Lab Ops_Mandar Shah: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Samantha Black:
By building a platform to share challenges, network, and thoughts from leaders, the LabOps Leadership Podcast is elevating LabOps professionals as well as the industry as a whole. With the intent of unlocking the power of LabOps, we deliver unique insights to execute the mission at hand, standardize the practice of LabOps, their development, and training. Welcome to the LabOps Leadership Podcast.
Samantha Black:
Hi, I’m Samantha Black. I’m here at the LabOps Leadership Podcast today with Mandar Shah, who is the vice president of R&D at Odin Pharma. Thanks for joining us today.
Mandar Shah:
A pleasure to be here. Thank you, Samantha.
Samantha Black:
Awesome, so let’s jump right in. Can you just tell us a little bit about who you are and how you got to be at Odin Pharma today?
Mandar Shah:
Sure, I got my Ph.D. in ’91. My first job was with Bristol-Myers Squibb and then I was in the development of New Chemical Entity, what is known as NCE. So at that time, I developed two molecules. Sotalol for arrhythmia and Etopiside … for cancer. Anyway, moving on, then I went to Alcon and developed several surgical products at Alcon for cataract surgeries. Then I was with Pfizer, Johnson & Johnson, and there I was in the consumer division of those two companies. In 2012, I was laid off from Johnson & Johnson, and in India somebody offered me a job at the BP level at a generic company and that is how I ended up in the generic business. So I have seen it all from new drug development to surgical, to consumer, to generic business, and here I am in a generic company.
Samantha Black:
Awesome, so can you tell us a little bit more about Odin Pharma and what you guys are doing there?
Mandar Shah:
Sure, we develop sterile products, mostly ophthalmic solutions and injectable products. So those are the sterile products that we developed and marketed. That is the total generic business. We don’t innovate or do anything different in those products. However, in the last couple of years, we have reverted to the idea of evergreening of the patents. So what that means is that you take an existing drug and you improve some portion, some aspect of it. For example, if you have a drug product, which is to be dosed three times in a day, the eye drops, there are some antibiotics and some glaucoma drops that we do three times in a day, then you decrease the frequency of dosing like once in a day. So that will improve the patient compliance and we can get a new patent on it or a new formulation of that same molecule, and so it’s a win-win situation for the patient as well as for the company. And so then there are lyophilized products, we change them in … to use. So you don’t have to mix it up with the WFI before you inject, so it is ready to use. So those are the kinds of innovation that we have started and there are many examples that you can look at the company’s website and the patents of the company and you will be able to see many such examples where we are going. Well, everything cannot be discussed over here as some of it is confidential, but the patent is public knowledge.
Samantha Black:
Yeah, no, that’s awesome, and it sounds like innovation is really key for you guys. And, you know, making stepwise improvements is really important to you. So I imagine that you’re doing a lot of this research in the lab. And so I know that you’re kind of at the strategic level at the higher up stage, but lab operations or LabOps is obviously very important to your business to develop these products and these improvements and produce these improvements that you’re working on. So I’m kind of wondering how you view LabOps and maybe how you would define laboratory operations within Odin Pharma.
Mandar Shah:
Lab is absolutely the most critical piece of the entire thing. If the lab generates negative data, especially for the innovation, that’s the end of that strategic idea, and if that data is wrong data and somebody generated wrong data, that will terminate one project and therefore the integrity of the lab data is of the highest importance. And I don’t know how much I can stress on it more, but that is very, very critical.
Samantha Black:
Awesome, and so what kind of interactions do you have with the team, the LabOps team, like do you interact with like a lab director or a lab manager or how, give a little insight into like what your structure is for your research and development team.
Mandar Shah:
Sure, so, look, I’m going to say that I generate an idea, but it is not just my singular effort, it is a group effort, but once we have the idea, we have a formulation that is developed and we evaluate the physical aspects of the formulation together. I see that you can see if something is … Something that’s turning black, yellow, color change, all those things, you can see that. But having none of these, if the formulation has none of this, and then we put it on stability, then that is a person in charge of the analytical group who will determine the stability of it. Once all that thing is cleared, then if required, we send it to different tissue culture lab for the tissue culture evaluation. All that works, eventually, we scale it up. We have a manufacturing plant in India and we scale it up. Once it is scaled up, it’s sterile product and we evaluate the stability again in different settings, in a manufactured, scaled-up product. Then those are sent for, those samples are sent for human clinical evaluation, and eventually, it gets to be filed with the FDA. In between, sometimes we talk with the FDA, so it’s a long, drawn-out process. But the lab evaluation is the first starting piece to this whole gamut of things that we do, and if somebody goofs up there, that’s the end of it. So that is why the lab piece is probably the most critical of all.
Samantha Black:
Yeah, absolutely. And I would imagine seeing as you’re in manufacturing, supply chain has been challenging in some way, shape, or form for you over the last couple of years. And so are those lab teams, like they’re the ones sourcing all the materials to do the research, so have you had any struggles with that over like the COVID era or, you know, how have those team members really helped to play an important role in making sure the business can still get the work done?
Mandar Shah:
That is a very good question. We had, even before COVID, we had a lot of supply chain issues. Once we order, once you want some particular drug, it will not arrive in time, sometimes the cost is high, sometimes the quality is not right, a lot of issues are there. Then our CEO made one very good executive decision, …, that he said that, let us take one lab person, a very efficient lab person, and transfer her to the sourcing or purchasing so she understands what the lab is looking for. So once she got transferred to the purchasing or sourcing, a lot of issues went away because up till now what was happening is that this person used to talk to different companies, we talked to that person and a lot of things were getting lost in the communication. And now that this lady, whom we have hired in this position, she knows exactly what she is doing. And regarding the actual transport of the material, we have been fortunate that we have not been hit so badly because medical drugs are high in cost, so we can afford to transport them through plane by airlifting it, it doesn’t come by sea. So we do not have that big an issue. But whatever the other issue that the world faced, we faced. There is nothing unique about that.
Samantha Black:
Yeah, no, I think that brings up an important point that we’ve heard in the LabOps community is that context is so important, and having that expertise in the science arena can be so important for achieving business objectives. You know, somebody in purchasing and procurement, they just know about purchasing and sourcing equipment and supplies, they might not have that expertise or knowledge in the scientific realm. So it’s really like partnering those two expertises together that really makes them really important and special and great at their jobs. So that’s something we’ve heard before. And I do think it’s interesting that it’s an interesting case study in exactly bringing those two areas together to really make a process efficient and really help the organization, so that’s awesome. I do want to ask, what do you think the role of technology is in helping these team members to support the business? You know, all of this wouldn’t be possible without technology and information. So kind of like what do you see for the future of LabOps and how technology plays a part in that going forward?
Mandar Shah:
Technology is absolutely critical piece in the LabOps thing. The reason why it is so important is because it brings the cost down. For example, if I had to submit a sample to an analytical group to analyze, and if I had to fill up a manual form each time, which I used to do a few decades ago, that will take me 10 minutes, 5, depending upon how complex it is, 5 to 10 minutes, versus if I had to do it online, and it automatically pulls up a lot of information. So that can be done in 2 minutes, so that is time-saving. Plus it is recorded information, electronically, so when they see that, they can put the numbers electronically. So all this is verifiable information, and tomorrow, if the FDA wants to view it, if anybody has made changes, corrections, to it, that also can be also noted. And these days, FDA is laying a lot of importance on the lab integrity piece, and it requires all this documentation to be electronic so that they can to see changes that are done to it. So that technology helps us in reducing the cost, saves the time, and will also make sure that it is verifiable so it will ensure the integrity of the data.
Samantha Black:
Yeah, no, that’s awesome. I think that it’s interesting that the FDA, I wonder what the next step for, that the FDA is going to require because I remember just a few short years ago, they didn’t, they did everything on paper. And so I wonder what the next step that they’re going to ask for in terms of digital information. Yeah, so anyway, that’s just a thought, food for thought. Next question I wanted to kind of bring up was LabOps is obviously essential for your business and for a lot of other businesses out there, so I’m kind of wondering how you would define like excellence in LabOps? Like if you had to describe a perfect scenario where everything went right in the lab and managing the day-to-day, what would that look like for you and your team?
Mandar Shah:
Okay, I just want to clarify, when you say lab, I believe you are talking about an analytical lab, right? Because there are, there is another lab that is the formulation development lab. And so I’m going to answer, I’m assuming that it is analytical that you’re talking and I’ll accordingly answer.
Samantha Black:
Yeah, it could be. Yeah, it could be for either. I think they’re in both but yeah. Go, go for it.
Mandar Shah:
The formulation lab is difficult to define what would be the perfect day because it varies day to day and you don’t know whether you would develop something good or not until you analyze it properly and it is successfully analyzed and successfully scaled up and all that thing. So it’s a long way to know whether it is good or bad. But analytical thing, the technology is removing the guesswork out of the day-to-day operations. Today, the HPLC instruments, today, the different kinds of software are so good that if you are deviating outside your limit, if something is not right, the instrument tells you that you have goofed up. So gone are the days where people were making big mistakes and it used to go unnoticed. Today you cannot do that even if you want to do it. It is difficult, it is difficult. You will require a lot of planning to mess it up.
Samantha Black:
Well, yeah, but you’re relying on technology and so is technology always 100% right too, you know, take out the human element completely?
Mandar Shah:
No, no, no, no, no. I’m not saying you take it out completely. You supplement it. Basically, you know how, let’s take in, for instance, car driving. You don’t have a completely autonomous drive car where you just look at the rearview window and the car goes in the front. No, you also are looking in the front and you are also doing it. You are relying on somebody in the blind spot, somebody whether you are going in the right direction. So you are relying on technology to help you navigate different aspects of it, not the full. Similarly, we don’t have the robots in the lab who will do everything, the analysis. So there is a human element to it, but I don’t have enough time to go through different pieces, but there are so many different pieces of corrections and checking and counter checking we have placed in place so that we generate good quality data.
Samantha Black:
Yeah, no, I like that analogy. You know, I think it really is fitting for lab operations and kind of the day-to-day operation of equipment, and the running of the lab. I think that’s a really good analogy and it kind of leads into my last question that I want to close with. And I was just wondering if you could maybe share a story with us or a short anecdote of a time when the LabOps teams, like people in the lab, really helped to make something better for you or really improved efficiency or made a notable kind of impact on your life and your, the business goals.
Mandar Shah:
I’ll give you one example, but I cannot name the drug or anything like that. The person who is leading the, I was so delighted by this because it happened only two days ago, and the person who has been leading our analytical effort does it mechanically. He doesn’t, he develops a radical method mechanically, he does everything mechanically. Every time in the last few years I have a new idea, a new formulation, and use something new. I would tell him, okay, this is what we are going to do. He cared less. He says, you gave me the stuff, I analyze it. He didn’t say that on my phone, on my face, but that’s what I can tell. But I still go through my route of explaining, what am I doing? Why am I doing it? I was so delighted, two years ago this Monday. I was telling him, you know what, we’ll have to drop this project, it’s not going to work. So he’s, he came up with a string of ideas. Can we do this? Can we do this? Can we do this? I was stunned. I said, look, in the last four years that I’ve been working with you, you never gave me a single idea, you never participated in any discussion, and here I’m trying to drop a project, and you are coming up with these ideas. And I said, you gave me so much material to take, now I’ll have to think through, I’ll do some literature search and I’ll get back with you, and if it really works, I’ll put your name on the patent. If it really works, I’ll put your name first, and if I can justify my name, I’ll put mine second, if it is that good. So that just goes to say the importance of lab operations people, and my only advice to them is that please don’t be mechanical. Start to think, please think what you are doing, why you are doing? How can you innovate? How can you make it better? That is my only advice to you guys, and what that will do is that it will remove the monotonous nature of the job.
Samantha Black:
No, that’s awesome. I mean, they have really good ideas and they have a different perspective. So anybody with a different perspective can be potentially helpful to the group. So I love that example. Thanks for sharing.
Mandar Shah:
You’re welcome.
Samantha Black:
Yeah. Awesome. Well, Mandar, that’s all I have. Thank you so much for joining us. We really appreciate it.
Mandar Shah:
Thank you, Samantha, and I really appreciate you talking. Thank you.
Samantha Black:
Thank you for tuning in to this episode of the LabOps Leadership Podcast. We hope you enjoyed today’s guest. For show notes, resources, and more information about LabOps Unite, please visit us at LabOps.Community/Podcast. This show is powered by Elemental Machines.
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