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Service Provider Executive Series Episode #3 - Toban Zolman (Kivo)
51 Plays3 months ago
Welcome to the Executive Series of the Gens & Associates Podcast.
In today’s episode, host Steve Gens is joined by Toban Zolman (CEO of Kivo). Together, they discuss Kivo’s success with smaller stage companies, their process for quickly getting clients live on their platform, and Kivo’s exciting plans for the future!
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Transcript
Introduction of Tobin Zollman
00:00:00
Speaker
Welcome to the Gens & Associates Regulatory Executive Podcast Series. I'm your host, Steve Gens, Managing Partner. Today, I'm delighted to have the founder and CEO Tobin Zollman of Kivo. So Tobin, um I think you and I go back when we first met. You were at ISI and this had to be 15, 18, 20 years ago and I know when that we reconnected when you started Kiva, which I think is about three and a half, four years young. Yep. So I'm looking forward to this conversation quite a bit. But before we get started, for our listeners, once you give a brief introduction of your yourself, ah yourself and Kiva to
00:00:46
Speaker
Yeah, sounds good.
Tobin's Career Journey
00:00:47
Speaker
First off, great to be here, super excited to to talk to you and kind of catch up. um Yeah, to your point, we we first met, ah not to date us but probably 20 years ago, maybe a little longer even at this point back at ISI.
00:01:03
Speaker
um I've had kind of a winding career. I did an early stint at ISI back in the the early 2000s. For folks that aren't familiar, we were kind of ah an early leader, you might say, in regulatory software, created ISI Toolbox and and ISI Writer, things like that. And I kind of was at the intersection there between product and services.
00:01:27
Speaker
and which was really a great learning experience. Frankly, it let me get a lot of feedback from customers by running all of our training and business process programs, feed that directly back into the product and usability and see what worked and what didn't. And then kind of as my decade at ISI ah progressed, I spent more and more time leaning into process consulting and working with a lot of major pharma companies of the time to transition to ECTD. And I think in my time there, I got increasingly frustrated not not so much with ISI, but just with kind of how software gets developed.
Challenges in Regulated Markets
00:02:10
Speaker
in regulated markets and we kind of ran into increasing headwinds where customers literally were asking us not to do feature releases because they didn't have the budget to implement them.
00:02:24
Speaker
And so when ISI got acquired, that was coincided to be my last day there as well. And I went and spent about a dozen years um working in enterprise SaaS startups across a whole bunch of markets. I was super early in social and e-commerce and was part of the transition from ah IT t to DevOps and cloud software development.
00:02:52
Speaker
then ops, and then leaned into commercial IoT and managing distributed compute centers for commercial IoT operations. So all sorts of really unique and different markets. And I think the one thing that was always kind of an an itch in the back of my head is as I went into those other markets and looked at how to run these new technologies and tackle the organizational challenges with them is from a pattern recognition standpoint, a lot of that felt awfully familiar to the sorts of
00:03:30
Speaker
process and organizational challenges that we dealt with in the transition from paper to electronic submissions and just generally how you run large distributed teams managing lots and lots of disparate assets with their own life cycles.
Applying Lessons to Drug Development
00:03:47
Speaker
And so in, I don't know, 2019, 2020, I started to just increasingly look at, man,
00:03:56
Speaker
are there ways that we could take some of these cool tricks we're doing in these other markets and apply them back into drug development? And so I would call you know my old friends and colleagues and share some of the ideas that I had. And it was clear that nobody was doing, was was really tackling the organizational or process challenges ah that in drug development in ways that it was being done outside of life sciences.
00:04:26
Speaker
And so we kind of merged the the ideas and and lessons from from the ISI days with what I had done outside of life sciences and enterprise SaaS development and formed Kivo. And so we're you know basically a platform to manage all of the regulatory and compliance activities during drug development.
00:04:51
Speaker
And that spans kind of the whole the whole gamut. We've got a full QMS to handle controlled documents and incident management and training, and we can manage clinical trials and handle sites in the TMF and activities like study startup. And then on the regulatory side, do submission management and document authoring and manage all of the correspondence and commitments. and What we've layered around all of that is kind of this process management methodology that ah we've adapted from from other markets we've worked in. and I think it offers a really unique take on how work gets done during drug development.
Kivo's Unique Approach
00:05:36
Speaker
And so that's what we're super excited about at Kivo is is really changing how people do work during drug development and do all of that in a compliant and repeatable way. So thanks for that, Tobin. And certainly with what we do with our benchmark, because clients always want to know What are our peers doing? and We answer that with what we do here at Jensen Associates. But the other thing they always ask, especially if they're looking at something new, is what can we learn from other industries and kind of with your.
00:06:09
Speaker
Introduction and everything in the past decade that you're applying and putting into kind of Kivo you know certainly makes a difference because I know your initial, even though you're a startup, you're way, way with the ah number of customers. Yeah, the other thing as far as you mentioned toolbox, you know that's still relevant today for a lot of companies. And I know when you were at ISI, it was a very innovative time at ISI before you know they were ah sold.
00:06:35
Speaker
So ah let's get started. Like I said, you know you guys are fairly new to the market about three or four years young, I would say. um And certainly as we've talked you know over the years and certainly at the RSI DM show, and that's coming up pretty soon, you've had a lot of success with smaller stage companies, but also I understand the whole CRO and and sponsor world. So if you could share with our listeners kind of your strategy and more importantly, the value proposition, why this has the Kibo,
00:07:04
Speaker
platform has been so quickly adopted for these market segments, that would be great. Yeah, sure. Well, I mean, maybe to start with some of our core value propositions, if you will, I think the thing that that we get an immediate reaction to the most is just how easy to use Kivo is. And some of that is being super intentional about workflows and and how the work happens in the system. And some of it is the fact that it's just a ah modern web app. And you know I think if you look at a lot of the tools that are in market,
00:07:43
Speaker
Some of these were developed prior to the iPhone being invented. So UX patterns and features and functionality have have changed dramatically in the past decade. And because we're a youngish company, we have the benefit of both learning you know how folks are actually doing work today and also leveraging more modern UI-UX frameworks and and tools. um I think we also find that a lot of folks feel like Kivo is really
00:08:18
Speaker
a fit for purpose platform. And that's a term that gets used a lot. But I think for an emerging company, what that means is a little bit different because the way in which they run their business and their business goals are frankly different from what we're used to with traditional big pharma drug development. um Emerging companies rely on lots and lots of partners and outsourced folks that come in and out. ah We're able to offer a single platform that spans all of these different areas, regulatory, clinical and quality, which also means
00:08:59
Speaker
There's only one set of ah learning that needs to happen when it comes to how to manage documents or process in the platform. And we also just frankly price the platform in a way that ah that's super transparent and aligns to these smaller organizations as they scale very rapidly in some cases.
00:09:22
Speaker
And so we can support that sort of growth without kind of breaking them along the way. And the final thing I would say is, you know from an operational standpoint, a lot of these emerging companies, a lot of our customers don't even have an IT department
Supporting Small Scaling Companies
00:09:37
Speaker
yet. And the ones that do or have an internal quality group, they don't have the headcount or the resources to manage a multi-quarter implementation and handle all of the validation and vendor qualification. And so we take a lot of that off of their plates. We do that work as part of the the offering. And so it really aligns, I think, kind of soup to nuts from
00:10:03
Speaker
the process you follow in the app, how we get it up and going, how we support it over time and how we price it, just all is is really tailored specifically for small scaling companies. And that seems to have really scratched and itched and allowed us to to grow very rapidly.
00:10:25
Speaker
Yeah, and there's there's thousands of those organizations around the ah you know globe. And you know with the scalability, I always say you know cash is king in those companies, and you're investing to the growth curve of the company. So it's a very, very different dynamic and actually really, really exciting.
00:10:44
Speaker
So um I want to move on to something when you when you first told me it's like, i I don't know if that's true or not. How could it be true? And certainly it is. So I think for our listeners, let me give a little background in context, because we live in the age of your your cell phone gets updated overnight, right, or whenever you reboot it.
00:11:03
Speaker
And you know traditionally in this space is we have the episodic you know update or new vendor. It takes two years. Maybe now um a lot of the competition saying, hey, we can get you live in six months or maybe ah nine months. And that's more of a technical go live versus a business go live.
00:11:22
Speaker
and Certainly with a lot of providers, you know um you know, Viva started with, hey, continuous improvement three times a year. Other providers have kind of also, you know, two times a year or at least, you know, annually.
00:11:37
Speaker
you know but the The world that you live in is weeks you know or maybe a month or two to actually go live, um you know the rapid updates, because again, they tend not to have you know IT t or mature IT t colleagues. And just like the cell phone that's that's had this up in the cloud, so it's minimal you know upkeep because we're growing and scaling and we can't spend our time or resources on kind of classic classic IT. t So with that said you know as far as maybe just help our listeners out from. When a client signs up to where they go live with your platform and I think maybe my questions is what's the secret behind this innovation not to open yeah well so this is a big part of.
00:12:24
Speaker
both why I was interested in coming back into drug development and also, frankly, a requirement for me and for the company. I didn't want to go back. you know I spent over a decade in a world where we largely did continuous deployments. And so we were doing production, rolling production updates on a daily basis.
00:12:50
Speaker
and um Certainly, there are challenges doing that with ah with validated software. But we wanted to get as close to that as possible. And so we really architected Kivo from the ground up to support that sort of rapid deployment model. We average a release about every two weeks. um And you know over the over the course of a year, probably do somewhere around 30 to 40 releases.
00:13:21
Speaker
Because we are architected as a multi-tenant system, all of our customers are on the same infrastructure. But not everybody has to take the same features. We have a variety of mechanisms that we use to ensure that um when we do a release, if there are new features, customers opt into those. We perform all of the validation on behalf of our customers.
00:13:48
Speaker
And so we're able to, for every release, run all of the validation tests, ah both to you know both things like OQ as well as UAT for our customers. And so what that lets us do is really drive features, quality improvements, performance improvements out, get those in the hands of customers in very rapid fashion, but do that in a way that's super controlled so customers can get bug fixes as an example and aren't dealing with long running defects in the software.
00:14:26
Speaker
But at the same time, don't have to take new features, don't have to retrain users or train their or change their process as we ship things. So the end result of all of that is when somebody signs a contract with us, it depends you know on the amount of data they're migrating into the system.
00:14:45
Speaker
But if they don't have a system in place today, we typically measure the time from contract signing to go live in days, not months or quarters. And so it's just a ah fundamentally different process and paradigm.
Enhancing Customer Interaction
00:15:02
Speaker
It's one that you know we have to kind of coach heads of quality through on on how this works and where we can take burden off of them and how it leads ultimately to higher quality software because you're fixing things and improving things ah literally weekly instead of twice a year. um It also means
00:15:26
Speaker
We're massively connected to our customers. That feedback loop on, hey, we would like to do X, Y, or Z. And they can literally have access to that within two to four weeks and in many cases. i Man, it's it's the coolest relationship I've ever had, I think, in any of the industries I've worked in, in terms of how we're able to take customer feedback, implement it, and deploy it ah in ways that that really drive ah improvements to how folks are are doing work day in and day out. And the final thing I'll say is is I think for these emerging companies,
00:16:09
Speaker
They are they're fundamentally different. A lot of people, I don't think fully grok how unique the business model is for a venture backed early stage drug development company. Their time horizon to liquidity and needs to be much shorter than the traditional drug development cycle of 13 and a half years to go from patent to approval. ah that That's too long for a traditional venture fund to get a return. So if you're trying to squeeze that down to six or seven years,
00:16:48
Speaker
um which is what a lot of venture capital investors are looking for. That means you've got to get to early inflection points, licensing agreements, et cetera. You can't take six months out of a six-year time horizon just to implement software. So you've got to be able to move quicker. We typically can support that. And so it's just been it's been really a fun way, I think, to and surprise and delight folks that are used to these multi-quarter slogs to get software live ah to be able to come in and offer such a different model ah has been a blast.
00:17:32
Speaker
And I'm trying to you know unpack everything you said. First of all, it's it's very impressive. And you know from time to time, we work and we see them in our survey as we've expanded our survey from you know the large, mid-tier, smaller. We call it the very small. So they're in the clinical stage. They might have their first product on the market. And you know certainly, everybody focuses on um kind of money, but then there's the thing called time. And in that stage, time is not your friend, like you just very nicely described, because even if you can bring, you know, you know, six or seven years, if the product finally does go to the market, you have a ah longer, you maximize your patent window, and a lot of these companies get bought, right?
00:18:18
Speaker
So it is a really, really interesting dynamic. And the other point that you made about the customer touch points, you know, you know, we feel here, we're unique, even though we're a consultancy, but also kind of a, you know, research benchmark, but we talk about customer touch points and ah And most of them are when we're not doing an active project, you know, so it isn't transactional, like it might be our SD expert, you know, we're pulling people into design sessions, you know, with our next piece of research that we do, we have unstructured time where we're just connecting and seeing how it goes. But you know, as you can describe, it's a lot of fun, you know, just staying constantly connected.
00:18:57
Speaker
and just really focusing on your ah client success. So that that gets us you know excited here you know also. um one One more thing before my final question. And I thought um this might be nice too, because in these earlier stage, it's been our
Process Compliance for Emerging Companies
00:19:13
Speaker
experience. And and I mean, you're working with 50, 60 companies. you know It might be five or 10 for us.
00:19:20
Speaker
But we usually see the first investment where they want to get the content under control. Most of them outsource the publishing, or you know they might or their sponsor does the you know CTA or you know the IND on that. And as they get a little larger, they think about you know kind of registration management.
00:19:39
Speaker
even if they have one product because they want to show a very disciplined kind of business in case that they're acquired. But i mean what's your sense? Do clients usually reach out? They're trying to get a hold of their content. you know You have the quality side of that, the regulatory side, the clinical side. Or is there other kind of drivers to take that first step or first investment with software? Yeah, great question. So I think we see a few different inflection points, especially since we span regulatory, clinical, and quality. The first thing I would say is these emerging companies, I'm really impressed with ah um really impressed with their talent acquisition.
00:20:22
Speaker
What I mean by that is they're bringing really experienced operators into these companies. Often these folks have worked for top tier pharma companies. So they really get what they need as an organization when it comes to process compliance, et cetera. Where I think we help those sorts of ah leaders make decisions is really to to kind of show them how the the model works differently ah in these emerging companies. you know they They may have been eight layers from the CEO in their prior role and they come into an emerging company and they're
00:21:09
Speaker
Talking in board meetings and so that's ah that's a very different sort of corporate culture to navigate. But I think what we typically see is when those early operators are brought in and often it's the first set of quality or in the first set of regulatory. And they say, man, we've got to get our act together in order to really ah ah get ready for this first IND or this first clinical trial. So we often see folks pull us in at that point.
00:21:43
Speaker
we will occasionally get brought in after that when they try to DIY their way through using SharePoint on their first IND or something and they call timeout and are like, we just can't do this. Increasingly, we're also getting approached from investors ah who want to build essentially an operating system across their portfolio companies to really make it possible to standardize operations, to move leaders from portfolio company to portfolio company, and frankly, to increase transparency and visibility back up to the investor pool on what's really happening. The the thing that we didn't set out to do, but I think have found is really valuable
00:22:36
Speaker
As we talk about Kivo, essentially making your company always diligence ready because all of your assets are in one controlled platform. We have literally had built user roles for ah due diligence to allow folks to come in and securely review content.
00:22:54
Speaker
um So I think there's like there to your point, there is a different model in how work gets done, how and what the expectations are from investors. And so we've really tried to align the features and the tools and the platform to really facilitate that and make reduce the friction out of that entire process.
00:23:20
Speaker
Yeah, again, very impressive about you know Tobin and just kind of you know enjoy watching watching the growth and actually learning from you guys, too. So my final question, and I don't get to ask it that often, but it is my favorite question because it's it's founder to founder. And I would say, in your case, founder and innovator.
Kivo's Future and Innovation
00:23:39
Speaker
um And when you just try to, it's one thing to go out and find a company, and there's a lot of me tos, but to do something fundamentally different and and innovate is really ah a neat place to give you a lot of excitement. So so speaking of excitement, sheesh, you're just three, four years young. What what excites you most about where Kibo is headed, both both in the short term and in the longer term?
00:24:07
Speaker
Yeah. um Well, there's a lot, but I think I can kind of focus maybe on two areas that I get the most excited about. One is is really the market in which we exist in, the the market dynamics around emerging companies. I'll be honest, when we when we started Kivo,
00:24:32
Speaker
I like had some ideas on on how emerging companies worked and why this flywheel of innovation was was happening by buy small companies, not necessarily by the the large incumbents. ah But this is a trend that that really excites me. And so what I mean by that is I think what we are seeing increasingly is the combination of new investment models, new drug discovery models, you know, everything from zebrafish are being used to AI are really accelerating
00:25:13
Speaker
a drug discovery timelines, which yields more promising drugs for for development. It also is driving down the cost for those activities. So there's no longer any real structural benefit to size when it comes to ah drug discovery and drug development. And that means you know thousand companies a year are being formed to pursue drug development and clinical trials. And that number is accelerating the amount of investment that's pouring in to drug discovery and kind of ah the early stage of this process is accelerating. I think $60 billion dollars has flowed into drug discovery, just earmarked for for AI innovations. And so I think what makes me excited is
00:26:08
Speaker
it's going to fundamentally transform how drugs are developed and brought to market. And that is a transformation that I don't think most folks in traditional pharma see every day and certainly don't understand that ah the entire business model, tech model ah are fundamentally changed. And so I think that's gonna bring all sorts of innovation break all sorts of of and kind of standard practice on how this stuff happens and I'm really excited to be kind of right in the middle of that trying to figure that out shoulder to shoulder with our customers. And then I think the second thing that really makes me excited
00:26:57
Speaker
a And there's both short-term and long-term implications here, but I feel like the market by and large has really focused on compliance ah over the past two decades effectively and really missed the boat on helping people do their
Streamlining Processes with Technology
00:27:16
Speaker
work. And I think there's a rich set of tools and approaches to managing workloads in other industries that have some assumptions that probably are going to sound familiar. you know Large distributed teams, crossing employees and partners, large numbers of assets, dynamic data sets, accelerating timelines. like Those are ways that we described five years ago
00:27:47
Speaker
workloads in in the cloud and how that was transforming ah software developments in IT. And those equally apply to how drugs are getting developed these days. And so what really excites me is you take these kind of transformational trends in how people do their work ae and overlay on that newer technologies, cloud, SaaS, AI, machine learning. And while those aren't objectives in and of themselves, they're really just supporting technologies to really make the work that people do faster, more transparent, and frankly, easier.
00:28:35
Speaker
And so I think if you look at what we've got in the hopper for 2025, it's a lot of work that really leans into this area to streamline how people do work, to a reduce the amount of back and forth and manual tracking, auto generate as many things as we possibly can in the process,
00:29:00
Speaker
And I just i literally cannot wait to get some of this stuff in people's hands because I think it's going to really accelerate as well. As I talk about this feedback loop we have with our customers, accelerate that feedback loop. And as soon as people start to use it, it's going to be light bulb moments of, oh, wow, we could also apply this over here. And that could take two hours off my plate each week. And so we're starting to see some of those sorts of oh, wow, this saves me a ton of time moments in the software. And I think that's really going to accelerate the longer where we we stay at this.
Conclusion and Future Plans
00:29:43
Speaker
So you you're certainly in a sweet spot, and kind of what you're envisioning is is very exciting and and inspiring. And I would say kind of for that segment, it's a big game changer. um But just even how you describe, you know, discovery, I mean, in the old days, it was you moved ahead by brute force, and now it's rapid smart force, if there is such a such a word. So, you know, great talking with you and and certainly, you know, looking forward next year seeing you at the RSIDM show. So we'll put a little plug in for the DIA there, right. And um I think the last thing real quick, um some of our listeners might want to get ahold of you get get your contact you or the Kibo team. So, um so how should they do that?
00:30:26
Speaker
Yeah, ah well, first off, we will be at that show. And we're actually hosting a session focused specifically on how the operational model has changed for emerging companies, which I think will be a much deeper dive on a lot of these topics. And we're we're doing that with ah some of our customers and partners. So we're excited about that.
00:30:47
Speaker
um I can be found on LinkedIn and also contacted through our website kivo dot io k i v o.io. So would love to talk shop and dig deep on any of this stuff with ah with your listeners and appreciate the opportunity to catch up today.
00:31:06
Speaker
Yeah, thanks. And I think likewise for our listeners, we're all over LinkedIn, um you know, on it actually daily, or we have our contact form off the ah the website. So yeah, Tobin, thanks again. Really enjoyed this and, you know, hats off to you, kind of the niche that you found and ah the value you're bringing to that important segment that, as you said, it's just exploding now. It's it's just really, really interesting times to be in life sciences, and especially that segment. So thanks so much again. And I think what we need to do is, you know, maybe in nine or 12 months have you back and you can report back in with your progress. So thanks again, Tobin. Yeah, I would love that. Thanks a lot, Steve.