Vivek Gera  00:00 
Yeah. So during the first year, we had absolutely no idea what we were doing. We did not have any product-market fit, and in fact, we spent 70% of our time just figuring things out.

Harsh Thakkar  00:16 
[Podcast Intro Message]

Alright, we're live! Thank you, Vivek, for joining us, and thank you to all the listeners who are tuned in to another episode of Life Sciences 360. Our guest today is Vivek Gera, co-founder and CEO of Leucine. Thank you for joining us, Vivek.

Vivek Gera  00:49
Hey, thanks for inviting me, Harsh. I'm happy to be here.

Harsh Thakkar  00:53
Great. So, I want to start off with something that I found when I was researching your profile. You've lived in some really cool places all across the world. I saw Norway, I saw the US, Australia. Was this all planned or did it just happen to work out that you lived in all these places?

Vivek Gera  01:09
It was all planned, Harsh. I was actually quite lucky to be around some really high-quality people during my undergraduate days. And my immediate seniors, people who I knew well, were all doing internships pretty much all over the world. I always found that people who had come back brought back some really exciting learnings, not only about science and technology, but also about problem-solving and approaching different situations. It inspired me to explore and go out of my comfort zone, which is why I tried working towards some of these opportunities. I was lucky enough to get a chance.

Harsh Thakkar  01:59 
Great. I also saw that you went to undergrad. You went to IIT, is that correct?

Vivek Gera  02:06 
Yes, that's correct.

Harsh Thakkar  02:07 
I'm from India as well, so I know IIT is not an easy school to get into. How has your time in IIT and all other places or all other education that you got or internships that you got helped you in running a software company like Leucine? We'll dive more into what you're doing there.

Vivek Gera  02:28 
Yeah, Harsh, you always have lots of talented people around you when you are in a place like IIT, or there are several other really great universities in India as well. However, what I found is that people who were doing really well, in addition to the talent that they had, were doing a lot of hard work. They had discipline, and those who combined their talent with some of these things were showing predictable, consistent, repeatable, successful outcomes. That's exactly what you want in a tech company. You want to grow fast, but month after month, quarter after quarter, you want that consistent, repeatable, predictable journey for the company. So I would say that combining talent with hard work and discipline leads to predictable and repeatable outcomes for the company. In a way, it did help, but there is no real way to learn how to run a tech company other than to run a tech company. You pretty much learn on the job.

Harsh Thakkar  03:56
Yeah, I can relate to the importance of a community, whether you go to an Ivy League or a top school or any school, you can always learn from people around you. You mentioned having ideas or bouncing off ideas. So the next question I have for you is, how did you get the idea for Leucine? Do you remember the day or the moment when you first thought, "I want to build this company, and this is what it's going to do?"

Vivek Gera  04:28
It all happened quite naturally, but gradually, Harsh. So I started my career at a company called Rio Tinto. Rio Tinto is a large mining and operations company in Western Australia. They have mines and offices around the world. While working at Rio Tinto, I was able to observe how critical compliance can be as a function for the growth and sustainability of an enterprise. I was doing a majority of my work in building compliance systems while I was there. Coming from a chemical engineering background, I always had a good network and lots of friends in the industry. The pharma industry was trying to solve challenges that were quite similar to what I was working on. It gradually got me into understanding the industry a little bit more. I started doing some consulting before starting Leucine. While I was spending more and more time, it became clear to me that using software and technology has to be the way to solve the compliance challenges that the pharma industry is facing today.

Harsh Thakkar  05:56 
Okay. I know from talking to other people like you who've started companies in the last five or 10 years that the first year is so important, not only for defining what the company is but also for finding product market fit. Did you have that fit with the clients right from day one? How was the first year? Can you share any challenges that you had as you were trying to fit your product to the industry?

Vivek Gera  06:34 
During the first year, we had no idea what we were doing. We did not have any product market fit. In fact, we spent 70% of our time just learning about 21 CFR part 11 and how to incorporate that into software development. We also learned about the expectations of the FDA when it comes to auditing software solutions at pharma companies. We were just learning a lot about what it means to use software in the production environment within a pharma company.

Harsh Thakkar  07:16 
Do you have any stories or examples of how you found out about regulatory requirements, either from talking to a customer or from your own research, and then came back to your tech team and said, "Hey, we need to build this feature because this is a requirement"?

Vivek Gera  07:42 
Yes, it happens all the time. However, we were able to partner with a couple of high-quality pharma companies to begin with, so we didn't have to figure out all the regulatory requirements for ourselves. We were lucky enough to have great partners who were facing critical compliance challenges at the time. We made it a lot easier for them to start investing not only in technology but also in building a relationship with an early technology company like Leucine. We were able to work with high-quality pharma companies and figure out how to bake the regulatory aspects within the product along with the users, rather than doing a lot of independent research.

Harsh Thakkar  08:37 
I know a little bit about Leucine because we've had a chance to connect before this show, and you've also shown me some of the capabilities of the platform. I know that in one line, it's a no-code platform that helps pharmaceutical manufacturers maintain compliance and stay audit-ready. What I want to ask you is, from your perspective, what are the one or two things that separate Leucine from all other product platforms or tech products in the market serving the life sciences?

Vivek Gera  09:11
First of all, I deeply respect all the other players who have been in the pharmaceutical software industry, and specifically companies that are 15 years old or 20 years old, who have been building software for pharma for quite a while. I know from my own experience how challenging it can be to create adoption for software within pharma. Now imagine doing that 15 years ago when there was no precedence and no urgency. Today, the environment has become a lot easier. People are comfortable with technology, and there are compliance drivers that are driving the behavior to adopt software more and more. So I'm first of all deeply thankful and respectful of all the companies that are in the pharma industry.

Now, what we are trying to do at Leucine is deeply almost obsessed with solving problems using the product-driven approach. We try to stay away from services as much as we can, break down problems into logical pieces, and apply that product-first thinking. I'll give you an example here, Harsh. Today, an end-user can create a new process on the Leucine no-code platform within 75 minutes on average. Whereas with traditional technologies, you have to build out the recipe, and being in pharma, you know that it has to go through that review approval lifecycle, which can take days if not weeks. This has dramatically slowed down the innovation or digitalization when it comes to pharma. However, by applying no-code methodologies and baking in some of the software validation concepts in the way you design the no-code components, it creates ease and simplicity around building new processes on the no-code platform. Hence, we are able to realize much better results than we would have seen, let's say five years ago when the no-code revolution was probably not as much as it is today.

Harsh Thakkar  12:09
Yeah. And, I have done some research on no-code as well, because even at Qualtivate, we are mostly into regulatory and compliance services, but we help clients with simple automations using off-the-shelf no-code tools. So I've been reading a lot about no-code, but you're right, if you had asked me in 2020 what's no-code, I would have said, "I don't know," <laugh>. I only started reading about it in 2020 and slowly started looking up tools like Airtable, Zapier, Make, and others that are now so popular in the no-code space.

So, one thing that I want to ask you, and this is what I've observed as well, why do you think that life sciences or regulated industries are a little bit playing catch up to technologies like no-code and low-code? I've seen other industries adopt them and implement them much faster with the right use cases, but I tend to see that pharma is still playing catch up.

Vivek Gera  13:14 
Yeah. So I would actually segment the pharma industry into two components here. Harsh, there are a good number of companies today who I would say are early adopters of no-code and have been using it at scale throughout their operations, such as QA, QC, manufacturing, engineering, and warehouse. For this specific segment of the industry, who are early adopters of no code, I wouldn't say that they are playing catch-up. In fact, they're leveraging it as much as any other industry. However, there is a second segment which is catching up on digitalization in the first place. It's not specifically about no code or low code, but they are just gearing up to become more digital over the next couple of years. The way they would catch up, in my opinion, would be via no-code. We would probably see a rapid wave of no-code adoption coming up soon in the second segment as well, which are not early adopters at the same level as the first segment.

Harsh Thakkar  14:43 
Yeah, I can definitely understand how you broke those two down. What I want to ask you is when did you first become aware of no-code and connect the dots between no-code, Leucine, and the problems with pharmaceutical manufacturers? How did you connect those three dots? When was the time?

Vivek Gera  15:10 
In today's technology-driven world, we are all using no-code technologies in our day-to-day life. Like you said, you are using things like Zapier, Notion, and Airtable. So we have pretty much been using all of these tools in running our business operations. Hence, everybody on the team has been super familiar with the power of automation that it can bring. We started applying some of these concepts when we started scaling up a little bit. From our customers' standpoint, they were using the Leucine platform in its early days for maybe one or two processes. But we were getting a massive amount of interest and requests for extending it to other areas. It just became a natural solution for us to incorporate no-code components in our platform so that we can scale the platform faster across different process types within different functions of a pharma company.

If you look at the journey of manufacturing one batch of drugs, you have engagement from multiple teams. You have to have manufacturing teams performing hundreds of operations, QA, QC, engineering, maintenance, and everybody has to come together to bring that successful batch out. There are probably hundreds of procedures that have to be carried out successfully while keeping all the compliance and quality checks in place. To achieve that successful outcome, you want to have a solution that doesn't take care of just one area, but it looks at the journey of the manufacturing batch as a whole and delivers compliance and speed across the entire journey. No code just makes a lot of sense in capturing some of those processes in a platform approach rather than an application approach. It was pretty natural for us to start looking in this direction while working with some of our early users.

Harsh Thakkar  17:32 
Yeah. The way you broke it down, you have the early users or the early adopters, and then the others that are still embarking on their digitalization journey. What advice do you have for life science companies who are just learning about no code or maybe have plans of implementing some use cases? The starting point has to be something simple that they can get their feet wet and understand how it works. Do you have any use cases that companies can start adopting who are new to this no-code space?

Vivek Gera  18:07 
Yeah, absolutely. And Harsh, if you look at the life sciences technology stack, some of the mature companies are using as many as 80 applications across their enterprise, including teams like quality, manufacturing, warehouse, and engineering. So for companies that are just starting their digital journey, it can be a daunting task to even think about investing in, let's say, 80 applications. This is something that large pharmaceutical companies have done over the last five years. What I have experienced in the last couple of years is that by analyzing your critical operations from two points of view - compliance and productivity - you can break down all of your operations into four segments.

The first segment that we like to start with in any pharma enterprise is the kind of jobs that happen on a daily basis, such as logging equipment usage data, batch release, quality control, and orchestration. These jobs happen on a daily basis but do not necessarily have the highest risk of compliance. Starting here allows you to capture a high ROI from day one because you are executing high-frequency jobs that are less risky. Your operators and teams have the opportunity to start adopting technology. You can do this for a month or two and then move on to the high-frequency jobs. This time, you can pick up jobs that are more compliance-critical, such as batch or execution of sample STPs.

These are some of the things that we generally pick up in the second stage. Once you do these two stages, you can move on to the third stage, where you want to address all the compliance-critical gaps. Finally, in the fourth stage, you can digitalize the long tail of procedures, the hundreds of procedures that are left, to make everything completely paperless. We approach this problem in a scientific manner and by attacking high-frequency but simple jobs, we create a foundation for success for any pharmaceutical digitalization effort.

Harsh Thakkar  21:10
Yeah, I definitely agree with that. I have to ask you this - have you thought about whether no-code tools and automation or drag-and-drop interface tools will eventually replace traditional software development? What's your take on that?

Vivek Gera  21:29 
I was actually talking to one of my friends recently who works at a large tech company, and if you believe him, it has already happened. No-code has already taken over traditional software development methodologies. Today, specifically for industrial use cases, people are not writing software - software is writing software. So if you believe what you see around you, no-code has probably already taken over the conventional software development landscape.

Harsh Thakkar  22:07
Yeah. I can personally tell you from my experience that when I first heard about no-code, I used tools like Notion for managing my notes. Then, I started following people in this space and saw the possibilities. Not that I'm going to build something, but there are tools where you can clone something like Airbnb using no code. This wasn't possible five or six years ago, but now there are blogs and YouTube videos that tell you how to do it and which tools to use. When I start seeing those use cases and comparing the numbers with what Airbnb or other companies are pulling in, I'm like, "Wow, is this really that easy?" You know how to connect the right tools? So I really had that realization when I saw that, and the first question was, "How fast can this take out software development?" Now people are talking about things like AI and Chat GPT and how fast it can replace Google's search. I don't know, but things like that look pretty scary when you first see them. Then you learn and see how people are creative and use them to solve problems.

Vivek Gera  23:37
Yeah, no, I think that's great insight.

Harsh Thakkar  23:40
Yeah. So I want to ask you something about entrepreneurship. You've been running Leucine for over four years, and you have a lot of friends who are running tech companies or other companies. What advice do you have for any entrepreneurs who are listening to this show?

Vivek Gera  23:58 
At Leucine, some of the best performing people, Harsh, had zero experience and learned on the job. We have people who were experienced coming in from software backgrounds, product, design, and pharmaceutical operations. But in my experience, some of the most successful people at Leucine have a sense of curiosity. When you start building out your team, definitely look at adding people who are inherently curious, even if they don't have a lot of other traits. Hard work is also essential for success. You have a recipe for successful team members who will do wonders. That would be my one piece of advice for everybody.

Harsh Thakkar  25:31 
It's not easy for everyone to accept that, especially if the mindset is that you can only hire somebody who has tremendous experience in the past or has done things. But I agree with your thinking. I feel like I've discussed this with other people and people that have hired on my team who've said, "Hey, I don't have experience. I don't think I can help you." And I'm like, "No, it's fine. I can tell you how to do it. We'll learn together and figure it out." With the amount of information that's available to us, necessarily disregarding somebody just because they don't have the right experience is a missed opportunity. Because just because of the amount of information we have, it's easy to learn and implement. If you take a risk or a bet on somebody that figures it out, you reap the rewards for having them on your team as well. Yeah. So I want to ask you, I like reading books, and I always talk to people about how books help shape our thinking and the way we do things in our life, whether it's habits or business success. So I want to ask you as an entrepreneur, are there any books that you've read recently? What was a key takeaway that stuck with you when you read those books?

Vivek Gera  27:02 
Yeah, so one specific book that comes to my mind, Harsh, that has truly changed the way I have been thinking about solving problems is the classic favorite, Thinking, Fast and Slow. Now, you know, when you start consciously thinking about the way you think, that's where the magic can happen. After reading through Thinking, Fast and Slow, I have read similar books, like Predictably Irrational and maybe five to ten books on the same topic. Something that has helped me be conscious about the way I think about solving problems. So, I have probably read hundreds of books over the last three to four years. I probably read one book every week or a couple of weeks or so. But they're all from different functions and different kinds of jobs. I try not to stay focused on only one theme, just try to read whatever people around me are reading. But I truly appreciate some of the books like Thinking, Fast and Slow, which truly inspire you to think in a different and critical manner.

Harsh Thakkar  28:31 
Yeah, that's a great recommendation. So what is your preferred format for reading? We live in an age where we have eBooks, Kindles, audiobooks, and physical books. What is your preferred format for reading books?

Vivek Gera  28:50
So I would say I'm a bit old-fashioned. I use Audible to listen to my books. I don't think anybody reads books anymore. Everybody's using some kind of technology, but I haven't graduated to things like The Blinks. There are other things which I have been recommended by my friends and family, but I'm a bit old-fashioned still, and I would just listen to the entire book.

Harsh Thakkar  29:17 
Isn't Blink the one that gives you a summary of a book? I don't know, maybe I've heard of it too.

Vivek Gera  29:27 
Yeah, I think you're a bit like me, so maybe you're also reading entire books. Blinks is like a 15-20 minute summary.

Harsh Thakkar  29:38 
Yeah. I used to try to read entire books, but I stopped because it was too much pressure. If I picked up a book and didn't finish it, I felt bad because I had spent $20 on it. So, I got a library card in every place I lived, including San Francisco and now in North Carolina. Now I don't have that pressure. I just skim through 10 books and forget about them if I don't like them after a day or two. I no longer try to read books just to finish them because it felt like homework. If I liked a book, I would finish it. Otherwise, it would just sit on my bookshelf.

Vivek Gera  30:39 
And it would haunt you in your dreams.

Harsh Thakkar  30:41 
Yeah. <laugh>. Do you have any big goals for 2023 for you or for Leucine that you can share with us?

Vivek Gera  30:49 
Yeah, for 2023, we're excited to bring more data-driven capabilities to the platform. We've partnered with the life sciences industry to run pilots using early AI technologies, and we're seeing great results. Over the next quarter, we plan to productionize and make it available to our user base. We're excited to see what kind of results we can achieve for everybody. We're really looking forward to using data more and more this year.

Harsh Thakkar  31:40 
Yeah, that sounds pretty interesting. So I wish you all the best for all the goals that you have. Where can listeners find you if they want to connect with you or talk about anything that you shared with us today?

Vivek Gera  31:54
Yeah, so you can reach out to me by visiting Leucine.io L E U C I N E .io, and my email ID is Vivek.gera@leucine.io.

Harsh Thakkar  32:10
Great. Any final thoughts you want to add or any questions that you thought I would ask you but I didn't?

Vivek Gera  32:17 
Yeah, I thought you would probably ask me about the interaction that we have had to begin with, you know, how did we come to know about each other? So I think I would really like to thank you as well, Harsh. You were probably one of the first few people who I had interacted with after moving to the US. All the great advice that I have received from you in the beginning has been still helpful. So I would like to thank you for being a supporter from the early days, being a mentor, and being a good friend.

Harsh Thakkar  33:00
Yeah. Thank you so much. This show is all about getting people like you who are doing stuff in the life sciences space that are not getting the attention or many people don't know about companies like yours. We want to connect people and help them network. It's amazing to have platforms like LinkedIn that help us do that. We no longer have to fly somewhere and meet somebody in a coffee shop or restaurant. It's all about sending direct messages and getting on a call or a show like this. So, thank you so much for your time. I really enjoyed this conversation just because I'm biased to no code and learning all this stuff. I loved listening to you talk about everything you're doing. So, thank you so much for coming on the show.

Vivek Gera  34:01 
Yeah, thank you for having me, Harsh. It was a true pleasure having this chat.

Harsh Thakkar  34:05
Yep. I wish you all the best for 2023 and beyond. I'll talk to you on LinkedIn or some other way.

Vivek Gera  34:10
Yeah, same to you. And thank you so much.