Expansion of Modern Technology Adoption in Life Sciences

Raj Indupuri 
Hello, everyone. I'm excited to be here with Venu, who joined us recently as VP Global Strategy and Operations. This is a new role at eClinical, and I see this as a very critical role as we grow and as we scale. I’m incredibly excited to have him on board & on the team. So, we really want to just share more about your background and your previous expertise before joining eClinical. 

Venu Mallarapu 
Yeah, sure. First of all, you know, thanks for the opportunity. I'm really excited to be part of the team and look forward to working with you all. In terms of my background, I was working as a head of the R&D Solutions group at Cognizant, which is a large, global system integrations service provider. And I've been in the industry for over 20 years. 23 years, to be precise. Most of that spent in life sciences -- even more so in life sciences R&D – and I started off with technology and stayed through technology while playing other roles as well. Be it delivery management or relationship management with clients, or leading practices like the most recent job that I've had. So I have a very good background, but most of it in life sciences and life sciences R&D. 

Raj Indupuri 
Excellent. Thank you, Venu. And again, I'm really excited that you're part of eClinical now. So what factors made you interested in joining your team? 

Venu Mallarapu 
Yeah, good question. So I think as I was going through the thought process -- first of all, I wasn't planning on a change. Two, the attractiveness of working here was very exciting. And then I started asking myself “why is it so exciting?” and then I did my own research, so to speak. And, first and foremost, I think the people. In our interactions, even before I joined eCS, you and I have interacted quite a bit in the world with some of the other colleagues of ours as I was establishing the partnership between Cognizant and eClinical Solutions. So first of all, I have to say it's the people. Our interactions have been very, very good -- informational and forward looking, I should say. Then the second thing was, obviously, as I was trying to take decide on the course, I thought [about] product development and bringing a product to life, even though here it's already up and running. But being able to make an impact through product is something that I thought would be really cool to do and elluminate being a leader in clinical data aggregation and analytics especially providing that cloud-based platform. Now, that was quite exciting. It's already a leader and we're just getting started and there is much more that we can accomplish. I thought it would be a great experience to have. And bringing in my experience on the global insights side, I could also help expand the services that have to go hand in hand with the platform, if you will. Yeah, those two, I should say, they're important for me and that excited me and not to mention how the market is today and the growth opportunities there are, especially when it comes to data and analytics. 

Raj Indupuri 
So excellent. Thank you. That's heartening to hear. And again, your role -- it's a new role to the organization. And I'm really excited because it's kind of a 360-degree role and one of the biggest differentiators with our company compared to others is we have the software and services business. And I truly believe having this global strategy role can help our customers maximize their investment into either the software side or the services side. I'm really glad to hear your perspective – it’s all about the people. And also I'm always excited to hear about how elluminate can help, not only in the current state, but also help our customers with their future needs. So I know it's only week three, and you briefly alluded to your expertise with R&D and you also talked about how your role can make an impact. So what's your perspective around the opportunities for eClinical to help your customers across the entire R&D technology landscape? 

Venu Mallarapu 
I think there's a huge upside as we tackle more data, diversity of data, volume of data, and all of these -- they are already complex and it's only going to grow more in terms of complexity. And from elluminate’s standpoint, as I mentioned coming in more like an outside perspective, I consider it already as the leader in the market be it in terms of the vision for the product, be it in terms of the capabilities that already exist in the platform, and be it in terms of the customer base that already exists. 

Venu Mallarapu 
And that was one of the reasons why I wanted to partner with you all in the first place. So from that standpoint, we are already in a leading position and some of the mid-to large customers are coming to terms with how much more complicated their environment and their situation is going to get. From this point on, with the advent of decentralized clinical trials, with increased use of sensors, devices and such, and also variety of data structured and unstructured and so on and so forth. So from that standpoint, I see a huge upside for elluminate in mid to large biotechs, pharma, med devices, even consumer health and other segments of the broader life sciences industry, if you will. The platform should also be complemented well with services that go hand-in-hand with that, be it in terms of bringing the platform to life through effective program and change management, or effective roll out of the platform for various users and stakeholders within the ecosystem, and drive to increase the adoption and use of the platform itself. And when it comes to the usage of the platform, how quickly can the adoption grow and how quickly can existing capabilities be tailored for various stakeholders, be it data managers, medical monitors, or even IT staff for that matter? So from that standpoint, I feel the services aspect becomes very critical, and that's another area with the established services we already have and with the scope for further growth, even more so when it comes to mid-to large pharma where they would lean heavily on those services, I feel a combination there will create many more opportunities for us at eClinical. 

Raj Mallarapu 
Yeah, no, that's good. So again, I think that's something that we always believe in in terms of the synergies between both businesses. I know when you and I talked, you talked about again, right now, with the elluminate clinical data cloud -- we have the clinical data repository hub, operation data hub or repository. Your feedback once you learned about elluminate -- and also, the last two weeks being part of the team -- is the opportunity lies within that complete R&D technology landscape to provide similar capabilities for safety or pharmacovigilance or regulatory. So, that was the context in terms of my question: do you see the capabilities that we have are able to address the needs of other stakeholders within the R&D lifecycle or the value chain? That's what excites me. So, I'm curious, coming from where you are, working with larger companies & helping with their entire R&D space, are there any specific parts or ideas you might have on how elluminate can further evolve and help our customers? 

Venu Mallarapu 
Yeah, if you ask me, I feel that's the most exciting part: the clinical and the capabilities that we have, the way I see it, that’s just the tip of the iceberg. And as important as it is to have what we have to accelerate the clinical development process, to make it easy for data acquisition, aggregation and insight generation standpoint in the clinical context, the iceberg that we do not see is all the other cross-functional aspects that have to come together to make our study successful or to get the product to the market faster. And as our region says, we want to bring these products to market faster so that we are able to positively impact the lives of the patients. That's what our model is, to bring these treatments to market faster so we can impact the lives of patients in a positive way. So that's where I feel some of the capabilities, even within the context of clinical, expanding the capabilities we have to include things like metadata repositories, maybe even master data management to some extent, but drive automation of the entire data flow, if you will. 

Venu Mallarapu 
And then going beyond that, into additional capability as you are indicating -- I feel the reason why I think this way is the fact that we have figured out what it takes to bring data together in terms of all the orchestration that is required, the repositories that will be required, the audit capabilities and such that will be needed for us to do this in a meaningful and controlled way. 

Venu Mallarapu 
So that we have figured out, we're doing that in the context of clinical. Now, it's just a matter of extending that capability to regulatory, to safety, to even medical affairs, discovery and research, because I see the industry itself struggling to be able to get a hang of all this data and then bring it all together and then be able to view that in a comprehensive and cohesive manner to drive decisions that are beyond clinical as well, from an operational standpoint or scientific standpoint, whatever the context may be. That is exciting. 

Venu Mallarapu 
And now if you extend that part even further into, “hey, this is just R&D and we have similar challenges with regards to manufacturing and supply chain, how can we automate the entire manufacturing process?”. People are talking about industry, you know, 4.0 and so on and so forth, how do we improve the overall manufacturing process, make the products available, make the supply chain seamless? With the pandemic, I think we all, even people that don't know about supply chains, are learning about supply chains and what the impact there is. Similarly, on the sales and marketing side, how can we make it easier for us to commercialize the product from that standpoint? 

Venu Mallarapu 
So like I said, clinical is just the tip of the iceberg. We have everything that is required to handle data, in terms of acquisition, aggregation, analysis, automation of the entire process. If I think about that, that's that much more exciting. And the more of that we build, large pharma will get excited as well and would be interested in talking to us about that. 

Raj Indupuri 
Yeah, makes total sense. So, when we started -- this is our 10th year, really special for us -- we anticipated that trials are going to get complex, there would be more and more data, expectations from stakeholders in terms of insight generation would be rapidly evolving; that came to fruition. And again, we talk to existing clients about their enterprise data initiatives. I see the point in terms of how existing capabilities can be replicated and scaled up across the entire enterprise. So yeah, I'm excited in terms of the opportunities that are out there for us to help our customers beyond clinical development. And again, I don't believe that's far-fetched in terms of what we are doing right now, and I'm really thrilled to think in that direction and help our customers in a big way. So that makes total sense. 

Raj Indupuri 
Connected tightly to this question or the conversation that we just had, you're coming from Cognizant, a technology service solutions provider, with a lot of experience with systems integrations, and I assume you worked with several larger companies and you might have heard a lot of conversations that are build versus buy. So obviously we are an enterprise software company, and you know my take and my position in terms of when companies invest in new technologies, what would provide more value, etc., but I’d love to hear your pragmatic thoughts in terms of the build versus buy, the pros and cons, and what goes into the customer's mindset in choosing the optimal path when investing into new technologies, something like elluminate. 

Venu Mallarapu 
Yeah, I think, was it last year? I think we had a whole panel discussion around this, and it was very diverse in the perspectives that we discussed there, but the thought process behind and the need for having that conversation arises at large pharma because of the thinking kind of relating to the previous question that we had a conversation on is, “hey, what else?”. So that's where I feel many of them are happy to bring in a cloud-based SAAS platform, provided the platform gives the capability that they're looking for to address their problems. And in fact, that's probably a preferred option for a lot of CIOs and broader organizations as well because that takes away the burden of building teams from scratch, maintaining, managing, continuous upkeep of the infrastructure, the technology, all of that that is required. 

Venu Mallarapu 
While that is the case, there are also situations where, based on the vision, the strategy, and the roadmap that they are creating to set up broader platforms that go beyond the capabilities that are available from the SAAS solutions. That's where I think this conversation arises in terms of build versus buy. So that's one aspect. The second aspect is the adoption of hyperscale infrastructure in terms of, you know, AWS, Google Cloud, R, Microsoft that's increasing at the enterprise level for our customers. And because they're making those choices, making those investments, there's also that perspective of, “hey, how can we maximize, or optimize if not maximize, the investments that we are already making in these platforms?”. 

Venu Mallarapu 
So to me, I feel it's a combination of either wanting a capability that could be available in the future today, or, trying to optimize this investment that they have already made. In my mind, it's a no brainer, which is to bring the capability that it's already tried and tested for you. Why even think about custom? And if you have the investment dollars, the time, and you want to use the hyper scaling infrastructure like AWS and Google or others, do so for other needs that the enterprise might have. But nevertheless, that conversation is happening actively across the industry and different organizations are making different decisions that they feel will work for them and are comfortable. But nevertheless, as I stated earlier, for me at least, it's pretty straightforward, which is bring in the capability that's tried and tested. If you really want to expand the capability, work with partners like eClinical to expand that capability even further because our platform itself is born in the cloud, born for SAAS, born for our multi-tenant VMs, so on and so forth. And you are getting the ability to scale as required by large customers as well. 

Raj Indupuri 
Yeah, no, that makes total sense. I think, again, as the needs are rapidly evolving, as trials are getting more complex, expectations from all stakeholders are rapidly evolving. In that context, to keep up with the change and the needs, you need to innovate at scale. It's not to say that pharma companies will not be able to do that, but I think you should be able to get these capabilities right out of the box. And of course, to your point, I think that's well said, collaborate with companies like us to push the boundaries so you’re able to not only address current needs, but also build something that's ready for the future. So, I think you could have collaborative relationships just across our software providers in the industry to minimize the build aspect of it. I think to your point, there might be some components within the enterprise that would require custom development, but I would say the majority should be investing into existing digital systems with interoperability as a critical component. You can minimize the custom development aspect of it to achieve these outcomes. 

Raj Indupuri 
I think you touched on it a bit in terms of the future as well. You talked about how we can expand beyond clinical development and we touched, from the context of build versus buy, on the opportunities out there to take advantage of the technologies that have matured over the years. You briefly talked about cloud, I don't think we talked about AI, there are several trends that are helping the industry and also helping companies like eClinical to help our customers. So, what are any major trends that you think will impact life sciences at a macro level? And how do you think eClinical can help in both the near-term and also longer term? 

Venu Mallarapu 
Yeah, certainly. I think the industry itself is going through a transformative phase. If you ask me in terms of novel approaches to clinical research and clinical development, some of the things that come to mind are things like cell and gene therapy. That is that that is going to transform. Just last week, I was reading a piece of news around CAR-T and CAR-T cell-based therapy where all the patients in a particular study showed complete, great improvement in terms of their disease condition using that treatment. And those require a totally new approach to how you develop and sustain the products, how you treat patients, and how closely you have to work with the patients in treatments like that.  

Venu Mallarapu 
On similar lines, the one thing that the pandemic, if I see any silver lining at all that we can think of, is the adoption of decentralized clinical trials. As you know, hundreds of studies came to a grinding halt due to the pandemic, all of the stakeholders scrambled, but came up with a solution that works, which is adoption of what you call trials, and they’re different under different names. But the industry seems to have converged on decentralized clinical trials as the term to adopt. 

Venu Mallarapu 
And we have seen, you know, a tremendous increase in adoption. And I don't think we are going back on that. Things may vary in terms of different phases and levels of adoption and so on and different aspects of decentralized clinical trials also with varying degrees of adoption. But we are not going back. I, for one, believe that technological innovation is critical for finding that next breakthrough treatment for some of the unmet needs in the industry or for some of the toughest diseases that exist today, and that technological innovation most likely could be in the form of, as you mentioned, AI, ML, NLP, evolutionary learning and all of that in a basket of innovations that go hand in hand, in my mind at least, under the guise of automation. So, I think that's another aspect that's going to have a huge impact. 

Venu Mallarapu 
We talked quite a bit, you know, about data. How do we handle the complexity of that data, which is ever increasing when you only have so many resources to add that? Also, from a platform standpoint, why there is certainly a bit of a gravitation towards homogeneous platforms that can do a blend, but you also have to think about putting all your eggs in one basket as well, which could drive some of the sponsors towards adopting multiple micro ecosystems to address different functional problems within the end-to-end life sciences value chain and if you are doing so, you have to think about interoperability. You have to think about, how do I create an environment where it becomes plug and play almost? 

Venu Mallarapu 
How do you bring these pieces together, be it in terms of integration, be it in terms of data aggregation, be it in terms of decision making and driving adoption of these decisions. There's also talk about data fabric and things like that. So, these are some of the things that immediately come to mind that I feel are going to drive the next phase of development. But nevertheless, I think the growth is going to be exponential in terms of adoption of these as a reaction to some of these needs in the industry. 

Raj Indupuri 
Excellent. I think you talked about the technology trends with interoperability or the data fabric, which is sort of shaded as services, so that you can adopt digital systems at scale. You talked about cloud and also you talked about AI. You clumped several things under AI, which is machine learning and LP. That's a trend that's only going to accelerate in terms of maturing and adoption. 

Raj Indupuri 
And you also talk from the industry point of view, if I can summarize, in terms of using more advanced techniques to deliver personalized medicine to patients. I agree with you, it's an exciting term, the convergence of both tech and biotech is going to create tremendous opportunities and it's going to create tremendous value for all stakeholders involved. And I feel fortunate, I know our entire team at eClinical is fortunate to support the industry with this evolution. And we are super excited that you are now part of the team. You will help realize our vision and our objective to make elluminate as the platform of choice within our industry. 

Raj Indupuri 
And of course, to your point, you talk a lot about how services play a critical role in helping maximize this investment made by our customers. I agree with you, it's exciting times ahead and I'm really looking forward to you being part of the team and helping our customers solve their problems, problems that are only going to get more complex moving ahead. Thank you. 

Venu Mallarapu 
Certainly excited, as I mentioned, it's been an amazing couple of weeks. The people, which is what I heard outside and which I experienced firsthand, are amazing to work with and we are at the forefront of that technological innovation that's going to bring the next treatments to market to improve patients' lives. 

Venu Mallarapu 
I think we are already there, and we will be doing even more of that. That in itself, even more exciting is for me to be part of the team. I look forward to working with you, with the rest of our team here, amazing people, to bring that strategy, the partnerships that will be acquired, the platform capabilities that exist, plus more that we are going to build, complemented by the services, both in terms of bringing the platform to life, as well as using the platform to its utmost potential and driving the next phase of clinical research and treatments to market. So thank you. I appreciate the opportunity. 

Raj Indupuri 
Excellent. Welcome again. Thanks Venu. 

Venu Mallarapu 
Thank you.