Harsha Rajasimha is the founder and CEO of Jeeva Informatics Solutions, a company that provides SaaS products to clinical researchers and biotech sponsors to help accelerate remote patient recruitment. We talk about key metrics that define a successful SaaS company, the common issues that affect patients during clinical trials, and the FDA vaccine testing and approval process.
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Canvass Your Business Modell with Harsha Rajasimha
Our guest is Harsha Rajasimha. Harsha is the founder and CEO of Jeeva Informatics Solutions that offers a SaaS product that helps clinical researchers, CROs, and biotech sponsors accelerate remote patient recruitment. Jeeva Informatics has received the Biosense Company of the Year Award and Harsha Rajasimha was the co-recipient of the Sanofi Genzymes Rare Diseases Pell Award. So Harsha, welcome to the show.
Thank you for having me, Steve.
It’s exciting to have you. And we don’t have too many entrepreneurs in the healthcare space, although we had one recently, but I’m always excited when we can talk about something which is really topical, we’ll touch upon COVID and vaccines and stuff like that. But let’s start at the beginning. Harsha, how did you transition from an engineering scientist to entrepreneur? How does that even happen?
Absolutely, necessity is the mother of invention as they say, right? So I was loving my job. I never felt like I had a job as a data scientist trained with genetics and bioinformatics background. And my work at National Institutes of Health and FDA were highly impactful, and I was really passionate about what I was doing. That included analyzing, you know, genetic sequence data from people and animals and deriving insights out of that.
In 2012, I had a personal experience of a child born in our family with a rare disease that we lost very soon. And three years ago, I had a younger brother that I lost to a chronic disease that was very moving for me. And I wanted to do something in that chronic and rare disease space. And that really moved, you know, transitioned me out of that passion and personal story that, you know, I decided to do everything in my hands to accelerate therapies for patients who need rare diseases and, you know, treatments for their disease, irrespective of their geographic location, you know, because most of the clinical trials, right?
So you see Boston, Chicago, and major areas, and what about the rest of the country that’s in dark, right? And think about the rest of the world that’s even more darker than what we are seeing here on this map. So I think with digital revolution that has unfolded in front of us, and with the pandemic, it’s become very obvious now. But, you know, when we started this journey eight years ago, it was still very early days. And the pandemic has now accelerated quite a bit as well. So that’s how I had to transition doing discovery on a computer to entrepreneur, getting out of the building, listening to people, you know, ultimately it’s solving people’s problem.
So how did you just basically pull the plug? You resigned from your job and you walked across the street and started the company?
Absolutely. That’s exactly what I did. And my company CEO was shocked. He was like, Harsha, we support you. You know, if you really think, you know, we don’t, we want you to take some time, don’t make an emotional decision, but if this is really what you want to do, we will support you. And I’ve received support from many, many friends, family, and many investors who put money in the company so far. It’s been a wonderful journey so far, but we still have a long way to go.
That’s an amazing story. And, the kind of, uh, I had a similar experience walking across the street. I didn’t resign of my own accord, but it turned out to be the best thing that happened to me and, uh, you know, I started my company right after that. But, you know, my former employer didn’t offer to fund my new venture. That’s kind of another difference. But anyway, going back to this topic of building this company and you basically it was a startup company, right? And you said you received some investor money. So one of the things that we talked a little bit about in the pre-interview, these management blueprints, and you mentioned one of these, which is the startup owner’s manual. Steve Blank helped you along the journey. Can you speak a little bit about that and how it helped you?
Absolutely. You know, I was, when I started the company, I was thinking of when can I start building the product, right? It’s a software product and I thought I needed to find money and software engineers and start building the product. And that would have been the biggest mistake if I had done that in retrospect. Fortunately, I met Bob Smith, who is now on our advisory board. And Bob has been a mentor for the National Science Foundation in training technology and scientific entrepreneurs on transitioning into the business world, particularly the venture-backed startups, right?
So his thing was, who is your target customer? Who is going to buy it? Who is going to use, who are the end users? Who are your saboteurs? And I didn’t have answers to many of those questions. So I said, it will benefit you greatly if you went through a two-week program at the George Mason University Small Business Development Center. And I had nothing to lose, you know, it was a free program offered by the state of Virginia and it was educational.
So I went through that and we were asked to do 20 interviews with customers, real customers, face-to-face. And this was in 2018, so in-person meetings were still allowed. So we did 20 meetings in two weeks and then we were referred to the National Science Foundation on a national level where they invited us to participate in a seven week program where we were challenged to interview a hundred customers and validate why would they buy Jeeva, if at all, and what is the problem that this would solve or not solve, and what would be there for buying Jeeva? What are they doing right now, today? It’s not like they are not trying.
This is a 70-year-old industry and clinical trials have been run for 100 years and randomized controlled clinical trials have been run for since 1950s. And so, what kind of tools and solutions are they using today and why would they buy Jeeva, right? So, that was very eye-opening for me. And without understanding all that, if we had developed a product hoping that somebody will buy it, and that’s the biggest reason why most companies fail. As we know, 99% of the small businesses fail, right? They don’t see there’s some staggering statistic like that, right? So 90, 95% don’t live three years or more and or nine, five years or more, something like that.
90%. Yeah, it’s about that. It’s an hour and a half.
So I’m glad we are close to the third anniversary and we have enough runway to survive the third year anniversary. So that’s how we would minimize our risk of failing.
You’re improving the statistics.
So that’s awesome. So tell me a little bit about, so clearly the customer discovery process to make sure you understand what the customer wants so you can tell your product. That’s a big idea and it’s a big important thing. Anything else from this startup owners manual, and I have it on my desk. I ordered it as soon as we spoke about it. Anything else that comes to mind that you would like to mention that you used the idea or the process in your business?
Yeah, absolutely. The startup manual that I just pointed out has something called business model canvas. There are nine components in the business model. The two biggest ones are problem areas, or pain points and value propositions, right? And what’s the, who are the customer segments? So we, for example, sell to biotech companies, pharmaceutical companies, medical device companies, hospital sites, nonprofit academic medical centers. Each customer has their own set of pain points and own set of value propositions.
And their criteria to choose a solution is very different. You know, the nonprofit side, cost is the number one criteria. On the pharmaceutical side, the compliance, regulatory compliance is the number one criteria. So, you need to know your customer, each segment, and understand where to focus on first and how do you prioritize and rank them. And then there is other seven boxes, right? Where you need to know your customer channels, how do you get to your customers, who are your partners, what are the key resources you would need to execute on this vision, what are the cost items, or where do you need to spend money to get the product done and get to the market?
And what are your revenue streams? Where is the money going to flow into the business from? So getting a well-rounded understanding of these nine components of the business model is really was eye-opening for me, right? Like I had really not, coming as a computer science engineer major out of college and as a computer science master’s and genetics PhD, I never had any exposure to business model cameras and the exercise.
And more importantly, while the book that we have from Steve Blank provides a blueprint, it’s really what it says is get out of the building and listen to the customers, right? And that’s something we never do in our grad school. So, nor did I do as a scientist at NIH right so we are more reading the scientific literature and driven by science, which is where this entire field of clinical trials is grounded in science and medicine, but ultimately, it’s human being that solve or overcome these problems and barriers so we have to listen to these human beings.
That’s so critical and thank you for explaining this, and the business model canvas is a really good tool. I recommend to our listeners as well to check it out. So switching gears here, one of the things that they recently heard, I was kind of shocked by it, was that the Moderna, and maybe that’s incorrect. So please correct me if that’s not accurate. But what I heard was that the Moderna vaccine was basically ready in March, but it took another six to eight months for the FDA to give its approval and for it to really be useful and people to be able to have access it. Is this true? And if this is true or this is remotely true, what is slowing down this process? Why does the FDA, and I know this is super fast, but why did they even need the six to eight months to approve it, the vaccine that the whole world was waiting for?
I’m so glad you’re asking this question because that’s a big myth for some people still, and I’m surprised. It’s because six to eight months is amazingly fast, right? So this is the fastest ever, any vaccine has ever been approved by mankind, right? Period. So it can’t get any faster than this. In the sense, people are questioning how did FDA get this approval done within six to eight months, right? So it’s the question is the other way around because historically a vaccine from when it is discovered to get a regulatory approval takes six to eight years, not months.
And so getting it done in this phenomenal record breaking timeframe is absolutely super fast. And I’ll tell you why. The making a vaccine in a laboratory is very much faster, right? Now, get testing it on animals to make sure it doesn’t kill any animals that have very similar genetic makeup as human beings is the first prerequisite. Right, so you have to grow mice in the lab and treat them with the vaccine and see that they don’t develop any significant adverse events.
And then to get into humans, you have to start with the lowest possible dose that even if it were having any adverse events, it would be extremely minimal, so that in the first iteration itself, it’s still not you know causing any so safety is very critical and then you test for efficacy you know is it really working or not but number one thing is do no harm right so that’s the in the clinical world doing no harm is half the good you have done already so if you can even do a little bit of good, then that’s significant without doing any harm.
So it’s a balance between risk and benefit that is weighed in by FDA, right? So now, yes, maybe the Moderna vaccine was ready in March, but it had to be tested, right? And the testing period is what takes six to seven years, typically. Phase one, phase two, phase three. And for vaccines, the safety standards are extremely high because you are giving vaccine to a healthy individual like the general population. They have no problem, right? They have not been infected by COVID, you are still injecting some foreign substance.
So it has to be tested, tested over a long period of time to see after giving vaccine, this person is either not developing severe symptoms of COVID, even if exposed to the virus. If they develop severe symptoms they are not dying because of vaccine. You know, with the vaccine was without vaccine right. So, they have to compare the population that was vaccinated, versus the population that was not vaccinated. And it has to be done in a controlled fashion, and so that doing getting that done in six to eight months is phenomenal.
Okay. All right, so, so maybe this is a misdirected question what I understand and now that you explained it I never thought about the increasing the dose I actually was wondering why phase one was even allowed when there’s so much this but yes the was the patient enrollment. So how important is patient recruitment? Sounds like in the COVID case, there probably was an exception. It’s not an issue and all the patients were available. But you told me that this is a big issue, patient enrollment. It’s hard to enroll patients and that slows the process down. So tell us a little bit about why that is an issue and how it can be overcome.
Absolutely. So, you know, the first step in human clinical trials is finding the right patients who match the inclusion exclusion criteria for a given clinical trial. Right. As we know, the initial recipients of vaccine where elderly population and then the pediatric, right, and we are still not gone below 12 years of age or — so that’s usually typically how it goes. And now you have to find people who meet the eligibility criteria, and then once you identify them, the second step is enrolling them into the study.The first step in human clinical trials is finding the right patients who match the inclusion exclusion criteria for a given clinical trial. Click To Tweet
Historically, patients were expected to travel in person to a hospital site to participate, you know, get the vaccine injected. And then they have to show up every week or every month and, you know, get tested for COVID. Have they been now infected or not? And then they have to report any adverse events that they experienced over a period of time. Now, all of that was done in in-person visits to the hospital. During COVID, obviously in-person visits were not possible, and so significant allowances were made by FDA and other regulatory agencies where patients could report it from their home on a smartphone or an app.
And the researchers could call the patient on their phone and talk to them and do remote assessments. And so that was very, still relatively new. While some of that has been done in the last 15, 20 years, the entire process of doing most of the clinical trial remotely is still relatively new and was not as well accepted. During COVID pandemic, like that’s became, now that’s what enabled the FDA to approve the drug vaccine in six to eight months, right? So very fast. Now, can we scale that to all diseases for all types of drugs, not just vaccines and many other disease areas and age groups? That’s really what my vision is.
And the vision that I started way before the pandemic, but now got really accelerated because of the pandemic in terms of regulatory frameworks, making allow allowance for that, and the customers being more brave and willing to take a risk and adopt this because this is in the best interest of patients. We, in the clinical trial space, we talk about patient centricity, right? And customers want to do everything that’s in the best interest of the patients.
So when we spoke with 2000 stakeholders of clinical trials, they said patient enrollment is the biggest problem because we don’t have a database where we can query and find out all the matching patients. And if we do find them, we are not able to reach them through digital social channels, by email, anti-spam laws were there and are still there, right? And for good reason. And there are phone spamming and all those other things. So they need a regulated framework, but also tools that are compliant with these regulatory frameworks so that they can contact and enroll patients remotely. And that’s exactly-
Is this what Jeeva does?
That’s exactly what Jeeva does. It’s democratized that and make it as fast for, you know, in rare diseases, for example, there are 7,000 rare diseases. Only 5% of them have any FDA approved treatment. 95% do not have any treatment. And so they can all benefit greatly. If what we did to the COVID vaccine trial, in six to eight months, if we can find a treatment for a rare disease, that’s huge. That can save lives.
Yeah, that’s awesome. So how much can you accelerate this patient enrollment? And my follow-up question is that if you get this to the maximum, what’s going to be the next bottleneck that is going to need to be resolved? To make the process even faster.
Great question. You know, it’s been long known that patient enrollment is a huge problem in clinical trials. It’s nothing new necessarily, but we understood the nitty-gritty detail. As we got out of the building and listened to customers, they said, you know, patients have to take time off their work, patients have to find daycare for their children if they have to go into a clinical trial site. Patients may have to travel long distance even airplane travel, and if they have special needs, you know, they have to get someone to go with them to these sites, and so on. So there’s like a lot of logistical burden involved in getting to the site, a patient to the site.
And that often weighs them down, right? When they think of, you know, can you go to Boston every Monday or every other Monday to participate in a clinical trial for five years? You know, how many people are brave enough to say yes, right? So if it is something they say, you know, you only travel once in a quarter or twice a year, and the rest of the time you can participate from your app, that’s a lot more, you know, fits within the patient’s lifestyle. So that’s what we mapped as a fit, you know, between the product and the problem, where the market was.
And so what’s gonna be the next step? So you accelerate, you have everyone remote, that’s gonna, you know, accelerate it three times, four times, whatever. What’s gonna be the next bottleneck? And is this something that Jeeva maybe can, could tackle in the future?
Absolutely, so we are focused on, you know, after we get through the enrollment, we think at least three times, right? So out of say, 100 patients that match the criteria for a trial, only 97% of them do not enroll in the clinical trial, only 3% enroll. So now with Jeeva, if we can increase that from 3% to 9%, that’s already three times acceleration. Because now with Jeeva, they don’t have to travel every single time. The burden is reduced significantly.
So after that, it’s keeping them in the trial, right? So 30% of the patients, after enrolling, they drop out during the course of a trial. You know, six months, eight months. Some of these trials are multiple years, three years, five years, like that. So patients lose interest and they feel the burden more as they go through the pain more. So they end up dropping out. So retaining patients in the trial throughout the trial is very important because if someone drops out after two years, now there is incomplete data and they cannot convince the FDA that we have enough data and evidence to prove the safety and efficacy. So that’s the second problem is retention of patients.
The third is, did the patient actually adhere to the protocol, right? So if the protocol says you have to take this medicine once daily, every single day, are they actually taking it or not? How many days are they forgetting the medication? And if they forget, obviously the drug has no chance to show its effectiveness. That would be the third problem. And there is a long list of issues in clinical trials that we are going to tackle. But those are the top three.
So, you are just at the beginning of a long journey with JEEVA and you have plenty of problems to solve. You don’t have to worry about you running out of problems and essentially your work is done.
So that’s awesome. So let’s switch a little bit to the business side of things. Jeeva is a SaaS product, right? It’s a software as a service. And software as a service companies are very, you know, are apparently very difficult to get off the ground. There’s so many companies that never get off the ground, that get funding, but then they fizzle out. So what do you feel are the three success factors for a SaaS company to be able to break through and gain traction?
Yeah, you know, SaaS may not always be the right solution for all types of businesses and industries. So you need to really listen to your customers and make that determination. Even in our case, SAS may not necessarily be the right fit for all of our customer segments. So SAS has its biggest advantage of being highly scalable. And it’s centralized, and it’s a subscription-based. So it helps convert a capital expenditure for the customer into an operating expense so that they can only pay as they use the product or service on an ongoing basis.SaaS may not always be the right solution for all types of businesses and industries. So you need to really listen to your customers and make that determination. Click To Tweet
So, that’s the biggest advantage. Now, the biggest disadvantage for some customers is that all the data stores is stored on the centralized server. And so, the data privacy, all that concern whether who owns the access to the data, is it secure, is it encrypted, all that kind of information becomes critical. So usually, SAS companies have to maintain a checklist of hundreds of criteria that the customers are looking for. And that’s pretty daunting for beginners. That’s something you need to be prepared for.
But in general, to get it to succeed, you know, one, pricing is an issue because you are changing an enterprise software license model to a cloud-based software subscription model. So say something which costs $100,000 per year as a pay-one-time-per-year software license, you have all 100 features loaded in the product, for example, and the customer only wants 20 features. They still have to pay $100,000 because they are buying the entire product.
In SAS, if you do modularity, you know, the customer can only get the specific modules that they really need, and they don’t have to pay the full $100,000 and not up front, and they would have paid maybe $20,000 or $30,000 over the period of time if they only use small percentage of the overall software. So there is a lot to consider when you’re building the SaaS, and including which cloud platform do you get on, right? There’s Amazon, Microsoft, and Google all competing in that market, and there’s pros and cons in all of them. So which one would you build on, the foundation and so on and so forth.
Is there a resource, a book that you can recommend for entrepreneurs who are considering turning their business into a subscription model, some kind of SaaS service that is your go-to?
Sure, there is a book, let me see, not finding it, not finding it here, but it’s called the platform revolution is one book I would recommend platform revolution.
Ok, I’m sorry for putting you on the spot, but I couldn’t resist getting your advice on this.
Absolutely. No, there’s a number of good, good books, but platform revolution essentially points out how, you know, starting with Jeff Bezos, how he moved his book business, selling books in a bookstore to an online bookstore and then scaling that. And that’s a platform. And then he converted that into a marketplace, right? So it’s now buyers and sellers became a marketplace and a platform. So having that type of platform is revolutionary and it’s happening right now in front of our eyes, many times we may not realize.
Yeah, marketplaces are a big trend as well. So what about for Jeeva? If you look ahead five to 10 years, I mean, if you’re raising money, then for sure your investors will be asking for your vision. Where can you take this company? What is your vision for Jeeva? Where are you gonna be in five years?
Yeah, my vision is really to make Jeeva a human-centric platform, right? So technology is not the limiting factor. There is so much of technology out there. Number of products, you know, the number of apps in the app store, there’s no shortage of any of those things. But what’s needed is real focus on the customer and recognizing that that customer is a human and getting that to not just biotech, pharmaceutical, medical devices which can bring life-saving therapies to patients faster, but also in the long term there is opportunity to make it more widely accessible for public health, you know, ability surveillance over the population scale. That would be my long-term vision.
Wow, okay, that’s a pretty big vision. That sound like a unicorn. By the time that you fulfill that vision, Jeeva’s going to be a billion-dollar company, right? Absolutely. This is an enormous marketplace.
It’s a 16 billion market for e-clinical solutions. And if we achieve 1% to 5% of the market share in the next five years, we will be at 157 million to 800 million annual revenue in five years from now.
So, you just have to run it up and you’re at a billion. That’s pretty exciting. So thank you for sharing all that. So if the listeners would like to learn more about Jeeva and about these kinds of technologies and where the industry is trending. How can they connect with you or where can they reach information from your sources?
Absolutely, I’m relatively easy to find on LinkedIn with my name, Harsha Rajasimha, on LinkedIn, Facebook, Twitter, most of the social channels and the company information you can find on jeevatrials.com, J-E-E-V-A-T-R-I-A-L-S, jeevatrials.com.
Okay, well, definitely, listeners, check out Harsha. He’s got lots of interesting information and where he’s taking his business and helping, essentially, our healthcare system to be much more efficient and fast and get the future vaccines out quicker so that we don’t have to suffer so much, hopefully, if that happens again. Thank you, Harsha, for coming on our show. I really enjoyed talking with you and learning a little bit about the startup and the startup owner’s manual, which is another blueprint here, Steve Blank and Bob Dorf. Thanks for bringing the business model canvas, which is an important concept, and thanks for bringing a little bit of information about SaaS companies and the platform revolution that you recommended. And do check out Harsha Rajasimha’s LinkedIn profile and jeevatrans.com is probably the easiest one to Google.
Thank you so much for having me, Steve. And this is a very important time in the journey of my entrepreneurial life. And we are in the middle of a seed financing round. So far, we have raised close to 1.4 million, and we have produced enormous results, and we are seeing, we are at the cusp of a breakthrough right now. So, invite anyone, any of the audience or listeners to reach out if they’d like to be part of our journey and be part of us, our team. Thank you.
Yes, and hopefully we’ll look back in five years on this podcast as the one that made many people into multi-millionaires by investing in your company. So thanks for tuning in. Please rate and review the Management Grouping Podcast on Apple Podcasts or subscribe on YouTube. We’d love to have you, your comments and your presence and accessing all the future episodes as well and seeing you on the show. Have a great day. And thank you, Harsha Rajasimha, the founder and CEO of Jeeva Informatic Solutions. Thanks for joining me today.
Thank you, Steve. Have a good one.
- Pinnacle: Five Principles that Take Your Business to the Top of the Mountain
- Harsha’s LinkedIn Page
- Harsha’s Twitter Handle
- Jeeva Informatics Solutions Website
- Platform Revolution by Geoffrey G. Parker
- Startup Owners Manual by Steve Blank and Bob Dorf
- Steve Preda’s Book: Buyable
- Complete the Buyability Assessment for your business