From the Army Commander to the CDMO Corner Office

[Music] Hey guys and girls, welcome back to Monogulta Market where we go inside the outsourcing space of farmer services and farmer tools covering every stage of the global drug development and commercialization life cycle. I am your host Romantical and today's episode I'll be speaking about the farmer and biofarmer ecosystem with Dennis Johnson who is the CEO at Grand River Aseptic Manufacturing. What a lovely guy Dennis is and super experienced as you're about to hear on the sector makes for an excellent guest today. A bit of background on my guest Dennis brings extensive life science leadership by manufacturing experience to his role as CEO at Grand Minclune Significant Pryace Tarralphal Finish. He has learned operations and commercial senior leadership roles in biologics, farmer and combination of ISIS for over 25 years. Before being appointed CEO at Grand Minclune his prior roles include being head of global manufacturing technical ops at Biogen as well as leadership roles at Catalan to Boston Scientific and Johnson and Johnson in the start of his career in the US Army managing logistics and operations which we talk about today. And Dennis is under his BSC, I'm sorry just as BSC in economics from the University of Wisconsin-Madison and an MBA from the University of South Carolina. Super super great episode that I think you'll enjoy. Don't forget to subscribe and rate wherever you're listening. Enjoy today's show. This episode is brought to you by Borat Farmaceuticals. I've got a real soft spot for Borat. I first met Bobby Scheng, the CEO back in 2017 and it's been amazing to watch the business grow and expand to become truly top tier global CDMO. Bobby was in fact one of our first ever guests on molecule to market. A great great guy. Borat now supports many of the biggest farmer companies across the globe. Borat has become known as the CDMO that brings a genuine partnership to clients shown through their shared risk promise, their white glove service and their PLS on time, in full delivery record. If you want to feel more confident about your CDMO and I suggest you head to BoratCDMO.com. Hey Dennis, welcome to Molecule to market my friend. Thank you much Ronan. It's a pleasure to be here. Yeah, lovely to have you on the podcast. We were fortunate after me a few months ago and then we met briefly as well at DCAT as well. So yeah, I know a little bit about your background but I'm so excited to tell your story on the podcast today and for our listeners to get a sense of your background and how you ended up where you are today at at Graham. So let's start off with your backstory because I believe you're in the army when we go way back. So interested in you're not the first guest. I have to say we've had many guests that I've interviewed that I've ended up in the in kind of senior kind of CDMO or farmer rules that come from an army background. So maybe just talked us about that early phase and I'm curious to know how you ended up in the in the pharmaceutical sector eventually. Thanks for the question and very proud of my service. I didn't have yours active duty. I was in the logistics field and I think it has a lot to do with me ending up in the CDMO space because I really enjoyed my time in the service and I enjoyed being a company commander leading troops leading people being in a position to to make decisions and have a culture where things have to be executed very rapidly and I do think a lot of that has translated to me ending up in the CDMO after 25 years in the GMP space and also the GMP space as a whole when you think about the GMP space what makes it unique is in that space if you don't work in a controlled fashion. You have problems from a regulatory perspective there's regulations just like there are in the army and you have to follow those regulations but you also have to move quickly right. The places where that meets the most the need for speed and the need for control at the same time and balancing the two is actually the CDMO space and it's one of the reasons I enjoyed so much it's a lot of fun. It's an interesting take that I mean I'm going to account a slightly because I just think as it just came off a call with a private equity guy in Europe who I know pretty well and he was talking about how slow things are in the CDMO so I don't mean from a market perspective I mean like often CDMOs take you know it was talking about adopting technology and he was talking about how slow CDMOs can be to adopt technology but what do you if I've understood correctly your meaning like I know you have to deliver for lots of clients a lot you know whatever it's different dosage forms a drug substance or whatever across multiple sites you got to move quickly and stay organized and obviously go it's fit within the regulations and rules as well. Yeah I think look what CDMO is a big space and I would agree with the person you talk to I think we are slow to adopt technology sometime because we may be dealing with 30 or 40 companies that each have their own quality system and so to harmonize a different quality system sometimes it's difficult and sometimes from a technology perspective in terms of the interfaces with a quality system you have to keep it relatively simple so you can adopt to all the different requirements. I think on the technology from an equipment perspective we tend to be pretty fast movers actually but I would agree with him from an IT perspective that is an area where we're slow. I was talking more about the business side and I think one of the things that I love about the CDMO space it's it's high at least the the sterile fill on the niche that I'm in it is high mix and I think high mix manufacturing is very very different in a regulatory regulatory environment from from a low mix high volume right so if you're doing one thing and a lot of the big farmers you know if they have a really blockbuster drug they may build their own manufacturer plan to do it and they don't necessarily need to take it or desire to take it outside in some cases but they tend to do well in high volume low mix manufacturing and where they tend to look for CDMO hell is when there's a lot of mix if you put yourself in a big pharma put yourself in their shoes they're going to have about a 10% batting average going from a phase long clinical to commercial so that means for every year if they want to launch a big drug every year or two years they got to have 20 30 drugs in the pipeline and that's a lot of phase one and then followed by phase two is in the followed by phase three so that's really what I mean by mix at least in the sterile filling space I do think there's some generic CDMOs and some drug substance CDMOs that may focus on on high volume low mix right and I do think that those have different demand yield are very important and there's certain areas but to use your tagline molecule to market I think in the space that goes from a phase one to launching product one of the key gates to getting success in that area for pharmaceutical companies is getting the capability to do a lot of the different things and it's complicated and they often go to experts or CDMOs that specialize in it. Yeah yeah great point and well said as well I have to say and to talk to you through then you obviously spend time at the army and then you ended up kind of more on the big pharma side and you know and kind of bounce between big pharma and CDMOs so maybe just talk to us about the the journey and you know some very stellar names very Boston scientific J and J cattle and biote like serious kind of experience on your way so maybe just talk our listeners through that kind of journey and the kind of big roles that you did and the experiences that you gained along along the way. The first pure play of GMP space that I've worked in was with G&J and I was hired originally to implement into a small startup that they had purchased you know implement the basics of materials management they were on paper and I was trying to integrate them into the the G&J systems for European and then I was very quickly promoted to be a plant manager or heading up a business segment and setting up a new plant actually in Tijuana at a time and I think that was my first experience and I loved it. It was a lot of fun, G&J is a great company and really enjoyed working for them. They eventually decided to close that plant and I moved on but I stayed in that space and went eventually to Boston scientific where I spent 13 years and the great company loved the medical device space. I do think when you go back to my time in the army when I was a company commander I've got to tell you I had never had as much control even as a CEO as I did as a company commander in the military when I was a little youngster and I've always enjoyed being in a position and making the decision and being a critical part. One of the things I learned is a lot of big medical device and big farmer companies are really more marketing and development companies than they do some do operations and some do it very well but that's usually not their lead. They're leading with coming up with new molecules or new devices and operations is a means to end not the end. One of the things that's unique about the CDMO space is operations is really what we sell and market our ability to that's critical and I think there's no business where operations is so front and center, it is the product, for CDMO. And that's what differentiates a little bit. I enjoy Boston Scientific, I ran four different plants, I was in a GM position, I helped them lift three different warm letters when plants were having trouble, I would volunteer to go there. And I think that's part of the reason for my success is whenever there was a potato, I would volunteer to go help out. And I think that's why my career has progressed so much is the willingness to take on those kind of challenges. And when I advise people that are reporting to me or I mentor people, it's a tough thing to ask them to do, but career wise, if you want to take the risk and help companies with a problem, my experience is you get recognized really well for that. And they really enjoy players that will come and help the team out, even if it's not always, it's scary at times, right? But I was there for 13 years, ran four different plants, I wanted to get more in the business side, I was strictly in the operation side, and I would go to cath labs and see my price getting used with doctors and I would talk to them, and I enjoyed that process so much and Boston gave me the opportunity to do that. And I'm still linked into some doctors to this day, but it was a really good experience seeing how the price could use, seeing the impact on the patient's firsthand, seeing the conditions that the nurses and doctors had in the cath labs. And I just want to be more involved in that side of the business. And that's one of the things that drove me to CDMO was the opportunity to be more in the business side where I could lead a P&L. And that's why I moved to Calint. First as a GM in a small molecule plant in Winchester, Kentucky, did a lot of Worcester coating, a lot of multi-layer drug applications on beads. And so it was more of the small molecule side. Did that for a couple of years, and then they had bought a Bloomington from Cook Farmerka, and at the time one of the largest, at least under isolator, CDMOs in the world, at a single site, and was very happy to go there and very rapidly grew before COVID, and then continue to grow through COVID. And I think as a highlight, we had a Vice President Pence and many people from politicians and the governor. And so we were going to visit all the time, it was a lot of fun. So did that for a couple of years, and then I had an opportunity with Biogen to run all their internal like short manufacturing. And I tell you, I love Biogen, and I learned a lot about that side of the business and how the uncertainty and the risk involved with launches and how you have to buffer for patients. So it has really helped me out in the CDMO space, knowing what big farmer companies go through at a launch, how they look in situations, and how I should anticipate what their behavior is going to be in different situations. - Just about asking there, actually, you know that, you were at at Katland for such a defining period of Katlands. You just before COVID, while like five years or so before COVID, where Katland just grew crazy quick, and then through COVID, where the company continued to grow as well, like through some of the best times, I suspect that business had, and then interesting then to then kind of go on to the other side of the fence. And was that decision to go to Biogen, like a very intentional, I wanna go on the client side, I wanna see things from the other side, with a view to ending a back on the CDMO side in the future, always just an opportunity to work for such a well-respected organization that you just, he couldn't say no to. - I think in the back of my mind, ironically, I always wanted to be a CEO. And I think when you look at the progression at some of the big CDMOs, and I knew I wasn't going to be a CEO, a necessarily company like Katland, or Biogen, right? You know, nobody's gonna put it in a big public CEO without having done a smaller CEO job before. So I was realistic about that it wasn't gonna be there, and what do I need, and how do I develop my career? And I think I've proven all I could prove, like if I did another operational job at Katland, I don't think it would have necessarily moved the ball further for me to the end of being a CEO. And I did think that moving to Biogen, and really expanding my scope at Biogen, you know, I had well over 50 CDMOs that I was working with, and I had three campuses, you know, one internationally. Compared to what I did at Biogen, it greatly expanded my scope, and I really enjoyed it. I still consider my balls there a personal mentor, and I think it's a great organization, and they care deeply about patients, and I will never say anything bad about it, but there came a point where I realized that, even though it was really a wonderful place to be, at the stage of my career, if I wanted to be a CEO, I had to make a move, and I had to get into the sweet, see, sweet, and the most likely place to do that was to, to go back to the CDMO side, and try to get to a see, sweet level, and to get to a CEO role. And that's the one it up to. - And we're gonna get to now your kind of, you know, joining in a ground river, accepting manufacturing, known as Gram for many of us, that know the business in the industry. Before we do that, what, one thing I really admire about your journey has been your willingness to move in order to kind of get to where you wanna be, right? Like you said before, that you wanted to become a CEO of a CDMO, and you know, I might have the fact that you, it's one thing known that, but recognizing that, hey, I'm gonna have to, would that have happened if you stayed at Catlin, you know, who would have known, but probably not because obviously that's a, it's a difficult thing to accomplish in an organization like that, but you were willing to move and navigate your way to eventually be coming, which I think is a great learning for, for people listening to the podcast. But what was the, what was the desire for you to be a CEO? Like where did that come from? Is that just because you've done a lot of senior roles, you kind of, you know, and you've had a good balance by this point of, obviously commercial experience and the operational experience that you feel, you know, you felt like you had the tools now to become a CEO. Keanu, for a lot of people, they never wanna be CEO 'cause it also comes with all the pressure. And everything that comes with it, I'm sure you're gonna talk about, but yeah, just curious to understand kind of where, where that desire to become CEO came from. You know, I get to tell you, it comes back to the military. I, if I could have stayed a command, a company commander in the military, the military role takes you between different types of roles so you can expand your knowledge base and scope. But in a peacetime army, you go into a company commander role, you'll be on staff after that, probably for 10, 12, 14 years in staff roles, right? And learning different things before you get a battalion command. And you just look at that progression and the amount of time you spend in command versus out of command doing staff roles. I love company command. I've always been looking for something that was very similar. But when I look at my time at, at, at Calend, as a side GM, they let me run the business, they run me, let me run the PNL and they let me run the operations. It's very similar to the control, the ability to put together a strategy and then have the tactical execution against that strategy under my control. I really like that. And I always have. And when I was hired first into the GMP space and they asked me what I want to do with my career, I said, I want to run things. And I don't care if I'm running a Starbucks or I'm running a farmer plant. I want something where I have the ability to run it and make decisions and work with teams and build the team. And that's just for me a lot of fun. You know, it's not for everyone to your point. You know, I think there's certain things like, I wasn't great at basketball when I was in high school and I think I'm not sure I'd want the ball to make the game winning shot at the end because I knew I was really that good at it, right? I didn't want to let the team down. And so I was on a great basketball player. But I think if you do well in a certain area of leadership and you really enjoy it, that's what you want to do. And that's what I want to do. And I think to me, the ultimate on the civilian side, it is to be a CEO. And I think a step shorter that is to be a GM of a plant with a P&L, a real P&L, not just an expense P&L but a revenue P&L where you're dealing with clients, you're having to understand their problems and you have to create a service that they appreciate and want to buy more of, right? And I think when you look at my career, it's all been getting back to that. But for me, it doesn't feel that much. I'm a lot older, but it still feels the same as when I was a company commander in terms of having the ability to build teams and having a lot of ability to influence it and set the direction for the team. And some don't want that ball at the end of the game and some do, I don't want to be basketball, but in business, I really do. - It is here and how you talk about what you like and obviously your own background as well. You definitely strike me as it, there's definitely a theme in the interview of, you like to get your hands dirty and be on the front line so to speak with your team, trying to make decisions and make things happen which is obviously a great fit for being a CEO. So okay, so you've been a gram for just over a year now, I think, and what, so how is your first CEO being? And then again, like maybe give our listeners a bit of insight into what you guys do. Obviously it's in the name in terms of the early septic manufacturing capability, but maybe give our listeners our haven't come across. and sitting in North American side like me will know the business, but I'm sure this people in Asia or Europe that might not have come across to come you before. So talk to us, Fissey about then your Fissey area in the role and how that has been. And also then the capabilities that you guys have, the facilities and all that good stuff. Sure. So Graham has been in the business of sterile filling, has been a dedicated sterile filler for about 15 years now. And started with one small rep filler 15 years ago and then expanded and right before COVID came along, they had just bought their second filler and COVID came along and basically monopolized it almost right away. And that was a springboard and very quickly that there was a need to get third, fourth and fifth filler on order. Those were brought in but as you know in the sterile filling space, it takes a while to commercialize those fillers and we're in a very unique position that we have four brand new isolator fillers and what was our third GMP facility. And we are just now ramping them up commercially. So it's you know great timing. So to speak that there's a high demand out there. And we then turn around and we've invested in adding an additional filler in a brand new facility, 150,000 square foot facility that is going to be focused on the range and cartridge filling. And we have a growing or a head of filler going in there. And it just went through factory acceptance testing and it'll be in little region and we're going to be filling media fills in Q1 of 27 in that line. And we also have a 200,000 square foot, a new packaging and inspection where we have 3 ADIs and automated visual inspection. So the facility has really kind of bootstrapped itself up from a single filler to now being at five fillers with a six on the way and from being at two facilities to five facilities. And we're having a lot of success and there's a lot of demand. Business is really good on the sterile fill site. And sterile fill strikes me as being a good market to be in at the minute, especially in the US. Is that sound about right to you? 100% 100% and we can talk about that more, you know, an hour later if you'd like, but there's a shortage of capacity. It's not always the capacity people think about. What I mean by that is I think there's a lot of a new lines coming on board right now and we'll be over the next three to four years. A lot of big farmers bought lines. You see the investments in the paper all the time. Obviously, no nervous, bought the talent facility in Bloomington, which was a very large sterile filler, CDMO. Lily's done multiple expansion and now it's what you can find it. I'll go go if you'd like. People always point to the number of lines that people are putting in. And they asked me, Dennis, are you worried that there's going to be an overcapacity situation? And I'm really not. I think the the lines and the people are different things. I think what makes a CDMO successful is the ability to handle high mix and the ability to do multiple tech transfers. So to build a team with experience on doing tech transfers in the sterile fill space, how many of those locations in big farmer can do 20, 30 tech transfers a year? And I would say most of them haven't built the muscle to do that. They tend to focus on the ones they're launching and they tend to do those very well. There's a lot of people who have their own lines that still come to us because they need the tech transfer capability. So when you look at those announcements, building the skill sets and getting a line commercially approved, first of all, I think it's going to be multiple years. And secondly, I do think the high mix environment is one that lends itself well to the CDMO. You can have the equipment, but if people don't do the job of tech transfer day in and day out, and if a PM is not doing a couple tech transfers a year, are they really current? Are they up on the technology? Are they up on the procedures? And I think it's one of those things where practice is really critical on the tech transfer capabilities. I think people underplay the tech transfer capabilities. And it's one of the things that's key to our strategy. Yes, we're bringing in new lines. Yes, other people are bringing in new lines. But I think we have 15 years of building up capacity and tech transfer. And I think we're very focused on being a sterile filler where a lot of people are trying to be like the Swiss Army knife, and they can do a little bit of this and a little bit of that and a little bit of API, and they can do your DS. Are they willing to carry the overhead to have a world-class tech transfer capability? I'm sad and project management. And I think the answer is self-evident and not enough do that. And I do think even big farmers, when you look at the number of blockbusters, even the big farmers rarely launch a single blockbuster every year, right? So they I think they really value partnering with people that they're able to keep adoring. And I just want to say a special thanks to the team at Leigh Candidate that support Monarchy to market. They really are the go-to talent partner for the farmer and bio-farmate outsourcing space. I should know because I helped co-founded that business and they are doing amazing things for CROs and CDMOs in the sector. So for any talent needs, give the guys a shout. Let me kind of zoom in on a couple of things that you mentioned there. I love the Swiss Army Knight, Knife, Peace, which I'd love to expand on as well. But you mentioned kind of high mix. And how do you, you know, if I look at your capabilities, obviously in one regard to you are a vertical kind of specialist CDMO in that you've obviously excelled in sterile filth finish. But I'm interested in knowing how do you how do you decide to place your bet from a modality's perspective, right? Like, you know, whether it's liquid or vials or a liar, whatever, like, how do you make the call as to like where to place your bet? Because you can't spend all the dollars on absolutely everything. You have to kind of make some calls based on data. So I'm just curious kind of like in this kind of CEO role that you do, like all those decisions ultimately lie with you in obviously the board as well. So I'm just kind of curious how you think about, you know, where to expand and, you know, where to twist and where to stick when it comes to the kind of mix of capabilities that you guys have. No, that's a really good question. And it's a tough question to answer because there used to be a pretty clear life cycle in and cross product development. And I think, I think different pharmaceutical companies are going in a different direction. So some of our trying to leap over and go straight to auto injectors, for example. And there you need syringes or cartridges to put in those auto injectors. But traditionally, you know, to say development for the first shot on goal, a lot of companies would go out with them would not have finally tuned formulation, but they would go out with a liel, a liel program for stability. And then they would stick to vial. And then they would move to syringe and then they moved to auto injector, right? What's clear to me is that biologics and sterile small molecules are nowhere near going away. You know, I think a lot of, the predictions of the fall off in that industry and it wasn't maybe 10 years ago. People, I heard a lot of talk, oh Dennis, it's everything's going to be Jane therapy. They won't need biologic anymore because they'll tune it through gene. That hasn't really come to fruition. If you look at the new drug application percentages, the small molecules, you know, are still in the 70s and the biologics are in the 30s and as subset of small, you look at biologics, you look at the ADCs, maybe a little bit more than, but cell and gene still went in the 2 to 4% approval rate. So, and this is all just public information off different websites. When you look at it, for me, that really indicates that the biologics has been sticky and small molecules been sticky too. But the percentage of small molecules that go into solid oral doses versus sterile, I actually think the small molecule that go into sterile have been increasing. I think the biologics are struggling with the blood brain barrier a little bit in terms of getting through that for brain related type of programs. And so, where does that all end up? That means there's a lot of small molecules that leak into the bloodstream and not through an oral application. And there's a lot of biologics still needing to be filled. And I haven't seen a drop off. I've seen a continued increase. And if you go back to the NDAs and go, what about the flavor of the month in XYZ, right? Whether it's cell, whether it's gene, whether it's, you know, and I believe some of those technologies really were medically, like especially cell therapies. However, getting them to a viable high percentage of the drug market, I haven't seen a shift in the new drug approvals. The volumes are still, and I think that will be the case for the next 10 years from now, it'll be 80% cell therapy or something. But I think that transition, you know, that sterile fillers, I think, will be great demand. And what's continuing is really that there's more and more applications that people are using. It is a specialized small molecules or biologics and what I'm seeing is The new shots on goal are actually going up and there's a huge demand for sterile filling in the US For for those type of applications And I'm gonna go on to the huge demand piece of it And we kind of talk about what trends are you seeing and I'm guessing that kind of resharing trend to The US is one that will no doubt come up before we do that. I wanted to just ask you about You talk about tech transfers before when I wanted to kind of double click on that a little bit and just get a just understand that more if Is that tech transfers coming to you guys At it like that's a commercial scale so where you guys are taking projects from other CDMOs or direct from in-housing In preparation for a launch or is it somewhere else in the process that you're typically because you guys are having to handle presumably quite a lot of tech transfers So just understanding like where from a face perspective are you seeing seeing this you know kind of velocity? Assume you're out to share of course. I Think there's enough to go around for all segments of the industry. I will tell you that One of the things I learned when I was at biogen and others is Call-in-port blockbuster launches are and one of the things that big companies such as biogen probably do now want to be Taking a lot of risks operationally on their tech transfers. They want a high probability of success What does that mean to me that means to me if you're in a phase three and getting ready to go to commercial It's not the time to go to a new site with a new process and change everything right So you want you you want a partner on the CDMO front that can help you launch and get you into commercial and if it's truly a blockbuster Defined as a billionaire above everybody in the industry will a second source that and you may have a split with Somebody you know your own internal sites or you may have a split with with another CDMO Nobody's gonna stay a sole source on the blockbuster But you probably want the person that brought you to the dance to take you out dancing You want that person to get you into commercial right and and you don't want to be doing the tech transfer And get into new equipment at a new site with people that don't know the process When you're trying to launch it you need to have the stability So I think there's a high level of interest. There are some CDMOs that specialize just on doing phase one and two clinicals That's not our focus is to just be phase what we we we're focused on being a commercial filler that also does The early phase is almost as a service for our partners some people have the business model They're just early phase and they can't really handle the commercial or even if they claim they can you as a large farm out probably they may not meet your Needs per commercial Element we're focused on doing that commercial in my perfect role people would just bring us tech transfer to us phase three's And you know it would make our lives easier and then we just go commercial on it and I think for us That would be that would be a perfect scenario But when you get into strategic relationship with clients they see you doing a good job And then they have a derivative of it or they have some other you know next version of it And they really want you to be doing the phase one and two so We do we do all the phases You know we don't actively shop or try to land very small companies that don't have a track record that are doing the one phase one And never done anything be that's probably not our target There's people out there that target that they tend to be really small shops with one small filler or something like that That's not our business model all our fillers right now We have on site are commercially approved and have commercial approval from an agency and so I Think we are in a position where we're trying to do that But it's part of the business model that or it's part of the business I think that if you're in a strategic relationship and you have three or four molecules Which is not unusual for us We do a lot of business with big pharma and there's a lot of repeat business and there's a lot of multi molecules You have to listen to those clients and if they need phase one you give them you do phase ones for them right? It's part of it's part of a strategic relationship. It's not a Tactical one-off relationship where you know where you're bidding on one molecule at a time and that's kind of more the generic world On our space we we want to be very deep in a certain space of sterile filling We're not trying to do everything for anybody But in that space if a client has needs we want to be able to do it Now you asked earlier, you know, how do we make those decisions on what's next? I think we we had such the manual while we were probably a little slow to We invested in in good clinical scale and early commercial scale filler But it's a two-headed filler and we have so many clients that are getting to high-veh divine commercial On that filler that they they're really looking for us to expand and so we are doing that That's why we built a new facility and we're getting a lot of We're getting clients that already with us moving it from a small filler to a large filler with us But I think you know one criticism of ourselves is it takes a couple years to get commercial on a sterile fill line And we probably could have started that Six to twelve months before but we we were getting so much demand on the wild side That I think we focus a lot of our capital investments there. We do have capability in syringe and cartridge, but I think The the man we had has our pace our capacity of ill-about which is which is a great spot to be in right now I'm sure you the envy of many many people in the sector and I kind of demand out stripping supply leads me to kind of The last few minutes and an area I wanted to explore with you which is around kind of trends and shifts and headwinds and tailwinds that you're seeing in the market Dennis and certainly like I said before like my assumption would be given you know the kind of The move that we've seen geopolitically the kind of current administration the desire to do more manufacturing You know in in the US in particular I'm right in assuming that that is That is driven more in trust more demand into what gram do and in addition to that are there any other You obviously already talked about kind of the pipeline and what's coming through the pipeline But just curious to know if there's anything else that you're seeing that you're able to share From a headwinds tailwinds perspective. It's interesting because there's a lot of capacity out there the tech transfer and and the ability to Have the people to do At a high quality level It is what differentiates right now You know there's some use equipment sellers right now you could buy a sterile filler from right the Arab sterile filler and a deep discount That's not that's not what the clients are looking for right They're looking for capability and I think Then you know, I think it's good to start with their needs anytime you're looking at a business and your client's needs If you're a farmer company and and you're launching a drug and you're going Need sterile filling and using using your podcast name molecule to market What is the thing that keeps you from market the most? What keeps you from successfully a marketing a molecule and The answer is manufacturing issues now that sounds kind of weird because I think I would have thought you know 10 years ago Well, the drug isn't working Well, if you look at CRL's they keep you know where the FDA says no to you got through phase one you got through phase two a Lot of the drugs and that working get kind of shake out there But if you're at the end of the game you you're investing a billion dollars who and I've seen estimates from a one to five billion dollars to launch a drug But when you get down to phase three and and getting it to commercial gets really expensive and You got to have the drug ready when you get approval if you build a lot of drug and you don't get approval that's really expensive and the the the number one source of CRL's and there's a couple of quotes I can give you guys seem two different numbers one from farmer manufacturing quotas 74% from 2020 to 2024 And there was another one that that was a little bit Lord 56% of the CRL's are due to manufacturing issues and not drug or E claim issue and in the literature They weren't like people are saying it's all say and it doesn't where it doesn't work or the clinical wasn't well designed It's manufacturing and at least recently I have not found a study that gives a split between Drug substance manufacturing or the API and the drug product or or the Packaging and other things but the CRL's I have seen recently in the last year and a half have Disproportionately been on sterile filling and I can give you specific examples But but I don't want to quote any any my competition, but but but there's it's been a source and and you know Someone comes from the annex one requirements and the FDA has has identified sterile filming I believe as a source of a potential risk for patients and and they are making and enforcing those requirements You know for for making sure that you have good process for sterility good first pass air that you know That your isolators and everything are up to you know stuff your media fills a robust and mayor What you're supposed to be doing that your smoke studies show the air flow maintained the sterility I those Those requirements, I think you can look at the 43s and the one letters on the FDA website and That there is a shortage of people that that can navigate that meet those standards and it's not just having production lines It's the ability to run them within that framework and get those drug to market successfully And when you look at some of the biggest launches in the last couple years like I'll say again You can you can just google for CRLs and see what some of them are but and the FDA publishes them now If you're a farmer CEO and you spend a billion dollars to get a drug through a phase one and two and you're getting ready to To launch you don't want to trip up on the five-yard line With your sterile fill it and that's that's why I think there's a real search for people that can execute that right now That are in good standing with the FDA that have had successful track record there and they have moderate equipment that's not likely to be Not need the annex one standards and have the people that can execute it Whether it's executing to me the as the smoke studies of probably you know the the tech transfers That's the trend I see in the industry is that the bars been raised It's a good thing because we're ensuring better drugs for patients But the bars been raised and it's tripped up a lot of drugs right the five-yard line the last year and after two years and I think that's I think the farm industry is reacting to that and they're moving business to the players like that had been successful in executing that It's interesting. I mean I was just kind of like listening to you talk there and you exude passion for Not only obviously what you do at ground, but for your role and that coming back to what you said before there the operations and the delivery and sort of in problems and you know just kind of it Seeds it sees out you in a very very positive way and I have to like I suppose it leads on to my final question which is around You know you talked before Dennis about this being the CEO gig that that you wanted so you know how are you feeling about it now and also You never strike me as someone who's gonna be slowing down anytime soon, but you know Said you've been in the sector for a long time, but you know There's no plans. I'm assumption is there's no plans for you to slow down because it sounds like you were just Really enjoying life and what you're doing right now? Oh 100% it's a lot of fun It's a lot of if you were a great golfer and you were doing well on the pga Well, you know, why would you ever retire as long as you're winning tournaments, right? And I think from my perspective I enjoy what I'm doing and I see no reason to slow down either for the company to slow down It's growth or for me to personally slow down. I will say I am passionate about it. I've had the opportunity to have several drugs over the years And one device that was used on family members, right and we talk about patients, but the pipeline and getting new drugs to market I think the data is clear that helps people live longer and What we do is really important and I think to be part of it is an honor and whenever the bar gets raised a little bit I think you have to have a perspective that we're trying to do things better for for patients But I don't see that as they need to slow down Because not getting the drugs to patients isn't the answer is to make sure we look at the changes and make sure we're always trying to move ahead of the changes And be ready with the right equipment to the right people right training But no, it's a blast and I don't see Either gram or myself slowing down. I think it it's a lot of fun But I do think you've mentioned roll up your sleeve. I do think that's one thing that sets aside a high mix environment with really critical rolls There there there's some places where you can you can be a CEO and be did you know you you're 10 levels above And to be successful I think in the sterile fill space and it goes a little bit to organizational structure and why we're staying Strictly focused on sterile fill. I think the show manufacturing heads I I work with if they were to call they'd expect me to know how How they're batch-wad right if they have a critical ppq and a critical launch this type of business doesn't lend itself to Steele's that are just going to focus 100% on stretch nor does it lead itself to somebody who's You know just doing the shop floor right you have to be able to do both at the same time in in this space I believe the service acclince Right, it's a very unique field. It's a very fast-paced field and it's very fun field Well, what a what a great What great sentiment it's and the conversation you know what a fun field you said it was an honor to work in this field couldn't agree More and yeah, thank you for bringing it back to the patient as well and that's ultimately what it's what it's all about and Well, Dennis what fantastic guests you have been today. I'm so glad we're able to get you on the podcast share your story And not just that of grand but yours personally from you know your military background to A very successful career and congratulations on all you're doing and yeah, we wish you all the best and thanks for being a guest On what a good market. Thank you very much. I really enjoyed speaking on your podcast. Thank you This episode is brought to you by Borat pharmaceuticals. I've got a real soft spot for Borat I first met Bobby Scheng CEO back in 2017 and it's been amazing To watch the business grow and expand to become truly top tier global CDMO Bobby was in fact one of our first ever guests on molecule to market in great great guy Borat now supports many of the biggest farm companies across the globe As far as become known as the CDMO that brings a genuine partnership to clients Shown through their shared risk promise their white glove service and their PLS on time Info delivery record if you want to feel more confident about your CDMO And I suggest you head to boratstidiumo.com And I just want to say a special thanks to the team at lead candidate that support molecule to market They really are the go to Talon partner for the farmer and bio farmer outsourcing space I should know because I helped co-founded that business and they are doing amazing things For CEO Rose and CDMOs in the sector so for any talent needs give the guys a shout And there you have it that was Dennis Johnson who is the CEO at Grand River Eceptic manufacturing aka Graham Super guests really enjoyed today's conversation His passion for operations the sector Becoming a CEO just yeah exudes through every every part of today's interview Just kind of like you know he always looks like desperate to share his views and Give a perspective and help people in the sector which I thought was was lovely Some of the things I kind of picked up on today's episode I really found the parallels from his military time to You know what he'd learned and how he'd navigate the career in the CDMO space Really fascinating it's something that we've picked up on a couple of times over over the years this kind of Correlation between army leaders doing well in CDMO was interesting to hear Dennis talking about that kind of rules and regulations piece but the speed of decision making the operations It can kind of see where he was coming from Another thing that really struck to me was this kind of realization of becoming a CEO and why that was important to him and how we navigated it as well I thought was really Really super fascinating from a perspective of being you know willing to jump around and you know and move from Very successful roles that he was doing and as was the last third of the the conversation around Oh, you know how grand think about it's vertical and why that market is is is going You know is in demand right now, particularly in the US and almost like this sense of not being a Swiss army knife and getting tempted by that I thought was an interesting perspective as well one we've again who before but a good having it reinforced by by someone Of Dennis this statue so thank you to Dennis For being a guest. Thank you to you. Let's know wherever you are in the will for being on For being here on the journey with us and for giving us your You know invaluable time and attention. We appreciate it. Thanks to my team Tony and Susan from making this all possible I'm bringing this podcast super professionally edited to your ears if you like today's episode please share it with a colleague and rate or comment on The platform you're listening and if you puttin' enough, this is your time. Come on. Let's do it today To do this as soon as I stop talking just do it. Cheers guys. Thanks Hi again. Thanks for tuning in to today's show really hope you enjoyed the episode And more shows have a look on Spotify, Apple or Amazon wherever you like to listen and do make sure that you subscribe So the next episode comes direct to your device automatically And please get in touch via our website at Molecule to Market Pod or via LinkedIn or Twitter We love to hear from you So if you have a guest that you want to suggest or someone in your organization You think would make great guests on Molecule to Market and please let us know We'll see you very soon