Become a Creator today!Start creating today - Share your story with the world!
Start for free
00:00:00
00:00:01
Service Provider Executive Series #14: Building the Operational Fabric of Modern R&D - Toban Zolman, Founder & CEO of Kivo.
52 Plays1 month ago
In todays episode, host Steve Gens welcomes back Toban Zolman (Founder and CEO of Kivo) for a founder to founder discussion on Kivo's rapid growth, why sponsors and CROs are embracing the platform, and how tectonic shifts, like AI, are reshaping R&D. They explore the tipping point for AI adoption, emerging trends in Biotechs, and Kivo's unique relationship with the community.
To learn more about Kivo’s unified platform for regulatory, quality, and clinical operations, visit kivo.io or follow them on LinkedIn.
Recommended
Transcript
00:00:07
Speaker
Welcome to the Gens and Associates Regulatory Executive Podcast Series, where we explore innovation in the regulatory space. Today, I'm happy to be speaking with Tobin Zolman, founder and CEO of Kivo.
00:00:19
Speaker
It's always a treat on these, and welcome back, first of all, Tobin. I do enjoy the founder-to-founder conversations. Yeah, ultimately it's it's your baby and it's been a little bit, you know, I think it was the end of last year when we had our first session and I know there's a lot going on that we're going to cover. So before we get to that, if you could just quickly introduce yourself and the company for our listeners.
00:00:42
Speaker
Yeah, sure. Thanks. Great to be back. Appreciate the opportunity. HEVO, for those who aren't familiar with us, is a platform for drug development companies to manage really all aspects of R&D. So we've got a document management system and then really purpose-built features for regulatory, clinical, and quality.
00:01:04
Speaker
So that looks like a full QMS, a pretty much everything a ClinOps group needs to run a clinical trial as well as manage TMFs at the end of that.
00:01:15
Speaker
And then a RIM platform as well to handle submissions and basically get your drug to market. So it's pretty much one-stop shopping, a single platform for most of the activities that happen during R&D.
00:01:29
Speaker
And that's an exciting place to be. My last tenure at Janssen, part of Johnson & Johnson, and I won't say how long ago. You know, it was a unique job because I was running part of CleanOps and also all the technology. And I did start in technology, as you know. And we were digitizing the trial master file.
00:01:46
Speaker
So that's a long time ago. But... It was paper CRFs that were doing and just imaging them and this really fantastic technology called OMR and OCR. So things have come, if you're a Star Trek fan, light years ahead.
00:02:01
Speaker
So that's where I want to start. You know, really enjoyed our first podcast last year. And since then, you guys have really had tremendous growth. You're rapidly... and I would say you're growing, but you're disrupting, in our opinion, that small tier space, you know, the clinical space as you defined it. And a lot of it is, and why we use the term disruption. So it's speed to production. And it's really, really impressive and what you've done.
00:02:27
Speaker
So why don't we start out with why are so many customers? And I know it's not only into sponsors, but CROs and others are adapting the platform. And if you can talk about, you know, the value they're receiving in the short and longer term.
00:02:42
Speaker
Yeah, happy to dig into that. I think there's a few different dimensions to this. To your point, we're seeing a lot of traction as well with service providers and CROs.
00:02:53
Speaker
So let me just unpack it a little bit. I think from a headline perspective, there's kind of two pieces that virtually all of our customers can are identifying speed and flexibility, which of those matters most depends a little bit on where they're at, maybe on the maturity curve.
00:03:12
Speaker
If you think about the types of customers that seek Kivo out, there's really two motions that we see, ah so to speak. One is companies that have outgrown kind of a DIY approach where they're using SharePoint and Excel and Box or whatever it is to try and get work done and need like an actual fit for purpose compliance system. And so they turned to Kivo as...
00:03:37
Speaker
as a solution that really fits the needs of smaller companies. And that's really where we've seen the bulk of the growth in Kivo historically. But increasingly, we're seeing companies that already have solutions, maybe across all of Redclin and Qual, maybe just one or two of those companies.
00:04:01
Speaker
And so we're doing a lot more replacements these days. In fact, I would say about 40% of our pipeline this year has been helping companies replace existing software that they have and consolidate all of their activities on Kivo.
00:04:16
Speaker
And really what's driving that, I think, for them is the flexibility and the our ability to really standardize their process across the entire drug development process.
00:04:29
Speaker
So it's literally the same document management principles and under the hood, the same DMS, whether you're in quality or in regulatory. Yeah. And so we've seen that being able to bring a platform to the table simplifies process development, training, onboarding employees as they're scaling, simplifies their IT needs, their validation needs, et cetera.
00:04:55
Speaker
So whether you're trying to move quick because you're maturing as a company and starting from ah drug discovery stage or you have products in market and are dying under the weight of some legacy system, we've seen that speed and flexibility trade off really being what drives a lot.
00:05:15
Speaker
The other dynamic, though, that I think is really interesting, and I'll be honest, it's not one that that I thought was going to be ah huge driver for us, but increasingly, CROs and service providers are consolidating their operations on Kivo as well.
00:05:33
Speaker
And about 30% to 40% of all of our deals at this point are referrals from other service providers. So CRO worked with a sponsor who was using Kivo.
00:05:46
Speaker
was like, oh my God, this would make our lives so much easier. They buy it, they implement it, they manage their entire quality process in Kivo. They give investigator sites access and do site management and TMF management through it.
00:06:02
Speaker
And then when it's time for one of their ah sponsors to take possession of the TMF, they come knocking on our door and we get this nice little cycle where it's,
00:06:13
Speaker
really seamless for the service providers to develop a recipe or a playbook and bring that from company to company and have everything work in a really simple but elegant way that's repeatable from company to company.
00:06:28
Speaker
So that's been a pretty major trend for us this year. And frankly, one that's just further accelerating our growth. So that that's been fun to establish those relationships with CROs and service providers in addition to sponsors and create a nice ecosystem.
00:06:46
Speaker
So I guess I got the word disruptive because the last time we talked and you're kind of your first scenario and that's where you're at. You know, we have the basic tools. We need some compliance systems.
00:06:59
Speaker
Speed is important. We're trying to preserve cash. We're investing to the growth curve. It's classic scale, right? When you landed in that spot and have been successful, but that 40% replacement is actually really, really impressive because whoever you were replacing, we won't mention that on the podcast.
00:07:16
Speaker
Is why were they replaced? The whole thing about speed and flexibility you mentioned, it's just so important, as you know, you live with these people every day, you know, having the agility both from a tech and an organizational. lot of times people don't talk enough about organizational agility on that.
00:07:33
Speaker
And hey, when you're doing really well, you get referrals. It's a beautiful thing. So hats off to you. To be honest, the second question I have for you, and I would say it's your own fault there, Tobin, because I am on your email newsletter, you know, and when...
00:07:51
Speaker
When they come out, it's very enjoyable. It's not like, hey, this is the latest feature of functions with Kivo, but it's really sharing a lot of thought leadership, what's going on in industry, so many dynamics going on in our industry.
00:08:05
Speaker
So where I want to go with this is, you know, I believe there's a lot of tectonic shifts going on. and We have the current geopolitical environment. Early days of AI impact on life sciences, and everybody's tried to significantly reduce the time from the clinical stage, you know, to classic last patient visit database lock, to filing, which for a lot of larger companies, they're trying to get that into single-digit weeks. Like four or five years ago, it used to be about 30 weeks.
00:08:32
Speaker
So it'll be interesting. You guys share a lot of your views in this newsletter and other things. And again, it's really interesting. So for our listeners, get on their newsletter. So where do you see this? i would call it a bullet train going in the next two or three years.
00:08:46
Speaker
Yeah, so there's a lot of meat in that question. and I think maybe I look at this from from maybe three different perspectives. So let me unpack those.
00:08:59
Speaker
I can talk about ai I can talk about, I'll just call it the trend on internationalization on clinical trials and also head on, to your point, the the general acceleration in R&D. I think all three of those, if you were to create a Venn diagram overlap in a really interesting way. And I think Kivo often is working with and selling to companies that are the intersection of that kind of three-part Venn diagram.
00:09:30
Speaker
Maybe just to orient you to my thinking on this a little bit before I ah get into it, though, There's this famous quote from Bill Gates, which I'll paraphrase, where he says something to the effect of people overestimate the amount of change that technology is going to generate in the next two years, but underestimate the amount of change it's going to generate in the next 10.
00:09:54
Speaker
And i think that's very much true in drug development and life sciences more broadly, because And when we look at AI, I think this is an area we really feel it where there's no question AI is going to fundamentally change how drugs get developed, the submission and approval process. I mean, it's going to fundamentally change every aspect of every business.
00:10:19
Speaker
But I think... What's been interesting for us is we talk to a lot of generative AI companies. Kivo is often the repository for them to train documents for our customers and offer generative content creation services.
00:10:39
Speaker
Kivo's done a lot of work in this area, but there's a, I won't say what it is, but there's this Holy grail feature based on AI that I have. And so we've done for the past two years, we do these engineering spikes every three to six months. Cause I want to get there and,
00:10:57
Speaker
When we first started doing it, that spike was like two weeks to get to a prototype. Every time we do it, it takes a shorter amount of time to get to the prototype and the quality of the prototype gets better. So we did this last month and in a couple of hours had the entire feature stood up as an example. So in two years, that development time has dropped from two weeks to two hours.
00:11:21
Speaker
And so I think really what we're seeing is ai is going to accelerate every step of the process, if you will. But it's not good enough yet to really take over the process on most of these items.
00:11:40
Speaker
Since it's non-deterministic, it's really tough to integrate into a validated workflow because you do the feature you execute the command one time and you get one result. You do it another time, you get a different result or different order.
00:11:56
Speaker
So there's a gap that needs to be closed, even outside of generative use cases, but just having ah automate processes where it's getting there, but it's not quite there yet. And I think a lot of companies are burning a ton of resources trying to close that gap when If they were to take a beat in 18 months or so, i think the models are just going to improve so much that it will close on its own without them kind of pushing rope to try and get the model to be more deterministic.
00:12:31
Speaker
So I think AI is going to be super fascinating and how that works and how it influences the process. But i I think it's probably a couple of years before it is so slam dunk that everybody pours into it. And I could be off by a year on that, but that's my hunch is that a lot of people are going to break picks in the next year trying to make it happen. And it's just not quite there yet for a lot of life science use cases.
00:13:07
Speaker
So I think that's one dimension to it. The other thing, though, that I would say from a tectonic shift standpoint is the change in the R&D business model and this internationalization trend that's happening I think are really shifting how drug development happens. And let me take just a minute and unpack that. So i think I talked about this last time I was on the podcast where we've really seen ah business model shift in industry where a lot of companies are not trying to build a company. They're trying to build an asset, a product pipeline, and then sell that asset to drive additional research.
00:13:50
Speaker
And that's, That's being driven by venture investment needing faster cycle times to returns. And they can't like bet on a 13 year process to get a product in market.
00:14:04
Speaker
They need more like a five year process to get it in deep and enough into clinical trials to sell the asset. Yeah. If you look at funding trends, you can really start to see this take shape.
00:14:17
Speaker
So this is something we pay a lot of attention to at Kivo because we focus so much effort on early stage companies and, Last year, 40% of all venture rounds in life sciences were seed stage investments.
00:14:35
Speaker
So basically funding companies coming out of drug discovery and into drug development. The net result of that is that we're like, I think, two years away from there being a total of 10,000 independent R&D companies.
00:14:52
Speaker
I think the hypothesis for a long time was that the way drug development worked, even in this new model, was that a company would take a promising compound or asset, raise a venture round, get it deep into the clinical trial process, sell the asset,
00:15:11
Speaker
wind down the company, start over. Increasingly what we're seeing is these molecules, I'll call them, not actual molecules, but corporate molecules where it's the same entrepreneurs, the same investor syndicate taking the same R&D approach and maybe they wind the company down, maybe they don't, but they just throw off asset after asset after asset.
00:15:38
Speaker
And so I've been stealing from you for years, Steve, with this metaphor that we talked about at RISDM a few years back around early stage companies are a roller coaster, mature companies are a merry-go-round, and it's a different model.
00:15:57
Speaker
I think what we're seeing increasingly is a new merry-go-round being developed where these companies layer a new asset in get it into the clinical trial process, sell it off, get a new one in and just keep that motion going.
00:16:16
Speaker
I've met several biotech investors this year who are literally running this playbook over and over and over again They'll take a partner, they'll go to China, they'll find an asset that they think is promising, form a company, buy the asset, get it into a clinical trial, send it off, do it again.
00:16:39
Speaker
And they're able to... Take about $150 to $500 million dollars worth of investment and in two to three years sell that asset off for $800 million to $1 billion and a half is kind of what we're seeing.
00:16:58
Speaker
So there is a real repeatable model here that we're seeing accelerate, not plateau and M&A just kind of keeps the number of those companies the same.
00:17:13
Speaker
So that's really fascinating to see. And I think... you know That model of going to China or other emerging markets, finding promising assets is really going two ways. It's pulling those in to do the development on.
00:17:29
Speaker
And then the second half of that is increasingly running clinical trials in those other markets, getting out of the drama of the U.S. and the uncertainty of the U.S., and doing that in other markets.
00:17:42
Speaker
And we get that question more and more frequently at Kivo, basically how decoupled from US or FDA paradigms are we?
00:17:54
Speaker
And how easy would it be for them to spin up clinical trials in Australia, Africa, whatever it is, there's definitely a movement in that direction.
00:18:05
Speaker
So that's a lot. Yeah, it is. and And that's why I asked you the question, because there is a lot going on. And I like the Venn diagram. So when you have all these kind of complementary competing factors come in where is this going? So since we last talked, and I know you guys participated too, but just for our listeners, AI, and I really like the Gates thing about Just underestimate or overestimate in two years and underestimate in 10, you know, because that seems the bit like a glove here. But on that advanced technology poll survey we did, so like you were one of 17 software providers and we had 41 with industry because the reason why we asked that question, we're looking for the implementation tipping point. And the key words are being the tipping point because if individual companies today you believe everything, wow, we're really behind. And you really aren't, you know.
00:18:58
Speaker
So yeah part of that was the intention. When can we predict the implementation tipping point? And we had nine use cases. I won't go through on them, but they're easy to complex, some generative AI, some bot stuff, translations. Like we sprinkled it all the way through.
00:19:13
Speaker
And survey said the bell curve perfectly for industry, 26, 27. twenty six twenty seven And that was six months ago. So like kind of in the next two years, hey, we're going to probably overestimate, but this thing's going to come out. And as you know, there's so much experimentation. Some of the early stuff is really, really impressive, but it takes a little bit to mature. And one of the best digital strategy roadmaps I saw, and this was last summer, and they're really smart because in any really good roadmap, you're trying to predict when you're going to invest in resources, blah, blah, blah.
00:19:47
Speaker
But it's also setting expectations, and they really talked... about AI from an accuracy standpoint. We believe in this year, it's going to be 80%, then it's going to be 90%.
00:19:58
Speaker
And that guided the roadmap. And I thought that was really, really smart because they're, you know, what's pragmatic, but also that's actually, as we're communicating this, we're educating too, that this is not like other technologies to turn it on and off.
00:20:12
Speaker
There's that exponential learning curve. And maybe that that metaphor is outdated now. It's one of my favorite ones, the roller coaster and the merry-go-round. But the picture that I drew when you were talking about this, where they're spitting out these assets, it's it's like a classic manufacturing.
00:20:28
Speaker
Yeah, totally. They're just manufacturing this and boom, boom, it's just coming right off the line. Quality on the line and boom, you take it out. So the last question, to Tobin, and I like enjoying this again when it's founder to founder. So as a founder, what's the one thing you're most proud of since your inception? And then looking forward, what are you most excited about in the the future with Kivo?
00:20:52
Speaker
Yeah, well, look, I'm a product guy. I like to build things. I like to ship things. So there's an awful lot that that I get excited about and can geek out on with what we've done with the product. I think the thing, though, that at the risk of being cheesy, that has really stuck out to me this year is as we've scaled very rapidly this year and layered on lots and lots of new customers,
00:21:22
Speaker
the relationships that we've built there and the amount of mutual trust that we have with our customer base is really, i think something pretty unique that I haven't fully experienced before.
00:21:36
Speaker
And i mentioned earlier, like how important to our growth referrals have been. And i think that is somewhat of a proxy of what, what that is like, but Because Kivo is a relatively young company and because we are really, i think we're doing two things that are unique. I think we are really trying to understand the business model shift that is happening and how can our technology really dovetail with that in a way that aligns what we are building with what they really need.
00:22:18
Speaker
And because secondly, We're really trying to build a tool that helps people get work done, not just store a document or run a project, but we want to be the operating system of R&D and how they manage their work.
00:22:37
Speaker
I think what we've seen there is a feedback loop that's really rewarding where customers get what we're trying to accomplish. They build it into their process and build their process into Kivo.
00:22:53
Speaker
give us input on where there's gaps, where they could lean in more. And since we're now getting that feedback from emerging companies, from more established companies, and from CROs and service providers,
00:23:09
Speaker
You can just literally feel the puzzle pieces like locking into place for this to be an operational fabric, if you will, to how this kind of new generation of R&D company or drug development company, how that whole ecosystem works.
00:23:29
Speaker
participates in a collaborative way. And that is, man, that's cool to see. It's fun to have that feedback loop as a founder and executive. It's fun to have it as a product to guy, but it's just fascinating as someone who's been working in this industry and really focused on business process in drug development for 20 plus years to really see a lot of the ideas that we talked about, you know, in the early 2000s around ECTD, like those principles and those aspirations, like actually come true, not through some XML or something, but
00:24:09
Speaker
through supporting technology and software. That's been really cool. And I think to the second part of your question, what am I excited about going forward? It's it's literally seeing that mature. I think there is a, to to my point about seeing the pieces lock in,
00:24:27
Speaker
There's an ecosystem that is organically forming around this that I think is going to be pretty powerful and transformational and excited to be part of it, both because of what it could mean for Kivo and our customers.
00:24:41
Speaker
And I'm also just excited about it as a process nerd, because I i think it's going to be an awful lot of fun to like figure out how to optimize that over time. So yeah, that's that's what I would...
00:24:53
Speaker
That's what I would say. I think that kind of scratches the itch in terms of leading a company and nerding out on the stuff that we do. Super fascinating all around. yeah I really like the term operational fabric because that's what it is, especially in these early stage companies. And I'm sure you this resonates with you completely and because you're doing it. Is any critical decision from me starting the company to Instead of just focusing on industry, bringing the whole provider space into our benchmarks to starting the membership is, I always say, let your customers guide you.
00:25:31
Speaker
But they only give good guidance and it's something that you hit on. I call it customer intimacy, but customer intimacy and trust, right? Because that is so critical. I'm a big believer in the boomerang effect. and What you put out will come in and that you just keep on contributing, giving to the community and it does come back. So...
00:25:50
Speaker
But operational fabric, that's right. I'm a visual person, as you know. so wow So that that's actually ah sounds like a very special term because how you've described kind of in our earlier conversation, especially about the replacement, and we can talk about standards, consistency, and all that, but it is an operational fabric. And the stronger that fabric is, the more stress it can take, you can go quicker. There's just a lot of things that go with that. If it's dependable, brings confidence, yeah better, quicker decisions, et cetera, et cetera.
00:26:19
Speaker
So ah always a pleasure. And if we have some listeners that didn't hear our first podcast together, how can they get ahold of you? Yeah, feel free to track us down. Kivo.io is our website. We're also active on LinkedIn.
00:26:36
Speaker
All the conferences will be at Fierce and Bio this fall. So feel free to track us down at either of those. Yeah. yeah Great. Great. And for our listeners, you know the drill. LinkedIn, G-E-N-S, it's a basic word you don't want to get a hold of me or off our contact page on the website.
00:26:56
Speaker
So Tobin, always a pleasure. And who knows, a year from now, we'll get back together and I'm sure I'll be blown away where Kivo and you kind of steering the ship goes. And I guess keep on nerding out because you're getting great results. So congratulations.
00:27:11
Speaker
Thanks so much.