourcing. And so for us, it's really looking at what is critical path? What is the key personnel that will remain accountable to keeping on that critical path? And maybe the last point or the second and last point I'd make is there's a couple of positions that are often overlooked.

Absolutely.

And I think it's worth companies taking a look at key areas that some companies ignore altogether. The two that I think of that come to mind straight away, program management, sort of project and program management, really tying everything together, people that have an understanding of the entire process. And the other one is financial analysis. I mean, I often try to hire a financial planner within a clinical team sooner rather than, not always, but sooner rather than later because

Just knowing where your dollars have gone, where that spend is, I think that's key. take a critical look at what you want to be experts at or what you should be experts at and everything else that's scalable and maybe less close to the decision making process you can think about outsourcing. That's how I think.

Yep. Yep.

Yeah, that's really an interesting point too. Also the financial side, if you think, if you're talking about working with vendors and CROs too, the complexity of the invoicing that happens. And I think oftentimes that's very underestimated. The change orders, the really digging into the invoices and making sure that you're getting billed what you're supposed to be getting billed. And there can be lots of dollars or euros or whatever currency we're talking about left on the table if that's not done well.

And I think it's just common sense. I think we all we're all taught as youngsters to become financially aware and financially responsible and If you're in a small biotech and you're working on seed money or series A money you're spending other people's money It's as simple as that and you you have to have a sense of awareness of what's going on But the problem is the complexity as you point out that if you've got small teams, they're usually not given the bandwidth, the time to spend on financial controls when they're trying to manage studies and sort of other critical safety issues. So I think you have to realize that people have certain bandwidths and have certain expertise. And if you place that much emphasis on financial responsibility and awareness, then you should bring in somebody who knows how to do that. I mean, of course, finance departments and accounting departments are pretty good, and they know what they're doing financially.

But they often don't understand the nuances of the clinical program. So you have to be able to translate for them. So I think having people internally who can translate across those two domains is really key.

And would you also say that there are roles that you mentioned too that are kind of underestimated that you think that often that aren't pulled in. And if you look at the program management and financial pieces, are there ones that you can hire too early or later? Like how do you decide who to bring in when? And then when you do that, I think what I've seen in the past is that we tend to go to the people that we know.

And do you think that that's always the best decision?

So let me unwrap that one. I don't want this to be a trick question on me, Sabine

No, it's not a trick one, I promise.

Well, I'm sure you can hire too early. I think that, let's take Kestrel for instance. I think Kestrel made a decision, and Frank, our CEO, I think was very wise when he came to this, that if there are good people out there that know their areas, hire them, if they're available. It may be they're a fraction too early for the process, but having them in place to prep and build. So in the biotech world,

Mm.

Mm-hmm.

I don't think you can hire a clinical team too early. You'll usually start with your scientists, obviously, unless you're acquiring an asset, you'll start with your scientists and pre-clinical team. But having your clinical team in place to manage the transition and take it to clinic incredibly quickly, that's one of those key corporate milestones that are so critical to get done and get done right that I don't think you can hire too early. But within those groups,

I think you've got to remain sort of very aware and savvy about not over hiring. But the way to do that is to actually hire senior first rather than junior. Now this is the thing that we debate over and over again in my world. Do you hire a, take clinical operations, do you just hire a senior manager or a director who can just step in and keep things moving or do you hire a senior vice president or vice president who actually has a great deal of experience?

My personal preference is the latter because as long as they're prepared to still roll their sleeves up and get dirty, their experience counts for so much that however well-intentioned and keen and enthusiastic and more junior person is, they just haven't got the experience of the things that can go wrong. And I think a lot of things go wrong in that building phase, that startup phase. Once things start rolling, things

then you can hire more junior people who can keep things that the I's dotted and the T's crossed. But I would suggest people rethink that whole dynamic, although it's a more expensive route to take, that you go with senior people rather than junior people earlier.

Yeah, absolutely. I definitely have seen that payoff in milestones and having that review, I think on your team, the people that we've engaged with as well, it's very clear that those are some key strong individuals that you hired for sure.

And then I think then to the second point, what is a core competency? That's what you've really got to focus on is what do you want to be a core competency of your organization and have those really tough and critical decisions, discussions, sorry, around that with your management team and say, do we really want to be experts at this? And if we do, then hire well there. Spend the time, take the time to find the right people and the right resource and hire well.

Mm-hmm.

And then the rest you fill in. I think as you know Sabine, we have a very large network. We're only 20 people in our organization. So that means by default we're working with providers and partners, but a strong consulting group as well. We have a lot of strong individuals who we know it's probably not the best value to the organization to have them on full time, but to have that level of expertise and be able to call upon it as we go through the milestones and the stage gates of development, that's critical to us. So building a strong stable of really experienced and sort of, again, fairly senior consultants is important.

Absolutely. How do you ensure that if you're thinking about the cultural piece of that as well, because that's an interesting dynamics to have a strong internal team. You said you're fairly small with 20 people, but then bringing consultants in that can be very powerful, but that cultural fit and to ensure that the consultants aren't just using what they think and the way that they want to work, but ensuring that it's the Kestrel way of working.

I think it's how you treat them, to be honest. think we, I always remember a couple of discussions that have happened at multiple companies where you have a company meeting and the question goes around, do we invite our consultants? I think the answer to that should always be yes. You've got to treat them as a team member consistently and to create that continuity. If you just bring them in, ask them a question, you're going to get exactly what you said. You're going to get their opinion, their viewpoint. If you treat them as a team member and involve them in meetings and discussions, they're going to start to understand your culture, your way of working. And they will probably naturally adapt their advice and their input to say, well, this might be the way I do it, but I think Kestrel should do it this way because that's going to suit your structure and your infrastructure. So I think it's more about breaking down that barrier of FTE versus consultant. Just treat them all as team members. And I think they acknowledge that respect and then tweak and create this nuance around their advice that is more in line with your culture. So I think once they understand your culture, they can work within it. Whereas if you just keep bringing them in, it's not.

Yeah, yeah, true. And you've a bit around, you you have staff, have consultants, you work with vendors. How do you make those decisions? Again, you've touched on it about what do you want to be great at as an organization? And so how do you make those decisions about who are we going to work with and what are we going to in-house?

So I think it changes as you go along. I mean, I think you can frame a straw man a plan early on, but I think you can't just put a plan on paper and execute forever. You're constantly reevaluating. I mean, we just have the tough discussions. We have an executive team, like most small companies, and hiring projections, we talk about.

at least annually and probably more often than that obviously when I say annually we have a projected hiring plan but beyond that we know our needs change on an ongoing basis and we assess whether we think it's an appropriate full-time position or whether we think it's something that because of the nature of the job or the nature of the time requirement or commitment that it's going to be more suited to a consultant. I think

We're constantly having those discussions. It's not as simple as, we need this person, and that's the end of it. It's, OK, what are we going to project that we might need? And then let's talk about it critically as to, I don't want to say narrow it down, but literally go through one by one and say, OK, what is the value here? Is this going to help us get to a certain milestone? Has this got some long-term needs in the company, or is it sort of a one and done type thing?

And we sit down and have those discussions constantly. I think that way you can really

I'm trying to look for the right word. I can't find it to be honest. But I guess sort of match the need with the person. Because the need may instantly shout out at you, consultant. And you just know. You just know that, OK, that's a need that we have for the next two months or we have for a particular project. And to be honest, the work we do with you at Seuss+ we know we have a need. We know what the framework is going to be. We're not going to go out and hire five people to do that. We're going come and talk to an expert group and say, look, we know you're an expert at this.

This is what we need, and we need to be working on it over this time frame to meet this milestone. And I think that's just case of, some of it's just common sense. It's just sitting down and working through the requirements. Some of it's a gut feel. Some of it you just know. I think to some of the positions I mentioned earlier, you kind of know that if we had that person here at Kestrel, they'd be a Kestrelite, they'd be a true team member, and they'd fit well.

Whereas other times you say, that's not a direction we want to go. It might cause too many problems. It might cause us few more issues than we really want to see.

Yeah. You mentioned when we started working together that you also know when you want to free up your team because we talked about your team could do everything that we or another company like us could do. So it's not that the competence isn't in house. So again, making those decisions, why did you make the decision to not have your team do some of the work that we're doing?

So I think that one was very much attention to detail. for the benefits of everybody listening or watching, we're talking about an RFP process, a request for proposal with major CROs and contracting. It's an intense period of time. It's a huge amount of effort. I think there's a number of things you can miss quite easily, even though you're going through the stages. You know what to do. The level of detail and attention to detail that you must have throughout that period probably minimizes what else you can do. So protecting my team, I know they're very capable of doing it, but having your team to say, okay, put no fine point on it, we're paying you to focus on this and this one issue, you're not gonna let anything slip through the cracks, whereas we probably would. And to be honest, we pay for that downstream in a big, big way if we miss these things.

We're still going to miss things, even partnering with you. But I think we'd miss a lot more if we had to suddenly flick a switch and say, OK, you can't work on this now. You've got to go and work on the RFP. And if you're going to do it properly, you've got to work on that RFP for four months straight. That doesn't allow you to do anything else. I mean, you know the size of my team. It's two people, essentially, that would have been in that role. And you can't do it. So I think the value of being able to create a full-time environment through a consultant or consulting group is incredibly valuable to the protection of people's time on the team itself.

Yeah, that's so true. Yeah, I think that's overlooked so often that everyone looks at the currency, the Euro, the dollar, whatever you're looking at and then, we don't want to spend that. But it's the long-term vision to think about, okay, what impact does that bring later? Yeah, that's so true, regardless of what kind of service it is. It does, absolutely.

Yeah.

It pays for itself. It pays for itself. It truly does. I think people so underestimate the value of time. you can't put a monetary value on time that often. I mean, know consultants do. But I mean, the time you lose, the time you lose, the time that you spend being distracted,

It's so true. Yeah.

the time you spend fixing quality issues, I think this is the most quoted one, right? What you pay for bad quality is often really overlooked. And so I think in the case of the Kestrel-Seuss relationship, it really was paying for quality upfront so that we weren't continually backtracking and fixing things later on. And it was more efficient. It was more efficient. I think we had an intense period that still involved

Mm-hmm. Yeah.

my team as well. when you step back and look at what we accomplished in that short period of time, we would have had to have done that 24-7 for three, four, five months, and at the expense of everything else my team was doing. So that's just not feasible to me. Just not feasible.

Absolutely.

Yeah. Yeah. We've talked a lot, about picking your vendors, relationships with vendors, how, you know, we totally dated ourselves right when we were like back in the day, we were reminiscing about what it used to be like dinosaurs exactly. And

with dinosaurs around the earth. Yeah, that was it.

And things are changing and it becomes, know, relationships with vendors, whoever they are, can be a challenge. And you've done a lot of this, you've picked a lot of vendors in the past and looked at those relationships. When you look at how to manage those relationships with you and your team,

Maybe you could just walk us through this. This was just by the way, everybody, didn't tell Ross I was going to ask him this question, but it just kind of popped up. because it is a challenge and I think so many people struggle with these relationships and it's interesting. I had a conversation with a CRO a while back and they were talking about, you know, we can't be vulnerable. And this is a word that

Ha ha ha.

Yeah

we, you know, it's kind of interesting to use in a conversation when, you know, in the industry that we're in, they were like, if we're vulnerable and we show we can't do something, that could be a strike against us. And, and I think that that's such a shame that that is the, that's the mindset that they have instead of saying, we can't do this, but this is potential. This is how we would, you know, work on that. Or we could, we could fix it. But I thought that that was, you know, they have this sense that they need to be kind of this knight in shining armor galloping, you know, with a the wind flying and not be able to show their weaknesses or their vulnerability.

That's really interesting. I haven't heard that expressed before, but I think it is indicative of where we are in the whole partner provider type environment now. I think it's changed dramatically. You and I have talked about this, and I don't think my views come as to any surprise to people that know me. I think that the way in which clinical partnerships, providers, whether they're CROs or labs or anything. I think the approach has changed. I think there used to be a lot more ownership, whereas now I think they're under pressure to book business and the larger CROs are under pressure to book a huge amount of business and it's not about owning a relationship with a sponsor. It's about, okay, we've just got to get this done. And that's, I think, trickled down to the way the work is done. It's become a box checking exercise. It's an SOP. And I think back in the day, don't think, and having been on the CRO side, that's not how we thought about it. We thought about, what a great opportunity to partner with Company X and let's, back to my comment about being part of the team, you became part of the team and you wanted to own it. And that's not to say CROs and their employees don't want to do that. I just think there are internal pressures that don't allow them to do that.

Mm-hmm. Yeah.

Yeah.

And they become gun shy. So this vulnerability question is a big one because they're only people. The reason we go to other providers is the volume of work they've done. And because of the volume of work they've done, the expertise they have gained from that. So I go to the CROs of the world because they've done hundreds and hundreds and hundreds of trials, more than I've done. And certainly in the small biotech world where you don't have volume, it's very spiked up and down. You're going to pay for expertise and to be honest, being up to date, being present. So you could come to me and ask my opinion. It may be a year old because it's the last time I did it. If you're going to a CRO, they should be sort of on the pulse and say, yeah, this is what's happening in the world today. But if they don't know and they can't show that vulnerability. That's problematic because I think that's when we should be sitting down as partners and team members and saying, we don't know this. How are we going to find out? Not pretending we know and really use an AI term, hallucinating with an answer that makes no sense or is just made up. And I hope that doesn't become part of what a provider has to show. As you say, a knight in shining armor all the time. I think they should be able to let their guard down once in a while and say,

Yeah.

You know what? We don't know that either, but let's figure it out together. For years and years, nobody ever turned down work. That was the other thing. I think now, at least I'm seeing organizations say, that's not for me, or maybe we're not the right experts, or maybe I have got a competitive program that I can't firewall properly, and I have to divide and conquer. So it's not the right project for me. I think that's one improvement I'm seeing is that

That's true.

There's a little bit more realism in what the providers are experts at. But yeah, vulnerability is that now you've piqued my interest. I'm going to be thinking about this all day long. Yeah, exactly.

We'll talk about that more at the summit in November, Ross. It's one of the keys because it is an interesting thing is that I really, I want to have like more conversations around this because I think that that is going to open up the relationships and people like, we can't be talking about that. Well, maybe we should be because that's going to, that that's going to maybe open up the, the doors to be able to have more open and honest conversations.

Well, you asked how, I mean, I think the crux of your original question was how do we go about, how do I go about thinking about selecting vendors? I mean, it is about relationship building and it does stem from trust. I think nearly every relationship I have in the world of clinical trials starts with the BD person. I know that sounds kind of obvious, but what I mean by that is I've usually built a really strong relationship with a business development representative or somebody in the group who I feel I can trust and even if even if I don't know that company I know that that BD person is going to give me or get me a straight and honest answer and then that essentially just flows into the next stage right you meet a team and hopefully you build that trust and that relationship with that team I think it's all trust and relationship I think expertise of course is a I don't want to say a given, it's a byproduct of everything else. But I don't need to have the best of the best, but I do need a team that I can trust and I can rely on. And that's how I select. And that's certainly how I look back historically. I mean, I don't necessarily have the luxury of being able to keep the same team forever. Again, another small biotech problem. You work with the CRO, they can't sit around and wait for you for a year. But if I understand the people, the culture of that company and I can trust and respect them, that when it comes around again, I'll be able to rely on their inputs and their insights, then they're the groups I'm going to go back to and reselect.

And if you kind of reverse that and you look at the biotechs or you look at your organization, one of the, we were at an event here in the Netherlands and one of the other clients that we have, he was like, I would not want to work for us. He goes, we are. We're also, because they're small, they're dynamic. Things are constantly changing. This board member wants this. This person wants this. Everything is quick. One person decides something different. So the change is just such a part of their organization. And what do you think about that? Because there's, you know, it's always two to tango, right? They're also biotechs also struggle with things and potentially also with vulnerability and how honest can you be about internal challenges that are happening in your relationship, for instance, with a CRO?

See this is a hard one because I know I'm too transparent sometimes. That's the problem. I think it's a fine balance, but I think you've got to be... You can't be totally opaque. You can't of block everybody out and have this need-to-know approach. And I guess that you could probably give up too much, and I would probably be leaning on that side. There's a balance somewhere in the middle, but I think it does involve transparency because I think...

Progress within biotech is not about milestones and activities. It's about making good decisions quickly. I was at a talk yesterday and we were on this topic. mean, decision quality and how quickly you can get to that decision and make a good decision, that's the key. And I think to get there, you have to have very open, candid discussions. can't come in with everything hidden. bit of smoke and mirrors. It's got to be, look, this is the problem. And if we need to circumvent that problem, I've got to be able to disclose it to you. I've got to show that vulnerability. So I think that that's where biotech is. It's not predictable at the beginning. Progress at the end is predictability. Once we get it right, once we've built everything, we can measure productivity by predictability and scalability of execution, things along those lines. But when we're at the beginning, it's about learning. It's learning velocity. How quickly can we learn from each other as partners? How quickly can we come to that decision? And when we get to that decision, we make a good decision. And then we'll progress. If we make a bad decision, it usually means we're going to stop ourselves in our tracks and not go any further. So that's the signal, I think, to me, is those quality decisions. And to get there, I have to be running.

I have to be transparent up to a certain point. Within the rules of the law. Within the rules of the law. That's all I'm going to say.

And do you... Yeah, yeah. Always within the rules. And if you look, because the leadership team, of course, that you work with every day is just the base of that. how... had you all worked together? Did you find... How was that in the beginning without obviously sharing any kind of, you know, confidential information?

Yeah, no, I I know, I think it was my CEO and I have worked together in the past. It was a long time ago, 15 years ago, but at least we knew each other's approach. And I think it does help. I think often you'll see leadership teams in biotech built from people that know each other and have worked together before. mean, you'll see people do it serially, right? They'll start company A, sell that company, they'll start company B.

Mmm.

And then if you look at our leadership team, there are a couple of exceptions, but there are quite a few interpersonal relationships from the past that have been built. I think that does, it helps you because it breaks down that first barrier, which is getting to understand each other's approach. And if you understand each other's approach, the way we like to work, then I think it's a lot easier to make progress rather than dancing around like, is that what they want to hear? So yeah, I think that there are a few at Kestrel, not all of them. And the ones that we don't have were very much rigorous hiring processes. And I don't mean long hiring process. This is another thing that drives us all crazy. People apply for jobs, and God forbid, they don't hear for eight weeks, nine weeks, and then suddenly they get put through 25 interviews.

We know who needs to work with those people and we make sure that we're all aligned as to whether they're a good Kestrel person, a Kestrelite, right? And that's worked for us. We're a very, very small team, as you know. As I said, I think we're 20, 21 full-time employees. But all of those employees, I think we see as being people that we like the way they approach things. It's not that other people aren't good at their job, but they just don't do it the Kestrel way.

And so the Kestrel way is important. The secret sauce, can't tell you the secrets. I can't give away all the secrets. It's very, well I'll come back to what I said earlier. It's transparent, it's candid, it's pushing back on each other. Let's call it a healthy tension. I think you have to work with groups, you have to work with people that you and can disagree with or certainly provide a different alternative path, but you have to respect where they're coming from. And I think that's where our management team will push back on each other. We'll actually really ask the entire team to push back on us, right? But then we challenge them. And I think there's often a, it's not quite the Socratic Q &A method, but it is, we're looking for people to come up with their ideas and then we give them all the time and sort of respect it deserves. I everybody comes up with some good ideas, it's great. So I think the Kestrel way is transparency, a sort of healthy tension and an expertise. I think we hire people who have been around the block, know what they're doing in certain areas. And a lot of our consultants, this is going back to our earlier discussion,

A lot of our consultants are people we know. And we very much are going to a pool of people that we respect from prior lives. There's a lot of people out there who, if they've been doing this as long as I have, have decided, OK, the corporate life is not for me. I'm going to consult. They've been a huge asset to us. We've found some tremendous team members who are just, we know they're out there. We know what they're good at. And we know that they will sort of respect the way we do things as well.

I don't think there's a secret sauce, think that transparency, healthy tension, that's what really comes to.

I think too many people underestimate the healthly tension I think that's so important. I remember when I was working for an organization, we had a new leader that came in and he said, don't ever contradict me in a meeting. Like, okay.

Yeah.

Well, that's an interesting because we had that dynamic with the previous one. would push that we, was obvious, it was very much in a respectful way, but we challenged each other and that made us stronger and we would leave meetings, you know, we could still go have a beer together. So it's not that we didn't, you know, we disliked each other, but that healthy tension is so important.

Yeah, and I think you really have to, and there are some tensions that naturally exist in the world of development, right? And I think this is, the classic one is the operations versus medical type approach. And I think that's an easy one to analyze, right? So I think, you know, I am an operations person. I'm not a physician. I don't play one on TV. I've never even thought of training. And then my chief medical officer is a physician. So there's a scientific aspect and a clinical lens and then there's a feasibility and operational lens. And they don't always connect. So my CMR and I have to understand that we're coming from where we've got the same shared objective. We're coming at it from a slightly different place and there's always going to be a tension. We, and I'm talking about Ashwin, my CMO, and myself, we allow that to be a healthy tension. It can become an unhealthy one very quickly.

but it's to your point, it's being able to sit down, thrash it out and then go and have a beer afterwards. That's what it's all about. And I think operations used to be purely an executional function. That's what it was. So speaking as an ops guy, because that's what I am, it's taken many, years for clinical operations to become

Yeah, it's so important.

even considered a strategic function. But it really is because it's taking reality, It's taking the scientific ambition and turning it into reality, operational reality. And so if you think that is just execution, then I think that's where many, many companies go wrong. They're still treating clean ops as they did 30, 40 years ago, which is it became a function just because clinical trials became so complex and so big somebody had to deal with a minutiae but they weren't listening to the ops feedback about the operational reality or feasibility versus that scientific ambition so I think the companies that I see fail or the companies that see have trouble are those ones that don't allow that healthy tension don't understand that development and operations are truly strategic functions and

That's just a recipe for disaster.

Absolutely. And it is so true with operations, very strategic role. Also just looking at your team members, the ones that I know, they definitely think at that level, plus they're able to execute. that's a beautiful, obviously a beautiful match. Yeah, that's a bonus. Yeah. And they think strategically. You find more of those, more of those valuable people. Well, you,

That's a bonus. If they can do both, right, if they can check the boxes and think strategically, that's a bonus.

actually Actually you just had first patient in so big congratulations on that. was an exciting moment. And if you think back to when you started because which, tell me about number, how many at Kestrel when you started? Of people? Yeah, 13, yeah.

Thank you.

When I started, number of people, I was employee number 13. So we really haven't, and that was two and a half years ago. And so again, that shows you that we did have a reduction. We pivoted from preclinical to clinical. there was a sort of exchange, a switch out of personnel, but we've kept very lean and sort of kept fit for purpose at the time we're at. I mean, we're very proud of what we accomplished as far as a rapid IND a rapid trial site, a very seamless move into the operational aspects. We're still going from strength to strength. We're getting sites up and running and things that operations teams naturally struggle with or criticize for. I think we, back to the point we discussed right at beginning, we planned well. We got people in early. It wasn't a my goodness, FDA just approved our IND, now we've got to do a trial, let's go find somebody to do it. And you know, I think we gave the CRO that we partnered with plenty of time to ramp up, probably too much time. We probably had more issues from giving them too much time than too little. Time was not at a premium.

and what now?

Then...

Mm-hmm. Yeah.

plenty of time we'd selected early. So I think all of those things were really from proactive planning. But again, just starting early, just making sure you're prepared, you think ahead, you know what your next milestone is going to be, and you build that team and infrastructure to meet those milestones.

Would you do anything differently?

I always would. always would. think having that lessons learned, there's always something. I'll be honest, I think some decisions you're sort of pushed into, not ones I could disclose publicly all the time, but there's things you're pushed into that you think, I wish I pushed back on that a little harder. I think you make, you potentially do make decisions about

Mm-hmm.

hiring that we talked about earlier that are wrong. I there's always something that you can tweak. I've sort of become a serial startup, so build out person. And I've done it numerous times now. And I've done them all a little differently. And there's probably, looking back at them with each build, I probably should have done them differently as well. I'm constantly learning. So I think I love networking now.

Mm-hmm. Right.

really sort of started to appreciate and value networking and you know I have a WhatsApp group and chat groups with other peers in the industry in this area and we're constantly learning from each other as well because we all do it a little differently and we all face different problems so there's no magic sauce because there's no rule book on how to run a clinical program. There's FDA guidances and European guidances But there really is no rule book on how to do it properly. And I think we've made that same mistake by, to be honest, perpetuating things that we shouldn't have perpetuated. So I think we as an industry have to start picking things apart and saying, is this really necessary? So I think that's the big umbrella lesson learned is we're still over complicating things. So wherever I can try to simplify things, I think that's the next step. Keep it simple. As long as we don't end up on the front page of the Wall Street Journal and we protect patient safety, which is things people in this industry have for years and years, then what's wrong with it? I think you can cut a few corners, can slim things down, make them little easier.

That's usually my lesson learned is take a look about what's something that took too long or cost too much.

Yeah. But also the adaptable piece. think that's so important what you say. A lot of people take, they get, they step into a new role or a new company and they want to do it exactly the same way and you can't. The dynamics are different. The people are, everything is different. The asset is different. So yeah, that's impossible to do, but take those learnings and adjust.

Yeah, yeah, yeah, we.

Yeah, it's interesting. When we talk about hiring Ops people, sometimes there's this viewpoint that you have to hire therapeutically. So I have a lot of friends who are in the CNS world, some who are the rare disease world. We as Ops people tend to take the viewpoint that you can be therapeutically agnostic. A good Ops person is a good Ops person. But the underpinning of that is that they understand the mechanics of clinical operations. They're not saying they're therapeutic experts.

And it comes back to that other piece. They learn the scientific lens from the medical team. But there is a lot of crossover between a CNS ops person and an oncology ops person where we can learn from each other. And I think some hiring managers are a bit short-sighted about saying, if I'm looking for an oncology ops person, they have to have done oncology before. Yeah, sure, it will help. But you could miss out on some really good ops people if you take that viewpoint.

So I think Ops people know how to accelerate their learning curve early and they know who to ask. So I think you can be adaptable from that. And what we've learned from in rare disease, we can apply to oncology. So there's things that have surfaced very quickly in different therapeutic areas that we can adopt in other therapeutic areas. And there just hasn't been enough crosstalk. But now it's easy. We've got Zoom. We have WhatsApp. We have everything we can do. We can talk to each other.

Yeah, exactly. yeah, that's a good thing to do too. Exactly. We can do that. But the what you know, it's interesting that you say that because I interviewed a couple of senior ladies for the for my book and they they did that as well. They have their groups, their WhatsApp groups that they go to for different things. They this network is also something that is just so key and can save a lot of headaches being able to tap into those individuals that you can go back to the trust piece as well that you trust and that you know are going to give you

We can still go down to pub and chat as well, but that's a different story.

responses that are valuable and fitting to what you need. So, key piece.

I think as time goes on, if you were to do this from scratch, I'd like to think that my, it used to be my Rolodex, but now my LinkedIn index or whatever it is, I know who to go to to help me build, to put those building blocks in place. And even if I don't know the person directly, I know someone who knows them. And so I think that the, I think networking in the business world has obviously incredibly important, but I still find myself

Yeah.

you're teaching my own kids and others that the importance of networking and how it's going to pay for itself in time. You never know when it's going to come in handy, but when it does, it's a huge thing.

Yeah, it is.

It's a huge thing, absolutely. Well, Ross, I still have, think there's like another, I don't know how many questions I could ask. So, cause I did go off a little bit in a direction, so maybe I'll have to do another session sometime in the future. Yeah. Number two, get to the other bits, but thank you.

You can have Ross the sequel. If the audience aren't too upset about it, we're going to have Ross the sequel. Ross part two. we'll try to get to it. But it was a pleasure.

Yeah, thank you so much. Really enjoyed the conversation. Thanks also for the openness because we talked about a couple of things that we didn't plan to go in the direction of, but I think that those are the valuable conversations that are going to help. And that's the idea behind this podcast in general is to bring up these topics and to address things that maybe not everybody's talking about, but wants to. So thanks for that, Ralph. I really appreciate it and I wish you a good rest of the day.

Thank you, was a lot of fun. Thanks, Sabine.