Harsh Thakkar (00:01)
All right, have you ever wondered what are some of the challenges that pharmaceutical companies face when they go to market after spending years and billions of dollars in clinical trials and regulatory approvals? Let me show you some interesting data.

So as I was preparing for, oops, wrong screen.

So as I was preparing for this episode, the one question that I had in my mind, and I'm not gonna tell you, I'll tell you more about the guest, but the one question I had in my mind as soon as I knew I was gonna be talking to this guest is, what are the new therapies that are coming out in 2025? And I landed on this article out of bunch of other resources. So I wanted to share this because this is going to set the context of the stuff we're gonna be talking about today.

So this article tells me there are 69 new approvals across 66 discreet drugs. 35 are gonna be unique. And if I further dive into the data, it tells me oncology is one of the most represented therapeutic areas. There's gonna be 14 different tumor types that are likely to see treatment options. And this infographic is pretty cool if you are wondering, by the way,

If you're listening to this episode on your phone, I know it might be hard to grasp with what I'm going on here with the infographics and stats. So we also have a YouTube version of this podcast. So if you're interested in following along, please go and check out the YouTube video. That way you get to follow along the data points and also see what I look like and what my guests going to look like. So back to this data point, right? So we have oncology that I already mentioned up here.

We have tons of other therapeutic areas that you can see here. I'm going to scroll down. Okay, this is interesting. If we want to look at modality, small molecules, looks like is half of the launches, maybe close enough. We have some in RNA and gene therapy. I was hoping gene therapy would be a bit more louder. I'm kind of surprised that it's only four, but okay.

And then here's the bottom line, right? So why am I sharing this article? I'm sharing this article because when you look at all these data points, obviously, you know, if you're in life sciences industry, you're super excited. If you're working with any of these companies who are developing these products, you're very busy, you're working on interesting stuff and, you know, looking forward to that end goal in mind. But these companies...

getting through clinical trials and regulatory approvals is only half the battle, right? Like this article says. The other half is how do you commercialize that product? How do you go to market? How do you define value and patient access? All these different things. And because of that, the guest I have today is Dan Cummings. He is one of the most sought after leaders in the industry for go-to-market strategy and

He's consulted with some of the top health tech and med tech and biotech startups. And I really wanted to pick his brain and talk about this. But before I ask him tons of questions, Dan, welcome to the show. What are your opening remarks on these data points?

Dan Cummings (03:37)
Absolutely. one fun fact that actually works for a company that is owned by the data that's pulled here that in a previous life. So it feels like I'm coming home. One of the most surprising things that I've ever said when I've talked to hundreds of

Harsh Thakkar (03:46)
Okay.

Dan Cummings (03:54)
It really comes down to data, right? It really comes down to data and kind of five key data points that ground us in the actions that need to be taken and the sheer amount of things that have to go right, ultimately even to get to commercialization. What's the most important piece to all of that? And I'll share the data in a second, is it really starts all the way back in phase one. It doesn't start when the FDA or another regulatory body across the world approves your drug.

starts all the way back in phase one. Can obviously go deeper, second, but do you want me to jump into the data?

Harsh Thakkar (04:31)
Yeah, yeah, let me share. Do you want me to share it again?

Dan Cummings (04:32)
Perfect.

Nope, can hit, I'll hit some data points that matter and then I'll jump into why that all matters and what's the number one. So what's the data? One of the things that I always like to look at, there was an MIT study back in 2018, somewhat dated, but candidly, the numbers look very similar right now. I'll begin with the headline. Even if you get to phase three, even if you get to phase three, you have a 50-50 shot of getting to approval. That's not the best odds, right? If you go all the way back to phase two,

Harsh Thakkar (04:39)
Yes.

Yep, go ahead.

Mm. Yeah.

Dan Cummings (05:05)
you have a 15 % shot of getting the proof. If you go back to phase one, less than 10%. And even when you get all the way past phase three and you submit an NDA or BLA, it's still not 100 % shot, it's about an 85%. And why is that? Well, one, of course, R &D and science. But number two is ultimately this concept of connectivity and centralization of evidence. And what we're seeing, the number one thing I'm seeing across

Harsh Thakkar (05:29)
Mmm.

Dan Cummings (05:35)
the hundreds of companies we help at the company I work with right now, folks that I advise, is everything's centered around evidence. And when you look at how a pharma company or biotech set up, and the reason why biotechs can move faster by and large than pharma, is you have an R &D function, you have a medical affairs function, and then eventually, right, pending how mature you are as a company, you have a commercial and value or market access function. And they don't all talk to each other. But what's interesting,

Harsh Thakkar (05:43)
Hmm.

Dan Cummings (06:05)
is more and more every day we're seeing medical affairs be at the center of research and development and commercial and value and access. And they're really helping connect the dots in this new model of commercialization. And we're seeing medical affairs teams fulfill increasing responsibilities, not just be publications, not just generate data, but become leaders, become strategists around evidence, both the curation and the action that comes from that evidence, right?

And that's evidence around what patients, you know, will be most impacted and why that's evidence around how am I differentiated versus the treatment protocols of today? And more importantly, the treatment protocols of when I hit the market or projected to hit the market, they focus on engagement, right? How do you start to create those unique customer relationships? And really most importantly, education. You could have the greatest science in the world, but no one gets it. Gene therapies, great example. You talk more in a great example of no one gets it.

Harsh Thakkar (07:00)
Yeah.

Dan Cummings (07:03)
both on the clinical side and then ultimately the patient side, the asset's not gonna do great, right? The product's not going to take off. The product will not sell itself, especially in the environment we're in today. So that's the biggest thing that I've been seeing personally as it relates to the various companies we work with. And then taking that even further, not only is medical affairs being at the center of all that evidence kind of triangle, right? But you need to move in a faster and more efficient way today.

Harsh Thakkar (07:14)
Yeah.

Dan Cummings (07:32)
to actually meet the needs of the market we're in. And quite literally, if you pull way back, and I think back to my digital health experience, there's an expectation of ruthless customer centricity, as I like to call it. In a world that I can click one button and get something in my door in minutes, the same human beings that do that are patients, are doctors, are nurses, are executives at...

Harsh Thakkar (07:35)
Hmm.

Yeah.

Dan Cummings (07:57)
PBMs and health insurance companies. And so we start to think that way and we can go into that more as we talk. But excited for the chat.

Harsh Thakkar (08:03)
Yeah.

Yeah, yeah. And, you know, one of the things that I have, you know, I wanted to ask you is you obviously have tons of experience on the, you know, phase three or going from phase three to commercialization. I know I've had people on this podcast who are, you know, scientists and researchers who are, you know, playing like earlier in the preclinical or like

you know research and development stage and then I have others who are in the middle who are Getting the drugs approved and you know going through the regulatory milestones when you look at your career Did you always want to be in this like later stage of the game like taking companies? helping companies go to market or Did that happen because of any opportunities that came along your

Dan Cummings (08:55)
Yeah, absolutely. I always like to begin at the start, right? So I come from, you know, a very modest place in Northern New Jersey. My father was a car salesman. And so ultimately, I remember being a young guy sitting next to him crafting deals, right? Because there was no daycare. We didn't have money for daycare, quite literally. One of the pieces that over that time I like to, and I figured out, is I like to solve really hard problems. And so over the last, you know, 15 or so years, I started my career, like we said, as a consultant.

Harsh Thakkar (08:57)
Yeah.

Yeah.

Mm-hmm.

Dan Cummings (09:23)
I started at a company that was previously known as DRG, got gobbled up, and then went to a tiny company called the Dedum Group and scaled with them. And eventually they got acquired by North Stella. And it was really at the Dedum Group that I had this aha moment. We're at the Dedum Group, we were hyper-focused on working on the most cutting edge specialty therapeutics, doing value access, distribution designs. And I worked with this company that eventually, and I won't name them, but Gob got

got acquired by Advie for $21 billion. And in doing that, we worked so closely with them, we were really designing how do they make sure that their drug gets from the company to the patient, and it's supported in every step of the way. And I had this aha moment when I was doing that project. I said, well, I'm doing all this work and putting in hundreds of hours to build a strategy for a company that just got acquired for $21 billion. And I don't even know if they're going to execute it.

Harsh Thakkar (09:55)
Mmm.

Dan Cummings (10:20)
All right. And I've never executed and I had this aha that I need to learn how to execute. And so I purposely picked a mission where I could help grow companies and scale, go to market functions, whether that's business development, partnerships, affiliations, reb, ops, sales, ops, marketing, corp, comms, right. I purposely picked a career path where I could help organizations both rebuild that's private equity backed or build from zero venture capital back on how.

Harsh Thakkar (10:22)
to write.

Dan Cummings (10:50)
to affect that tip of the spear of revenue production in a way that is both impactful to humanity. And that's a broad statement, but that's why I like life sciences. The other reason why did I even go into life sciences? Quite honestly, I have a history of cancer in my family. Luckily, no one has passed, but my mother beat cancer twice. And so from day zero, it either do want to be a doctor or do I want to work in the business of life sciences?

Harsh Thakkar (10:53)
Right.

Yeah.

Yeah.

Dan Cummings (11:18)
And I landed on the ladder for many, many reasons and haven't.

Harsh Thakkar (11:23)
Yeah, no, that's a of respect to you and the toughness for your mother and everything that you guys have to go through. It's not easy. I don't have anybody in my family with cancer, but I know people with other conditions. And it's always good when you work in the industry and you can connect the dots to the deeper purpose of your job. Otherwise, mean, we're all behind computers doing stuff, but you

Dan Cummings (11:49)
Absolutely.

Harsh Thakkar (11:52)
It's hard to find purpose.

Dan Cummings (11:54)
I absolutely wake up every day and it reminds me explicitly as to why.

Harsh Thakkar (12:00)
I want to ask you a wild prediction time. Sorry to put you on a spot, but when you see 69 launches in 2025, based on your years of consulting experience, working with companies, either going through successful launches or in parallel to going with the launch, getting acquired. That happened to me when I was at Juno Therapeutics and our CAR-T product was

Dan Cummings (12:04)
Let's do it.

Harsh Thakkar (12:28)
had really positive signs of being commercialized, we were acquired by Celgene and then within months we were acquired by BMS, right? Because they saw the potential and they were competing with Novartis that had acquired Avexis for the Zolgesma drug. So the prediction question I have for you is out of these 69, how many do you think will make it by end of 2025?

Dan Cummings (12:37)
Yeah.

I would say

less than a third will meet their launch curve expectations. And ultimately, right, that doesn't mean that the rest will fail. They're just going to miss expectations. Secondarily, would just say to you, Celgene, which is now BMS, is about a mile from where I live today. So it comes home. I drive right past Celgene to drive all the time. But less than a third is my provocative prediction. And candidly, the reason I say that, because you can't just throw out a crazy number.

Harsh Thakkar (12:58)
Wow.

Okay.

Nice.

Okay.

Mm-hmm.

Dan Cummings (13:23)
is there's a very big cost-reductive mindset, not just in pharma, but by and large across the globe and across many different verticals. It's especially loud, that cost-reductive mindset in large pharma. And large pharma is looking at and kind of moving towards this internalization mindset. Suddenly large pharma is doing a lot more work than, I'm going to build my own tech, my own AI, my own omnichannel, my own business insight, my own marketing.

Harsh Thakkar (13:47)
Hmm.

Dan Cummings (13:53)
Right. And that's okay, but it is a concentric circle or two out from what they're the great at, which is science, right. And impacting patients' lives. And so large pharma has been especially looking at AI, not as a augmenter, but as a reason to push their providers, their people that help support them, whether they're advisory consultancies, their agencies that create content, their tech providers or AI providers.

to lower their prices, right? Now on the flip side, what I'm seeing is in biotech, which is on bullish on, right? Very bullish on biotech. Where you're from, right? And originally came from this. You're seeing the biotechs look at how can I use partnerships, both in AI, technology services, and so on and so forth, to really have more speed and efficiency, but not at the expense of confidence and certainty, right?

So the thing that's powerful with that, and I was just talking with a couple of biotech executives the other day, one of the things we have to position our company, the company Envision Farmer Group, is we do and provide combined intelligence. Buzzword, combined intelligence. You'll start to hear it, right? What is combined intelligence? It's not blockchain. We're not going go back to that. But what combined intelligence really is, is this concept of AI enhanced, of surrounded by human beings.

Harsh Thakkar (15:17)
Hmm.

Dan Cummings (15:19)
that can both interpret the so what and help your company learn how to fish, right? Because just because you have these tools doesn't mean you know how to use these tools. And so I come to a third. Why? Because in a cost-reducted mindset where most of the total addressable market is in large, large mid-pharma, 60 % of the total addressable market of SG &A spend, if you're in cost-reducted and you're trying to internalize things, you're actually gonna move slower, right?

Harsh Thakkar (15:30)
Hmm.

Dan Cummings (15:48)
and you're going

Harsh Thakkar (15:48)
Hmm.

Dan Cummings (15:48)
to be biased. And you might not have the most cutting edge thinking. And you might have the one person that you do one time versus someone like on my teams that have done it hundreds of times, right? On the flip side, you're going to have those biotechs that are willing, that are provocative, that are eager to lean in, right? To this combined intelligence concept, to lean in to doing efficiency, but not at the expense of confidence and certainty. And so

Harsh Thakkar (15:57)
Right. Right.

Dan Cummings (16:14)
That's what ultimately predicates my decision.

Harsh Thakkar (16:18)
No, that's great that you brought up that. And I actually want to double click on that and go deeper. What are some other, I don't want to call them mistakes, mistakes is not the right word because every company has a sound strategy and they want to execute until it's too late and they find out that now they don't have time to revise it. So if you're talking about one third that are going to make it great, but out of the other 66 that might fail or that

Dan Cummings (16:24)
Yeah.

Harsh Thakkar (16:48)
you know, might be slowed down or may not make it. What are some of the things that or mistakes that they're doing that would cause them to miss that mark?

Dan Cummings (16:59)
Yeah, I love it. It's beginning with the beginning, quite literally. And so phase two, by the time you hit phase two, if your medical affairs function, commercial market access function, and R &D functions are not communicating routinely based upon the evidence generation, the evidence needed to be generated, not for today, but for when you're projected to launch, then you are missing the mark, right? So you have to start before you even got there.

Harsh Thakkar (17:14)
Mmm.

Dan Cummings (17:29)
So what happens is you can't catch up. If you ran a head-to-head versus an asset or a drug that no longer is what the clinical protocol expects from a head-to-head, then it's not impactful. It doesn't matter, right? And you could have caught that way sooner. And so in the end, I think you actually have to start in the beginning. You have to start at least at phase two to create that connectivity centered on evidence and be really purposeful to say, where are my evidence gaps? Not right now when I'm doing my clinical trial.

Harsh Thakkar (17:31)
Yeah.

Dan Cummings (17:59)
but for the five, the 10 years of projected into the future. And what are those stop gaps and those black swan events that could ultimately change the direction of my launch curve? That's one. Number two, I think the other thing is being real, really purposeful in how and where you spend your commercialization budget. No longer are the days of, know, throwing all at the field team, right?

Harsh Thakkar (18:03)
Hmm.

Dan Cummings (18:25)
And so you have to be thoughtful on who do you target, how do you target and how do you drive your uptake and really think in your commercial model, similar to how I run my teams. have five standards of performance, but really think from a position of first principles on rather than overspending, can I underspend and sequentially execute based upon my assets, current clinical differentiation and perceived clinical differentiation accordingly. Number three, how do you actually do number two? Cause that was really academic.

MSLs, bullish on MSLs personally. MSLs have the capability to talk to folks not from a sales perspective, but from really a clinical utility perspective. They have an understanding of the clinical protocol and how it's evolving uniquely, not only in a specific healthcare ecosystem, but at a specific health system, right? They have an understanding of what are the things that are going over the physicians in the patient's head. And so if you can actually collect,

distill, enhance all those medical science liaison notes that you're capturing. If you can coalesce it and add to that things that are going on in your publications, your congresses, your ad boards. If you can then build into that additional data to understand kind of how that aligns with your medical strategy, you can actually start to affect change rather than just building a top-down medical strategy and hoping for the best. Instead, you're building

Harsh Thakkar (19:55)
Right.

Dan Cummings (19:55)
A medical strategy bottoms up and you're iterating on it from a point of data. And the only way you can do that, cause no one does that well right now. That's a big, it's where the industry needs to go. The only way you can do that is connecting people, process, platform, like an AI and ultimately to drive that performance. so that's where the industry has to go. It's shifting that, that classic sales rep to more medical kind of focus in my point of view.

Harsh Thakkar (20:22)
Yeah, I agree with you 100 % because even doing consulting in the quality and compliance and technology management space, when I work with clients at Cultivate, I tell them the same thing, right? They wanna build a quality system. They wanna have a regulatory strategy. Like, yes, I can do all of that for them, but at the end of the day, if their people process systems, and by systems, I mean, softwares,

equipment, all that, and the data, right? Because now if you're doing manual, the data is on paper, but majority of companies are electronic. If you don't have your people process your tech and your data connected to each other or passing information like a relay race, you are not going to win that marathon. Like somebody is going to drop that relay or they're going to run in a different direction than the finish line.

Dan Cummings (20:59)
Yeah.

Harsh Thakkar (21:21)
That's what's happening. Like it sounds, you know, when people like me and you say this as consultants, feel like we're trying to be wise, but it's not. It really comes down just to those four.

Dan Cummings (21:26)
It's simple. All right.

And I would even pull further and that's what I like to call combined intelligence, right? And it's not easy to do at a company, but it's simple because all that falls down. can't just do the platform. You can't just do the data. Yet you have to do it all together and you actually have to change how your company works, right? You fundamentally have to change how your company makes decisions, how your company thinks from first principles, how your company

Harsh Thakkar (21:52)
Right.

Dan Cummings (21:58)
ultimately sees and does a high iteration of many tests to prove or disprove your hypothesis. So I love it. I love it. I'm absolutely...

Harsh Thakkar (22:07)
Yeah.

And you mentioned, it's not to go off topic, but you mentioned Black Swan events. I literally, my laptop is sitting on the hard copy of Black Swan from Naseem Taleb. So if anyone's interested in reading that book, highly recommend, check it out. It's really interesting. Let me share this other data here. This is also interesting because

Dan Cummings (22:22)
Yeah.

I love that.

Sure.

Harsh Thakkar (22:38)
When I was looking at the article from the other company about 69 products, it referenced this Sightline Biomed Tracker Report. And this is really interesting. I'm not going to go through it. It's like 80 pages or something. this is very interesting if you're an investor trying to target any of these specific therapeutic areas or...

If you're a consultant or a service provider trying to work with any of these companies, this is really interesting. And what's interesting here is this LOA. I wonder how they calculated this. I'm not sure, but it basically has a likelihood of acceptance, or likelihood of approval for each of these, every single drug here. And then at the end, it has an appendix.

Dan Cummings (23:27)
approval.

Harsh Thakkar (23:36)
with all the 69 or whatever drugs that are listed. So yeah, if anybody wants to nerd out, this is also a really interesting article or report.

Dan Cummings (23:46)
Absolutely. Fun fact we use here at Envision Pharma Group, a biomed tracker all the time to support how we think about who we want to help drive and partner with. And then ultimately leverage and beat up even that LOA, which is an algorithm, which is helpful, directional. And so that's a pretty powerful tool.

Harsh Thakkar (24:03)
Yeah. Yep. Yep.

Yeah, I wasn't sure how it's calculated, but I figured there's some algorithm. So we'll see if you can beat the biometracker algorithm with your prediction. We'll see. Yeah. Yeah, it's always fun to do that, right? But I want to ask you another philosophical question. When companies are going to market, right, we've heard this

Dan Cummings (24:20)
Hey, you said it here. We'll come back in a few years.

Absolutely.

Please.

Harsh Thakkar (24:37)
debate on why are some drugs, you know, $10,000 and others are 1.5 million. It's all about value, know, value based pricing. And, you know, if there's only 50 people in the world that need that drug, then obviously, you know, it's the access and demand is also in play. The question I want to ask you is what is your definition of value and access? And what are some of the other definitions in the industry that make you

go like, don't get this.

Dan Cummings (25:10)
Yeah, love it.

you know, I'll start with one interesting thing is the synonyms of value and access and market access. And you've seen recently, it kind of going up a level. I look at value access as the overarching arc. It's actually where I come from. Brings me all the way home. My first job ever, my first work ever. I was reading Obamacare and I had to summarize it for, you know, mid-sized pharma company on the impact of their market access strategies,

Harsh Thakkar (25:17)
Mm.

Right.

Dan Cummings (25:37)
That was a long thing to read, got to tell you. But it was interesting. Value and access. The way I look at value and access, quite honestly, is how do you ensure that organized customers understand the value of your drug and make sure that it gets to the patient? That's how I define it, which is much more of a tactical definition, I would say, than many would ultimately argue. But I look at it as a function that is

Harsh Thakkar (25:40)
Hahaha.

Mm-hmm.

Dan Cummings (26:06)
in the gauntlet fighting every day with these organized customers to help them understand the value. think number two, to your concept of the importance, the interesting piece 15 years ago is all sales and marketing. There's some stat, don't quote me on this, but I remember I looked at top 50 pharma, nearly 50 % of them held the bag at one moment or another right in their career. That's going down pretty precipitously. And what's happening is you see functions like value and access and medical affairs.

becoming more close on that table of decision making and more important. Because in the end, if you don't have a standing and situation and strategy that is sound, that is connected to your value and access strategy, which ensures organized customers understand your value, right? And that patients understand your value. It doesn't matter how strong your R &D was, just absolutely doesn't.

Harsh Thakkar (26:56)
Mm-hmm.

Dan Cummings (27:04)
So that's my definition, more tactical. I think where people sometimes miss the mark, market access or value and access is just coordinating with insurance companies and designing patient assistance programs. Value and access is everything from pricing to gross to net distribution rates. It's almost to myopic. That's why I like to bring it out a bit further personally in my experience.

I also see it as that trifecta of success. You can't do one without the other, right, ultimately to get drug to market. So it's pretty powerful. What have you heard? How about yourself?

Harsh Thakkar (27:39)
Mm-hmm.

Yeah, mean, I don't personally work much in the, you know, go to market or commercialization type of projects, but I feel like, I mean, I don't know much about access. Like, yes, if there are certain unmet needs and there's only a small percentage of population that is going to get access to that drug, I see why

developing that drug is gonna be more expensive than developing some other drugs where it's much easier to do the manufacturing and all of that, right? Because you already know a bit about the science compared to a completely unique product. But yeah, I don't get much involved in the pricing and all of that kind of stuff, mainly because...

once I, my goal is mainly to walk companies from phase one to get their BLA or ND approved. And from there on, I kind of take a back seat. that's why this is a, yeah, this is a very interesting conversation for me, because for me, for us, if if a client gets a BLA or ND approved, we're like popping champagne, right? Like for us, it's, yeah.

Dan Cummings (28:51)
Right, I love it.

Right. We did it. We made it. And then what's interesting

is how many times do you look at biotech, right? If you're an investor, the stock doesn't pop, right? Sometimes it falls quite literally. Then you say, my gosh, this biotech has no commercial infrastructure. They're not ready. And even thinking about it, right. And this is one of the simplest things. remember sitting with a client value noxious asked six questions. say, can you divide your clinical value to me in one sentence, your economic value in one sentence.

Harsh Thakkar (29:11)
Yeah, it does, yes.

Mmm.

Dan Cummings (29:31)
patient value in one sense. Then can you tell me market access wise, what are you doing right now to secure for formerly placement? What is your pricing strategy? And what are your reimbursement models and stakeholder engagement plan? If you can tell me those six things, I can help you. If you can't tell me any of those six things, that's exactly why we're talking, right? And that's what value and access ultimately is. And you have to start, like I said, at phase two. You can't say, you got approved today.

Harsh Thakkar (29:48)
Nice.

Right.

Dan Cummings (30:00)
Okay, let's start defining those items. You need to work from really the beginning, as we keep saying, and work in a way, right? And this is why in biotech, again, this concept of combined intelligence is important. You need to work in a way that's efficient, speed-driven, but not the expense, again, of confidentiality and confidence and certainty, right? That's ultimately the most important piece. And that's why biotech is moving fast, quite honestly.

Harsh Thakkar (30:02)
Hmm.

Yeah,

yeah. You know, talking to you for like the last 30 minutes, it's obvious that you are knee deep into this. You do a ton of research, go through a lot of reports and insights. What is what is a trend that you're seeing in, you know, either 2025 or the next five years, either in commercialization or go to market something? Are you seeing something new that's happening?

that is good for the industry and that other companies can also adapt.

Dan Cummings (31:00)
Yeah, yeah, that's a really good question. The number one trend I'm saying, I know I beat this, is the companies that will win, quote unquote, win and help the most patients and drive the most success and be the most cutting edge, whether that's in oncology via ADCs or doubling down in endocrinology on the next phase of weight loss and diabetes assets, or even, hey, what's a really underserved market?

Harsh Thakkar (31:18)
Mm-hmm.

Dan Cummings (31:29)
antibiotics, for example, or allergy or rare, rare disease. The companies that will win are going to figure out how to leverage AI not to replace, but to enhance the three functions of pharma, R &D, medical affairs, and ultimately value and access. That is the biggest thing that I would place a bet on right now, by and large, without going into the weeds of, therapeutic wise, what are the trends going into the weeds of

Harsh Thakkar (31:50)
Mm.

Dan Cummings (31:58)
structure wise company, what are the trends? I think this concept of AI enhancement, right? This concept of combined intelligence is where pharma has to go and why? And I love pharma, been in it forever. Pharma is 10 to 15 years behind some other industries. Take general commerce, e-commerce, exactly how they go to market, right? It's hyper, hyper to the nth degree personalized. And yes, there's regulatory differentiation between that and pharma.

Harsh Thakkar (32:16)
Right.

Yes.

Dan Cummings (32:28)
But that's where we're going. And that's the concept of combined intelligence.

Harsh Thakkar (32:33)
Yeah, it's interesting that you mentioned that because when I have said that to other people, they're like, no, pharma is not behind. Pharma is ahead. We're using AI. But I'm saying like, yeah, we might be using AI in R &D to analyze millions of... Yeah, yeah. Yeah, we're analyzing...

Dan Cummings (32:47)
correct.

which is beautiful, powerful, right? But we're not using

AI on positioning, on go to market, on personalization, on value and access, on medical, we're not using it at scale that's actually effective in driving what we need, efficiency, Confidence, certainty, and iteration from a first principles mindset, Which is really.

Harsh Thakkar (32:59)
Correct.

Yeah,

yeah. No, I agree with you. And also you mentioned the example of e-commerce, right? Like there's a lot of things to learn from that. Just if you take the example of, again, I'm only mentioning this because I can only think of this example, but if you think of Tesla and Elon, how they started selling cars, they learned from e-commerce that, you know, car buying, going to a dealership and sitting there and, you know, wasting your entire day.

is not a good way to buy a car, you should be just able to buy it online, just like you can buy anything from Amazon. And they completely took the car, like people were driving Teslas when there wasn't a Tesla car dealership in US. Right? so that's also, he stole that playbook from e-commerce and just now you have Carvana, CarMax, all these other companies that are reselling other cars because they figured out like, wow,

Dan Cummings (33:53)
Yep.

Exactly. Exactly.

Harsh Thakkar (34:15)
People do buy cars just by clicking a button on the internet and, you know, yeah.

Dan Cummings (34:19)
Right, right. And you know,

that's that's the funny thing I always say. I was talking to my team a while ago about this concept of like, what is an expert? Right. And what does it mean to be an expert? And I jokingly said, like, I am I am by no means an expert. actually hate experts. And the reason why is experts tend to be limited by what they believe. Right. And I truly believe that anything is possible and plausible as long as you think from a place of what is the what is the

Harsh Thakkar (34:41)
Mm-hmm.

Dan Cummings (34:49)
root cause that can drive XYZ outcome. And so, like you said, the more and more that we have Mavericks and Pharma driving that, the more and more that these providers like Envision Pharma that I work for now and the many thousands of companies push that concept, we as an industry are only gonna help more patients, period. And that's a beautiful place to be.

Harsh Thakkar (35:09)
Right.

Yeah, yeah. No, I like to think that, yeah, the industry is competitive. There is a lot of companies going on the race against similar type of products or therapeutic areas. But I feel like there's opportunities for everyone. I feel there's opportunities for everyone. And the point that you mentioned about AI, that trend of how to sort of

not be scared or not to look for replacing outright functions, but how to use it side by side to make it slightly better. think that's a trend we're gonna see in all phases of drug development and other areas as well.

Dan Cummings (35:53)
Absolutely, absolutely.

Harsh Thakkar (35:56)
Dan, I want to really thank you for your time for coming here. It's been really interesting. I wanted to do something different with this episode. I was researching these articles and I was like, okay, I'm just going to throw them on the screen and start the conversation going. And I really appreciate all your insights. Do you want to share with the audience how they can get in touch with you? I know you do some consulting, coaching on the side. You speak at other events and stuff.

Dan Cummings (36:20)
Please.

Yeah, please. So one, you can find me on LinkedIn. Very simple. We'll drop the link in here, but it's danielcoming.com. Number two, if you want to come directly my way, come to my work email right now. I work for Envision Pharma Group, is the number one powerhouse in medical affairs tech enabled solutions. So it's daniel.com. Let's connect. Let's talk at a very minimum. I like to meet new people.

Harsh Thakkar (36:49)
Yeah, that's it. That's the part. And before we drop off, I'm going to let the audience know that if you enjoyed this conversation, we have a few other episodes linked somewhere here. One is with the VP of Model N, which is a company that does a lot of work in the pricing. I had that guest on here, Jesse, who talked about the Inflation Reduction Act. So you might like that if you enjoyed this conversation. And the other one is

from a marketing expert who just talks about how to blend the science with storytelling. as you heard Dan say today, science is where the industry is great at, but how do you take that science and convert it into a product and put it into hands of the patient? That's ultimately what every company is shooting for. So check out those episodes and I'll see you in the next one.Harsh Thakkar (00:01)
All right, have you ever wondered what are some of the challenges that pharmaceutical companies face when they go to market after spending years and billions of dollars in clinical trials and regulatory approvals? Let me show you some interesting data.

So as I was preparing for, oops, wrong screen.

So as I was preparing for this episode, the one question that I had in my mind, and I'm not gonna tell you, I'll tell you more about the guest, but the one question I had in my mind as soon as I knew I was gonna be talking to this guest is, what are the new therapies that are coming out in 2025? And I landed on this article out of bunch of other resources. So I wanted to share this because this is going to set the context of the stuff we're gonna be talking about today.

So this article tells me there are 69 new approvals across 66 discreet drugs. 35 are gonna be unique. And if I further dive into the data, it tells me oncology is one of the most represented therapeutic areas. There's gonna be 14 different tumor types that are likely to see treatment options. And this infographic is pretty cool if you are wondering, by the way,

If you're listening to this episode on your phone, I know it might be hard to grasp with what I'm going on here with the infographics and stats. So we also have a YouTube version of this podcast. So if you're interested in following along, please go and check out the YouTube video. That way you get to follow along the data points and also see what I look like and what my guests going to look like. So back to this data point, right? So we have oncology that I already mentioned up here.

We have tons of other therapeutic areas that you can see here. I'm going to scroll down. Okay, this is interesting. If we want to look at modality, small molecules, looks like is half of the launches, maybe close enough. We have some in RNA and gene therapy. I was hoping gene therapy would be a bit more louder. I'm kind of surprised that it's only four, but okay.

And then here's the bottom line, right? So why am I sharing this article? I'm sharing this article because when you look at all these data points, obviously, you know, if you're in life sciences industry, you're super excited. If you're working with any of these companies who are developing these products, you're very busy, you're working on interesting stuff and, you know, looking forward to that end goal in mind. But these companies...

getting through clinical trials and regulatory approvals is only half the battle, right? Like this article says. The other half is how do you commercialize that product? How do you go to market? How do you define value and patient access? All these different things. And because of that, the guest I have today is Dan Cummings. He is one of the most sought after leaders in the industry for go-to-market strategy and

He's consulted with some of the top health tech and med tech and biotech startups. And I really wanted to pick his brain and talk about this. But before I ask him tons of questions, Dan, welcome to the show. What are your opening remarks on these data points?

Dan Cummings (03:37)
Absolutely. one fun fact that actually works for a company that is owned by the data that's pulled here that in a previous life. So it feels like I'm coming home. One of the most surprising things that I've ever said when I've talked to hundreds of

Harsh Thakkar (03:46)
Okay.

Dan Cummings (03:54)
It really comes down to data, right? It really comes down to data and kind of five key data points that ground us in the actions that need to be taken and the sheer amount of things that have to go right, ultimately even to get to commercialization. What's the most important piece to all of that? And I'll share the data in a second, is it really starts all the way back in phase one. It doesn't start when the FDA or another regulatory body across the world approves your drug.

starts all the way back in phase one. Can obviously go deeper, second, but do you want me to jump into the data?

Harsh Thakkar (04:31)
Yeah, yeah, let me share. Do you want me to share it again?

Dan Cummings (04:32)
Perfect.

Nope, can hit, I'll hit some data points that matter and then I'll jump into why that all matters and what's the number one. So what's the data? One of the things that I always like to look at, there was an MIT study back in 2018, somewhat dated, but candidly, the numbers look very similar right now. I'll begin with the headline. Even if you get to phase three, even if you get to phase three, you have a 50-50 shot of getting to approval. That's not the best odds, right? If you go all the way back to phase two,

Harsh Thakkar (04:39)
Yes.

Yep, go ahead.

Mm. Yeah.

Dan Cummings (05:05)
you have a 15 % shot of getting the proof. If you go back to phase one, less than 10%. And even when you get all the way past phase three and you submit an NDA or BLA, it's still not 100 % shot, it's about an 85%. And why is that? Well, one, of course, R &D and science. But number two is ultimately this concept of connectivity and centralization of evidence. And what we're seeing, the number one thing I'm seeing across

Harsh Thakkar (05:29)
Mmm.

Dan Cummings (05:35)
the hundreds of companies we help at the company I work with right now, folks that I advise, is everything's centered around evidence. And when you look at how a pharma company or biotech set up, and the reason why biotechs can move faster by and large than pharma, is you have an R &D function, you have a medical affairs function, and then eventually, right, pending how mature you are as a company, you have a commercial and value or market access function. And they don't all talk to each other. But what's interesting,

Harsh Thakkar (05:43)
Hmm.

Dan Cummings (06:05)
is more and more every day we're seeing medical affairs be at the center of research and development and commercial and value and access. And they're really helping connect the dots in this new model of commercialization. And we're seeing medical affairs teams fulfill increasing responsibilities, not just be publications, not just generate data, but become leaders, become strategists around evidence, both the curation and the action that comes from that evidence, right?

And that's evidence around what patients, you know, will be most impacted and why that's evidence around how am I differentiated versus the treatment protocols of today? And more importantly, the treatment protocols of when I hit the market or projected to hit the market, they focus on engagement, right? How do you start to create those unique customer relationships? And really most importantly, education. You could have the greatest science in the world, but no one gets it. Gene therapies, great example. You talk more in a great example of no one gets it.

Harsh Thakkar (07:00)
Yeah.

Dan Cummings (07:03)
both on the clinical side and then ultimately the patient side, the asset's not gonna do great, right? The product's not going to take off. The product will not sell itself, especially in the environment we're in today. So that's the biggest thing that I've been seeing personally as it relates to the various companies we work with. And then taking that even further, not only is medical affairs being at the center of all that evidence kind of triangle, right? But you need to move in a faster and more efficient way today.

Harsh Thakkar (07:14)
Yeah.

Dan Cummings (07:32)
to actually meet the needs of the market we're in. And quite literally, if you pull way back, and I think back to my digital health experience, there's an expectation of ruthless customer centricity, as I like to call it. In a world that I can click one button and get something in my door in minutes, the same human beings that do that are patients, are doctors, are nurses, are executives at...

Harsh Thakkar (07:35)
Hmm.

Yeah.

Dan Cummings (07:57)
PBMs and health insurance companies. And so we start to think that way and we can go into that more as we talk. But excited for the chat.

Harsh Thakkar (08:03)
Yeah.

Yeah, yeah. And, you know, one of the things that I have, you know, I wanted to ask you is you obviously have tons of experience on the, you know, phase three or going from phase three to commercialization. I know I've had people on this podcast who are, you know, scientists and researchers who are, you know, playing like earlier in the preclinical or like

you know research and development stage and then I have others who are in the middle who are Getting the drugs approved and you know going through the regulatory milestones when you look at your career Did you always want to be in this like later stage of the game like taking companies? helping companies go to market or Did that happen because of any opportunities that came along your

Dan Cummings (08:55)
Yeah, absolutely. I always like to begin at the start, right? So I come from, you know, a very modest place in Northern New Jersey. My father was a car salesman. And so ultimately, I remember being a young guy sitting next to him crafting deals, right? Because there was no daycare. We didn't have money for daycare, quite literally. One of the pieces that over that time I like to, and I figured out, is I like to solve really hard problems. And so over the last, you know, 15 or so years, I started my career, like we said, as a consultant.

Harsh Thakkar (08:57)
Yeah.

Yeah.

Mm-hmm.

Dan Cummings (09:23)
I started at a company that was previously known as DRG, got gobbled up, and then went to a tiny company called the Dedum Group and scaled with them. And eventually they got acquired by North Stella. And it was really at the Dedum Group that I had this aha moment. We're at the Dedum Group, we were hyper-focused on working on the most cutting edge specialty therapeutics, doing value access, distribution designs. And I worked with this company that eventually, and I won't name them, but Gob got

got acquired by Advie for $21 billion. And in doing that, we worked so closely with them, we were really designing how do they make sure that their drug gets from the company to the patient, and it's supported in every step of the way. And I had this aha moment when I was doing that project. I said, well, I'm doing all this work and putting in hundreds of hours to build a strategy for a company that just got acquired for $21 billion. And I don't even know if they're going to execute it.

Harsh Thakkar (09:55)
Mmm.

Dan Cummings (10:20)
All right. And I've never executed and I had this aha that I need to learn how to execute. And so I purposely picked a mission where I could help grow companies and scale, go to market functions, whether that's business development, partnerships, affiliations, reb, ops, sales, ops, marketing, corp, comms, right. I purposely picked a career path where I could help organizations both rebuild that's private equity backed or build from zero venture capital back on how.

Harsh Thakkar (10:22)
to write.

Dan Cummings (10:50)
to affect that tip of the spear of revenue production in a way that is both impactful to humanity. And that's a broad statement, but that's why I like life sciences. The other reason why did I even go into life sciences? Quite honestly, I have a history of cancer in my family. Luckily, no one has passed, but my mother beat cancer twice. And so from day zero, it either do want to be a doctor or do I want to work in the business of life sciences?

Harsh Thakkar (10:53)
Right.

Yeah.

Yeah.

Dan Cummings (11:18)
And I landed on the ladder for many, many reasons and haven't.

Harsh Thakkar (11:23)
Yeah, no, that's a of respect to you and the toughness for your mother and everything that you guys have to go through. It's not easy. I don't have anybody in my family with cancer, but I know people with other conditions. And it's always good when you work in the industry and you can connect the dots to the deeper purpose of your job. Otherwise, mean, we're all behind computers doing stuff, but you

Dan Cummings (11:49)
Absolutely.

Harsh Thakkar (11:52)
It's hard to find purpose.

Dan Cummings (11:54)
I absolutely wake up every day and it reminds me explicitly as to why.

Harsh Thakkar (12:00)
I want to ask you a wild prediction time. Sorry to put you on a spot, but when you see 69 launches in 2025, based on your years of consulting experience, working with companies, either going through successful launches or in parallel to going with the launch, getting acquired. That happened to me when I was at Juno Therapeutics and our CAR-T product was

Dan Cummings (12:04)
Let's do it.

Harsh Thakkar (12:28)
had really positive signs of being commercialized, we were acquired by Celgene and then within months we were acquired by BMS, right? Because they saw the potential and they were competing with Novartis that had acquired Avexis for the Zolgesma drug. So the prediction question I have for you is out of these 69, how many do you think will make it by end of 2025?

Dan Cummings (12:37)
Yeah.

I would say

less than a third will meet their launch curve expectations. And ultimately, right, that doesn't mean that the rest will fail. They're just going to miss expectations. Secondarily, would just say to you, Celgene, which is now BMS, is about a mile from where I live today. So it comes home. I drive right past Celgene to drive all the time. But less than a third is my provocative prediction. And candidly, the reason I say that, because you can't just throw out a crazy number.

Harsh Thakkar (12:58)
Wow.

Okay.

Nice.

Okay.

Mm-hmm.

Dan Cummings (13:23)
is there's a very big cost-reductive mindset, not just in pharma, but by and large across the globe and across many different verticals. It's especially loud, that cost-reductive mindset in large pharma. And large pharma is looking at and kind of moving towards this internalization mindset. Suddenly large pharma is doing a lot more work than, I'm going to build my own tech, my own AI, my own omnichannel, my own business insight, my own marketing.

Harsh Thakkar (13:47)
Hmm.

Dan Cummings (13:53)
Right. And that's okay, but it is a concentric circle or two out from what they're the great at, which is science, right. And impacting patients' lives. And so large pharma has been especially looking at AI, not as a augmenter, but as a reason to push their providers, their people that help support them, whether they're advisory consultancies, their agencies that create content, their tech providers or AI providers.

to lower their prices, right? Now on the flip side, what I'm seeing is in biotech, which is on bullish on, right? Very bullish on biotech. Where you're from, right? And originally came from this. You're seeing the biotechs look at how can I use partnerships, both in AI, technology services, and so on and so forth, to really have more speed and efficiency, but not at the expense of confidence and certainty, right?

So the thing that's powerful with that, and I was just talking with a couple of biotech executives the other day, one of the things we have to position our company, the company Envision Farmer Group, is we do and provide combined intelligence. Buzzword, combined intelligence. You'll start to hear it, right? What is combined intelligence? It's not blockchain. We're not going go back to that. But what combined intelligence really is, is this concept of AI enhanced, of surrounded by human beings.

Harsh Thakkar (15:17)
Hmm.

Dan Cummings (15:19)
that can both interpret the so what and help your company learn how to fish, right? Because just because you have these tools doesn't mean you know how to use these tools. And so I come to a third. Why? Because in a cost-reducted mindset where most of the total addressable market is in large, large mid-pharma, 60 % of the total addressable market of SG &A spend, if you're in cost-reducted and you're trying to internalize things, you're actually gonna move slower, right?

Harsh Thakkar (15:30)
Hmm.

Dan Cummings (15:48)
and you're going

Harsh Thakkar (15:48)
Hmm.

Dan Cummings (15:48)
to be biased. And you might not have the most cutting edge thinking. And you might have the one person that you do one time versus someone like on my teams that have done it hundreds of times, right? On the flip side, you're going to have those biotechs that are willing, that are provocative, that are eager to lean in, right? To this combined intelligence concept, to lean in to doing efficiency, but not at the expense of confidence and certainty. And so

Harsh Thakkar (15:57)
Right. Right.

Dan Cummings (16:14)
That's what ultimately predicates my decision.

Harsh Thakkar (16:18)
No, that's great that you brought up that. And I actually want to double click on that and go deeper. What are some other, I don't want to call them mistakes, mistakes is not the right word because every company has a sound strategy and they want to execute until it's too late and they find out that now they don't have time to revise it. So if you're talking about one third that are going to make it great, but out of the other 66 that might fail or that

Dan Cummings (16:24)
Yeah.

Harsh Thakkar (16:48)
you know, might be slowed down or may not make it. What are some of the things that or mistakes that they're doing that would cause them to miss that mark?

Dan Cummings (16:59)
Yeah, I love it. It's beginning with the beginning, quite literally. And so phase two, by the time you hit phase two, if your medical affairs function, commercial market access function, and R &D functions are not communicating routinely based upon the evidence generation, the evidence needed to be generated, not for today, but for when you're projected to launch, then you are missing the mark, right? So you have to start before you even got there.

Harsh Thakkar (17:14)
Mmm.

Dan Cummings (17:29)
So what happens is you can't catch up. If you ran a head-to-head versus an asset or a drug that no longer is what the clinical protocol expects from a head-to-head, then it's not impactful. It doesn't matter, right? And you could have caught that way sooner. And so in the end, I think you actually have to start in the beginning. You have to start at least at phase two to create that connectivity centered on evidence and be really purposeful to say, where are my evidence gaps? Not right now when I'm doing my clinical trial.

Harsh Thakkar (17:31)
Yeah.

Dan Cummings (17:59)
but for the five, the 10 years of projected into the future. And what are those stop gaps and those black swan events that could ultimately change the direction of my launch curve? That's one. Number two, I think the other thing is being real, really purposeful in how and where you spend your commercialization budget. No longer are the days of, know, throwing all at the field team, right?

Harsh Thakkar (18:03)
Hmm.

Dan Cummings (18:25)
And so you have to be thoughtful on who do you target, how do you target and how do you drive your uptake and really think in your commercial model, similar to how I run my teams. have five standards of performance, but really think from a position of first principles on rather than overspending, can I underspend and sequentially execute based upon my assets, current clinical differentiation and perceived clinical differentiation accordingly. Number three, how do you actually do number two? Cause that was really academic.

MSLs, bullish on MSLs personally. MSLs have the capability to talk to folks not from a sales perspective, but from really a clinical utility perspective. They have an understanding of the clinical protocol and how it's evolving uniquely, not only in a specific healthcare ecosystem, but at a specific health system, right? They have an understanding of what are the things that are going over the physicians in the patient's head. And so if you can actually collect,

distill, enhance all those medical science liaison notes that you're capturing. If you can coalesce it and add to that things that are going on in your publications, your congresses, your ad boards. If you can then build into that additional data to understand kind of how that aligns with your medical strategy, you can actually start to affect change rather than just building a top-down medical strategy and hoping for the best. Instead, you're building

Harsh Thakkar (19:55)
Right.

Dan Cummings (19:55)
A medical strategy bottoms up and you're iterating on it from a point of data. And the only way you can do that, cause no one does that well right now. That's a big, it's where the industry needs to go. The only way you can do that is connecting people, process, platform, like an AI and ultimately to drive that performance. so that's where the industry has to go. It's shifting that, that classic sales rep to more medical kind of focus in my point of view.

Harsh Thakkar (20:22)
Yeah, I agree with you 100 % because even doing consulting in the quality and compliance and technology management space, when I work with clients at Cultivate, I tell them the same thing, right? They wanna build a quality system. They wanna have a regulatory strategy. Like, yes, I can do all of that for them, but at the end of the day, if their people process systems, and by systems, I mean, softwares,

equipment, all that, and the data, right? Because now if you're doing manual, the data is on paper, but majority of companies are electronic. If you don't have your people process your tech and your data connected to each other or passing information like a relay race, you are not going to win that marathon. Like somebody is going to drop that relay or they're going to run in a different direction than the finish line.

Dan Cummings (20:59)
Yeah.

Harsh Thakkar (21:21)
That's what's happening. Like it sounds, you know, when people like me and you say this as consultants, feel like we're trying to be wise, but it's not. It really comes down just to those four.

Dan Cummings (21:26)
It's simple. All right.

And I would even pull further and that's what I like to call combined intelligence, right? And it's not easy to do at a company, but it's simple because all that falls down. can't just do the platform. You can't just do the data. Yet you have to do it all together and you actually have to change how your company works, right? You fundamentally have to change how your company makes decisions, how your company thinks from first principles, how your company

Harsh Thakkar (21:52)
Right.

Dan Cummings (21:58)
ultimately sees and does a high iteration of many tests to prove or disprove your hypothesis. So I love it. I love it. I'm absolutely...

Harsh Thakkar (22:07)
Yeah.

And you mentioned, it's not to go off topic, but you mentioned Black Swan events. I literally, my laptop is sitting on the hard copy of Black Swan from Naseem Taleb. So if anyone's interested in reading that book, highly recommend, check it out. It's really interesting. Let me share this other data here. This is also interesting because

Dan Cummings (22:22)
Yeah.

I love that.

Sure.

Harsh Thakkar (22:38)
When I was looking at the article from the other company about 69 products, it referenced this Sightline Biomed Tracker Report. And this is really interesting. I'm not going to go through it. It's like 80 pages or something. this is very interesting if you're an investor trying to target any of these specific therapeutic areas or...

If you're a consultant or a service provider trying to work with any of these companies, this is really interesting. And what's interesting here is this LOA. I wonder how they calculated this. I'm not sure, but it basically has a likelihood of acceptance, or likelihood of approval for each of these, every single drug here. And then at the end, it has an appendix.

Dan Cummings (23:27)
approval.

Harsh Thakkar (23:36)
with all the 69 or whatever drugs that are listed. So yeah, if anybody wants to nerd out, this is also a really interesting article or report.

Dan Cummings (23:46)
Absolutely. Fun fact we use here at Envision Pharma Group, a biomed tracker all the time to support how we think about who we want to help drive and partner with. And then ultimately leverage and beat up even that LOA, which is an algorithm, which is helpful, directional. And so that's a pretty powerful tool.

Harsh Thakkar (24:03)
Yeah. Yep. Yep.

Yeah, I wasn't sure how it's calculated, but I figured there's some algorithm. So we'll see if you can beat the biometracker algorithm with your prediction. We'll see. Yeah. Yeah, it's always fun to do that, right? But I want to ask you another philosophical question. When companies are going to market, right, we've heard this

Dan Cummings (24:20)
Hey, you said it here. We'll come back in a few years.

Absolutely.

Please.

Harsh Thakkar (24:37)
debate on why are some drugs, you know, $10,000 and others are 1.5 million. It's all about value, know, value based pricing. And, you know, if there's only 50 people in the world that need that drug, then obviously, you know, it's the access and demand is also in play. The question I want to ask you is what is your definition of value and access? And what are some of the other definitions in the industry that make you

go like, don't get this.

Dan Cummings (25:10)
Yeah, love it.

you know, I'll start with one interesting thing is the synonyms of value and access and market access. And you've seen recently, it kind of going up a level. I look at value access as the overarching arc. It's actually where I come from. Brings me all the way home. My first job ever, my first work ever. I was reading Obamacare and I had to summarize it for, you know, mid-sized pharma company on the impact of their market access strategies,

Harsh Thakkar (25:17)
Mm.

Right.

Dan Cummings (25:37)
That was a long thing to read, got to tell you. But it was interesting. Value and access. The way I look at value and access, quite honestly, is how do you ensure that organized customers understand the value of your drug and make sure that it gets to the patient? That's how I define it, which is much more of a tactical definition, I would say, than many would ultimately argue. But I look at it as a function that is

Harsh Thakkar (25:40)
Hahaha.

Mm-hmm.

Dan Cummings (26:06)
in the gauntlet fighting every day with these organized customers to help them understand the value. think number two, to your concept of the importance, the interesting piece 15 years ago is all sales and marketing. There's some stat, don't quote me on this, but I remember I looked at top 50 pharma, nearly 50 % of them held the bag at one moment or another right in their career. That's going down pretty precipitously. And what's happening is you see functions like value and access and medical affairs.

becoming more close on that table of decision making and more important. Because in the end, if you don't have a standing and situation and strategy that is sound, that is connected to your value and access strategy, which ensures organized customers understand your value, right? And that patients understand your value. It doesn't matter how strong your R &D was, just absolutely doesn't.

Harsh Thakkar (26:56)
Mm-hmm.

Dan Cummings (27:04)
So that's my definition, more tactical. I think where people sometimes miss the mark, market access or value and access is just coordinating with insurance companies and designing patient assistance programs. Value and access is everything from pricing to gross to net distribution rates. It's almost to myopic. That's why I like to bring it out a bit further personally in my experience.

I also see it as that trifecta of success. You can't do one without the other, right, ultimately to get drug to market. So it's pretty powerful. What have you heard? How about yourself?

Harsh Thakkar (27:39)
Mm-hmm.

Yeah, mean, I don't personally work much in the, you know, go to market or commercialization type of projects, but I feel like, I mean, I don't know much about access. Like, yes, if there are certain unmet needs and there's only a small percentage of population that is going to get access to that drug, I see why

developing that drug is gonna be more expensive than developing some other drugs where it's much easier to do the manufacturing and all of that, right? Because you already know a bit about the science compared to a completely unique product. But yeah, I don't get much involved in the pricing and all of that kind of stuff, mainly because...

once I, my goal is mainly to walk companies from phase one to get their BLA or ND approved. And from there on, I kind of take a back seat. that's why this is a, yeah, this is a very interesting conversation for me, because for me, for us, if if a client gets a BLA or ND approved, we're like popping champagne, right? Like for us, it's, yeah.

Dan Cummings (28:51)
Right, I love it.

Right. We did it. We made it. And then what's interesting

is how many times do you look at biotech, right? If you're an investor, the stock doesn't pop, right? Sometimes it falls quite literally. Then you say, my gosh, this biotech has no commercial infrastructure. They're not ready. And even thinking about it, right. And this is one of the simplest things. remember sitting with a client value noxious asked six questions. say, can you divide your clinical value to me in one sentence, your economic value in one sentence.

Harsh Thakkar (29:11)
Yeah, it does, yes.

Mmm.

Dan Cummings (29:31)
patient value in one sense. Then can you tell me market access wise, what are you doing right now to secure for formerly placement? What is your pricing strategy? And what are your reimbursement models and stakeholder engagement plan? If you can tell me those six things, I can help you. If you can't tell me any of those six things, that's exactly why we're talking, right? And that's what value and access ultimately is. And you have to start, like I said, at phase two. You can't say, you got approved today.

Harsh Thakkar (29:48)
Nice.

Right.

Dan Cummings (30:00)
Okay, let's start defining those items. You need to work from really the beginning, as we keep saying, and work in a way, right? And this is why in biotech, again, this concept of combined intelligence is important. You need to work in a way that's efficient, speed-driven, but not the expense, again, of confidentiality and confidence and certainty, right? That's ultimately the most important piece. And that's why biotech is moving fast, quite honestly.

Harsh Thakkar (30:02)
Hmm.

Yeah,

yeah. You know, talking to you for like the last 30 minutes, it's obvious that you are knee deep into this. You do a ton of research, go through a lot of reports and insights. What is what is a trend that you're seeing in, you know, either 2025 or the next five years, either in commercialization or go to market something? Are you seeing something new that's happening?

that is good for the industry and that other companies can also adapt.

Dan Cummings (31:00)
Yeah, yeah, that's a really good question. The number one trend I'm saying, I know I beat this, is the companies that will win, quote unquote, win and help the most patients and drive the most success and be the most cutting edge, whether that's in oncology via ADCs or doubling down in endocrinology on the next phase of weight loss and diabetes assets, or even, hey, what's a really underserved market?

Harsh Thakkar (31:18)
Mm-hmm.

Dan Cummings (31:29)
antibiotics, for example, or allergy or rare, rare disease. The companies that will win are going to figure out how to leverage AI not to replace, but to enhance the three functions of pharma, R &D, medical affairs, and ultimately value and access. That is the biggest thing that I would place a bet on right now, by and large, without going into the weeds of, therapeutic wise, what are the trends going into the weeds of

Harsh Thakkar (31:50)
Mm.

Dan Cummings (31:58)
structure wise company, what are the trends? I think this concept of AI enhancement, right? This concept of combined intelligence is where pharma has to go and why? And I love pharma, been in it forever. Pharma is 10 to 15 years behind some other industries. Take general commerce, e-commerce, exactly how they go to market, right? It's hyper, hyper to the nth degree personalized. And yes, there's regulatory differentiation between that and pharma.

Harsh Thakkar (32:16)
Right.

Yes.

Dan Cummings (32:28)
But that's where we're going. And that's the concept of combined intelligence.

Harsh Thakkar (32:33)
Yeah, it's interesting that you mentioned that because when I have said that to other people, they're like, no, pharma is not behind. Pharma is ahead. We're using AI. But I'm saying like, yeah, we might be using AI in R &D to analyze millions of... Yeah, yeah. Yeah, we're analyzing...

Dan Cummings (32:47)
correct.

which is beautiful, powerful, right? But we're not using

AI on positioning, on go to market, on personalization, on value and access, on medical, we're not using it at scale that's actually effective in driving what we need, efficiency, Confidence, certainty, and iteration from a first principles mindset, Which is really.

Harsh Thakkar (32:59)
Correct.

Yeah,

yeah. No, I agree with you. And also you mentioned the example of e-commerce, right? Like there's a lot of things to learn from that. Just if you take the example of, again, I'm only mentioning this because I can only think of this example, but if you think of Tesla and Elon, how they started selling cars, they learned from e-commerce that, you know, car buying, going to a dealership and sitting there and, you know, wasting your entire day.

is not a good way to buy a car, you should be just able to buy it online, just like you can buy anything from Amazon. And they completely took the car, like people were driving Teslas when there wasn't a Tesla car dealership in US. Right? so that's also, he stole that playbook from e-commerce and just now you have Carvana, CarMax, all these other companies that are reselling other cars because they figured out like, wow,

Dan Cummings (33:53)
Yep.

Exactly. Exactly.

Harsh Thakkar (34:15)
People do buy cars just by clicking a button on the internet and, you know, yeah.

Dan Cummings (34:19)
Right, right. And you know,

that's that's the funny thing I always say. I was talking to my team a while ago about this concept of like, what is an expert? Right. And what does it mean to be an expert? And I jokingly said, like, I am I am by no means an expert. actually hate experts. And the reason why is experts tend to be limited by what they believe. Right. And I truly believe that anything is possible and plausible as long as you think from a place of what is the what is the

Harsh Thakkar (34:41)
Mm-hmm.

Dan Cummings (34:49)
root cause that can drive XYZ outcome. And so, like you said, the more and more that we have Mavericks and Pharma driving that, the more and more that these providers like Envision Pharma that I work for now and the many thousands of companies push that concept, we as an industry are only gonna help more patients, period. And that's a beautiful place to be.

Harsh Thakkar (35:09)
Right.

Yeah, yeah. No, I like to think that, yeah, the industry is competitive. There is a lot of companies going on the race against similar type of products or therapeutic areas. But I feel like there's opportunities for everyone. I feel there's opportunities for everyone. And the point that you mentioned about AI, that trend of how to sort of

not be scared or not to look for replacing outright functions, but how to use it side by side to make it slightly better. think that's a trend we're gonna see in all phases of drug development and other areas as well.

Dan Cummings (35:53)
Absolutely, absolutely.

Harsh Thakkar (35:56)
Dan, I want to really thank you for your time for coming here. It's been really interesting. I wanted to do something different with this episode. I was researching these articles and I was like, okay, I'm just going to throw them on the screen and start the conversation going. And I really appreciate all your insights. Do you want to share with the audience how they can get in touch with you? I know you do some consulting, coaching on the side. You speak at other events and stuff.

Dan Cummings (36:20)
Please.

Yeah, please. So one, you can find me on LinkedIn. Very simple. We'll drop the link in here, but it's danielcoming.com. Number two, if you want to come directly my way, come to my work email right now. I work for Envision Pharma Group, is the number one powerhouse in medical affairs tech enabled solutions. So it's daniel.com. Let's connect. Let's talk at a very minimum. I like to meet new people.

Harsh Thakkar (36:49)
Yeah, that's it. That's the part. And before we drop off, I'm going to let the audience know that if you enjoyed this conversation, we have a few other episodes linked somewhere here. One is with the VP of Model N, which is a company that does a lot of work in the pricing. I had that guest on here, Jesse, who talked about the Inflation Reduction Act. So you might like that if you enjoyed this conversation. And the other one is

from a marketing expert who just talks about how to blend the science with storytelling. as you heard Dan say today, science is where the industry is great at, but how do you take that science and convert it into a product and put it into hands of the patient? That's ultimately what every company is shooting for. So check out those episodes and I'll see you in the next one.