Hello, everybody. Welcome to the Healthy Enterprise Podcast. If you've been here before, I wanna thank you for coming back. And if it's your first time, I hope you enjoyed today's episode. It should be very interesting.
Heath Fletcher:My guest today is doctor Harshar Rajasima. He is a biotech entrepreneur, scientist, and patient advocate. He is the founder and CEO of Jeeva Clinical Trials, an AI driven platform streamlining global clinical trials for a much needed efficiency and accessibility. He also leads the Indo US Organization for Rare Diseases, advancing cross border collaboration to support patients with rare conditions. Motivated by a personal loss, Harsha brings over twenty years of experience in precision medicine, genomics, and health tech with affiliations at NIH, FDA, and George Mason University.
Heath Fletcher:Please welcome my guest, doctor Harsha Rajasimha. Hello, Harsha. Thank you for joining me today on this episode. I'm looking forward to our call today. So welcome.
Heath Fletcher:Why don't you give our listeners an introduction of yourself and and Jeeva Clinicals?
Harsha Rajasimha:Thank you, Heath. It's a pleasure to be here. I'm Harsha Rajasimha. I'm the founder of Jeeva Clinical Trials. I'm located in Northern Virginia.
Harsha Rajasimha:I'm a postdoctoral data scientist by training with a computational biology background. Spent a few years at National Institutes of Health, FDA, consulted with the big pharma for a few years in the clinical r and d space and, saw firsthand the various inefficiencies in the infrastructure supporting clinical trials, and saw why it's, so expensive, manual, burdensome, and slow. So decided to address that, barrier and bottleneck. Along the journey, I also became a, father of a child to a child with a rare disease, and lost a younger brother to juvenile diabetes. And those personal and professional experiences inspired me to make a difference.
Harsha Rajasimha:So I founded Jeeva about six years ago, and we have, what we have done is built a new infrastructure that takes advantage of AI in the modern technology stack and architecture, to essentially, make clinical trials more faster, efficient, less manual, and more automated, to take full advantage of the technology, that's available today, which the legacy systems that were originally built to move from paper to electronic data, capture in fifteen years ago, no longer serve the purpose of today. And this day and age is demanding a lot of efficiency, you know, in terms of cost and time. And AI does help in that regard, but the infrastructure can't be a broken infrastructure built on stitching together 15 disparate tools that don't necessarily talk to each other. And so a lot of effort goes into integration, interoperability, and connecting connecting them in a process which is quite complex, and it can vary from trial to trial. And so what we have is a scalable, and efficient, process automation platform that we built at Jeeva.
Harsha Rajasimha:So that's what we do.
Heath Fletcher:So and and there's probably several people who understand listeners that understand the clinical trial process and where where that fits in in the development of of medicines and pharmaceuticals. Right? Maybe can you just give us sort of a insider look at at what the clinical trial process typically looks like and how long that normally takes?
Harsha Rajasimha:Absolutely. Thanks for asking. So, you know, clinical trials are a essential part of drug development or any kind of medical device or therapy development process to take it through the regulatory review process. And so, typically, the traditional, trials involve Phase one, Phase two, and Phase three. And on an average all these three, phases, are necessary to complete before the drug, is, submitted to the FDA with all the data for review and approval.
Harsha Rajasimha:And this entire process of first in human trial through regulatory submission and review process can take eight to ten years. And so that's quite a long period of time when patients are waiting, especially with severe diseases like rare diseases where children don't live past their fifth birthday. And so there is a massive need for, speeding up that process, including with the novel trial design where the phase one, phase two, phase three are not necessarily a requirement, where there is opportunity to speed up this with basket trials, umbrella trials, and new trial designs, which can speed up the timelines, but also, often the operational and logistical burden of patient recruitment. In a in a specific clinical trial, there has to be these, critical steps, which is one, having a finalized protocol, which is approved by either the FDA or a regulatory body or, IRB or institutional review boards and ethics committee. So having that finalized approved protocol and informed consent form, is a, initial prerequisite and then having, principal investigator sites that that are set up to enroll patients and having enough patients to enroll who meet the eligibility criteria, to, get the study started.
Harsha Rajasimha:And then, there is data that has to be captured which is of high integrity and high quality. And finally, once the all the patients have been enrolled, all the data has been captured typically over a nine month duration in a phase one trial, eighteen month average duration in a Phase two, and about thirty six month average duration in Phase three. Then there is biostatistical data analysis to, assess the safety and the efficacy of the drug. And this entire package has to be standardized in, regulatory standard data formats and then submitted to the FDA. And so that's the full process.
Harsha Rajasimha:Now, this process, there is a lot of opportunity to make it efficient, especially with the modern technologies and AI. And, that's the infrastructure that we built to make this process be as automated as possible without removing human in the loop, which is critical, regulatory expertise, data expertise, clinical expertise that has to do the review and validation every step of the process. But the process itself is quite manual, and, you know, routine, mundane, repetitive tasks that a robot or an AI agent is, adept at doing better with little or no errors, once it's trained properly. And so that's the opportunity that we, have tapped into over the last few years and, well positioned with this modern infrastructure that's, designed to take full advantage of AI.
Heath Fletcher:Wow. And and so by using your tool, the software, that allows so all these various participants and bodies, organizations, people that have to participate in that process can all use this software, and they're all working from this centralized hub. Is that correct?
Harsha Rajasimha:You said it right. And although we primarily help the emerging biotech pharma med device sponsors who do not, necessarily specialize in information technology, software, and data. You know, they come with a chemistry biochemistry, molecular biology background. Scientists. They are the scientists.
Harsha Rajasimha:And we bring the data infrastructure and manage the operations. Typically, they usually outsource this to a contract research organization or a CRO that, have, a complex infrastructure that they put together, usually borrowing 15 to 30 different vendors and third party tools that that are independently designed and they keep updating their versions. And so an infrastructure like that can, at best, apply AI as a Band Aid. You know, there is an AI for this tool, another 15 Band Aids or 15 tools. Whereas with the unified platform, that, need not be in that way.
Harsha Rajasimha:So there's a architectural difference and the fundamental infrastructure unification of the process drives a significant simplicity, reduces the complexity of the process, and then automating only makes it better and better.
Heath Fletcher:Well and then it's contained too. Right? And and easier to mitigate any risks, you know, privacy breaches, cyber attacks Absolutely. Just just failure or relying on all these different subscriptions or or or software companies to keep updating so they aren't integrating properly and communicating, that's a lot. So to be able to contain it into one, I mean, it's a brilliant idea.
Harsha Rajasimha:Exactly. And and so the these different tools validating that they comply with data security, HIPAA, GDPR, FDA regulations. There is a long list of regulatory requirements that have to be verified with every single tool involved in the clinical trial process. If it it it only makes sense to reduce that complexity and, have only one unified platform to verify and maintain the security of, so it's easy to guard one Yeah. Location than 15 different one Yeah.
Heath Fletcher:Yeah. It makes perfect sense. Why has no one come up with this yet?
Harsha Rajasimha:Period. You know, although it it it may seem like it's a no brainer, The evolution of clinical trial process and infrastructure over the years has been incremental. Right? And so Yeah. When when the first came up with electronic data capture, then a clinical trial management system.
Harsha Rajasimha:Then during the pandemic, there has been, a deluge of digital health apps and, for patient reported outcomes, for televisits, remote patient monitoring
Heath Fletcher:Right.
Harsha Rajasimha:Remote electronic signatures and e consent. So, you know, it was easy to go on adding one tool here, another tool for e signatures, another tool for televisits, video visits. And so now the infrastructure has organically grown to be so complex. Now trying to wrap AI around this whole machinery is is not only difficult, impossible, in a way just because there are too many moving parts. So the moment you feel like you got it all in control, somebody releases a new version and the workflow breaks.
Heath Fletcher:Everything breaks. Yeah. Exactly. I mean, that happens just on their basic website
Harsha Rajasimha:Exactly.
Heath Fletcher:Every other month. Never mind an an intricate system like that. Yeah. That's crazy. So how much conceivably, how much time is this gonna save the process?
Heath Fletcher:Is it half time? Is it more or less?
Harsha Rajasimha:Our you know, we have our oldest customers started four years ago with a pharmaceutical clinical trial, that's still ongoing. They completed phase one, phase two a, two b, and ongoing trials. So, we we haven't really been around for eight, nine years to measure the full life cycle yet. Right. But, we estimate, eight to nine months of savings, in a phase three clinical trial, which, typically takes anywhere from three to five years.
Harsha Rajasimha:If we can knock off nine months from that, phase three, that's huge.
Heath Fletcher:Significant. Yeah.
Harsha Rajasimha:In fact, every day can be quite crucial and can cost hundreds of thousands or even millions for every day that gets delayed.
Heath Fletcher:Right. Because at this stage, they have they don't even know if it's been if it's going if it's going to work. There it you know, the the these are a lot of these are are pharmaceuticals that have really great intentions, and they have they've got vision and it's it's to it's to help somebody somewhere along the line, but there hasn't been proven yet. So it's a huge investment, like you said, financially and and time investment. Like, it's a to to so to be able to speed that up because they don't always end there.
Heath Fletcher:If it doesn't get through that phase, they gotta go back and start all over again. Right?
Harsha Rajasimha:Exactly. And so knowing whether a drug works or not faster, even if it's not if it's a negative, it's still a success because we found out sooner rather than later. Right. We found that out with less money and less time than investing hundreds of millions and then figuring out quite late in the game. Yeah.
Heath Fletcher:And the the the some of the obvious pushback may be, I I said it before, you know, risk of privacy, risk of, you know, information getting out to somebody that doesn't need it. Do you kinda get a lot of you know, when using when you bring up the word AI, it's like, well, people are gonna lose their jobs. Someone's gonna lose the information. You know, is that your kind of is there any other pushback that you hear from from people in the industry?
Harsha Rajasimha:Not really. I mean, we are, still just about to launch the first couple AI agents this year, in fall, so it's under development. But overall, the, platform efficiency is already significant compared to the current, standard, which is because just because of the unification of the process in one centralized platform. Yeah. And the user interfaces that we design, taking, very, serious note of what the users expect and what their anticipated process looks like and designing user interfaces that are easy and do it yourself with zero programming.
Harsha Rajasimha:There's, still a lot of statistical programming, data management, edit checks are done with traditional EDC systems that require technical understanding and programming to an extent, even if it's data processing and Excel and Python scripts. We we don't need any of that. So it's all user interface driven. Mhmm. Non technical person can run this, and the subject matter experts in clinical, medical affairs, clinical operations, can manage, the interface pipe, with with with little or no training, even.
Harsha Rajasimha:Although our team is always available to support our end users, as much as they need to perform their activities and tasks. And they love that, they can see patient recruitment, data management, trial scheduling, digital patient engagement, everything in one place. They are like, wow, This is groundbreaking for them already. Although in in the technical sense, it's not rocket science. But but and I think launching these AI agents later this year is going to make it even better.
Harsha Rajasimha:Right? And so AI or no AI, the regulations remain the same in the sense, like, data security, privacy concerns, the checklist to verify, what, how secure the platform is is is still intact. And so we meet we we continue to meet all those, 21 CFR part 11, HIPAA, GDPR, good clinical practice, and various SOC two, type one, type two, and various other requirements. We are built on the AWS cloud, and AWS provides certain in built features to monitor the performance, security, and architectural soundness, which we started right from ground zero, what they call foundational technical review and well architected framework review. So having, maintaining all that is a given, whether we use AI or not, and we continue to do that.
Harsha Rajasimha:And the key thing is not to expose the clinical trial data to public, models of large language models and such, which absolutely is not, going to happen in, and, you know, we, make sure whatever we do, the data is secure and protected, and we bring AI tools to the data, and Mhmm. It it's safe and secure in that sense.
Heath Fletcher:Now you you you said a phrase, AI agent. So can you for those that maybe don't necessarily know what an AI agent is because that's a relatively new term Yeah. Explain what an AI agent actually is because you're rolling out two of them, you said, soon. So explain what that what that is.
Harsha Rajasimha:Thank you for asking, Heath. Absolutely. It it's a new buzzword, but also a real real deal, in that AI has evolved from, you know, machine learning and AI kind of goes synonymous, but they are somewhat different. And with AI, there's, you know, ChatGPT or OpenAI and large language models, which came up with this ability to read and produce content, right, textual content and so on, what's the so called generative AI. Right?
Harsha Rajasimha:And that has evolved into various other advanced AI tools. And one of them is, AI agent, which is a huge opportunity for the whole AI industry in across various industry verticals, where agents perform tasks, and they learn from performing the task and keep getting better and better. And they are good at performing, rep repetitive tasks, and human, redundant mundane tasks that humans get bored and tend to make mistakes, but these AI agents don't. And they actually get better and better the more they perform. But, these AI agents essentially, can replace the human activity, to a great extent, And that's the opportunity that most industries are chasing right now.
Harsha Rajasimha:And there's going to be a lot of winners, and losers in in that race. Yeah. But it it's, not just being first, but it's being getting it right and doing it in a balanced approach of which tasks are most suitable for AI agent versus, say, real human expert who needs to verify, validate, or make sure it's done right. And so that's a delicate balance. In in clinical trials, that balance is not always easy and obvious to find, and that's the art and science of developing AI agents.
Harsha Rajasimha:So there many of these AI, model, providers, be it Claude, Gemini, or OpenAI and Anthropic and several other providers, offer these models that enable us to develop AI agents. And so that's we we have a unique approach to these AI agents, and it's a patent pending framework and technology that we building and working towards. So Mhmm. There's going to be a number of AI agents, that that will be coming out, with Jeeva. But this year, we want to start with the most impactful agents that will, do 20% of the task that's, going to have 80% of the impact.
Heath Fletcher:Amazing. Yeah. That's great. Those are good those are good percentages to play with. Hey?
Heath Fletcher:Mhmm. So those are rolling out, and then those will be available through the Jiva platform. And they're just it's you're you're adding you're adding functionality to what's
Harsha Rajasimha:it's a premium add on if if they like to, if they are short on staff or even if if not, they want they would rather use the staff for something more in intellectual. They can let the AI agents deal with the routine tasks, and the, in house staff can verify if the agents did right and make any, corrections if necessary. But, we we don't expect these agents to make much mistakes because the we are only assigning, simple repetitive tasks to these agents and keeping the any task that do require, human expertise are not something we want to push on an agent.
Heath Fletcher:Right. Right. Good. That was great. Thank you for explaining the AI agent in your from your perspective because, no one anyone thinking there is some private, double o sevens, wandering around.
Heath Fletcher:So and you said you are so right now, you you have companies using Jeeva. Absolutely. Are you fully are you fully up and running? Are you still in yeah. So people are actually you organizations are actually using the tool right now.
Harsha Rajasimha:Absolutely. The clinical trials are running. We have about, close to 15,000 active users on the platform from about 20 different, enterprises or organizations that have, been our customers, since inception, and, about 15 partners and resellers of our software like other, CROs, that use utilize our platform versus the legacy systems, in serving their clients. And so yeah. Yes.
Harsha Rajasimha:We have been out there in production and commercial use for a few years now.
Heath Fletcher:Very good. So when at what point so I know you you mentioned your brother and and your newborn. Those were definitely some, major losses that were part of the motivation for you to do this. Was there other were there other areas of your work that did you did you was everything you did up till now kinda leading you personally to this place
Harsha Rajasimha:in your absolutely career? Did. In in terms of looking at the genomic and clinical data, it was very striking to me that a majority of the data is from the global North, and rest of the world is not well represented in the datasets, know, with the molecular data, clinical data, or health information. A lot of the data in the low and middle income countries are still not digital. It it's sitting either in paper.
Harsha Rajasimha:And if even if it's digital, it's kind of PDF or images that's probably, siloed and fragmented and distributed, some sitting with patients, some sitting in hospital records, and some nowhere. And so, it it's, an opportunity for, making, clinical research and drug development more accessible to all people and the general population, so that it's not restricted to a 5% of the world's, population or 10%.
Heath Fletcher:Yeah. Right.
Harsha Rajasimha:And so, you know, I I am of Indian, origin, Indian diaspora, and knowing that, 15% of the world's population is Indian, whereas in drug development and clinical trials, only 1.2% of all trial participants are of Indian origin, historically. So while a good percentage of medical doctors or data engineers are Indian origin, patients are not in clinical trials. And so that's one, kind of, inspiration as well to address that massive inequity. And it's it's not just the Indian diaspora. It's a number of 90% of the world's population, actually.
Heath Fletcher:Mhmm. Yeah. There's definitely imbalance there. And and so the platform then is accessible globally.
Harsha Rajasimha:It
Heath Fletcher:is. Everyone can use it. Multiple languages. It's all translated and everything.
Harsha Rajasimha:Yeah. Just, because this was our mission and, motto, we have taken made, put in the effort to make sure we support all the languages, make it easy to, support language translations. Over 100 languages are supported, and a professional translation company is partnered with us, called Vistatec. And so it where it's a regulatory sensitive document like an informed consent form, certified translation and back translation is a expectation of the regulators. And so we we have partnered with Vistatec for that.
Harsha Rajasimha:And, also, ensuring rural populations, age, children, you know, adolescent, elderly, accessibility is very important. And then there's also remote engagement type tools like televisits, video visits, and, ability to use any of their existing devices, so they don't need to buy an expensive device to participate from their home and reduce the travel burden. You know, for those that are already burdened with the disease, they may have, different abilities and handicap, and we don't want them to, always travel to the site when it's really not necessary. So sort of supporting that decentralized home based trials as well as, traditional trials as well in in all these, different accessible language and remote patient setups.
Heath Fletcher:Well, I mean, that just opens up to so much more data and information that
Harsha Rajasimha:Exactly.
Heath Fletcher:You know, when it's so, you know, concentrated in in one group of of people, you don't you're not really getting a a really good array of of information, are you?
Harsha Rajasimha:Not, exactly. And so that heterogeneity of the because disease manifests itself differently in different, bodies. And so Yeah. Having a good understanding of how the different populations, are progressing naturally with the disease is critical, especially in rare diseases. These patient registries, natural history studies are critical hallmark, and a prerequisite, to have a well characterized dataset, demonstrating from early onset to diagnosis to prognosis and all the, from cradle to grave, what does the disease look like.
Harsha Rajasimha:Right. And, that databases that, characterize this information with the proper regulatory framework of obtaining informed consent from patients and capturing all the data without overly burdening the patients, is is critical. And that's what our platform enables.
Heath Fletcher:And then the opportunity for some of, these people in really remote locations to have access to some of these to be early adopters of these of these pharmaceuticals for treating conditions and and diseases that they would never normally have access to, right, if they weren't living in a major in a heavily populated center.
Harsha Rajasimha:Yeah. Exactly.
Heath Fletcher:Yeah. That's amazing. Yeah. You have a lot of philanthropic activities going on in in your life as well. Right?
Heath Fletcher:That's a really important part of of your leadership development, isn't it?
Harsha Rajasimha:It it has been heat, in that, you know, when you you have a mission, certain activities fall under the realm of, nonprofit philanthropic and charitable work. So I run this nonprofit called the Indo US Organization for Rare Diseases, realizing that a lot of the investments and funding for biomedical research happens in The US and the Western world, whereas there's a huge patient population and amazing medical doctors community in India, which is not tapped into for new drug development. While India is considered the pharmacy of the world with respect to APIs and manufacturing of generic drugs, patent expired drugs, for new drug development, which is where most rare diseases fall under, you know, because ninety five percent of rare diseases do not have an approved treatment. And so patients in, India and the rest of the world, they contact the nonprofit requesting for access or assistance on care navigation, how do we get a faster diagnosis, how do we access any approved treatments that may be available in US or other countries. So so it's a free service that we provide and offer to patients and, families that contact us.
Harsha Rajasimha:In fact, I spoke with one family just this morning, requesting, assistance, for, treatment.
Heath Fletcher:Oh, that's amazing. And so that what is the process for them then? They just they just submit, application, and then it's you review them. And
Harsha Rajasimha:That's correct. Yeah. So there is a indousrare.0rg. It's a website. They can go there under the programs.
Harsha Rajasimha:They will see a patient concierge on the top of that list, and they they submit a form, providing consent and sharing some information about their health condition, whether they have a diagnosis or symptoms, where this, where they stand in the journey as of now, and provide, information about what specific areas they need help with, whether it's, obtaining a diagnosis, accessing treatment, enrolling in a clinical trial, or financial assistance. And based on what, information they provide and consent, we have a network of, researchers, medical doctors, diagnostic labs, and patient advocacy groups that we can connect the individual family with, and also provide care navigation. And we partner with a crowdfunding, platform, which offers discount on their cut, if they refer through our organization. So depending on where the patient journey, is, we we we we have the ability to connect them. We have a staff and, virtual board, of experts that review any complex cases, and we Amazing.
Harsha Rajasimha:Almost always have a way to provide some assistance and guidance on where they should go.
Heath Fletcher:And how long has that been operating?
Harsha Rajasimha:Since 2014, in one form or, the other. And now we have a staff, a formal team of, members who are trained to provide this now. And so it it's I am no longer, critical to keep it operational.
Heath Fletcher:It operates without you. Right? Yes. That's great. That's where you want it to be.
Heath Fletcher:So it must be the demand must be high.
Harsha Rajasimha:It it it's growing more and more mostly through referrals and sometimes through Google searches, and they run into this concierge and contact us directly by phone, sometimes an email or the online form. And Right. Yeah. So we have a process to route them in the right way and efficiently. And you
Heath Fletcher:can take this AI into you may have to bring some AI into that.
Harsha Rajasimha:Exactly. That's essentially, it's the Jeeva platform that empowers that concierge service also.
Heath Fletcher:Oh, is that right? Oh, okay. Oh, great. Amazing.
Harsha Rajasimha:So patients can submit the request in any language and from their own keyboards from anywhere in the world actually.
Heath Fletcher:So in your, in your professional career, is this your first company that you founded, or you've you've had a series of entrepreneurial experiences?
Harsha Rajasimha:I have been part of startups founded by other founders, in in senior executive roles before this, at least two startups. One is genome,uh,.com, where I helped build a next generation DNA sequencing data analysis, platform on the cloud as a software as a service. Got commercially launched and, got, the first few customers, back in the days in between 2009 and 02/2012. And then I was part of Strand Life Sciences, which is a diagnostic clinical diagnostic precision medicine company that, you know, analyzes multi omic data, DNA, RNA, protein, cell, and develop, provide a clinically actionable report, for cancer and rare diseases. So that was part of a startup launch.
Harsha Rajasimha:It's a CAP and CLIA accredited lab, which is College of American Pathologists and Clinical Laboratory Information, Improvements Amendments Act, CLIA, which is essentially a lab developed test, for diagnosis and providing recommendations on potential treatments for patients with cancer or rare disease. So having launched several start up products, then, I I was consulting with Big Pharma where I saw firsthand with top 10 pharma.
Heath Fletcher:Right.
Harsha Rajasimha:In the clinical r and d, side, how the infrastructure was, so expensive, complex, and broken, and still they were investing more money in systems integration, data integration. That's a luxury that smaller biotech pharma companies do not have. And rare diseases do not have that. They don't receive anywhere as much funding and investments. And nonprofit, patient foundations can't afford that.
Harsha Rajasimha:And even the big pharma can't afford anymore.
Heath Fletcher:No.
Harsha Rajasimha:After the, post pandemic bust, now, they they had the right. And now even the regulations, the pricing control, and a lot of the environment is very difficult for even big pharma. And so everyone is seeking efficiency and, cost and time efficiency, without compromising quality, compliance, and patient centricity. And, you know, have having this well rounded perspective, both from a personal patient, family perspective as well as the technical perspective, propelled me and put me in the right place at the right time, I I I guess, to Yeah. Make this happen.
Heath Fletcher:And it sounds like a bit of a passion for technology too. Right?
Harsha Rajasimha:You're certainly
Heath Fletcher:drawn to that sort of side of things. Although, you do have a doctor you have you have a doctor in philosophy too. Right?
Harsha Rajasimha:That's right. I am a PhD in computational biology and bioinformatics from Virginia Tech. And so that's, although I'm I started off as a computer science engineer and interned at Microsoft, in Redmond, Washington, and that's
Heath Fletcher:Oh, what really? What
Harsha Rajasimha:you know, but core IT and core systems was not my thing. I I needed the human element. And and so yeah. Over over the course of my career and personal journey, those things kind of came together.
Heath Fletcher:Mhmm. And then the philosophy piece, where did that fall in? How did what what drew you to that?
Harsha Rajasimha:Essentially, you know, need I fell in love with science, and, engineering, is is what I did in my bachelor's, computer science engineering. But Mhmm. Science is, freaking awesome. You know? It's there's hundred plus years of literature for, biology.
Harsha Rajasimha:And so when I got a, you know, I was considering whether I should pursue MBA or, science and, philosophy career. And, around that time, I had to make that choice. And, you know, what I was advised by Sage, Sages is you can get MBA at any time in your career, but, if you want to do, do it now as a student while you are still full time student on, on a university campus, it's best to get a strong foundation in science. And so so I when I had a research assistantship, I I took it, and, I first wanted to write a master's thesis to make sure I I am I enjoy it, and I I did. You know, mitochondrial DNA, heteroplasmy.
Harsha Rajasimha:Mitochondria
Heath Fletcher:has more
Harsha Rajasimha:than hundred years of scientific literature behind it. And so so, reading those thousands of articles and, how the mitochondrial structure, m tDNA was discovered, like a bacteria getting into the human cell and settling down in the cytoplasm, becoming an organelle in in the body, it it's just fascinating.
Heath Fletcher:Yeah. No kidding. It is. Sounds fascinating. I biology is very interesting, actually.
Harsha Rajasimha:It is. And so the digital age of biology was, just beginning. You know? I I came to United States in February, straight to work genentech, as a student, and that was the time when human genome project was completed and genome sequencing was just, you know, it it it was a billion dollars to sequence, but the technology was there. Was there.
Harsha Rajasimha:Yeah. It's a few $100. You can swipe your credit card and get a whole genome sequence. And so the era of digital biology, digital medicine, computational biomedicine, that was fascinating to me, and I fell in love with that. And so that's what, know, helped me complete the PhD fairly quickly and, came to NIH, a fantastic place, absolutely top notch, scientists and medical researchers from all over the world who come to NIH had the opportunity to work at, the Doctor.
Harsha Rajasimha:Anandsvarup lab in the neurobiology, neurodegeneration, and repair lab where, mouse retina and human retina donated eyeballs. You know, those types of resources were available to study and understand how, retinal diseases are caused, what mutations drive the development of the retina. Yeah. And so that was another fascinating experience that I had. So, you know, as I realized, to really have an impact at scale, if I can help make these innovations that can bring new treatments to market faster in a patient centric way, that I would have made a huge part of it.
Harsha Rajasimha:I'm not a biologist by training. I'm not a wet lab scientist. I'm dry lab, in silico stuff. And so I I had to pick something which I could spend a few years of my life making an impact on, and this fell in my lap.
Heath Fletcher:Well, it sounds like a perfect fit. And now you're now you're CEO at Jeeva, and so you're that has a different that's a whole other role. And how do you how do you how do you manage that part of the job? I mean, you are it's a heavy burden. It's a heavy load to carry.
Heath Fletcher:So what do you do to for yourself to kinda stay on top of of all that that you're that you're responsible for?
Harsha Rajasimha:Yeah. Great question, Heath. And, it it I I absolutely love my job, although I have my down days and up days. But, it it the thing I love the most about being a CEO or or a founder is it challenges every aspect of my personality. Right?
Harsha Rajasimha:It it's not just my technical skills, my scientific skills, my business skills, my human skills, my interpersonal skills, my communication skill. You you gotta be on the top of your game the best you could be every single day, every single meeting, every single moment. And you you, you you are leading by example, and your team members, your colleagues, your customers, your partners, your investors are taking cues from your body language, your how do you feel, how you speak, what what do you say, and what setting the direction. And so having clarity of mind, constantly testing product market fit. You know, are we in the right direction?
Harsha Rajasimha:Is this what customers want? And if not, you know, it could be major directional correction or fine tuning of the product features. So the it it it takes, like, right brain, left brain, whole brain, and, you know, being able to zoom in to the Back
Heath Fletcher:brain, front brain. Takes it all.
Harsha Rajasimha:And so it it that that challenge is what I I enjoy because, otherwise, I I usually I I feel like I have gotten bored easily in my previous jobs. Mhmm. Not that they were not challenging, but they challenged only some parts of my brain, not as much as I feel challenged now.
Heath Fletcher:Not the whole thing. How do you keep it? How do you keep how do you keep clarity? How do you, what do you do to recharge and and and stay stay so focused and and current?
Harsha Rajasimha:I wish I had a good answer for that question. But, it's, you know, essentially being on your toes and, just knowing that I gotta be on the top of my game every single day. Yeah. It and it it's not usually possible to do that if, unless you have a larger than life mission. And luckily for me, I have that.
Harsha Rajasimha:And that mission works drives me. It it it's like, you know, you are in the final lap of your, marathon, and you can't give up at that last stage. Right? And you feel that way for I have been feeling that way for six years now that I'm I'm in the final lap.
Heath Fletcher:The final lap.
Harsha Rajasimha:But I don't know when that lap is going to complete. But, you know, it it it but you you know that it's worth completing that lap. And and so you keep running and you keep pushing yourself and wake up every day in the morning and feel like, yeah, you have a new opportunity, a new day, irrespective of how good or bad the last day was.
Heath Fletcher:Mhmm. So if you hear any advice for, you know, someone in you know, not maybe going to be in your shoes one of these days, but maybe on on course to doing what you're doing or something similar. Is there other any other advice as far as how to prepare for a role, the type of role that you that you are in?
Harsha Rajasimha:You know, my real advice is please don't, do what I'm doing because it's it's
Heath Fletcher:I didn't expect that.
Harsha Rajasimha:No. It's an honest answer. I I don't think it is as, rosy as it looks from the outside. It it it's a lot of sweat, blood, and tears. It's a lot of hard work, sacrifice, and all of that, and a lot of hard work.
Harsha Rajasimha:And, you may or may not, reap any benefit of all the hard work and effort and sacrifices. And so, unless you truly have a mission that you think you you feel obligated to complete that mission and you have a real passion that, you know, even if you failed, it it was still a worthwhile, journey to have taken, then maybe. But, if not, it it's not something that you you would take on for any other reason.
Heath Fletcher:Right. And I I think yeah. I mean, that you bring up a good point. It says that it's something that drives you, that it's a passion, like you say, or some sort of vision or purpose that you just can't get out of your head that really was what usually takes entrepreneurs down down that path, isn't it? It's something that they just can't explain.
Heath Fletcher:They just have to do it.
Harsha Rajasimha:Yeah. And if if you have already, gotten that far and you you know you you really want to do it, then my couple pieces of advice would be one, build a community. You you can't do it all alone and yourself no matter how smart you think you are. And, I I certainly have a huge number of people and the community to thank and support, including, obviously, family, but, people who have no relation whatsoever, and strangers and people we who we meet, prospects and customers who share their pain points, without any expectation during discovery interviews. And
Heath Fletcher:Right.
Harsha Rajasimha:Strangers who just generally appreciate entrepreneurship and the hard hard work that entrepreneurs have to put in and take mercy on us and help us. Right? And so there is having a community of, supporters, is absolute necessary. Without that, we we no one no entrepreneur can be successful. The second is, be physically fit, and, take care of yourself.
Harsha Rajasimha:Do whatever workout that suits you, but being physically fit is absolutely necessary and and mentally fit. And so, it goes hand in hand. So those would be two, two things I would highlight.
Heath Fletcher:I think that's great advice. So, I think you hit the nail on the head anyway. So, Harsha, thank you so much for sharing your world with us and your career. And the work you're doing at Jeeva Clinicals is very exciting. I think it's, yeah.
Heath Fletcher:Great job. I'm I'm excited for you and the future of the company. So, again, thank you for, spending your time with me today. And if people wanna reach out to you or find you, what what's the website and where where can they connect with you?
Harsha Rajasimha:It's easy to find me on either LinkedIn. I'm quite active on LinkedIn. If you search my name, Harsharajasimha, I suppose there's probably only one person with that name.
Heath Fletcher:Probably, yeah.
Harsha Rajasimha:And the website for Jeeva Clinical Trials is jeevatrials.com. That's jeevatrials, givatrials.com. And it was such a pleasure, hanging out with you, Heath. It was a great conversation. Thank you for having me.
Heath Fletcher:Yeah. It was a lot of fun. I really enjoyed it. And I'll put a make sure all those contacts are in the show notes below so so they'll be able to track you down. So
Harsha Rajasimha:Sounds great.
Heath Fletcher:Amazing. Great to meet you, and we'll talk again soon, I hope.
Harsha Rajasimha:Look forward to it. Thank you.
Heath Fletcher:Man, this conversation with Harsha really shines a light on how much potential there is to improve clinical trials just by rethinking the process and then, of course, bringing in an AI. It always helps. Blending that deep scientific knowledge with personal passion, and it's clear to me that his mission at Giva is more about more than just technology. It's about making clinical research more inclusive, efficient, and human centered. And his story is also a really good reminder for me behind every innovation is usually some sort of deeply rooted personal drive.
Heath Fletcher:And that with purpose, community, and resilience are just as important as any tech stack. And he had some honest, honest insights into what it really takes to be a mission driven entrepreneur. Never bad to hear that. If this episode resonated with you and you wanna share it, please go ahead and and don't forget to subscribe for more conversations about this crazy intersection of health science and technology. And stay healthy, and we will talk again soon.
Heath Fletcher:Thanks for listening.