Harsh Thakkar (00:12)
All right, so working with small companies and startups, I can tell you that they are often struggling with tight budgets, they have a lot of regulatory challenges, and they have very few people that are trying to achieve the same goal, which is how to get a product from early stages of research and development to clinical trials and into patients' hands or...

clinics or hospitals and get through the commercialization hurdles. Now they don't have a lot of resources and a lot of times even when these companies have a promising product, getting that product into market in front of the right people feels like running a marathon, right? So what if I told you the secret that for these companies, it's not always about spending more money. Yes, you can throw more money at a problem and that's one way to solve it, but the other way is to be more creative,

to operate in a lean fashion and to think about getting commercialization in a more creative and a smarter way. And because of that reason, I've been trying to find a person who can come on this podcast and talk to us about this specific topic and how can smaller startups and companies win the commercialization game and also compete, not just win, but also compete with Big Pharma.

in this challenging landscape. all that said, my guest today is John Harlow. He has over two decades of experience turning small pharma companies into high-performing machines. He's managed profit and loss statements from 35 million to 500 million and worked with big pharma companies like Pfizer and Novartis. And today, John is the chief commercial officer of Melinda Therapeutics.

And we're gonna dive into this conversation, talk to him and learn what insights he has for smaller startups and how can they get into defining the early commercialization strategies. So let's dive into this conversation and welcome John. Welcome to the show.

John Harlow (02:31)
Thank you, Harsh. Happy to be here. Looking forward to it.

Harsh Thakkar (02:33)
Yeah, for our audience that have not heard of Melinda Therapeutics, I've been researching a bit this week to prep for this episode, but what's your elevator pitch or a 30,000-foot overview of the portfolio or the focus of the company?

John Harlow (02:51)
Yeah, Melinta is a small company, which is focused in the hospital and acute care ecosystem. have a portfolio of anti-infectives ranging from antibacterial products, antibiotics, to an antifungal. We've coming off of a record year, 2024. So it's nice to be here, given the results that we've been able to drive over the last few years.

And our mission and vision is very much around ensuring that patients receive our life-saving therapies.

Harsh Thakkar (03:29)
Yeah, and you mentioned about having a record year, And to be honest with you, the last 10 calls I've had with companies and agencies and everybody in the life sciences ecosystem, I think you are one of the few people that have said that the last year was a record year. For everybody else, was, for some it was a struggle, for others nothing really changed. So it's great to hear that, you

Melinda is having this much success. As since our focus of today's episode is focusing on commercialization and the challenges, when we talk about commercialization, immediately we start thinking about Big Pharma and what they can do. We don't really focus or talk about the challenges in startups or even if you read a blog article or some deep analysis,

done by editor, they're mostly focusing on the top 20 or the top 50 companies. At least that's what I've seen. So from your experience, since you are in this smaller startup type company, what are some of the challenges that you want to shed light on that maybe don't get talked about much?

John Harlow (04:44)
Yeah, absolutely. So having worked at very large companies and now very small companies, it really comes down to resource constraints and prioritization. And I think for the viewers, I often bucket it into two types of small companies. One is a small company that is a clinical stage company and making that transition to become a commercial company or like Melinda.

We have an established infrastructure. We have a commercial team, and we're looking to continue to grow and be successful as a small commercial organization. And so the challenges in both of those settings, are a little bit different. When you're pivoting from a clinical stage organization to a commercial stage organization, the unique challenges that come along with that is one,

How long is your cash going to last? Right? How long is that runway? And that's a function of what do you think the market opportunity is for the product or products that you're going to launch? What do you think the expense profile and the spend is going to be to support that? And you have to really scenario plan at that point, right? You can't, you know.

Prepare for complete success because things happen, which I know we'll talk about and get in during this discussion. so managing that provides a lot of unique challenges. On the other side of the coin, so to speak, with companies that already have a commercial infrastructure, but they're still small and they're still commercializing, you still have resource constraints. And there you really need to focus on

Harsh Thakkar (06:34)
Hmm.

John Harlow (06:37)
How do you prioritize? How do you cite scenario plan where your new launch product may be great. It may not do as well as you like. And what, what impact does that have on the rest of the portfolio and the people? So I often look at commercialization in new companies, either is this your first time or is this your second, third or fourth time as an organization?

But at the end of the day, the common challenge in both scenarios is your resource constraint. You have to learn and unfortunately enjoy building the plane and flying it at the same time.

Harsh Thakkar (07:10)
Hmm.

Right, yeah, that's a great way to put it because even for us, being a consulting or a service, professional services organization, when we work with startups, we see this same difference, right? So we're mainly in the quality, compliance, technology management, data management space. But if I work with a 10 person startup to solve the same exact project or

do the same exact project versus a 5,000 person company, it's a very different mindset. I would argue that maybe the time is faster for the smaller companies, because when you get to bigger companies, you have more layers, you have more stakeholders. Decisions are, I think the advantage for the smaller companies is that the decision making can be faster if you get the right people involved.

And that's a big advantage across the board. I'm guessing even in commercialization, you would say that decision making is much faster and that's an advantage,

John Harlow (08:18)
school.

Absolutely, not only decision making, would say decision making and remaking, right? You have the ability to make a decision walking from around the corner in the office. And sometimes on your way back, you can rethink that decision and then go ahead and execute. And that is one of the benefits of being at a smaller company that I've always enjoyed is you can move more quickly. You can be small in them.

Harsh Thakkar (08:35)
Mm-hmm.

Yeah,

yeah, agreed. And you also touched upon this point that for smaller companies, everybody's often wearing a lot of hats. Like I've been in quality in smaller startups, but I was also talking to people in manufacturing. I was also talking to people in IT and helping them do other things, right? So since you have been in your career, you worked across

some very big types of departments or functions or things like marketing, sales, trade, training, know, all of this. So when you're in a small organization and you have fewer people, how do you sort of get these people to play more than one role and make sure that at the end, the orchestra is still producing the fine tune?

John Harlow (09:50)
is a great question that keeps me up at night every day, right? This is a simple comment, but difficult to execute. It's hire great people, right? Who have shared beliefs and values and really love to run fast. So from a hiring standpoint, it's looking at people who've been successful in other small companies, who understand.

Harsh Thakkar (09:54)
Yeah.

Mm.

John Harlow (10:15)
that you're not gonna have all the resources that you're used to and you're okay with that. It's also looking at people who've had a diverse set of experiences because to your point, you do wear many, many hats. And I think it's once you find those people, right, it's important to establish an intentional system, so to speak, that allows for that cross-functional collaboration and communication.

Harsh Thakkar (10:19)
Mm.

John Harlow (10:45)
And for us at Malinta, we do routine business reviews, team meetings across the country, bring people into the home office really to ensure that everyone is on the same page, working together to ensure patients have access to our life-saving therapies. So it's hiring great people and then over-communicating.

Harsh Thakkar (11:09)
Right, and do you like, in this, maybe in Melinda or just by talking to other leaders in other companies, have you seen an example of working on a project or working on making an important decision with a small team and thinking to yourself, wow, this could have never happened if I was at Pfizer or J &J.

John Harlow (11:33)
You know, absolutely all the time. mean, we've been able, whether it's at Malinta or some previous experiences, to have a strategic big idea and get it from ideation to execution in months. Where in my experience at other organizations and probably those that you've consulted with, that can take quarters, if not a year at time.

Harsh Thakkar (11:45)
Mm-mm.

John Harlow (12:02)
And that's one of the benefits that I really love being at a company like Malinta, and Malinta specifically, is we can go from whiteboard to executing in front of the customer very, very quickly.

Harsh Thakkar (12:18)
Yeah, yeah. I can imagine that with all the success you mentioned at the top of the episode that the companies had in the last year, you're constantly, you mentioned you're looking for talent, you're looking for people who are comfortable working in this environment. Not a lot of people are, right? Once I've observed even in consulting, when I'm looking to hire people, if somebody has worked in a big organization, they...

I don't wanna say they're not willing to change, but change is uncomfortable for them. It disrupts their routine, it disrupts their pattern, and they have to almost rewire how they work, so to speak. So my question to you is when you're hiring a candidate for executive or leadership type position, and you're one of the interviewers on that panel, if that person's not convinced,

that this is a right fit, what sort of pointers do you give them to explain to them, like maybe this is a good opportunity to step out from big pharma and try to come into a smaller organization and maybe shed light on what things they would learn if they spent one year in this type of role versus five years in a big company.

John Harlow (13:41)
Yeah. So fortunately for me, by the time a lot of candidates make their way to me, right, they've been well vetted by the team, right? And so a lot of the discussion, one is, is the candidate a good cultural?

Harsh Thakkar (13:48)
Yeah. Okay.

That's big.

John Harlow (13:57)
And then two,

and two, Harsh, to your point, it's having a very transparent discussion on what have they done in the past and what life at Malinta could be like for them. And having that honest conversation, look, don't want to convince anyone to come on board that has some hesitancy. Because if there's some hesitancy,

Harsh Thakkar (14:11)
Hmm.

John Harlow (14:25)
In my experience, you just don't see success, right? You can't want something for someone more than they want it for themselves. And so it's having a very transparent discussion. but then back to your other point of your question, there's so much that you can learn at a small organization. You can, you can go, there's a lot of value in depth, but there's also, in my experience to rise to a commercial leader.

There's a tremendous value in breadth of experience. So understanding trade, understanding market access, understanding marketing, understanding sales and sales leadership, working closely with finance and legal and HR. at larger companies, you, you often don't have the opportunity to be exposed to all of that. Right. And here at Malinta, I know everyone's name.

across the entire organization. Our CEO knows everyone's name, right? There's a lot of great opportunity to have exposure to all levels and that provides learning opportunities for people.

Harsh Thakkar (15:38)
Yeah, absolutely. I think that's a very important point that you made, which is about the smaller the group of people working together. It's also, you mentioned the point that if you're in bigger company, you don't get to work. Your responsibilities are much tighter and more defined. Maybe there's geographical limitations. You might have an office in Europe, in Asia.

and those people are sleeping when you're working and vice versa, right? So you never get to talk to them, but that's not the case with a smaller company when there's 50 or 100 people in the same building.

John Harlow (16:20)
Absolutely. Correct.

Harsh Thakkar (16:22)
Yeah.

So can you share one of the case studies when you look at commercialization and all the critical pieces that need to happen? Can you share a case study or an example where you have seen a smaller team that accomplished the same goals as it would have taken, let's say, 10 people accomplishing something that might have taken 100 people in a big pharma?

And what was exactly that those people did? Did they try to approach the problem in a creative way? Did they do something different? Can you maybe share an example that other startups maybe can learn from?

John Harlow (17:04)
Yeah, I have a couple of them, but the one that jumps to mind harsh is towards the end of last year, we decided to pivot or switch our distribution approach for two of our products from full line wholesale distribution to specialty distribution. And we did that one because it provided more consistent, reliable access to customers, to our product.

Harsh Thakkar (17:15)
Hmm.

John Harlow (17:33)
We limited the number of distribution centers. although we never had stock outs before, managing full line and all the distribution centers are, more complex than a more centralized specialty. So provided better access or perceived access, as well as it provided financial benefits. Specially distribution tends to be less expensive than full line.

distribution in our portfolio, although growing and doing well, it's a smaller portfolio than the portfolios of big pharma companies. And the team that worked on the idea, the strategy, the pros and cons, and ultimately the execution of this, right, was a very small yet nimble and mighty team. And from

Harsh Thakkar (18:29)
Hmm.

John Harlow (18:31)
idea to execution and the execution that we could control was just a few months. Now it took some time because you needed to renegotiate your distribution agreements with the wholesalers. So that takes time. if I had tried to do that at a larger company, it would have taken a lot more rounds of revisions, a lot more aligning.

Harsh Thakkar (18:37)
Yep.

Mm-hmm.

John Harlow (18:58)
through the organization to make the decision. And at Malinta, the team did a fantastic job of executing it, executing it quickly and flawlessly. And at the end of the day, generated great results from the standpoint of not just revenue and demand, but also outpatients and customers don't have a perception that there could be out of stock for our products.

Harsh Thakkar (19:19)
Hmm.

Yeah, yeah. No, that's a really great example that you mentioned about looking at your distribution workflow and trying to optimize that. I wanna dig deeper into that question, but maybe take it a step back. So let's say there's an executive leadership team at a very small company and they're extremely...

strapped for resources. Maybe they're expecting a certain amount of funding that they didn't get, whatever happened, right? When they're, let's say they're tight on resources and they want to save resources and laying people off is not a question, because we don't like layoffs. Personally, I don't like looking at that on LinkedIn and seeing my colleagues and friends I worked with. So let's say layoff is off the table. How do you ideate off like,

Okay, we should look at this process and if we do X, Y and Z, here's how much we'll save, here's the ROI. Here's another option, here's another option. How do you look at those before you pick one, like the distribution, like, yeah, let's do this one.

John Harlow (20:38)
Yeah. I would say it's a lot of open, transparent debate and discussion. I hate to, I hate to oversimplify things, but sometimes it's, we're all in the same room together. have an excellent tight knit executive committee and we, one of our teaming agreement items is to fearlessly debate. And we will debate items. will look at, we will also look harsh.

Harsh Thakkar (20:45)
Mm-hmm.

Yeah.

John Harlow (21:08)
What's our, what's within our functions, right? So on supply chain, distribution, commercial, obviously changing how we distributed two of our products made appropriate business sense and patient sense at the end of the day. There's other things that we continue to explore, whether it's tech transfers to lower the cost of goods. It's how are we, you know, supporting

Harsh Thakkar (21:11)
Hmm.

John Harlow (21:39)
possible and defilers. So it really runs the gamut. We've had situations, fortunately not in 24, but years prior where it's, look, we need to make some cuts and come forward with ideas and then let's prioritize. And how do we do it? We always try to make sure, is it a cut that's going to impact our patients?

Harsh Thakkar (21:54)
Hmm.

John Harlow (22:08)
We would never want to do that. Or is it going to cut quality of the product? That's obviously off the table. Is it going to impact revenue? No. But I'll even give another example with how we've been commercializing some of our products. And we've deployed inside sales specialists, as well as we have an outside team.

Harsh Thakkar (22:10)
Hmm.

John Harlow (22:35)
And that's given us a way to be more creative and innovative on how we service the customers that use our products.

Harsh Thakkar (22:44)
Yep. Those are great examples that you mentioned. Some of those things are non-negotiables like impact to patient safety or patients or access of the medicines to the patients or quality. So those are great examples to sort of go through that list and figure out which options are viable. So you have tons of experience in this space. You've spent times with all types of companies. I'm sure you've been in very interesting

situations, how do you still keep yourself up to date on everything that's happening in this space? Like, do you follow podcasts? Do you go to conferences? Do you read some books to understand how big, small, mid-sized companies are all trying to basically solve this commercialization puzzle? And you basically take whatever you can learn from it and apply it to Melinda. So what do you consume from like your curiosity or content side?

John Harlow (23:40)
Yeah.

That's a great question. I would say it really, it's a broad filter, right? Whether it's like that, as we talked about before, whether it was at JP Morgan and just absorbing the discussion, whether it is the various news channels about pharma, certainly podcasts, as well as, you know, even things now on other social media channels around leadership.

Harsh Thakkar (23:50)
Yeah, yeah.

Mm-hmm.

John Harlow (24:13)
What I've found is that I'm running out of time in the day to read a book, quite frankly. I do have time in the car though, when I am going to the office or traveling, so to listen to things, but also micro learning, right? Even a five minute clip here, a 10 minute clip here on how to continue to reinforce leadership and positive culture as an example.

Harsh Thakkar (24:19)
Yep.

Yes,

yep.

John Harlow (24:42)
So those are things that I really look at. In a prior lifetime, I was an equity research analyst on Wall Street at Merrill Lynch covering large cap pharma. So I think I still have a little bit of wiring in my system where I like to still read press releases and 10Ks and 8Ks to scan whether the companies are doing. But it's an endless struggle.

Harsh Thakkar (25:03)
Yeah.

Yep.

John Harlow (25:11)
to be honest with you. I would love to hear your thoughts on how you do it.

Harsh Thakkar (25:12)
Yeah, yeah.

No, I have to say that I'm jealous that you have that background, because I don't. So when I get to that level of detail, processing information, sometimes just because of time, I can't spend three hours and go down the rabbit hole of discussing. And because of the nature of my work, majority of my time is spent in reading regulatory guidances, regulatory documents, or...

know, best practices from other global organizations like ISO or anything else, because that is what applies to my job and the consulting that I do for clients. But yeah, I also oftentimes will go to Crunchbase and just start looking at companies that are getting funded. And then if some company jumps out, I'll start going to their website.

So I would say that my style is not structured. It's wherever the click takes me, I'll go until I reach a point where I'm like, okay, this is enough for today. And I just process that and then come back and do it. So it's not as structured, but still works.

John Harlow (26:28)
My way may have sound structured harsh, in no way is it structured. I love your analogy of wherever the click takes me, because it's very much that. The other thing I would add is it's continuing to talk to people, right? Talk to my peers at other companies, talk to peers at industry events, as well as talk to mentors. And consultants like yourself on the commercial space, they're working with a lot of other

Harsh Thakkar (26:31)
Yeah.

Yeah.

Yep. Yep.

Mm-hmm.

Yeah.

John Harlow (26:57)
clients. So learning from them of what they can share is always very valuable.

Harsh Thakkar (27:05)
Yeah, definitely, definitely. I know we talked a lot about commercialization, but I wanna take our minds off of that topic for a few seconds. And when you look at the biotech and pharma startups, let's say in the last five or 10 years, and look at how these companies are formed and how they go from clinical to commercial, are you seeing a trend or is there something that excites you about

how these companies are built and, know, because obviously they have access to better technology than the other companies had 30, 40 years ago. So that's definitely an advantage for them. But are you seeing any patterns of how these newer startups are being built that you find exciting?

John Harlow (27:53)
I think the one pattern that may be materializing is are they moving through the clinic faster than in the past, right? Through technology, better services, relationships with CROs, what have you, and therefore getting to market, as you know, sooner provides value. All right. So I think that's a trend.

Harsh Thakkar (28:03)
Mmm.

Yep.

John Harlow (28:23)
that may be materializing. Every company is different based upon the clinical program and the patient population, obviously, that they're trying to serve. I continue to see, maybe on the other side of a trend, scientific founders who are very smart and savvy still trying to give it a go on their own from a commercial standpoint.

Harsh Thakkar (28:50)
Hmm.

John Harlow (28:52)
at Malinta, we're looking to grow and build through, you know, BD, you know, acquisition. And we believe that consolidation certainly in the hospital space makes sense. There's a lot of, you know, wasted capital. If you have a lot of single product commercial companies. So we're hoping, you know, for Malinta's sake that we can continue to take advantage of that in, 2025 and, and beyond. So I think that's a trend that that is still.

you know, existing, you know, out there. But for us, we're very excited about today and the future, one coming off a great 2024. But I think as you look at even some of the larger companies coming out of JP Morgan saying they're looking to do more tuck in deals, if you will, that's exciting because that's something that we want to continue to do, you know, as well as a smaller organization.

Harsh Thakkar (29:52)
Yeah, yeah, I've been really fascinated about, you know, just looking or following the companies and looking at what are they doing from a build perspective and what are they doing from a buy perspective. I see a lot of buying happening just because, you know, building takes time. And if you're in a bigger company, building a portfolio of products internally also takes a lot of effort. So, you know,

I've seen many companies acquire smaller startups that exactly fit into their portfolio. It's almost like they were meant to be acquired by this big company. I don't know if they knew that from day one, or I don't know if any startup founders are building companies with that vision that one day they would like to be acquired by a bigger pharma and their portfolio is perfectly engineered for that acquisition.

John Harlow (30:49)
I think it's important. It's a good question. think it's always important. Certainly what we look at is you want to build a strong, sustainable platform. And for us, as a commercial organization, having a strong platform where we can continue to put more products into it. And that could be where you're seeing from larger companies that don't have a platform within a certain therapeutic area that then they now want to get into.

Harsh Thakkar (30:52)
Yeah.

Yeah.

Yes, yes, yeah, definitely, yep. Listen, this has been amazing discussion. I love everything you've shared so far and this is an area that I don't really get to learn much about given my role and the kind of stuff that I'm involved in. So, super excited that you came here today, shared from your experience. For people that wanna connect with you, learn more about the company or what you're doing,

Where can they reach out to you?

John Harlow (31:50)
Yeah, I'm on LinkedIn. So reaching out to me via LinkedIn is the best way to get a hold of me.

Harsh Thakkar (31:57)
All right, John, thank you so much for your time. It was really, really a pleasure having you on and I loved all the insights you shared. Any final words for our listeners before we drop off?

John Harlow (32:10)
think the final word for your listeners, for those that are looking to make the transition to a smaller organization, my advice for leaders entering the early commercialization for the first time would be to surround yourself with good people and listen. Get a mentor who's done it before, ask questions, and understand your new environment. And what made you successful at a large company?

Harsh Thakkar (32:17)
Yeah.

John Harlow (32:39)
may not transfer over, but I would get ready to roll up your sleeves and enjoy the ride because it is thrilling and fantastic.

Harsh Thakkar (32:49)
Yeah, I have to agree to that, especially because I have worked in both types of companies and I can tell you there's pros and cons to both, but there's no denying that the amount of learning I got working at a startup, I never got that at a big company. That doesn't mean those companies are bad, it's just that I was put into situations that I could not have imagined being in and I just had to make the best decision in that point of time.

John Harlow (32:59)
Mm-hmm.

Yeah,

I agree. Well, it was a pleasure, Harsh. It was nice meeting you and spending time with you. Thank you.

Harsh Thakkar (33:18)
All right.

Thank you, John. Thank you, John. Yep. All right.