In this episode of the Gens & Associates Podcast, Kivo CEO Toban Zolman joins managing partner Steve Gens to discuss Kivo's success with smaller stage life science companies, Kivo's process for rapid implementation, and Kivo's exciting plans for the future!
Key highlights:
- Formerly at ISI, Toban has experience in regulatory software and enterprise SaaS across diverse industries before founding Kivo in 2020.
- Kivo is a fit-for-purpose platform for managing regulatory, clinical, and quality processes in drug development, combining modern SaaS technologies with regulatory compliance.
- Kivo is designed for smaller, scaling companies with an easy-to-use interface and transparent pricing that supports rapid growth. Kivo is often adopted when companies need better control over content (e.g., IND submissions) or seek to standardize operations as they scale.
- Kivo can go live in days, not months, by handling IT and validation tasks, ensuring quick and seamless deployment for emerging companies. The platform releases updates every two weeks, ensuring fast improvements, bug fixes, and new features without disrupting users' workflows.
- A discussion of how trends in AI and innovation in drug discovery, combined with pressure from venture capital firms, are accelerating development timelines, and the effects these timelines have on how development work gets done.
- In 2025 and beyond, Kivo is focused on automating tasks, streamlining workflows, and integrating AI to make drug development faster, more transparent, and efficient.
Full Transcript
Steve Gens: Welcome to the Gens and Associates Regulatory Executive Podcast series. I'm your host, Steve Gens, managing partner. Today, I'm delighted to have the founder and CEO Toban Zolman of Kivo.
So, Toban, let's go back when we first met. You were at ISI, and this had to be 15-20 years ago, then we reconnected when you started Kivo, which I think is about 3.5, 4 years young?
Toban Zolman: Yep.
Steve Gens: I'm looking forward to this conversation quite a bit. Before we get started for our listeners, why don't you give a brief introduction of yourself and Kivo.
Toban Zolman: Sounds good. First off, great to be here. Super excited to talk to you and catch up. To your point, we first met - not to date us - but probably 20 years ago, maybe a little longer even back at ISI.
I've had a winding career. I did an early stint at ISI back in the early 2000s. For folks that aren't familiar, ISI was an early leader in regulatory software. We created ISI Toolbox and ISI Writer, things like that. I was at the intersection there between product and services, 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 that fed directly back into the product / usability. [I got to] see what worked and what didn't. As my decade at ISI progressed, I spent more time leaning into process consulting, working with a lot of major pharma companies to transition to eCTD.
In my time there, I got increasingly frustrated. Not with ISI, but with how software gets developed in regulated markets. We ran into increasing headwinds where customers were literally asking us not to do feature releases because they didn't have the budget to implement them. So when ISI got acquired, that was my last day there as well.
I then spent about a dozen years working in enterprise SaaS startups across a whole bunch of markets. I was super early in social and eCommerce, was part of the transition from IT to DevOps and cloud software development, FinOps, and then leaned into commercial IoT and managing distributed compute centers for commercial IoT operations. All sorts of really unique and different markets. And I think the one thing that was always an itch in the back of my head as I went into those other markets, looked at how to run these new technologies, and tackle the organizational challenges with them...is that from a pattern recognition standpoint, a lot of it felt awfully familiar to the sorts of 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 of disparate assets with their own life cycles.
So in, I don't know, 2019 or 2020, I started to increasingly think, "man, 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?" So I called my old friends and colleagues to share some of the ideas that I had. It was clear that nobody was really tackling the organizational or process challenges in drug development in the ways that it was being done outside of life sciences. So we merged the ideas and lessons from ISI with my experience outside of life sciences in enterprise SaaS development and formed Kivo.
[Kivo is] a platform to manage all of the regulatory and compliance activities during drug development. That spans the whole gamut. We've got a full QMS to handle controlled documents, incident management and training, and we can manage clinical trials and handle sites in the TMF. Then on the regulatory side, we do submission management, document authoring, and manage all of the correspondence and commitments. And what we've layered around all of that is a process management methodology that we've adapted from other markets we've worked in. And I think it offers a really unique take on how work gets done during drug development.
That's what we're super excited about at Kivo; really changing how people do work during drug development, and how to do all of that in a compliant and repeatable way.
Steve Gens: Thanks for that, Toban. With our benchmark (because clients always want to know, "what are our peers doing?"), we answer that with what we do here at Gens and Associates. But the other thing they always ask, especially if they're looking at something new, is "what can we learn from other industries?" With your introduction, everything in the past decade that you're applying and putting into Kivo certainly makes a difference, because even though you're a startup, you're way up in number of customers.
The other thing - as far as you mentioned toolbox - that's still relevant today for a lot of companies. I know when you were at ISI, it was a very innovative time at ISI before they were sold.
So let's get started. You guys are fairly new to the market, about three or four years young, I would say. We've talked over the years - certainly at the RSIDM show that's coming up pretty soon. You've had a lot of success with smaller stage companies, but the whole CRO and sponsor world [as well]. So if you could share with our listeners your strategy and more importantly, the value proposition. Why has the Kivo platform has been so quickly adopted for these market segments?
Toban Zolman: I'll start with some of our core value propositions. The thing that we get an immediate reaction to the most is just how easy it is to use Kivo. Some of that [stems from] being intentional about workflows and how the work happens in the system. And some of it is the fact that it's just a modern web app. If you look at a lot of the tools that are in market, some of these were developed prior to the iPhone being invented. So UX patterns, features and functionality have changed dramatically in the past decade. Because we're a young-ish company, we have the benefit of both learning how folks are actually doing work today and also leveraging more modern UI/UX frameworks and tools.
We also find that a lot of folks feel like Kivo is really a fit-for-purpose platform. 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. Emerging companies rely on lots of partners and outsourced folks that come in and out. We're able to offer a single platform that spans all of these different areas - Regulatory, Clinical and Quality. Which also means there's only one set of learning that needs to happen when it comes to how to manage documents or process in the platform. We also price the platform in a way that's super transparent and aligns to these smaller organizations as they scale very rapidly in some cases. So we can support that sort of growth without breaking them along the way.
The final thing I would say is from an operational standpoint. A lot of these emerging companies - a lot of our customers - don't even have an IT department 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. We take a lot of that off of their plates. We do that work. It's part of the offering. So it really aligns soup to nuts - from 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. It is all tailored specifically for small, scaling companies.That seems to have scratched an itch and allowed us to grow very rapidly.
Steve Gens: There's thousands of those organizations around the globe. With the scalability, you know, cash is king in those companies and you're investing into the growth curve of the company. It's a very, very different dynamic. Exciting.
So I want to move on to something that when you first told me, I was like, "I don't know if that's true or not. How could it be true?" And certainly it is. So for our listeners, let me give a little background context.
We live in the age where your cell phone gets updated overnight, right? Or whenever you reboot it. And traditionally in this space, we have the episodic update or new vendor and it takes two years. Maybe now a lot of the competition is saying "hey, we can get you live in six months" or maybe nine months. And that's more of a technical go-live versus a business go-live. Veeva started with continuous improvement three times a year. Other providers update two times a year or at least annually. But the world that you live in is weeks or maybe a month or two to actually go live. The rapid updates...because again, they tend not to have IT or mature IT colleagues. Just like the cell phone, [you] have this up in the cloud, so it's minimal upkeep because [these sponsors] growing and scaling and [they] can't spend time or resources on classic IT.
So with that said, help our listeners out from when a client signs up to where they go live with your platform. And what's the secret behind this innovation, Toban?
Toban Zolman: This was a big part of both why I was interested in coming back into drug development and also frankly, a requirement for me and for the company. I spent over a decade in a world where we largely did continuous deployments. We were doing rolling production updates on a daily basis. Certainly there are challenges doing that with validated software, but we wanted to get as close to that as possible. So we architected Kivo from the ground up to support that rapid deployment model. We average a release about every two weeks, and over the course of a year do somewhere around 30 to 40 releases.
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 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. We're able to, for every release, run all of the validation tests, for things like OQ as well as UAT. What that lets us do is 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, but at the same time don't have to take new features, don't have to retrain users 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 on the amount of data they're migrating into the system...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. It's a fundamentally different process and paradigm. We have to coach heads of quality on how this works, 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 weekly instead of twice a year.
It also means we're massively connected to our customers. That feedback loop for, "hey, we would like to do X, Y or Z" and they can literally have access to that within two to four weeks in many cases. Man, 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 in ways that really drive improvements to how folks are doing work day in and day out.
Final thing I'll say is, these emerging companies...they are, they're fundamentally different. A lot of people don't fully grok how unique the business model is for a venture-backed early stage drug development company. Their time horizon to liquidity needs to be much shorter than the traditional drug development cycle of 13.5 to go from patent to approval. 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 -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 been really a fun way to surprise and delight folks that are used to these multi-quarter slogs to get software live. To be able to come in and offer such a different model has been a blast.
Steve Gens: I'm trying to unpack everything you said! First of all, it's very impressive. As we've expanded our survey from the large & mid-tier [to] smaller [companies]...They're in the clinical stage, they might have their first product on the market...You know, everybody focuses on 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 [get to market in] six or seven years (if the product finally does go to the market), you maximize your patent window. And a lot of these companies get bought. So it is a really, really interesting dynamic.
The other point that you made about the customer touch points...we feel we're unique even though we're a consultancy, but also a research benchmark. We talk about customer touch points and most of them are when we're not doing an active project. It isn't transactional. It might be our "ask the expert". We're pulling people into design sessions, for example. With our next piece of research that we do, we have unstructured time where we're just connecting and seeing how it goes. As you described, it's a lot of fun staying constantly connected and just really focusing on your client success. That gets us excited here.
One more thing before my final question. I thought this might be nice because in these earlier stage, it's been our experience...you're working with 50-60 companies, and, it might be 5 or 10 for us, but we usually see the first investment when they want to get the content under control. Most of them outsource publishing. The sponsor does theCTA or IND on that. And as they get a little larger, they think about registration management even if they have one product because they want to show a very disciplined business case. What's your sense? Do clients usually reach out when they're trying to get a hold of their content? You have the quality side,, the regulatory side, the clinical side...are there other drivers to take that first step or first investment with software?
Toban Zolman: Great question.We see a few different inflection points, especially since we span regulatory, clinical and quality.
These emerging companies...I'm really impressed with their talent acquisition. They're bringing really experienced operators into these companies. Often these folks have worked for top -ier pharma companies, so they really get what they need as an organization when it comes to process, compliance, et cetera. Where we help those sorts of leaders make decisions is to show them how the model works differently in these emerging companies.
There may have been eight layers from the CEO in their prior role. [Then] they come into an emerging company and they're talking in board meetings! That's a very different sort of corporate culture to navigate. What we typically see is when those early operators are brought in, often it's the first set of quality or the first set of regulatory and they say, "man, we've got to get our act together in order to really get ready for this first IND or this first clinical trial". So we often see folks pull us in at that point.
We will occasionally get brought in after that when they try to DIY their way through using SharePoint on their first IND or something. They call timeout and are like, "we just can't do this". Increasingly, we're also getting approached from investors who want to build an operating system across their portfolio companies to 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.
We say that Kivo essentially makes your company diligence-ready, because all of your assets are in one controlled platform. We literally have built user roles for due diligence to allow folks to come in and securely review content. To your point, there is a different model now for how work gets done and how what the expectations are from investors. We've really tried to align the features, tools,and the platform to facilitate that and reduce the friction out of that entire process.
Steve Gens: Again, very impressive, Toban. I enjoy watching the growth and learning from you guys too.
So my final question - I don't get to ask it that often, but it is my favorite question because it's founder to founder, and I would say in your case, founder and innovator. It's one thing to go out and find a company, but to do something for fundamentally different and innovate is really a, a neat place to be. It gives you a lot of excitement.
Speaking of excitement - you're just three, four years young. What excites you most about where Kivo is headed? Both in the short term and then the longer term?
Toban Zolman: There's a lot! But I will focus on two areas that I get the most excited about. One is the market in which we exist and the market dynamics around emerging companies.
When we started Kivo, I had some ideas on how emerging companies worked and why this flywheel of innovation was happening at small companies and not necessarily by the large incumbents.This is a trend that really excites me.
We are increasingly seeing the combination of new investment models and new drug discovery models. Everything from how zebrafish are being used to AI are really accelerating drug discovery timelines, which yields more promising drugs for development. [The innovations are] driving down the cost for those activities. There's no longer any real structural benefit to size when it comes to drug discovery and drug development. That means a 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. The early stage of this process is accelerating. $60 billion has flowed into drug discovery just earmarked for AI innovations. It's going to fundamentally transform how drugs are developed and brought to market.
That is a transformation that I don't think most folks in traditional pharma see every day, and certainly don't understand that the entire business model and tech models are fundamentally changed. That's going to bring all sorts of innovation and break all sorts of standard practice on how this stuff happens. 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.
The second thing that really makes me excited - and there's both short term and long term implications here - The market by-and-large has really focused on compliance over the past two decades, and really missed the boat on helping people do their work. 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. 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, workloads in the cloud and how that was transforming software development and IT...and those equally apply to how drugs are getting developed these days. You take these kind of transformational trends in how people do their work and overlay on that newer technologies, cloud, SaaS, AI, machine learning...While those aren't objectives in and of themselves, they're supporting technologies to make the work that people do faster, more transparent and frankly easier.
If you look at what we've got in the hopper for 2025, we are leaning into how to streamline how people do work, to reduce the amount of back and forth and manual tracking, to auto-generate as many things as we possibly can in the process. I literally cannot wait to get some of this stuff in people's hands because I think it's going to really accelerate that feedback loop. 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". We're starting to see some of those "oh, wow, this saves me a ton of time" moments in the software and I think that's really going to accelerate the longer we stay at this.
Steve Gens: You're certainly in a sweet spot! What you're envisioning is very exciting and inspiring. For this segment, it's a big game changer. Even how you describe discovery...in the old days you moved ahead by brute force and now it's rapid smart force.
Great talking with you and looking forward to seeing you at the RSIDM show. Little plug in for the DIA there. Last thing - some of our listeners might want to contact you or the Kivo team. How should they do that?
Toban Zolman: 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 will be a much deeper dive on a lot of these topics. We're doing that with some of our customers and partners. So we're excited about that. I can be found on LinkedIn and also contacted through our website. We would love to talk shop and dig deep on any of this with your listeners. I appreciate the opportunity to catch up today.
Steve Gens: Thanks. Likewise for our listeners, we're on LinkedIn daily or we have our contact form on the website. Toban, thanks again. Really enjoyed this. And hats off to you, the niche that you found, and the value you're bringing to that important segment that's just exploding now. It's a really interesting time to be in life sciences, especially that segment. Thanks so much again. Maybe in 9 or 12 months we'll have you back and you can report back in with your progress. Thanks again, Toban.
Toban Zolman: I would love that. Thanks a lot, Steve.
