Transforming Pharma Regulatory Operations with Megha Sinha

Megha Sinha: On this podcast you'll find interviews with high performing successful individuals in life sciences on a weekly basis. We cover their proven methods, principles, strategies and mindsets to implement new technologies that scale to meet the needs of people in our world.

Don Davis: Welcome to this episode of Life Science Success. For those of you who don't know me, my name is Don and I'm a digital marketer in life sciences. And so in this episode of Life Science Success, I wanted to welcome Negha Sinha. She's the founder and CEO of Comet Consulting Group. She brings 17 years of experience in uh, the pharma and life sciences and regulatory operations, quality and large scale transformation, including senior leadership at PwC, solving complex regulatory, supply chain and lifecycle management challenges. So with that, welcome, it's great to have you on.

Megha Sinha: Thank you Don. Thank you for having me on.

Don Davis: Yeah, it's great to have you here. So would you mind just telling, taking a moment and just telling the listeners just a little bit about yourself and what was it that brought you to life sciences?

Megha Sinha: Sure, absolutely. So I'm a chemical and biomedical engineer by training. Um, you know, when I was in college, my senior project really was extraction of Resiprine, which is the active ingredient in antihypertensive drugs. And that was really the formation for me into getting into, you know, healthcare and life sciences. Um, I wanted to make sure that, you know, I understand how the products go from clinical to, you know, R and D through commercial and regulatory and um, so, you know, that's really what drew me in. Um, I started actually at a small medical device company where I grew into a role where I was managing R and D, regulatory quality and manufacturing quality which essentially gave me a full broad view into um, functions or really value streams that touches the product life cycle. Um, and you know, also I remember leading my two week ah, FDA on site audit, uh, you know, first job out of the college, which, you know, which was really fun for me and you know, that gave me um, the breadth of experience. Um, after that I went into Stryker. So really, you know, learning what I learned and applying that at scale. Um, but the Chemical Engineering Foundation, I always had the itch that I wanted to do, um, work in pharma and biotech also. And that's what led me to PwC. Um, and honestly that engineering training, uh, never really left me. So when I read a regulation today, I'm looking at it as an engineering problem. I'm looking at those regulations as what are the constraints that need to be solved for what's the critical path, what's the dependency and really that's the instinct that has um, stayed with me. And I always wanted to be in um, a environment where I'm making a little bit of difference in people's life. And so I've always uh, really wanted to be in healthcare and life sciences.

Don Davis: I find it interesting that you say that your first FDA audit was exciting and interesting because I don't think I would characterize it that way. I remember the first time I was in the back room of an FDA audit. I just, I mean one of the more anxious times in my career I think.

Megha Sinha: I know, but you know, when you are a uh, 25 year old new grad, you know, sitting in the front, you're not in the back room or the war room, but in the front as the management rep, you just you know, have to uh, swim or sink. Right. And I think um, you know, that's, that's what was fun. I did not understand probably at the time, um, the responsibility that I have for the company. But it was exciting because I learned so much. I learned to negotiate, I learned to really deal with regulators very early on in my career, which I feel like a lot of people um, don't really get so early on. So that's why I call it exciting and fun.

Don Davis: And you just mentioned your PwC experience a little bit ago. Um, how has your PwC experience influenced your con, your approach to your consulting business today?

Megha Sinha: Yeah, you know, by the time I got to PwC, as I mentioned, I had already, you know, built and led functions that most consultants only advise on, um, you know, from their experience doing projects. So you know, when I did this at um, the small medical device company and then at Stryker, I really was coming in um, you know, at a different level than a typical consultant. I really came in as I said, because I wanted to expand, expand into the pharma and biotech sector and not just stained medical device. And um, what BWC gave me was access to uh, transactions that most people never see, which is $25 billion acquisitions, $63 billion, uh, merger, then multi billion dollar divestitures. And when you are inside these programs, you learn very quickly that strategy without execution is just a slide deck. Right. Um, but execution in this space also meant hands on keyboard work. Right. It means really sitting in your clients regulatory operations or labeling or quality functions, really understanding how health authorities uh, react to certain things. Uh, knowing that in some countries if your GMP certificate is um, expiring in six months, they will not accept it. And that level of operational depth um, you can't really learn if you haven't done that. And I felt like that was the edge that I had. But on the other side, you do have firms that do do the hands on keyboard work. They know all of the regulatory complexities. They have done submissions, but then they haven't done, uh, strategic programs. So I think that's what shaped Gamut for me. I really saw a gap where, uh, you know, there weren't firms that were deep in both. And because I had, you know, um, LED strategies at that deal scale and I have done hands on keyboard work, that combination is what you know, kind of brings to every engagement. Um, you know, I don't think that is a perspective that a lot of firms have. And I think that is our uh, differentiator.

Don Davis: Yeah, for sure. That depth and breadth is important. And having, I mean, I kind of look at it as I hear your description. Right. Having an incubator where you can kind of come in and out of different organizations and gain all of that experience to kind of move on is very critically important. So let's talk a little bit about your experience and how it's sort of, um, shaped you. Um, with more than 17 years in working across regulatory operations, quality and supply chain, what are some of the largest pharma organizations that you've been, um, maybe had the opportunity to interact with. But also, what were some of those most pivotal moments?

Megha Sinha: Yeah, I wouldn't be able to name names. Right. We are all bound by confidentiality. But really there are a few, um, pivotal moments that stand out in my career. And I'll probably boil it down to three. Um, you know, the first really was my first job. Right. As I said, I grew. You know, I started out in uh, kind of doing R and D, regulatory, and then moving into this role where I was, um, you know, doing R and D, I was doing regulatory, I was doing quality and manufacturing quality. I remember even, you know, gowning up and going into a clean room and you know, my line worker showing me how to build a product. I think that experience, experience, um, you know, a lot of people don't get so early on and uh, you know, in your career, um, and you know, when you're at a small company, you wear many hats and so you learn a lot of things. And I think that shaped, um, how I thought about consulting, you know, or how I really thought about uh, dealing with problems as I moved on, you know. So that I think early experience was really, um, interesting and how it shaped my perspective to come. And you know, the Second one, I would say, which I always remember is what made me think about, you know, consulting completely differently. Um, so, you know, we were. I was leading. This was probably about five years into, you know, my career. I was leading one of my first, um, big spinoffs, um, you know, of a company where the standard playbook that most consulting firms, um, will run is, and this is true till date, and this is what we are trying to make sure we can disrupt is they'll create 100 column, um, survey which then gets sent out to the local affiliates that is asking bunch of questions, um, to ensure that they can plan, uh, the strategy and the, you know, kind of operational work behind it. But what was interesting about this deal was that the company was being acquired by an industrial conglomerate. So this was their first life sciences company. There was no international regulatory infrastructure, there was no affiliates, you know, to send this survey out to. So we were the affiliates. Um, so, you know, the standard playbook that we had ran till then kind of went out the window and I had to build an entirely new approach from scratch. So what we did is we sat down, we actually, um, read regulations country by country. We sent out regulations for translation, uh, to really understand what needs to happen when you set up legal entities. You can't just operationalize those legal entities. You have to actually get establishment licenses and operating permits to let those legal entities be a medical device company or be a pharma company. Right. So the level of depth, uh, that we got, you know, really through that program was, um, immense. And I think that gained us a lot of credibility, uh, not only with our own clients, but with the parent company because we were able to interact with their regulatory teams and with their supply chain teams with confidence that, you know, a survey summary will not give you. Right. Because it really is answered, um, in a way that people understand the question. Um, so I think that was really also a pivotal point for me because it changed how I now approach those projects or projects that have similar complexity. Um, and the third one very quickly was the large $63 billion pharma merger that I did. Um, you know, the same complexity at that scale with very complex, um, you know, portfolio and, you know, that we applied. And I think because we knew how to go deep, we were able to still coordinate, even though back then we were still doing all of this, you know, in spreadsheet. And I think, you know, even today, the typical consulting playbook is to facilitate and not to know. You know, companies hire us to be expert and to work with their expert, you know, we can't just be generalists and just be facilitator and just be the people who take other people's work. And so I think, you know, all of these experience have really planted the seed for everything I've built since then.

Don Davis: And then what was it that you know, inspired you to found Kamet?

Megha Sinha: Yeah, you know, I think a lot of what I've already said, but you know, really the gap wasn't that um, you know, the companies that are out there don't have talented, you know, regulatory operations or supply chain teams. Right. All of our clients do. They're very smart people. But the gap happens when those teams, uh, are hit with a major lifetime company, ah, lifetime event while doing all of their business usual. Business as usual work. Right. So when an acquisition closes or divestiture happens, or they're doing launch planning while still um, competing with all of the changes that are happening to their marketed product, uh, they are, you know, suddenly that same team is now stretch very thin. Um, you know, typically what happens is that when they go and look for help, they find two types of firms. You know, they find the large consulting firm, uh, that can really build a program and a governance framework. But again, when it comes to execution, they haven't done that hands on keyboard work. So they can't really, you know, give you a strategy that is operationally sound. Um, and then, you know, on the other side, as I said, there are firms that have done the operational work, but they haven't done the strategy and they haven't, you know, run six functional work stream, you know, in parallel. And what I saw is that, you know, clients needed both. Uh, they deserve both from the same team. They needed the strategic perspective and the operational depth, not one or the other. And uh, because we have done this at deal scale, that's what Gamut was built for. Uh, this combination is really what allows us to sit with our regops, uh, partner and supply chain team as a real extension of them, not as strategists who can't execute our operational teams that can't strategize because we, we do see that full picture.

Don Davis: Yeah. I don't know if the supplies in this space or not, but I wanted to sort of um, tease out a little bit more detail with regards to this as well. So. So, um, as I think about the bigger firms. Right. Um, in my large corporate experience, the main thing I ran into was they walk in with their, call it a program like whatever their normal menu is M framework. Yeah, here's our, here's our Slideshow. And here's what we do. We go from here to here, and aren't we great? Because we've done this across lots of different, let's say, bigger organizations. Now all of a sudden, if I'm a smaller organization, I've got a lot of things that are variables in my space and I've got a lot of things that I'm going to need help with and probably need help in educating people on my team, but also like educating some of the regulators as well, possibly especially in today's world of AI and everything else that's coming at us. Um, you know, I, is, I, I'm envisioning a firm like Cavett, you know, being able to help with those sort of, you know, hey, I've got a dynamic situation. I don't need your standard program. I need you to come in and help with this. Um, and that's probably a, a better fit. Unless I, uh, am not reading, you know, not reading the space. Right, so, so.

Megha Sinha: No, absolutely. That's exactly what it is. And you know, you will be surprised as how even the bigger companies now, you know, need that dynamic framework. Right, because everyone is trying to enable technology within their organization. And if you just come with a standard playbook, that is typically not going to work anymore. Right. So it's also about how can we be cost effective and efficient for our own clients, you know, and we work with, uh, startups, we work with a lot of student led startups, founder led startups, all the way through to the largest pharma, biotech, medical device companies. And I think that should tell you that the need is universal. Um, we have displaced some of the bigger firms and some of the deal work that we have done in the last couple of years. And I think that is because we are bringing the depth, uh, that a lot of these firms don't bring. They're very smart people. They just never had the chance to go as deep as our practitioners have. And I think that's where we are really differentiated. And I'm excited to continue to be at the frontier of that. Um, and I kind of want to put this tidbit. Um, a lot of people ask me why the name Gamet and Gamet actually was the first summit that was climbed on the Himalayas. It wasn't the highest, it's not the highest, but it was the first. And you know, that's what I want to be. I want to be first in how we innovate for our industry.

Don Davis: Very important. But this leads me naturally to my next question as well, which is what is the mission uh, for Kamet and then what types of problems do you really solve? I mean I feel like we've kind of touched on a few of them, but also like, are there more specifics?

Megha Sinha: Yeah, so the core mission is really when we want to be partnered to the life sciences ecosystem. So your pharmaceutical, biotech, med device as well as consumer health companies. Um, when a program is complex, it's multi market, global in nature or cross functional enough that a single team um, cannot really manage on top of their day job. So that can be a deal situation that I've already described. Uh, it can be that you're doing launch planning while you're adding new countries. So you're doing a global expansion and you're doing launch planning in already existing markets, you're doing a cross functional process transformation where you need to again understand those functional depths that need to come in. So those are the types of programs um, that we really excel in, um, where we have to really know the functions, we have to really know the requirements, we have to really know how the workflow or the value stream, um, flows. And as I said, what we do um, is we really want to work together. And together to me is the most critical word because nothing gets accomplished if you're coming in just as advisor, really handing in deliverables. So we embed ourselves in clients, regulatory operations or supply chain or quality or PMO teams, you know, where we can truly work together with them. Because sometimes you know, we will get the program started, we'll get it operational and then you know, we leave. Right. So we need to make sure that the clients, teams are coming along with us so that the program is successful in the end.

Don Davis: Let's talk a little bit about the global nature of some of the work that you do as well. Um, so in terms of the regulators that you work with or programs that you've worked on, I would imagine that you have to deal with lots of different regulatory agencies around the world. Just really curious here to kind of provide some um, again, um, some level of clarity for anybody that might be listening to this later.

Megha Sinha: Yeah, so uh, we have really worked as I said, or with over 80 plus countries at this point. Um, we're not going to do. Because a lot of um, uh, countries require local language submission. We're not going to write submissions in every language. But we can create core uh, dossier for you. Um, I know there's a lot of specialized firms that do that, but things that really make us different, um, from a programmatic Standpoint is um, first of all, we don't really separate strategy from execution. So um, you have to make sure your strategic plan is execution ready. Whatever sector or whatever part of the UM function you're doing, whatever part of the program it is in, whether you're doing large, uh, scale, um, process transformation or you're doing a merger and acquisition, or you're doing, you know, lifecycle change management, you have to make sure the strategy that you said can actually be executed. And I think that's where we're different because, um, you know, again, when we do these uh, you know, lifecycle change management programs or M and A programs, we don't leave at, hey, you know, you need to go and file variations in these, you know, 10 markets. We actually sit down with our clients and we say what type of variation? You know, in EU, is it a type 1A or type 2? Because that distinction really matters. Um, or do you also have, you know, other changes that are ongoing where we can bundle those changes? Uh, does these country actually allow you to bundle the changes or not? Um, you know, we also build um, kind of the submission sequencing, right. Very deliberately. Um, because as you probably know and our listeners that you know, pharma as well as medical device, you have to have a major market, or what is called a reference market approval in order for you to then cascade that to other countries. And if you don't really understand the requirements of, hey, Brazil actually needs you to submit a CPP that is legalized, which is going to take additional 90 days. Or uh, I actually need this corporate document from, you know, my legal team and it's going to take me, you know, 120 days to get that. Then if you create a plan which is in absence of those dependencies and in absence of those constraints, those programs, those strategic programs are, you know, not executable. And I think that's where we're different, where we are bringing that depth which is needed in strategy. Um, you know, I'll kind of give an anecdote. Um, I was at my previous firm and one of the um, early career consultant came to me and said, I want to be a strategy consultant. And I told him, how would you be a strategy consultant if you don't understand the operational aspects that CEOs and CFOs and all of these senior leaders care about? And I think that's what I've learned in my career is both sides are equally important and one doesn't exist without the other.

Don Davis: I think it's a really critical point because There are a lot of, in my experience, again with a lot of different consulting firms or a lot of, a lot of companies that uh, will drop off like, hey, here's the perfectly shaped plan and that's fine. But we all know whenever it comes down to execution, normally the path isn't a linear path. We're going to go through this never crooked line of getting to the end goal and it's going to be a, uh, you know, it's going to be something that we have to figure out along the way. How do we, how do we appropriately not only navigate it, but how do we navigate around the challenges we find too?

Megha Sinha: Yeah, you have to have a plan B and a plan C and a plan D. Right. You, you never, it will never work that your first plan is perfect. You obviously try to do it perfectly right. But I think this is where what you want to achieve, what's the um, and outcome is so critical and we are very transparent with our clients saying you probably won't be able to achieve everything. Um, you probably won't be able to make a cultural shift in your organization. At the same time you're doing this process transformation at the same time rolling out a new technology. You probably need to do that in a stepwise fashion. We will try to do it, but I think it's very difficult to um, be able to achieve. And so this is why, you know, you need a plan B and a plan C and a plan D to achieve what is the actual final outcome you want and then what are nice to haves, you know, along the way, you know, kind of cherry on top. So yeah, it's absolutely important to have those, um, you know, in your back pocket.

Don Davis: Yeah. So you've, you've mentioned large scale transformation. Transformation a few different times and I know that that can mean a few different, um, things as well. Um, can you give us a sense of what that looks like in practice whenever you engage with a pharmaceutical company and um, talk through the initial assessment, through the execution?

Megha Sinha: Yeah, absolutely. I'll give you a real example of a client that we are working with. Um, currently. Um, it's a $14 billion global spinoff. It's a major company carving out kind of their entire business into its own standalone, um, entity. And the programs like this are multiyear. Right. They're not. You, you can't just get them done. Right. So the, we typically kind of break them up into two phases. Right. So phase one is take control. Right. That's what I always tell my clients, uh, in these situations, especially spinoffs is you have to set up, you know, your legal entity structure, right? You have to make sure you can take control of all of the registrations, all of the logistics, uh, that exist out there. Your distribution centers, your quality agreements. Uh, what does that mean? How are you going to set that up? As I said early on, um, what operating permits do you need to actually, um, get these legal entities operating as a pharma or med device company. Um, and so set that up, take control. Because, you know, the first thing people want is brand change. You know, people want to get their new brand out there. You know, we're this, we're that, we want to get, you know, our brand out there. And you know that sometimes have to come later because you have to first own, you know, the products that you just divested. Right? Uh, so that takes about, you know, uh, anywhere from, um, you know, 12 to 18 months to just complete that phase one, right? So that's, you know, you do the assessment, you know, and uh, you do the plan and then you execute. Right? And, and then the next phase is really about everything else. Right? So, okay, now I need to change the name of these entities because, you know, sometimes you have a placeholder names. I now need to rebrand, I need to change, you know, who my product, uh, owner is or legal manufacturers on the medical device side. Right? So that's, that's another phase. And so if you think about just what I said, it's not just, oh, you are one and done, you're just changing legal entity or you're just changing legal manufacturer. Typically there are multitude of changes that are happening together, right? So you have to figure out the most efficient plan and strategy. Can you bundle them? If you can't bundle them, what are you going to do? Do you submit a new registry, new marketing application or new regist application? Um, so we have to, the way we start is we sit down with, um, the client's regulatory and supply chain and the PMO leadership to really map out the full impact together. Not just what is needed, what are the changes? A lot of times, uh, with this company we got brought in a little bit later, Phase one was already underway and they had identified some of the changes. And we said, no, you actually have more changes. Uh, and we showed them that they had actually missed, uh, seven other changes that would have happened over the course of the deal life cycle. And to me it really is um, like an orchestra. So you have to forward plan and then you have to backward plan and then you have to forward plan again till you get that perfect symphony. Um, and when I say large scale transformation, it doesn't just end there. It doesn't end. Oh, now you have a plan. We will stay through execution, making sure that the plan gets updated, um, on a regular basis because regulations change. Um, you may have planned to do submission at a point that um, went in late or went in early, which then will cascade into other things. Um, and that's what to me. And that takes about uh, 18 to 24 months. So that to me is what uh, large scale transformation looks like, really getting um, into the depth of the planning and the strategy and the execution and making sure that uh, the last product is moved into your normal logistics and supply chain process. And this is just one example. Obviously there are similar examples on the process transformation side or the organizational excellence side where you need to understand, you know, each element and each pillar keenly to really put that full puzzle together.

Don Davis: Yeah. Just to recognize as well. So, um, we have uh, Daniel Lozano with us. He said he completely agrees with you. And pharma, medical device transactions regulatory isn't a downstream work stream. It's a gathering function. So, um, there's much more to the comment that I'm sure you'll see on LinkedIn whenever you're there. But, uh, just wanted to just recognize. Daniel, thanks for believing the comment. I appreciate that. So, um, also in terms of um, your being a founder. Right. So you're a founder, you've got, um, this very specialized consulting firm as well. How is it that you think about building and scaling a team that can do all of this specialized work in the world's largest pharma companies?

Megha Sinha: Yeah, I think, uh, the work that we do, as I said, is very complex. Right. So it really starts with hiring the people who have actually done the work and not managed it from a distance. Right. So, um, really the talent pool for what we do is small. So we really, I'm very deliberate about who we bring into the team. We have a mix of people who, uh, were industry, um, and we hired them and then other big four firms that wanted to really go deep in one sector. And so I think that's kind of what we're hiring. And then really people who have the ability to, uh, as I said, read a technical guidance or a regulatory guidance and dissect it to build a strategy. So I think that combination is rare. So I think that's the piece of, um, the second part of how we scale is technology. And I think traditional consulting, uh, firms are not using it the way it really can Be and um, they typically scale by adding headcount. And I know there is buzz in the industry about more and more firms using AI, but um, it really is about how do you use AI? It's not just about using AI. And I think what I'm focused on is really using technology to encode the experience that we have had over these years and the operational knowledge that lives in our practitioners and consultants head or in spreadsheets so that a team of five can cover the ground that a team of 15 used to three years ago. And I think, um, this doesn't just help us with scale, but it makes us more effective and efficient for our clients. Um, and this is where we truly believe in, uh, delivering outcomes and then focusing our teams, uh, on um, really tasks that actually require human expertise. So technology handles the knowledge and our people handle the decision. So I think that's kind of how I'm thinking about it.

Don Davis: I do think it's interesting. Right. Because finding those people that can not only look at things tactically. Right. Because, uh, in my view, oftentimes the regulations are just a very tactical sort of document. If you read it word for word, it tells you exactly what the regulators are looking for. It's not like there's some mystery that's out there, that's not the intent of the regulation. But then also you have to have people that could say, okay, so that's what it said. Now this is how, not only how I apply it or how it impacts the larger organization or even the thing that I'm having to manage through. So, I mean, I could see how, how you're in reality, you're looking for a needle in the haystack. But also, um, there are a fair amount of needles that are out there, I think as well.

Megha Sinha: Yeah. Especially, especially in our industry. You know, I think we have, I truly believe we have one of the smartest talent pool, you know, in healthcare and life sciences. And I think it's, it's really about giving those people the right opportunity, uh, to be able to solve bigger problems. You know, I think that's uh, what we strive to do for, for our, you know, team. I'm sure when, if you talk to my team ever, they'll tell you, yes, she just throws us, you know, into the deep end and you know, they all swim. So, uh, you know, I'm hopefully doing a good job hiring the right people.

Don Davis: Yeah. And then I mean, you mentioned on tech on the technology side as well. Right. I think there's no greater time, um, than for anybody to use technology to try and optimize not only your workforce, but also like the responses that people can give and making sure that you're fed all the right information at the right time. And certainly with vector databases and AI and uh, you know, all of the technology that's out there, there's, you know, a great wealth of capability that's there.

Megha Sinha: Absolutely, completely agree. And I think especially with what technologies available to us today, you know, all of the frontier AI models are really out there. Um, you know, and we can really take operational work from 0 to 100 in matter of, you know, months, like solutions that would take us years to build, you know, now are at our fingertips. And yeah, it's very exciting, uh, you know, what technology can really help us achieve today.

Don Davis: Yeah, absolutely. So I have a few, few more questions about you before we wrap up here. So the first one is, what's the greatest piece of leadership advice that you've ever received and how has it influenced the way that you lead? Kamen?

Megha Sinha: Yeah, someone told me very early on in my career is don't confuse being busy with being effective. Um, and it sounds simple, but in consulting especially, there is a constant pressure to show activity and uh, you know, more meetings and more, uh, you know, status report. But at Gammon, you know, that's how, uh, we actually scope our engagements. You know, we don't sell hours, we actually sell outcomes. And if we can solve a client's problem in half the time with better solutions and sharper focus, that is a win, win situation for both us and the clients. And you know, that's, that's really shaped how I think about, you know, how we scope the engagements here.

Don Davis: So important. What inspires you?

Megha Sinha: I think it's the complexity itself, honestly. And I think this comes from the company being an engineer, um, and really the people managing it. I work with regulatory, uh, operational leaders who are tracking 200 submissions across 30 countries while onboarding a new site with their marketing authorizations. I work with manufacturing operation leaders that are managing different flavors of the same product, that are shipping to different countries while implementing multiple changes. That is highly complex operational work, um, to get the products to our patient. And they're doing it with, uh, really basic tools or spreadsheets and institutional knowledge and human glue. And to me that is resilience. And, um, their resilience and their expertise is genuinely inspiring. Um, and what really keeps me going is when I work with these leaders where we have solved a problem together that has, uh, solved our market blackout or continued the supply to patient and I think that is why this work is so critical and it really inspires me to keep going.

Don Davis: Absolutely. What concerns you?

Megha Sinha: I really think the growing gap between the pace of change and the tools that uh, we have available today to manage it. Uh, companies, I mean I'm sure you're seeing in the news, right, there's been how many acquisitions so far this year since the beginning, uh, so more M and A, more site transfers, more supplier switches. And um, the regulatory and supply chain leaders are really running these programs. Uh, they're incredibly capable, but they're running it on the infrastructure that hasn't evolved in 20 plus years. And that expertise really live in people's minds. Um, and spreadsheets still.

Don Davis: Um,

Megha Sinha: uh, that really concerns me because the consequences aren't abstract. If you look at the drug shortages that we track, it hit a all time high of 323 drugs in early 2024 for the US and even though these new shortages has been declining, there's still over 200 active shortages in the US and supply chain remains structurally, uh, fragile. Um, so when coordination breaks because the system really wasn't built to handle the volume and complexity of change, uh, patients are the ones who pay the price. Right. And we are all in this for the patients, um, and the people who are doing the work, uh, who know this and they really deserve better infrastructure. And I think that's what concerns me, um, right now.

Don Davis: Yeah, it's kind of funny because I mean some of my um, current active clients include um, I would say mid to larger size pharmaceutical companies and, and um, in my interactions it's kind of funny to watch the transformation from an AI standpoint come along and still, I mean they have further to go. Um, you know, we constantly are talking about, you know, tools that I use on the outside that, you know, I think they would benefit from. But at the same time, you know, we, I understand, like the reservation as well, let me put it that way. I, um, I appreciate the fact that maybe from a regulatory standpoint that there might be um, reluctance. But at the same time if we were to face the next global pandemic, um, tomorrow, and I think AI could honestly probably help and we probably would see somebody come along and go, hey, look, I use this and I got this and this is potential answer for whatever the thing might be. And I do think there's an opportunity to sort of continue. Even though you want to be conservative and understand that patients could, you know, feel uh, the impacts if we get this wrong, but on the other side there's Lots of things in every pharmaceutical company that I would say don't really touch a patient. So like let's uh, de risk all of those and like, let's move forward as quickly as we can. But then also like, let's take all of the other things that you know are higher risk and like build, build consideration programs for them and go, go measure that risk for yourself.

Megha Sinha: Yeah. And I think, you know, to build upon what you just said, Don, you know, that's really what is exciting to me. You know, as we look to the next, you know, three to five years, right. For the first time, I really think that we have the technology to actually encode, you know, the operational expertise that I've been talking about that's being trapped in spreadsheets and people's heads for decades. So not just automate, uh, document generation or track submission. I think that's table stakes, as you said. Um, and I want to be precise about the distinction here because it really matters. Most of what the industry calls digital transformation really is workflow automation. So moving tasks through a sequence, sending notifications are generating documents and that is not intelligence. And I think there is a fundamental difference. Um, what I'm talking about and what truly excites me is building truly intelligent systems, uh, that actually know what's required in each country for each change type or each new registration, and can reason through dependency or implementation requirements or submission sequencing the way we would as the regulatory operational leaders. And to me that's the leap and that is the art of the possible. Um, and it is possible today because of the frontier AI models that are being released by these companies. Um, and we can build systems that think through regulatory strategy and not just execute predefined steps. Um, and what excites me is in the future, a regulatory operation leader managing one of these programs already knowing that these are the requirements in Brazil and these requirements are shared between Brazil and Colombia, and those get shared or surfaced before they even start their planning. And that is the intelligence applied. Um, and that's the frontier I'm most excited about and I feel like we are closer to it than most people in the industry realize.

Don Davis: I think that's, I think that's an extremely exciting time because I kind of think about the fact that. Let's just talk about the program that you talked about in your company example, whenever you were talking about what you guys do from a large scale transformation standpoint. Imagine the world where you could walk in the door tomorrow and assess all of those risks and be able to point to all seven additional findings in a matter of seconds, versus spending a month, two months, or, you know, even longer trying to figure out where are the gaps so that we can make sure that we're protecting our clients. It seems to me like, uh, absolutely. Like, it's just like our cars today, whenever they beep, whenever we change, try and change lanes, um, with a car next to us. I mean, yes, part of that is table stakes, but also, thank goodness those sounds are there sometimes, because I know I've used. I've counted on that, that fact of having that traffic collision avoidance here and there.

Megha Sinha: So, yeah, oh, absolutely. It's almost like your execution partner or your strategist, uh, basically that is sitting with you. That's why Microsoft called it a copilot. Right. It truly is your copilot. And I think those are the solutions that we should be striving towards. Um, and I'm super excited about what WLC coming out in the next, you know, few months to the next year.

Don Davis: Well, Megan, thank you so much for being on the Life Science Success podcast.

Megha Sinha: Thank you.

Don Davis: I greatly appreciated you being here. And, um, it was exciting to get to talk to somebody in this space that, uh, you know, has all the experience that you have. And I greatly appreciate your sharing, uh, your story with us. So thanks a lot.

Megha Sinha: Yeah. Um, and thank you so much for having me, Don. And congratulations again for being, you know, one of the top podcasts for our industry.

Don Davis: Yeah, thanks a lot. Thank you for listening to Life Science Success. For complete details about this podcast, including show notes, how to get in touch with guests, and more episodes, please visit www.lifesciencesuccess.com. if there's someone you'd like for us to invite to the show as a guest, please let me know by sending me a message at the podcast website. Please click subscribe on your favorite podcast app, share the podcast or tell a friend about it. And last but not least, rate the podcast. Thank you again.