How Pharma Launches Products | Divya Yerraguntla, MMath, MBA

Speech to text: 

Mike Koelzer, Host: [00:00:00] Give yet for those who haven't come across you. Introduce yourself and tell our listeners what we're talking about today. 

Divya Yerraguntla, MMath, MBA: My name is Divya Yerraguntla. Um, I've been in the pharmaceutical industry for more than 20 years. Um, pharma is not just my passion, but it's also something I care very deeply about.

I've had multiple family members go through different states of diseases and I feel this is the one way we can really contribute. I have more expertise on commercialization of products. I got the opportunity to launch 32 products across, uh, leaven markets, nine therapeutic areas, which has been a great journey.

You 

Mike Koelzer, Host: have launched a ton of products. And from what I've read of you, there's maybe three larger ones that you have done. Would that be fair to say, even though you've said what you've been involved in 30 some product launches. Why do you focus on those three? Are those the ones that have made it? Or why do those get the attention in your LinkedIn profile?

Those three? 

Divya Yerraguntla, MMath, MBA: Because they made more than a billion dollars in sales. 

Mike Koelzer, Host: Oh, it's a profit game, huh? So those are the big ones 

Divya Yerraguntla, MMath, MBA: I have to make one thing very clear when you are part of a law. Every product is your baby. So if you had to ask me, you know, where these three, the most important know where these, the three products that taught me the most?

No. You know, every launch DTC does something , no matter how big or small. So the only reason they're highlighted out debt is because for the world, they mean 

Mike Koelzer, Host: something. When you had the chance to launch. Should these have been the three big ones or were there any surprises or were there any that didn't go that maybe should have been four big ones or were these three, the ones that.

We're going to be the 

Divya Yerraguntla, MMath, MBA: focus. So there were supposed to be five big ones. If I have to count three, make it big. Did not tell anybody. No, I'm not going to name names so nobody should feel bad, but no, but there were two that did not do as well as expected. And that's pretty normal because in the pharmaceutical industry, I think we compete.

To an extent that no other industry sometimes has to, especially in some of the therapeutic areas, there are so many companies investing. There are so many innovative products coming, you expect a product to do well, but then right before you launch, there might be a competitor that has launched another product, which is like, you know, really, really good, but really awesome data.

Then you may not reach your forecast that you had anticipated. It happens. But most of the time they're pretty accurate because they know what the market you're launching into, what to expect, how many patients will we be able to help? So those numbers are pretty right, but there definitely are sometimes misses, but at some times, not just in your hands, it's all the external factors playing into how your product 

Mike Koelzer, Host: does.

It was fascinating watching the launch of sir Richard Branson's spaceship. Yes. He's in the race with Elon Musk and then Bayzos got a little bit perturbed, you know, and he chimed in and said, well, you're not really going to space. You're going to sub space and that kind of stuff. But I told one of my kids this yesterday, it's like, that's how inventions have been all through time where it's not like Edison.

All of a sudden I just invented a light bulb out of the blue. The state of the economy was such that light bulbs were kind of being worked on by three or four different kinds of companies, you know, and same with, well, across time. Uh, same with flight and same with all kinds of things. I mean, rarely has there just been recently in the last a hundred years, just an invention that kind of came up on its own.

Everybody kind of had common knowledge and then kind of. All of a sudden there's like two or three people competing against each other. So when you talk about those drugs that you were bringing up, I imagine that's going on too, right? It's not like all of a sudden a drug gets released that no one's thought of using it before for a cure.

There's probably a couple or a few companies, at least working on similar things. And what happens when a competitor comes out? Maybe at the same time? 

Divya Yerraguntla, MMath, MBA: Yeah, and that's absolutely true. Um, you know, there are multiple companies trying to break through, right? The barriers and usually companies invest and it is a lot of investment.

They usually invest in areas where there is unmet need. You know, they, you feel. The patients don't have all the great options that they could have. And you have something that you could provide as an option that's when you invest that kind of money. So definitely there are multiple companies working at any given time in any therapeutic area to cure a certain disease.

So that's a given, sometimes what happens is based on the data, you [00:05:00] might get expedited approval. So you were expecting somebody to launch a year after you've worked. You could get delayed. That happens all the time. You may get a complete response letter, which in layman's terms is instead of getting approval from FDA, they're telling you, no, you can't launch.

You have to wait 2, 3, 4 years with some restrictions. You know, you either have to do a post-marketing study or you have to do pre-marketing study or cardiovascular study. It can be any number of reasons why they would ask you not to launch and give you a complete response letter. So you might get delayed on the flip side.

Somebody else might have great. And get an expedited approval. So instead of launching a year later, suddenly now they're in a position to file now and launch earlier than the anticipated launch date. So it works both ways. You know, many factors play into why two separate launches had some lag.

Now suddenly I'm either overlapping or somebody actually went ahead and. 

Mike Koelzer, Host: Are those ever surprises to you? I don't mean the surprise that someone else got to go quicker, but are these surprises that, oh, this company's working on this. I didn't know that. Or does the FDA like to make those signs public? And so, you know, kind of where you are in the launch sequence, it's not secret.

Divya Yerraguntla, MMath, MBA: FDA is a black hole. You don't know what's happening there. You don't know? No. But then each company has a team called a competitive intelligence team. These guys are awesome. They're like detectives, right? 

Mike Koelzer, Host: You have spies for the other companies. 

Divya Yerraguntla, MMath, MBA: No, no, it's not Spire. It's all public data. You know, you have publications coming out on people's clinicals trials.

You can go to the FDA clinical trials.gov site. You can see who's running what trials and what disease state. So that's not a secret. Got it. But then these people kind of go out and see what kind of data is coming out based on that you can make some assumptions. Okay. Data is great. They might get approval sooner.

Or, you know, um, if they actually start saying, you know, they're looking for positions out there, they're trying to hire, then, you know, there's some action happening. So they have some information that clearly you don't, and you may never have, but it's all these little fillers. Um, CIT themes actually help us a lot in determining what else is happening in the landscape.

And a lot of times you, when you start planning for a product, that's what you do. Um, a lot of market research teams help you market analytics teams. They come in and they give you a situation analysis. Which is, um, one word for a huge document, their work hours on it. What does it do to you? What's the landscape? How many more companies are working on products in this area?

What they think is the timelines for them. So they give you a view of what's coming in, so you can see. Marketplace, you're going to launch into what it is that you will have to face and you'll of course, do scenario planning, any good launch team does scenario planning. So you plan for it to say, okay, if this happens Plan A if this happens, plan B And I'll tell you from experience, there are a couple of products where we had to go to plan F and H.

I'm like, I'm just glad it never got to plan Z, but there are scenarios when things just keep happening. And I think that's the most exciting part of working on a launch. Like you ask anybody who's ever launched a product, the adrenaline rush. When you see things happening on the fly, things not working and how you come up with innovative solutions and you get to work extremely.

Intelligent smart teams because they are the ones thinking on their feet. It's it's, it's fun. 

Mike Koelzer, Host: It reminds me of the joke with the hemorrhoidal ointment preparation. H I would sure hate to be the guy that had to test preparation through G. Debbie are those I'm going to come spies. Are those spies, are they employed by like the drug company or are those usually outside firms that are specializing in that. 

Divya Yerraguntla, MMath, MBA: It depends. Some of the big firms of course have their own CIS right. CA teams that will actually work with them. Um, and then some smaller companies usually outsource that.

So there are agencies that do it for you, even the bigger pharma companies. They also use other smaller firms because you can be everywhere. They also go to conferences, they will see what else is being presented, how the Buddhas unite, and a lot of different kinds of information through them. Uh, but. They are so critical and every company has it, whether it's in-house or whether it's some other agency doing it for you, but they typically have it depending on the size of the company.

Mike Koelzer, Host: And I imagine some of the companies, they want some of the information to come out, right. For the shareholders. They want to say, Hey, we're working on this, but you don't [00:10:00] want to give too much away, but they probably want to keep the press going. 

Divya Yerraguntla, MMath, MBA: So that's the thing, all of this information, right? Like, because to your point, it's like a need to know basis, but at the same time, they do want to create the excitement, 

Mike Koelzer, Host: right?

Yeah. You got to let some secrets out. 

Divya Yerraguntla, MMath, MBA: How much do you share? But those investor reports are like, like if you're in that area, that's your goal mind because it gives you so much information and that's credible information. Because you do not just share something with the investors. That's not true. 

Mike Koelzer, Host: I'm sure it's illegal.

Plus you don't want the ramifications of someone coming back and saying, where did this information come from? Yeah. 

Divya Yerraguntla, MMath, MBA: And this, I, I think that's a great source, but just like the investor report, they go to multiple sources and. Um, now that I'm working for seniors, I see this, you know, like there are so many data sources that they saved through the look through.

It's incredible how much data is out there these days. And you know, this more than anybody, like it is everywhere, especially in pharmaceuticals, like there is so much data, clinical data, patient data, you have the publication data. It's like data is everywhere. How best we use it. And mine, I think, is going to be the next.

Mike Koelzer, Host: Instead of picking up on this gossip and just saying, oh, that's interesting. That must mean this. They turn that data almost into a science 

Divya Yerraguntla, MMath, MBA: more. Yeah. It's like the, and I know it's a buzzword, AI and ML, you know, artificial intelligence, machine learning. It is a buzzword today. Not a lot of companies have really adopted it the way we could some industries have we haven't.

But then if you look at. We have so much data that we can make some models and T what happens, that's those models and really apply that into the new data coming in. We have that opportunity, but I guess on the flip side, pharma is so constrained by compliance. We have so many constraints on it. So sometimes it's not easy to catch up.

There is a lot of technology out there that can help, but how do you adapt it? All the validation roles, all of the technology, the compliance, the legal ramifications. By the time you go through all these filters, there's very little you can really do. 

Mike Koelzer, Host: With nearly five blockbusters and three, at least to your name when this happened, were you part of a company that specialized in launches like these manufacturers would say, okay, we're getting ready for launch let's hire Divya and her firm, or were you part of the firm that actually like invented these from square one?

So 

Divya Yerraguntla, MMath, MBA: I was part of the firms that actually developed the drugs. So, um, yeah, so I was part of the company that was launching their own products. I was an employee of that company, but now what I do, so in the last six months I moved jobs and non part of Signo sell what seniors do. They actually work with smaller companies and mid-size big pharma companies that need these services.

But then again, what I did in my past was, uh, mostly commercialization. Now I am a part of a team that actually does everything from clinical, all the way to commercialization, which is so awesome because it's like end to end, you know, not just one piece of it or the middle piece, but you start from the very beginning and stay with the product all the way.

The only differences. These are not senior products. So yeah, the product is not developed by seniors, but they stay end to end. So that's that. Difference in the opportunity. So in January of this year, I was always on the other side with the company that manufactured the product. Now I'm on the other side, which is exciting to see the other side to see, you know, how things are done and very smart people.

So a lot of learning, a lot of excitement. 

Mike Koelzer, Host: Why didn't the companies that you worked for the manufacturers? Why did they not hire somebody like Cineos to say, all right, we've got this, uh, concoction pretty well set here. Let's hire a marketing company or someone to take it the rest of the way. They didn't need that because they were big enough to have their own.

Part of the business is to hire someone like you, who did that because they were big enough. And these companies now that Sydney house has maybe aren't big enough to have someone as skilled and talented as you in their company. 

Divya Yerraguntla, MMath, MBA: So it's a combination of both. Many big companies also hire companies to help them because they may have like a small team and they need additional support.

And they may hire agencies to help them with this. So they will have their own launch teams and they would hire external help to supplement wherever they have gaps that happen all the time. Then some companies actually have the entire [00:15:00] operations within, which has been mostly my experience. And the reason for that, at least the way, um, we have looked at it is when you know, you're going to launch multiple products.

And when you know that you would have learned. Having those critical relationships with the stakeholders, understanding what we can do right. The next time. All of that knowledge, if it stays in-house. You're not losing it. When you outsource that, all of that learning, every launch will be a new learning for some company or the same company.

Even if you outsource, you're not guaranteed the same team for every product, right? So there's always some learning that is kind of alive. There is a knowledge stream when that happens, when it's. You don't have that. So sometimes it's a combination, but that said many times, you also hire outside agencies because you may have one or two people working in that capacity within the team, but some of the lunches need so much more support, so much more help.

So they hired somebody else as well. 

Mike Koelzer, Host: When you did these 32 launches that had to be with your new. 

Divya Yerraguntla, MMath, MBA: No, the 32 lunches went on the industry side. I was an employee for those companies. So that's all their credit. One of the companies I worked for also had some licensing where they launched and they had their own products, as well as they bought some products.

So it's a combination. So they were all their own products. 

Mike Koelzer, Host: When you were in the industry, working for those companies, how many were they averaging? 

Divya Yerraguntla, MMath, MBA: So some of the bigger companies average less because their launches are big. So they do one every two years. Um, sometimes they may have an overlap. I have launched two big products within six months of each other.

That also happens that some of the smaller than upcoming midsize companies launch a lot more, especially if you're building your portfolio, um, you byproducts, you manufacture some on your own you license. So then you have more volume of launches in that. 

Mike Koelzer, Host: You have got a mathematics degree and a marketing degree.

Yes. And besides that, you're also an artist. You're a musician. Yes. Okay. In your job with these companies, was it strictly mathematics? I mean, could an old fart like me do it because it's very methodical. I'm thinking with your marketing and being an artist that there's more to it than just the methodical launch.

Where does the art come into this? Because obviously some fail we've talked about that and they don't just fail because there's been a competitor coming up. There's other reasons too. Where could you screw 

Divya Yerraguntla, MMath, MBA: up? Okay. So I see that as two questions. So the first one, um, I can say, you know, the creative part, how does creativity really help you in launching a product?

Yes. So the mat part is, uh, more the logical piece of it. You know, you kind of want to make sure everything's adding up, you know, which helps you die out. The loose ends. I think the most important thing that helped me do these jobs over the years has been my PT. Which was project management professional, which I bought in 2004, which actually teaches you the processes, the project management, how to do workshops, how to facilitate, how to negotiate, which I think was important, which also was part of my Ms.

To a certain extent, two separate aspects. Um, PMP really is very process-oriented and it gives you templates. It gives you methodologies to look at my marketing degree. On the other hand, it really teaches you how to look at it from the creative aspect of it, how to kind of move things along and still make it impactful for the end customer.

So those do blend in really nicely. My music background. I think the one thing that. If you are in any of the arts, whether it be music, dance, whatever you realize, you never stopped learning anything. You do. You want to improve yourself the next time. And I think that attitude is much stronger and creative.

Than anybody else, because you always want to be the better version of yourself the next time at home. And I think that attitude really helps when you're doing something at this scale. Cross-functionally for an organization with so much budget to say, where could we have done? What are the things we should learn?

How do we improve ourselves? And I think that having the data, looking at what went wrong in a very pragmatic way, it's not the blame game, but it's really understanding [00:20:00] for the product. What could we have done to make it a bigger success? How could we have reached more patients? How could we have done better and taken those learnings and applied.

Making it into a process and applying it repetitively is where I think the value is. So for me, all of the things I learned, but they'd be mad, whether it'd be, you know, an MBA or my music, it all converges really well in what I do. 

Mike Koelzer, Host: PMP certification. What does that stand for? A project management professional.

You mentioned a few methods in there. What were those? You 

Divya Yerraguntla, MMath, MBA: mentioned you have different kinds of methodologies. You have agile methodology, you have waterfall methodologies. So you have multiple methodologists and how to do things. Then you have, when you facilitate workshops. Like focus groups. Yeah. Like focus groups.

You would have cross-functional workshops on strategies, right? What do we want to do for the product? How do we want to build a strategy? Then you facilitate these workshops with all these different functions. You'll have people from marketing, from medical, from market access, from legal, from regulators.

All these functions that come together for a lunch, when you facilitate, they all have their own little jargons, their own language. How do you speak in a way that everybody understands what we want to do and how can we achieve the common goal, setting those up? Pre-launch you also plan to say, okay, who needs what?

By when? Right? You have to plan the entire thing. This is like a movie production, you know, we'd seen what comes after what's in what's the dependency, you know, what are the. If you are on a horse, in a blue t-shirt and you get down to the horse in the next scene, you can be wearing red. T-shirt not sure it has to be a blue t-shirt.

So the large team literally made it in seconds and you do what's the dependency. If this happens, these are the three teams that need something from them, because it's like a constant chain of events. You hand off something you make and the other person picks it up from there and then does their own thing.

Because at the end of the day, it's the same product, no matter which team is that. When 

Mike Koelzer, Host: you were talking pre stuff, I'm kind of having my marketing hat on thinking about what kind of outside people and outside focus groups you're working on. But what I'm hearing from you is that's a part of this, but you're also working with all of the internal, maybe not working at the company, but at least for the company you're working with.

Everybody. 

Divya Yerraguntla, MMath, MBA: Pre-launch where you call something like a summit summit is where you bring all the teams. You basically work with each team to say, what are the key things you need to do to make this product, to launch this product? And then you would take that list and then you would put the entire list out there and.

You would look at what's the dependency. If somebody says, oh, um, let's say there is a document that marketing is putting together. And then the medical says, oh, I need to provide input into that document. Right. Or I have something that'll come before they get to that piece. Then you want to make sure that marketing knows to wait until my, um, medical.

So that they can take that as an input. So you kind of have to map all of that out and that's done in a summit and these are all planning sessions. So this is really planning and strategy you decide. Okay. What, what kind of, um, physicians you'll go after? How many, um, you know, ads you would have, how many data trees, all of that is part of the planning and structure.

What 

Mike Koelzer, Host: might be a group out of order that said you should have waited for this to happen. 

Divya Yerraguntla, MMath, MBA: A good example would be, you know, the first thing is the medical team comes up with the clinical deck to say, you know, what is the product about, what are the benefits and what is the data showing? So that's your first thing.

So once you have that, usually the marketing team would take that and look at it because that's medically accurate. These are the things we can talk about. And then they will go out research, come up with their key messages. Once they have their key messages and you have the clinical deck, you know, market access teams would look at what the commercial key messages are and then try to align with that.

So when they go out to pair it speaks the same language, at least in the same Asia. So you have to share all these documents. So there is a red thread throughout. So the minute let's say somebody else goes out and they make them. Messaging without looking at the clinical deck or sometimes, you know, the bare materials is produced without looking at the commercial messaging.

They might be a little bit off and that's a problem. Not that it cannot be fixed, but sometimes given the time and the money it takes to fix things, it just eats into your. That's the other things which are critical for 

Mike Koelzer, Host: lunch. It wouldn't be as big as something like an age group, but it could be something like a percentage of something that is very detailed, but you have to have it.

It's got to be very detailed 

Divya Yerraguntla, MMath, MBA: and you should all align. What is it that you really want this product to say? You know, [00:25:00] like sometimes it may be, um, if, if it's a cancer product, like. And the other therapies out there are all injectable. So, you know, they have to take IV injections or something and your product is just a tablet you can eat.

And if we all, as a team agreed, that's a big differentiator. You know, because eating a tablet is very different than taking an IB or an injection all the time. Then you can say, okay, if you're all going to say, this is what is important for our product and that, then you align on that as a strategy and you go out, you're all working off of the same assumption.

Mike Koelzer, Host: After decisions like that is that we're like a marketing focus group would come in where you say, okay, we think this is our message. Now we're going to sit down with the focus group and say, Hey, how important is this? That this is chewable versus this, or grape flavored versus this or something. That's where then you take that and then you come back and say, Hey, no one gives a crap about this.

Or they wish it was this kind of thing. It may be, it doesn't change the product, but it changes your. Message. The important things about that product. Yeah. 

Divya Yerraguntla, MMath, MBA: I've seen it done both ways. You first think about what's important. You go out to do research. I've also seen it where the marketing team would actually go out and do some initial research and come back and say, these three things stood out now, what do we want to do?

The awards and then because all the teams have to agree. So they'll say just based on, let's say you do an HCP research, which is a healthcare professional research versus a patient research. So they can say, okay, patients prefer that it's, it's a tablet and it CP prefers the fact that it's, let's say once a month, Instead of every, every other week.

Mike Koelzer, Host: Right. And they don't really care if it's a tablet or this or that, but the other group does, but they don't care 

Divya Yerraguntla, MMath, MBA: about the month. Exactly. So now as a team, you should be aligned to say, okay, what is it that we want to talk about? So it can be done both ways. How 

Mike Koelzer, Host: long does all that take? I mean, this doesn't come together in an afternoon, but hopefully it's not 10 years by.

Right. Go find this and come back. How long are we talking? So 

Divya Yerraguntla, MMath, MBA: usually you start your launch prep anywhere. 24 months to 18 months before the anticipated launch is usually 10 to 12 months from the time you file for the product with FDA. So let's say you want to file for a product a year from today.

Because you have, you have the data you're in phase three, you know, you'll get there in a year. Companies start thinking about having a launch team in place now or within the next six months. So by the time you file your launch team, Be in place for at least six months working 

Mike Koelzer, Host: together, different things, working 

Divya Yerraguntla, MMath, MBA: on different things.

Yeah, because it is a lot of planning. It is a lot of coordination and a lot of things have to come together. And many times you want to create the awareness for your product buzz for it. Yeah, exactly. Like I'm not going to go to publications and read scientific publications every other day for fun.

No, I 

Mike Koelzer, Host: don't use slackers, might not do it, but I do. Of 

Divya Yerraguntla, MMath, MBA: course you do. Hey, more power to you. So, you need to create that as much as at least not at my level, but at least with the physicians to say, Hey, our data is coming out. It's looking very promising and we want to bring this product out. You can engage them in different ways, but you also want to get the word out.

You can talk about the product, but you can talk about the clinical aspects of it. That's why the publications are so important. You know, you start publishing your data in these. Um, medical conferences so that people at least become aware that there is a molecule that has a significant advantage over what's out there right 

Mike Koelzer, Host: now.

I bet there's a lot of rules there where you can talk about the molecule maybe, but I imagine you can't say what it is and name it and all that stuff. I bet there's a ton of rules. Yeah, 

Divya Yerraguntla, MMath, MBA: you can pre promote, uh, name is not finalized until you get the final approval from FDA. So you, yeah. You don't know yourself for the names.

You know what you submitted, right? Because you have to submit, you know, secondary names and everything. So, you know, you have submitted two or three names to them, but you don't know what the approval will come back 

Mike Koelzer, Host: with. Is there like a master program that a lot of the drug companies use that keep all this information sorted?

I mean, is it just like a database or is there like a program that drug companies use to follow all this? 

Divya Yerraguntla, MMath, MBA: There are many databases and there are many people within the company. That's their job to track like the regulatory teams make all the filing. They made sure they're getting all the data from their clinical teams.

So that accuracy is right. You have statisticians working through all the numbers, getting into percentages because they're just so much that goes on there. It's a team effort. It's huge. They have [00:30:00] specialists to do all of this. There is no one person or one system that can do everything. It's a 

Mike Koelzer, Host: combination.

There's no name brand program that captures all this. It's just too big. There's just too many things going on. 

Divya Yerraguntla, MMath, MBA: It's too many things. It's too many things, too many variables, um, that they have to track and they're all tracked in different systems. So there's no one system. 

Mike Koelzer, Host: When do you know? How do you know that a product is not the success you wanted it to be?

Divya Yerraguntla, MMath, MBA: I right after lunch, don't make it to their estimated forecast. And the forecast is like your guiding beam. Right? What did you expect it to do in the first six months versus what it is doing is telling you, because if you don't set that trajectory. In the beginning six months, the probability of you missing that forecast is 80%.

So that initial curve is all important. 

Mike Koelzer, Host: If you set a curve and you think this is how it's going to go, and if you aren't. On that curve right away, the likelihood of it being on that curve later, it's not going to come 

Divya Yerraguntla, MMath, MBA: back. It's very low, very low. So once you start, there's usually a data lag. So you start getting the same state in about four to six weeks from the time you launch.

You watch it on a weekly basis. You look at it every week. How are we doing? How is the trajectory going? So there is a lot of scrutiny on it from all angles, not just from launch success, but also from sales, from understanding and from investors to, you know, because you launch something, you make a big press release, everybody knows it's out there.

Everybody's watching to see, are you going to succeed? How is it doing? So did I. Lots of eyes on that one tracker that's moving up to see what's the angle. Is it close enough to what was estimated in the forecast or is it going a little bit off? So it gets very important to track it. Not just track it, but monitor it and do something about it.

Mike Koelzer, Host: What's that number you're 

Divya Yerraguntla, MMath, MBA: looking at? Usually it's like prescription data. How many 

Mike Koelzer, Host: prescriptions are written for it? Gotcha. 

Divya Yerraguntla, MMath, MBA: Again, there are many, many different trackers. You, at any point you look at around 11 different things to say, you know, and hopefully they all line up. Yeah. But the main one is really prescriptions.

Every company looks at, you know, how many prescriptions are being written because it's a new product 

Mike Koelzer, Host: And that's just data. You pick up through all the data firms that give that I imagine. Right? Yeah. So something is not on the curve. What can you do about it? Or what can you try to do? 

Divya Yerraguntla, MMath, MBA: No. That's a great question.

So these are called remediation plans. So you pull your entire launch team together again, the same folks that you pulled prelaunch, like your marketing teams, your market access teams, your medical teams, your legal, your compliance, or regulatory teams. And then you kind of go through this exercise of saying, okay, what did we plan?

What. Where do we see patterns that are not matching? So you basically sit down and say, okay, what are all the causes? And it can be the field telling you when we got to the office, they were saying, oh, we don't have. And so there might be somebody else telling your physicians that, oh, they don't even have a product.

So then you kind of have to counter detail and say, no, no, no, we do have products. So a lot of things happen in the field. They're the ones who are actually talking to them. So you take that feedback into account. You take all the data that's coming back and you do a root cause or. You use templates like fishbone diagrams, where it's like a fishbone, it's like the five whys you basically say, okay, on the regulatory side, what are the things that we think did not happen the way we anticipated?

It could be that the label didn't end up being what we had expected. So based on that, the forecast might be wrong completely because let's say we didn't get one of the indications we were going after. And that was a big chunk of the market. So is it okay, so we need to adjust beforehand. Because we didn't get that.

Whereas this let's say in the field, there is some detailing or there's some counter messaging happening then that's impacting. So we say, okay, what can we do about that? So based on these root cause analysis, you come up with an action plan to say, what can we do to fix these issues? And then you kind of prioritize and say, okay, did this needs to happen first, second, third, fourth, who is going to do it by when?

And then you have to have that loop or feedback to say, did you do it? And then again, the next week you look at the data and see, is there a trend? And again, as I initially mentioned, there's always a lag of data. So any action you take, it takes about four weeks to see if that action is helping or not.

And so time is a for sense, especially once you launch because every little action will have some kind of an impact, good, bad, or ugly, and you want to see the right impact happening 

Mike Koelzer, Host: and fast. Give me an idea of that time. So let's say something launches on the first of the year. For example, [00:35:00] when would you get together for your first meeting?

If things weren't going well. When does anything substantial come out of that, a change or something to make? Are we talking within a month or three months, 

Divya Yerraguntla, MMath, MBA: or it's usually five to six weeks because that's, when you start getting all the data in, you have to have data that you have to have facts before you start looking at things.

So, let's say we launched on first-hand. Um, if I am looking at this from a strategic point, I would say February 3rd week is when we all get together, look at everything that's available to say, okay, where are we going? If we are going positive, what more can we do to push it further? If we are not going positive and we are right on.

You know, the forecast line. Can we still push it up? If we are low, then it becomes imperative. We push it up to bring it back to where the forecast was. And that's when you come up with an action plan, let's say we have this workshop in the third week of February, we'd come up with the action plan, assign everybody actions.

And we take those actions sometimes even a basic thing. Let's say, we say, you need marketing. So that the reps can just go and drop it and it may take three to four weeks to develop that material. Then the reps will drop it. And then four weeks later the data will show. So it can be, you know, eight to 10 weeks before you see the impact.

Some things are very fast. It might be just, you know, let's have a conference call with all of the field sales and then tell them that this is what we want to message. It can happen within the week. And they started messaging the next week two and four weeks ago. Is that having an impact or not? So it depends on what that action item is, but it can take anywhere between three weeks to sometimes even six months.

Mike Koelzer, Host: How formal are those meetings? So when you talk about getting together, I mean, you guys aren't sitting down at lunch, I'm picturing like 12 people in a room. You've got a secretary who is capturing this, and then it goes into this official document and then the document gets distributed. And then you all got your marching orders and it says, who are you going to report to this back?

And all that kind of stuff? Is it that formal? 

Divya Yerraguntla, MMath, MBA: It's usually $4. And as you mentioned, you know, you have facilitators, uh, you have. Uh, structured workshop at the agenda to say, okay, these are the four things that came up. What was the feedback? People who go up and also share. So it's a mix. The structure of the meeting as such is very, um, strict to say, okay, four hours.

These are the people that can attend. But what happens within the meeting is sometimes really informal. Like somebody will say, oh, I heard this guy. I called him up to say, what's happening? And they said, this is what they're seeing. So the feedback is very informal, but the process of how we do it, how we capture the meeting minutes, the action item and how we distribute that and who's responsible.

And who do they report back to? All of that is very formal. I've been very fortunate to have extremely talented people on my team. These are program managers and launch managers. Who are extremely skilled. They are great at facilitation. They have subject matter expertise within the domain. So they understand what questions to ask, how to probe these guys have done launches.

So they have experience of that. So I've been very fortunate to have great team members. And so each launch is usually assigned to a team member and they will do it. And, um, as a team, we would be there supporting. But they run the workshops. I have run some as well myself because, um, yeah, it, it all depends on how many people you need to engage with and do.

And I had a great opportunity to really work with some really good team members. 

Mike Koelzer, Host: You've got people that are specialists that can run these kinds of meetings. 

Divya Yerraguntla, MMath, MBA: They would manage not just these meetings, but they would manage their entire launch. So they would have the entire plan. They would be managing all the weekly meetings, the weekly updates, the reports, everything.

So it definitely has a lot more than just the skills you need to be very analytical. You need to use a good word. A couple of tools that we use to use, um, like Microsoft project, smart sheets. So you have different tools to track. So of course they have to have, uh, expertise in that. Um, that was what the team was really chartered to do.

Uh, we also maintain all of the documents related to all the launches. So we basically had a history of everything that has happened. 

Mike Koelzer, Host: How many people. Do you have that to assist you, whether they officially worked for you or not? 

Divya Yerraguntla, MMath, MBA: Typically you have anywhere between three to six employees. And if you have other people helping you in some of the companies, when you have less employees, you may have some agency helping you and they will put in another two or three people because there's a lot of things that need to be coordinated.

And tracked and reported. And especially if something is, um, you know, running late, you also have to [00:40:00] start looking at the downward impact and how do we fix it? So again, it's, it's a lot of fixing as we go. Let's say somebody had given me this analogy, like we've built a plane. We know when it needs to land and you're building it while you're flying it.

So you're putting the pieces as it flies. And by the time you land, you have to have the complete plan done. Otherwise, it's a crash. 

Mike Koelzer, Host: At some point you leave the manufacturer itself, who's doing all this. You come to Cineo since Cineos is a huge company, right? They've got all these different functions, but one of them is helping these smaller companies do similar things.

Yeah. 

Divya Yerraguntla, MMath, MBA: So I'm part of a small group called seniors one, which actually does a lab for life. So they do everything from clinical trials, all the way to commercialization. So it's a great group of people who have a lot of expertise and a lot of not just launch experience, but extensive clinical experience.

They write protocols, they decide what kind of indications to go after. So. Group of people that actually taps into seniors as required and bolts people, the experts to the table. So we can talk through things. So it's been great, great learning, a lot of experts, um, I get to meet with and work with. So it's very exciting.

And this is the one chance where you get to do everything and doing all the way from, you know, um, I, I always use this as an example, if, if you're a. Company and you have a great product, but let's say you're just starting out. You're really small. You have maybe 10 employees, but do you have a great product?

Then news is like Uber. You know, you are the passenger, you put it in the Uber. It'll take the passenger from all the way from clinical trials to commercialization and launch the product for. It's still yours, but you don't have to buy the car, maintain the car, think about the tires or who's going to drive it.

Don't have to worry about all of that. Right. It 

Mike Koelzer, Host: seems to me that people that come to your agency inside of Cineos, they're like a couple of mad scientists in their garage and they say, we think we have something. They don't know. They have something. They think they've invented something good. 

Divya Yerraguntla, MMath, MBA: Right? Yeah.

So my group actually works with small to midsize counties. And helps them. Uh, the other groups work with big pharma as well. We work with small to midsize companies. Yeah. How small they can be as small as 10 people for the 

Mike Koelzer, Host: product. Would they already have like a patent on it or something you 

Divya Yerraguntla, MMath, MBA: usually do?

So I wouldn't call myself on 

Mike Koelzer, Host: that. What would these companies have done in the past? If they didn't have someone like Cineos like the Uber of this stuff, would they just go out and try to hire people? But then that would be a problem. Cause he'd have this maybe great drug, but maybe they don't want to grow this big company.

Divya Yerraguntla, MMath, MBA: Exactly. Maybe you don't want to get into that hiding sales reps and commercializing. Then usually those companies may license their product to a bigger company. Or they may partner with somebody. They may take it all the way to the point where they can say, okay, I just want to partner with another company.

They wouldn't have the chance to do it all the way themselves without hiding anybody. 

Mike Koelzer, Host: And then they might have to sell some of their company or something like that to grow. And they might have to divest of that a little bit. It sounds to me like after these launches and let's say it doesn't go the way it's supposed to go.

And you come back and you have your meetings. Does anybody ever get in trouble? It always sounds like we can always blame, like, oh, this didn't go. Like we thought it would, or this didn't go. Like we thought it would. What would a failure look like? Let's take a Cineos competitor. And let's say that one of these companies came to you and they say, we want to hire Cineos this time.

And you say why? And they say, well, the other company didn't work well for us. What would that look like? What does that mean? Not working well, because it sounds like a lot of this is mathematical work as a system. There's creativity in it with the marketing and so on. But there's gotta be a time when a company just doesn't do a good job.

Divya Yerraguntla, MMath, MBA: A lot of it is perception. I think a lot of times you have a vision in mind when you hire an agency, you want your vision to come to life. And you know how hard it is. You might've read the telephone game, right? You say something it goes through and the end result is completely different. So sometimes it's just a question of how well somebody interpreted what your expectation was.

Luckily for me in all the years I've worked, it has always been a quest of what can we learn from what hasn't worked rather than play the blame game, you know, because it gets you nowhere at the end of the day, instead of wasting our energies, blaming somebody, can we spend those energies on fixing what we can [00:45:00] and make the best of the situation?

Right? That's been the attitude that I've always used. 

Mike Koelzer, Host: I was just reading about Amazon. And you saw this too with Jack Welch in general. And they on purpose. What, by you're like the bottom 10%, 10%. And I read that and I'm like, gee, that's kind of cutthroat, but I guess companies do it. So you don't see a lot of someone saying this failed, we're firing and we're moving on.

It's more like this didn't go as well as we thought it's not black and white. It sounds 

Divya Yerraguntla, MMath, MBA: to me. It's not because there's no one person responsible. You know, it's, it's a group, it's a team. So it's very hard to say this one person didn't do it. Right. And that's why it didn't happen. But I agree though, Amazon is very controlled from what I've heard as well, but it's different philosophies, right?

How do you want to go about doing business? Like you, do you want to just eliminate the bottom 10%? The bottom 10, maybe. Higher than your competitors, you know, top 50, but then you still want to just keep it low. And I guess that's what you do. 

Mike Koelzer, Host: What do we get to blame when there's a really silly name of a product?

Who ultimately do we get to blame? If there's a drug, that's just a silly name. And we're like, how the hell did they think of that? Especially if there's something wrong with it, it rhymes with something I'm imagining, it goes through marketing. It goes through all this stuff. Who ultimately is to blame?

Is it the CEO? Um, my 

Divya Yerraguntla, MMath, MBA: kids asked this all the time. Mommy, how do you come up with these names? So usually they are naming agents. And this starts, so it's a joint effort. I'm actually not even joining. I would say it's more of a regulatory effort. They actually start the naming along with marketing. And because when you file for a product, you have to give them the name of what your proposed name is, and you give them two or three options.

Usually give you a primary, secondary and tertiary name. And because David does a search to see if it's timing or the colors are, you know, similar to other products in the market. And 

Mike Koelzer, Host: FDA is 

Divya Yerraguntla, MMath, MBA: doing that. FDA does that. Yes. So you have to give them options. So you come up with this, they do some research and they'll come up with names and sometimes you kind of.

Some meaningful names. Sometimes, sometimes they completely have no meaning, nothing to do with the product. They just have these random alphabets pull together that, but it's, it's that agency that does the research and comes up with names. So it's usually, sometimes you get the name as a commercial team, after the names have already been decided.

So you really can't do much with it. 

Mike Koelzer, Host: Who signs off on that though? Someone has to say, that's my responsibility. I hired that naming firm, or I could have said no. Or who ultimately is that as the CEO? 

Divya Yerraguntla, MMath, MBA: Yeah. At the end of the day, everything, the overall responsibility is with the CEO. 

Mike Koelzer, Host: Yeah. All right.

Divya. So with your mentoring, you're sitting down now. With yourself 20 years ago. So here you are. And you're talking to yourself back then. What are you telling yourself? What are you telling the younger you that you know now that you want to mentor the younger self? What are you telling her? 

Divya Yerraguntla, MMath, MBA: I would say, be kind, don't try to be nice to everybody because a lot of times.

When we go to work, we want to be known for being a good person, a friendly person. But at the end of the day, you go to do your job. You get paid to do your job, not to make friends. If you make friends in the process. Great. But focus on what's important. What's the job and what do you want to say?

You know, don't hold it back ever. 

Mike Koelzer, Host: So you're saying be kind, but don't necessarily be. Yeah, you can have a kind candor. You can say something that's important and maybe challenging, or sometimes even hurtful. You can do it as kindly as you can, but that's different than being nice. 

Divya Yerraguntla, MMath, MBA: Exactly. If feedback has to be given, give it, but say it in a way that's not.

You don't have to be nice and say, okay, I'm not going to say that because this person is going to feel bad because you're not doing them a service by not giving them feedback when it's. 

Mike Koelzer, Host: I like that just today. Basically I fired our alarm company at the pharmacy that we've had since I was a kid and some things weren't right.

And then I would call them and then they wouldn't know the answer and they'd come out and charge me for stuff I didn't want to be charged for. And this and that. And so anyways, today I sent them my 30 day letter because it was coming up in my year. So I finally [00:50:00] fired him after all this time. One of their main sales guys is a customer at the pharmacies.

I had to think about this whole thing. But I was just going to say, I'm done. Then I was going to say something like, thank you for the relationship or something like that. And then I thought, you know what? I'm going to say something that I can live with. I'm going to say it kind of. But I'm going to say it. And what I said was, I want to make this switch because of cost reasons, and I want more control over the equipment and my monitoring.

And so that's why I'm doing this. And I thought I'm kind of proud of myself because years ago I wouldn't have done that. And. It's a long story to say there's a ton of value in what you're saying. Be kind, but make sure you say 

Divya Yerraguntla, MMath, MBA: it, then speak up. Like you have to be yourself. You have to be true to yourself and you have to be able to sleep at night.

And that's been my mantra, you know, fix the problems of what cannot be fixed. We'll wait for the next day. You can't help that, but anything in your control that can be done today, so you can sleep peacefully, get it off your chest, you know, in a. 

Mike Koelzer, Host: When did you pick this up? Because I'm assuming that yourself 20 years ago may not have known this or else you may be wouldn't have chosen what you're telling yourself 20 years ago.

You would've maybe said something else, like buy Bitcoin or something like that. So it must be that maybe 20 years ago you didn't have this skill. Would that be. 

Divya Yerraguntla, MMath, MBA: That is fair. Great observation. Yes, I did not. I actually did not give candid treats back to people because I didn't want to hurt them. That happened a couple of times.

And I think in the process, because I didn't want to blame somebody else. I took a lot on myself, whether it be work, whether it be things I'd be like, don't worry, I'll do it because you can do it. But now thinking back, I'm like, no, I should have said something. We all had our roles and responsibilities.

And I don't need to do everybody else's job to make them feel better. I just need to say to them that, you know, life happens, big deal. Let's move on. This is what is expected of you at work. So please make sure that this gets delivered. Because it's, it's not my job to fill up all the gaps for somebody.

And I felt responsible for making sure everything is smooth across the board, but sometimes that's not your job. You just have to do your part and help others get their stuff done. You don't have to do it for them. 

Mike Koelzer, Host: You came to this realization probably through a lot of frustration. 

Divya Yerraguntla, MMath, MBA: Yeah. But, the good part is yeah.

At the beginning of my career, um, that, that was me. But then I think, um, after five years or so. Things started changing. I started realizing I had heard a few good lectures. Um, at which point I was like, okay, fine. It's not just me. A lot of women go through this. And now that I'm doing the woman to woman podcast, I kind of hear a lot of women say the same things.

You know, if you had to go back through things differently, when they're talking about these things, I'm like, oh my God, this was me. Now I'm reflecting back. I think it also might have been a lot of me, but also the fact that I was a woman in the workplace and things were different 20 years ago, things have changed a lot now, but when I started like 24 years ago, it was not the same.

When 

Mike Koelzer, Host: you Kathy's realizations, you can't go back and say, I wish I would've, or you can wish, but I should have, I should have. It's like, no things were different. A lot of things were different. I go back and I think about that, it's like, well, I was in a different spot in my career. You know, I had different spots in the business and you just.

Be thankful where you are. I sucked at that, but I either smiled through it all. Or I just was a son of a bitch to someone. I just let it all loose, you know, on him and just really lay into him. Of course, bringing all of the anger from something else and pouring it on this poor soul who happens to have hit them.

Yeah. Being kind with your candor. That's a huge thing when you're not, you're really lying to people and you're not giving them a chance to respond to reality. Now that person can't respond to the reality because you've chosen to hide that reality. You're just creating these layers of falsehoods. It's not fair to 

Divya Yerraguntla, MMath, MBA: people.

And one thing I also realized was that feedback. When I was getting constructive feedback or the years I was able to improve myself, I was able to improve my deliverables. I was being a better person, a better professional, and now being a mentor. I realize that that's the biggest gift I can give to my mentee, you know, just tell them what they need to fix so they can move forward in the best way possible and be the best version of themselves.

So that's important. Giving feedback is so important and taking the feedback in the right spirit is also equally important. Take it as a gift and take it in the right spirit and see what I can get out of it? How [00:55:00] can I improve from. 

Mike Koelzer, Host: I remember going to my doctor and my doctor would say, you're overweight.

You know, I didn't want to accept that. I said, I want a second opinion. He said, I don't like your haircut. So Divya, it's been a pleasure talking to you. Thanks for joining us today. That was a lot of fun. And if I see one of those names, I don't like it. Sometimes I'm one of those drugs. I'm going to come and ask you who is responsible for that.

Divya Yerraguntla, MMath, MBA: Sure. Thanks for having me. This was such a pleasure 

Mike Koelzer, Host: to have you take care. Thank you.