A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On today's episode of the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. In addition to contracts and master service agreements, the pair walk us through the day-to-day execution of the partnership and responsibilities of those involved in it. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On today's episode of the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. In addition to contracts and master service agreements, the pair walk us through the day-to-day execution of the partnership and responsibilities of those involved in it. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode.
You've listened along for years -- now you can watch along, too! Go to bioprocessonline.com/solution/the-business-of-biotech-podcast, where you can put faces to voices as you watch hundreds of interviews with the world's best biotech builders. While you're there, subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!
The business of biotech is produced by LifeScienceConnect and its community of learning, solving and sourcing resources for biopharma decision makers. If you're working on biologics process development and manufacturing challenges, you need to swing by bioprocessonlinecom. If you're trying to stay ahead of the Cell or Gene Therapy curve, visit cellenginecom. When it's time to map out your clinical course, let clinicalleadercom help, and if optimizing outsourcing decisions is what you're after, check out outsourcepharmacom. We're LifeScienceConnect and we're here to help.
Matt Pillar:So I've said it before and I'll say it again now CDMOs are typically not in the 10 ring or the sweet spot of guest selection for the business of biotech podcast. We like to focus on new and emerging biotech execs with their own therapeutic pipelines, or, in other words, the sponsor companies that CDMOs work with. However, when a CDMO exec can bring along a sponsor exec for a transparent look behind the scenes of what can at times be a complicated relationship, I'm all in. You might recall that we did this a few weeks ago when Ray Therapeutics, Jenny Holt and Forge Biologics, John Maslowski, gave us some up close and personal perspectives on the contracting and execution of the sponsor plus CDMO relationship. That was a well received episode, so today we're going to do it again. I'm Matt Pillar. This is the business of biotech, and here with me today are FINA Biosolutions Scientific Director and owner, dr Andrew Lees, and Scorpius BioManufacturing VP of Business Development and Client Partnerships, Steve Lavezoli, Steve and Andy welcome to the show, thank you, nice to meet you, nice to see you.
Matt Pillar:Yeah, pleasure to have you guys on the show. I appreciate it. Lavazoli, am I pronouncing that close enough to correctly?
Steve Lavezoli:No, you got it, that's perfect.
Matt Pillar:Steve, I got to tell you I don't. It's not a bone that I have to pick with you, but I do want to just point out and put you on blast here publicly for stealing one of my favorite people in the world, sniping her away from our company, abby Sorenson, who, by the way, into her credit, helped me arrange this interview and get you guys both on the horn at the same time. Thank you to her. But, boy, she's one of my favorite people of all time and you got a good one there, buddy.
Steve Lavezoli:Yeah, no, I have to agree with you, and actually I think Andy will probably agree with you as well as it relates to Abby's involvement with Fina and you know just her ability to bring Scorpius to a CDMO. That's known around the world. That you know. A year ago nobody knew who Scorpius was. Now we're kind of recognized when I say the name Scorpius. People know who it is.
Andrew Lees:Actually that is. That is exactly why we're here together is probably because of Abby. There was a period of time when we were getting I was getting essentially it felt like daily or multi times per day emails from Scorpius and I would just keep deleting and deleting. And then, you know, I saw they were, you know, a CDMO. We were, you know, looking around. I thought, well, let me just see what they are. And I looked at it. I thought they kind of had a weird logo I do a little origami and I thought, and then I, you know, passed on.
Andrew Lees:But then, you know, we were looking more and more seriously at a new CDMO and they had also penetrated our commercial officers, radar and the CMC group that we work with. And so they came to our attention and we met with Steve and Abby I think it was at BPI and met there, had dinner, talked, and that chemistry was really what you know from that meeting was really what started us down the path of considering them. So that was. I mean that, you know, once in a while a cold call and a random email does work and penetrate. It's getting there at the right timing.
Matt Pillar:Yeah, and you said that. Did I catch that right before we get to you, steve, did I catch that right that you had been working with a different CDMO previous to this relationship, or had you not been working with?
Andrew Lees:We had been working with another CDMO and I can give you a little bit of background about phenobio, because you need to understand a little bit of this. I started phenobio in 2006, based on my expertise in the area of protein polysaccharide conjugate vaccines, specifically the chemistry, and early in my career I developed chemistry that is now widely used, particularly for new manufacturers. It was licensed originally to Glaxo but because there were no patents in China or India, I began working. When I started phenobio, I began working with the Serum Institute of India and the idea would be that, although I can't affect prices, I could affect competition, and so by helping to bring in, teach the chemistry to new manufacturers, I could bring in some competition in the developing world to help reduce the price of these conjugate vaccines. And in fact that we've succeeded. The Serum Institute's Numom and Injukako vaccines are the lowest priced vaccines in these classes. So part of the model which I call my not-for-much-profit model is I don't have any investors, so what that means is I can make licensing arrangements and do deals without having to make money for investors. So in terms of the royalty rate, I looked at what did I used to get when I got royalties from India after it trickled through everybody else and I said, if I was happy with that percentage, then I'll take that percentage from the Serum. And it was low enough that I essentially turned what was a service contract into a royalty stream and that is now helping to fund the current work.
Andrew Lees:The next phase we were invited to. We were asked to see if we could develop the protein component of these protein polysaccharide conjugate vaccines, which had been one of the most expensive components, and, remarkably, a scientist who had been laid off from Glaxo came on, starting as a volunteer, and then when we got a small contract from the non-profit path, that set us on the path to develop this protein and as part of that we developed the scientist developed a E coli strain that can make soluble disulfide bond proteins in the cytoplasm without needing to refold and which grows remarkably well, and so that set us off to be able to produce the lowest cost version of this protein, and I deliberately set the price as low as I could rather than as high as I could. This was not from any particular business smarts, but it had to do with I didn't have to make money for other people and I was frustrated as a scientist that I could not afford to buy this protein previously. So as part of the because we had no money to do a GMP project what we did was execute a license essentially a license exchange with the company Invent Prize out in Seattle, which was founded by the former director from the Syram Institute of India.
Andrew Lees:It's funded largely by the Gates Foundation, again to develop low-cost conjugate vaccines. So they needed our CRM197, the carrier protein. We gave them the license to use it for their vaccines in exchange for their doing GMP manufacturing, and so that created the first batches and got our GMP product established. But they need to now focus on their own vaccines and we need to establish our phenobio as having, you know, being a reliable supplier of the protein. So if your clinical program depends on our protein, you want to make sure we're going to be around, and that's why we decided we needed to move to a larger manufacturer that could support the phase three and licensure.
Matt Pillar:Yeah, what kind of capacity are we talking about, andrew? You said a larger manufacturer, right? What's the sense for what kind of capacity you need, what you're putting out?
Andrew Lees:This is still small scale by others. So because we have such a highly productive strain, we are making from the E coli about three grams per liter of purified protein. So even a relatively small fermenter I think Scorpius is going to be going up to 300 liters, so that's going to be making almost a kilo of product. So a few runs would likely supply for the foreseeable future and it would be very easy to scale up beyond that. It's just because it's E coli, it's very simple to grow and we have a relatively simple purification process.
Matt Pillar:Steve, I'll let you jump in here when you first met Fina and that's a great story. I love it. You know Andrew's giving you some pretty candid feedback about your origami logo and the way that he put off the cold calls for a long time. It's an important element of relationship building, though, so one I want to get your perspective on that. What, from your perspective, made Fina a good fit for Scorpius, but also sort of your take on how Fina fits into the broader landscape of Scorpius clientele. Like you know, it seems maybe a little bit atypical, but I'm curious about how they kind of line up in terms of I'll jump in.
Andrew Lees:It's very atypical. And that's really their willingness to adapt to this atypical is a big part of it.
Steve Lavezoli:Atypical is kind of the keyword, right. I mean I think you know I came from large CDMO world and you know in the large CDMO world someone like Andy and his program, it would have never gotten any kind of attention from, you know, a big CDMO, it's just you know, and that's not a shot at Andy or a shot at Fina, it's just the Really where the focus is of that scale of a CDMO. So I mean we'll think about Scorpius. You know we're focused on both microbial and mammalian programs. We're also focused on a certain clientele, right. We want to be partnered with these smaller to mid-sized biotechs and essentially they can't get the type of attention. You know certain expectations from a CDMO as far as willingness to work with them, and I think that you know Fina fits right into that, andy fits into that, his personality, his willingness to kind of do things like this podcast and also do joint publications. You know those are all important to us. It's important to Fina so that they can grow their business and it's important to us from a new CDMO in the space. And it really made sense, you know, after we met with Andy and I think he mentioned, you know, abby was with us and Abby does join a lot of those.
Steve Lavezoli:You know initial meetings. I don't think that's even something that's characteristic of most. You know CDMO partnerships. You normally don't bring your marketing manager along with you to a dinner and it's really so that Abby can understand, or the marketing team can understand. You know what are the pains of Andy. How can we help him support his business, grow his business, promote his business and do things that other CDMOs just aren't doing right. And hopefully Andy sees the value in that and you know we'll continue to do those kind of things because it's important for him, it's important for us, and not only that. You know we're extremely dedicated to getting his program through. You know GMP manufacturing and making sure that he could bring you know really, really cool technology to the industry that maybe he wasn't able to do if he didn't have a partnership like Scorpius. So you know that's the great thing about you know this relationship with Andy at Fina in my eyes.
Andrew Lees:So I mentioned an important thing because we're providing an ingredient essentially in other people's conjugate, you know, other people's vaccines. It's going to take us a long time before we really scale up and start selling a lot of product and becoming, you know, highly profitable from it. The so so it's really, but without having an established manufacturer and demonstrating that you know we're going to be around in the for the future. It's kind of this chicken and egg thing where we got to get established and Steve and Scorpius were willing to recognize that and accommodate. You know that kind of scheduling and it's, from that sense has been a really good partnership and it's really the people I mean.
Andrew Lees:After this. You know the business meeting, we began meeting with the technical people and there was no question when we met with them, from the questions that they asked, we felt very comfortable. You know, working with them. This close communication Steve is on my joke of the day list that I send out and you know we talk almost every day about about various issues and if I have you know there are there is a concern, it's just as easy to talk to him first and it's it's. That part has been very successful. Yeah, the whole contracting process was extremely straightforward and working. You know, working with Steve is really been. Steve has really been a major part of why we're able to work together. His approach and willingness to to see both sides of the of the issue, of the problems that we hit, that we have both Scorpius and ours, because they got to get, they need to move forward as a CDMO and and be sick. You can't. You can't survive if you don't make some money.
Matt Pillar:Right, Right, yeah, and that's a good segue. I wanted to go there next and talk a little bit about contracting and MSAs. You know I've learned through doing interviews with CDMO plus sponsor execs that even in the more straightforward like Steve, maybe you sign a contract with someone who's manufacturing an antibody seems pretty cut and dried, but it's not always cookie cutter, it's not always. There are always nuances In this situation. Andrew just said it was a pretty straightforward contracting experience, which surprises me a little bit, I guess, given that it's sort of an atypical it's not quite true, actually, straightforward, I mean, it went, we got through it and I had a lot of.
Andrew Lees:I mean, I don't know how to do this kind of stuff. I'm not used to seeing what's normal, what's abnormal. I had the outside consultants who were 100% guiding me on the process and they were experienced.
Matt Pillar:Yeah, and full disclosure. And I know that one of the challenges in doing a sort of a series of episodes, including a sponsor plus a CDMO, is that you can only go so deep before the sponsor and or the CDMO want to say you know, there are details to this relationship that we're not willing to make public. And I totally get that. I totally understand. It's been a challenge, right, it's been a challenge to even get credit to you, Andy, for agreeing to come on. It's been a challenge to even get sponsors to come on and talk about the work they're doing with their CDMOs. But, to the extent that you can, can you just kind of walk us through what that contracting experience looks like in such a way that might offer some advice? For we cater to new and emerging biotech leaders. So in such a way that might offer some advice to those who maybe haven't contracted with the CDMO before but are entering that phase of their growth.
Andrew Lees:Sure. So the first thing is our CMC consultant, brevis Refero. Up in Canada they have a lot of contracting platform. It's called RFP Navigator.
Andrew Lees:So about I think it was two years ago, we began on that and we actually had selected another CDMO to go forward with and what happened was the royalties that I had been receiving. It started to be, you know, we're going up steeply and then they took a sharp drop and so I no longer had the money to go forward. So a year later at bio last, a year ago, june or this last June I guess we put out another RFP and invited Scorpius to participate, because now we knew about them. They didn't exist for the previous one and looking at the entire package, you know we selected them out of that and it was the, you know, the, the getting to know the CDMO ahead of time so that we had some idea about who to, you know who to talk, who to talk to and what we were looking for.
Andrew Lees:The first time, this using the RFP Navigator, was extremely useful. In comparing, I really had no idea how this whole thing went through and that platform really helped. The second time, I can't say it was as helpful for me, because we sort of had had our criteria set up, I knew what I was looking for, but it still made it much simpler. But having some you know the outside guidance. If you don't know anything about the CDMO world and the contracting and the pitfalls and what's, what's this, particularly these change orders and what that's going to involve and why one cheap con, you know low price contract may be the most expensive one, that's. That is something you really have to have to know about and innocent people like me are not going to know that.
Matt Pillar:Yeah, yeah, can I?
Steve Lavezoli:jump in there real fast.
Matt Pillar:No, no, steve, no, no, I'm just kidding Steve. Steve, you know, this is. This is where Steve comes in and he says well, you know, all an emerging biotech exec needs to know is to you know, skip the RFP Navigator application and come give Abby and I a visit.
Steve Lavezoli:That is that is. That would be great, I mean. But there's a couple of nuggets in there that Andy really threw out that are like the key to I don't care what company it is that's looking for a CDMO partner that you need to be aware of and you should be looking for, as a you know, early on, early on biotech or someone searching for a CDMO partner. The first is the details in the proposal are critical and you know, sitting down with Andy you know we probably had five sit downs together where we talked about what he was looking for, you know what his program needed, talked directly to his scientists about what the program required, and that really gives us, you know, a special understanding of exactly what they need in their proposal. So that we're not looking at, you know, multiple, multiple change orders. It's very easy to throw a proposal out there and just basically say, okay, yeah, we're going to do your program for X dollars, because once Andy signs up, then he's really on the hook and I can change order, change order, change order to the point where I put him out of business. Right, he is understand up front and that is critical. That then feeds into the RFP navigator, right? So so I would say that you know, any small biotech that's looking to do a CDMO partnership early on work and the person that's listening to you as a, as a potential business partner, is really critical to them as a CDMO, a CDMO relationship with their, with their business, and we're supposed to.
Steve Lavezoli:Second point is we're supposed to be a consultant, right, we are not. We are not there to dictate to Andy what he should do with his program. We're going to guide him and what's best for his program, based on our experience and what we think is going to get his program to the endpoint, which is GMP material, you know. But at the end of the day, he owns the program. His scientists own the program. It's his business. We're there as their manufacturing partner so we can make recommendations. At the end of the day, it's his decision, so, or the decision of the business, and I think those two things are critical so that they can be, you know, as successful as possible when it comes to selecting their CDMO partner and then getting material out for their whatever phase clinical trial that you're doing. So thanks for those nuggets, andy, because that's the key point.
Andrew Lees:Well, you did use that word that you're. You're not just a CDMO, you also act as a consultant and this kind of advice you know and being and it is extremely useful to you know people at our stage who really don't have much that much of a team. We rely on outside people for this and, you know, feeling like we are a major client even though we're very small, is important, and feeling like, yeah, I can call you up and ask for advice and suggestions, and that's not just about how you're going to make more money off of us.
Steve Lavezoli:That's right.
Matt Pillar:What is the? What does the day to day or week to week, sort of cadence of communication, business communication? Andy, I'm not talking about the joke of the day.
Andrew Lees:Yeah, I was going to say that's the number one communication.
Matt Pillar:The, the other joke of the day what you know. What's the expectation in terms of? You know, steve, you just mentioned, like you know, we could change order Fina to death. You know when situations arise where communication is is necessary. What does that look like versus like? Is there a regular cadence of you know, weekly or bi-weekly, or monthly or quarterly meetings where you're just touching base and making sure that everyone's paddling in the same direction? What's that look like?
Andrew Lees:Well, we have, yeah, we have bi-weekly technical meetings and I think we have I think it's bi-weekly management meeting, so looking at the overall program and then in between we have additional questions going back and forth. So we're looking at at additional data as it gets generated before the actual meeting and we get get the, the slides and, you know, ahead of the meeting so that we can review and prepare for for the questions. This, you know, our process is not an academic process that we're tossing over to, you know, phase one GMP manufacturer, because it's our. Our product has already been made GMP, it's already been in clinic, it's into clinical phase one conjugate vaccines. We have a pretty good handle on the product and it's it is not like a, it's not functional in the sense of an enzyme or an antibody, where it has to have. It's a protein. So it's, in that sense, it's simpler than you know, some other projects, but our the protein is also very finicky and that that's the challenge of of manufacturing it.
Matt Pillar:When those challenges arise, what's the what's the protocol for addressing them?
Andrew Lees:We have the Zoom calls and go through it Also can just directly call up. Generally we're going to go through their project manager but speak with a technical person.
Steve Lavezoli:Yeah, I think it's also important that there's a primary point of contact. That primary point of contact is their project manager. Everything as it relates to the program, everything gets put through them. But Andy has a direct line to me as well. So there's always going to be something in a program that comes up that's unexpected. Andy has to feel comfortable enough to call me and say hey, did you hear about this? And how are we handling that To make sure we're all lockstep in getting his program to the end point? So those are all open doors and clear lines of communication about what we need to do In order to get his anything moving in the right direction.
Andrew Lees:I'm going to come back to the marketing budget and the dinners. Getting to know the people is really important when you just I mean, zoom does help, but really there's nothing like spending hours at an event talking to somebody. That really helps. And we're not able to get to Texas now to go visit Scorpius, but that is high on my list of things to do to meet with the people in person. You know, it's good to know the personalities of the people and there you know. So the face-to-face meetings are important. That is something that we haven't gotten to, but that does relate to another reason why we picked Scorpius.
Andrew Lees:The other lead contender was a Northern European and it's just, you know, sending things back and forth. The time difference was all going to create issues for us. Very easy for us to ship material back and forth because we're you know we're making the material at essentially the same level in our own lab, just as you know, we're doing the five-liter scale, not the larger, that we're mimicking stuff. So material can go back and forth for us to evaluate and for them to evaluate. So to speed things up, for example, while they were doing, before they got to the fermentation, we sent paste that they could use for downstream processing and to start that in order to speed things up. So things didn't have to be done entirely in a linear fashion. I think that would have been harder to do with an overseas manufacturer.
Matt Pillar:Yeah, for sure, steve. I want to get back to something that Andy mentioned when we were talking about sort of the cadence of interaction and communications between the two companies you mentioned. You know that there are bi-weekly technical meetings and bi-weekly bi-weekly more managerial product level meetings. Is it, you know, full transparency? Is it more or less challenging in a relationship with, like FINA's, where you're probably having both those conversations with Andy? I get the impression that regardless of what level the conversation is on, you know, like that batch, that product, that long-term strategy, andy's probably the center of that conversation.
Steve Lavezoli:He wears multiple hats, right yeah, Like the person that sells you the ticket and gets you on the train at the same time and then drives the train, right so?
Matt Pillar:yeah.
Steve Lavezoli:So it's definitely a different level of conversation, right, and I think there is a clear separation. So, you know, andy does a pretty good job of wearing the hat at the time and I think he knows that I'm not the scientist on the calls, so he definitely dumps it down whenever he and I have a discussion and it's more about you know, kind of the meat and potatoes of what he's trying to get across. He doesn't go on about conjugated vaccines and what I need to do in order to help in that matter. I mean, we're more on the business side. I have a technical degree, but by no means am I at the level of the scientists that are at Scorpio.
Steve Lavezoli:So, yeah, so he, you know, I think, making sure that we direct the conversation to the right folks. If it starts to get a little bit too technical, then I'll pull on the strings of the people that need to get involved in that. But yeah, I'm there for the business side and support. Never do I want to be the person that is directing or guiding this program. We're going to rely on the experts to do that and yeah, yeah.
Andrew Lees:Those are the guys and the gals at San Antonio for sure.
Andrew Lees:On our end, I can't manage this kind of project. We have someone who's really good on details and staying on top of stuff I'm not much of a detailed person and we have someone who met, who, on our end, who's the project manager, keeps track of all of our paperwork, all of the communications, and that's really important. And then, you know, on the technical side, we have a mentality of the scientists who develop this, this, the whole process, and she's the one who really supervises the technical stuff. But, for example, you know we're looking at at the tech transfer and we know we're going to make another change in the process. So there's no point in trying to get the tech transfer perfect knowing that we're going to make changes down the road to something that's going to affect that anyway. So we know the process has been transferred and you know now we can.
Andrew Lees:So my decision was let's not make it perfect at this stage, let's let's get to the next phase and and then we can worry about the subsequent part. Yeah, so there is, you know, there is the certainly the business part of managing the work, the kind of the money, workflow, what's going to when things are going to happen. So we, you know, we know when we need. I think we're going to need the material, but we want to make sure that we have the money in place to get there.
Matt Pillar:Yeah, yeah, that's an interesting point. Like you know, when you, when you'll need the material, and then obviously that material is being produced for use in potentially another facility, definitely by another, another company, a relationship like this. It strikes me that there are probably multiple opportunities for third parties, for fourth parties, fifth parties, right to have their, if not in real time, to have their tentacles sort of intertwined down the road to so which, which can be, I mean from your perspective, steve, that that could be a goldmine down the road, right, like that that could be, at least, let's say pragmatically, that it could open up some new opportunities for Scorpius. But in the in the short term, it can also introduce complications. So tell me a little bit about that, like to the degree that you can talk about, like what, what sort of third party elements are involved, third party and beyond, and how it's managed.
Steve Lavezoli:Yeah, there's always third party relationships that are ongoing with programs because you know, regardless of whether you're considered a one-stop shop CDMO, you're always going to rely on some third party work, whether it's third party testing. Maybe you don't do drug product filling, maybe you don't do clinical packaging. In those cases the best thing again for me is to advise Andy on who he should potentially go with that might be a good fit for his program. There's a bunch out there. Again, Andy's going to run into those situations where he doesn't know necessarily who to work with or maybe doesn't have experience.
Steve Lavezoli:But my ears on the ground, as it relates to those relationships and the capabilities of other I guess what I would call contract manufacturers, but not necessarily on the GMP drug substance side I could make those connections for Andy. I can say hey, andy, these are the folks you want to talk to. I can certainly do it on their behalf. Essentially, continue to manage that with our project management. It really depends on how Andy wants that relationship to look. We can craft it however Andy wants that to be handled. Sometimes companies don't necessarily want the CDMO to handle clinical packaging and distribution, but if they want us to handle it and they want us to be that conduit between the clinical packaging business. We're happy to do those things. It's really all a car. Whatever he wants to do, we'll do it for.
Andrew Lees:I would say, on the other end, as we discussed before, I'm a magician. Part of that performing is I'd like to make other people happy. I like to help other people. I almost became a technical sales rep and the idea of going around and helping people with their problems I like when people come to the lab. I like to have a network of people In the same way and that's why I'm happy to be on programs like this. I like to work with other people. What I've found is, as I've run my company, we're not trying not to be transactional, try to make it relationship-based. Somebody will come around and maybe I don't need their product, but I can refer them somewhere else. I can help them. I've made a new friend. In the same way, Scorpius has really been helping me in reaching out to other people and other companies and I'm able to bring in referrals to Scorpius Some of them they can't do, but it's still bringing in business and helping to get their name out there. Helping other people is how you help yourself, is the philosophy.
Steve Lavezoli:Andy has done that. He has done a really good job of promoting our relationship. We've definitely seen the benefits from it, so we appreciate it.
Matt Pillar:That's fantastic. I want to be respectful of your time. I know we're running short here, but I've got a few last questions for you. One would be I could go long, andy. You were just talking about the relationship and the people, and I appreciate that man. I love that. I love to hear about that, the soft stuff. At the same time, I think about experiences that I've had being in business with family that have gone awry. It doesn't always go well when you care about the person you're doing business with. Sometimes those relationships do not juxtapose cleanly. Let's talk about expectations and measurables. How do you keep the business part business and chart the measurables and the expectations and work toward them?
Andrew Lees:We have a deliverable product. We need the GMP material. We're going to end up with a bunch of protein that meets specs in little vials. That's the bottom line. All the nice stuff and the jokes are just part of getting there. The way I understand, it's a business and we need to do this. It's a lot of money and we need to have a product at the end.
Matt Pillar:Yeah, it's early, steve, go ahead, go ahead.
Steve Lavezoli:I was going to say and there's definitely been scenarios that Andy and I have a great personal relationship, but there's also the point where we need to talk business right and on both sides, and we've had that. We've had very good discussions. We're going to solve those things and there's definitely a line between business and pleasure. Happy to go out and have a drink, we're happy to go out and have dinner, but we've got to make sure that we deliver. Andy has expectations from us as well that we need to make sure that he's attending to. We've had those good conversations as well. Healthy business.
Andrew Lees:Yeah, Running a small business and particularly when there's no investors involved and there's no pot of money anywhere, that cash flow is critical and so, working with Steve on managing that and expectations on both sides, I've made certain promises. I'm going to deliver by the end of the year and it's going to happen.
Matt Pillar:Yeah, the way I posed the question to I mentioned that I had Jenny Holt on from Ray Therapeutics. She's a chief business officer there, so she's answering to Paul Bresge, the president, CEO of Ray Therapeutics, and a board. Right, these are things, these are nuances that you don't need to deal with, Andy, because of your position. But the way I posed the question to her was I said, Jenny, if Paul and the board were to come into your office right now, as you and I are speaking, and say you need to rationalize in clear terms the money that we're spending on our relationship with Forge Biologics, how would you do it? And she gave me a really good response to that. But you, Andy, you don't necessarily need to rationalize it to a board or to your boss, but you have to be able to sleep at night and I sleep at night.
Andrew Lees:I think you answered the question. I don't have to rationalize it. I have to rationalize it to myself in the middle of the night. Yeah, yeah, you know where this is going to come from, because it's definitely. This is a major undertaking for a company that does not have outside funding, but you know it's moving forward. We have the resources to do this.
Steve Lavezoli:He does have to rationalize it to his wife, though.
Matt Pillar:That too, yes, that's an omnipresent challenge for all of us married men. I understand that one completely. You know, one of the conversations I frequently have with sponsors about outsourcing relationships is just, you were talking about tech transfer a few minutes ago, andy I frequently heard, you know, conversation with biotech execs around just how low they are to make a change, to go through that process again, which you guys did. And, andy, obviously it was an inflection point for the company. You needed more capacity, so it probably made sense. But I guess the dark side of this question, andy, would be what would be considered cause for change? What could Scorpius possibly do?
Andrew Lees:to screw up. How could they screw up? We're still on the honeymoon phase.
Matt Pillar:I know we're not. We're not we're not.
Andrew Lees:We haven't gotten to the assigning of the blame yet.
Matt Pillar:And I'm coming at you with such a downer of a question Really.
Andrew Lees:I mean we would. At this point I really can't think what would change.
Steve Lavezoli:I mean I can answer that, because if we can't deliver, then Andy needs to find someone who can. Yeah, that is our expectation is to deliver the product that we told Andy we would. That is what he should expect from us. And if we can't deliver, then he needs to take his program somewhere that somebody can, and that is the expectation of anyone who has a CDMO partner. You need to have material when you need it. You need to get material when you need it and the promises need to be kept.
Andrew Lees:And I mean that's the deliver We've. I believe Scorpius can deliver this. I mean we obviously wouldn't have selected that you don't get married with the expectation of getting divorced, right, and we're going to do everything that we can to make this work and I have no reason to believe otherwise based on anything that I've seen or any of our interactions. I've been really happy with the meetings and how things are going with Scorpius.
Steve Lavezoli:Yeah, you should never settle right. You should have high expectations and those expectations should be met from your partnership.
Andrew Lees:I will say I've been involved in several tech transfers now for both as part of FINA-Bio, because we transfer conjugation processes to GMP facilities. There is always you know it's, you're working, you spent years working on this process and then to essentially throw it over a bunch of paper over the fence and expect that it's going to be duplicated exactly Is unrealistic. So you really need to be working with the CDMO. You know, depending on your level here we've got batch records, gmp batch records to transfer. We know the process works. So it's a little bit different than an academic who's yes, it worked in a lab and now here, now just make it bigger. That never works.
Andrew Lees:Yeah, that is the classic mistake we'll do and I sort of learned that the hard way is projects come into us, so really it's understanding that it's not going to go perfect. I mean, humans make mistakes. It's how you address those mistakes that's key and I see Scorpius being willing to do this. One of the CDMOs I worked in the distant past. You know that it was. This is the way we do things, you know. So when you give them the process to improve it, they know what they've done and they won't recognize. There's a reason you ended up with this, you know, with this step.
Matt Pillar:Yeah. Yeah, you mentioned recognizing mistakes and it's just solid advice. It's not the mistakes you make but how you deal with them. And I know again, it's early in the relationship. But at this stage in the relationship, looking back on the, you know, the contracting process, the MSAs, the expectations that have been forged, what would you, either of you, do differently if you had a redo? You know, has there been a step in the process so far? You're like, yeah, we probably could have handled that a little bit better.
Steve Lavezoli:I'd probably ask for less daily jokes from Andy, but that's Really All right. You're off the list.
Matt Pillar:I was actually going to ask you where you're going.
Steve Lavezoli:Sometimes I get more than one daily joke, so it doesn't necessarily mean it's a daily joke.
Andrew Lees:It's a second daily joke, yeah Well sometimes I Matt, I miss the meetings because I have to go to my kleptomaniacs anonymous meetings, and you know I take something away from every session.
Matt Pillar:Mmm, I got that. That's very good. Is that exemplary of the day? I was going to actually ask where I could subscribe to Andy.
Andrew Lees:Lee's daily jokes. Now, it's just really a private, private, private list.
Matt Pillar:That's probably a good thing, because if that, if that, if that joke you just made as a good.
Andrew Lees:That's a better one.
Matt Pillar:Yeah, I'm out, I'm out.
Steve Lavezoli:Some of them are. Some of them are a little better than others, yeah.
Andrew Lees:We go with volume, not quality. That's right.
Matt Pillar:I love it.
Steve Lavezoli:If I had to change, if I had to change anything, you know I I think that I would have. I would have loved to get to Andy, andy, earlier, because you know, the sooner you can get to someone that helps them, you know, create their program and get it on a better pathway faster. You know, like I said, I had been doing this for a while and had come from large CDMO and I think that consultative opportunity for me to kind of give Andy guidance on what I would do if I were into his shoes. I personally like to do those kind of things, so especially for someone like Andy.
Andrew Lees:So you know, unfortunately I can't turn to, I can't turn back the clock, so I mean, we really started this project pretty much with Scorpius really starting up, and so you know we've it's about as early on as we could have gotten. Yeah, you know we're. You know there are not that many companies doing this kind of thing that are still, you know, solely owned by one person, and this is not the only only. You know we also are starting a company around our E coli strain that can make all kinds of other interesting proteins, and so that's, you know, that's the challenge. We still run our, we have our conjugation services business and then, early on, recognizing all this stuff takes time to make money.
Andrew Lees:We also sell polymer based diagnostic reagents, so based on conjugation. So we, we supply modified dextran polymers for research and for, you know, commercial products, and so we take our expertise in that. So all these to make what we think are the best, best products in this. So we really have four business areas. The carrier proteins for conjugate vaccines is just one of them, and so keeping all these things in the air as a one, you know, as a one, one person running four businesses essentially is a challenge, and so having, you know, really reliable help, outside help is key to making all this work, and I'd say the you know, the employees at Fina bio. I really make it, make it run, and the outside consultants that help are the other key. And again, helping other people. I found and having this We'll call it do good or approach to business means that people come in and want to, you know, are willing to help us and we get. We get a lot of help for that.
Matt Pillar:Yeah, yeah, well, I can. I can certainly appreciate that about you, andrew. After spending the last hour with you and I hope it's not the last hour that we spend together I'd love to have you guys back on, probably down the road you know what I mean as you get closer to achieving some of those output goals that you're looking at, we'd love to revisit the relationship. Steve, it's been a pleasure to meet you as well. I will let bygones be bygones. Let's water under the bridge. Abby's probably going to be mad that I that I even brought her up on this podcast, but but we'll let that go. In fact, steve, I'll be. You're down in the Pittsburgh area, right?
Steve Lavezoli:I am Yep.
Matt Pillar:All right. Well, if you happen to be in Market Square, the Market Square area at the Peoples Gas, what's it called the Peoples Gas? Yeah, it's good, peoples Gas Market.
Steve Lavezoli:Yeah, yeah.
Matt Pillar:Is it good because my wife, my wife is when are you going there? So my wife, she wants to go have dinner on the strip Saturday night and then do the Peoples Gas thing with my mother-in-law, my brother, my sister-in-law. So we're thinking about doing that Saturday night, is it good?
Steve Lavezoli:I mean I love the strip district. No, I mean I love the strip district. I'm not crazy about Market Square, but I love the strip. So I mean, I think, if you're going to have dinner in the strip, There'll be a highlight. There'll be good places down there. Yeah, it's going to be a good time for you. You're going to enjoy it.
Matt Pillar:It's going to be cool. Oh yeah, we've spent quite a bit of time down there. You know we like Luke Woolies and oh yeah, I'm not sure what it is.
Steve Lavezoli:Is it light up night? Is that why you're going down there?
Matt Pillar:Listen, I have instructions. You know where I need to be, when I need to be and what I'm driving. That's what I know. But I was just going to say, if you happen to find yourself downtown Saturday night, I'll keep an eye out for you. I'm buying you a beer for spending the last hour.
Andrew Lees:And I'm going to say welcome. We're located in Rockville, Maryland, where Fina Bio has been. I've been in that area now getting on 30 years. I've been within about a mile of where the same location. It's a great area is just packed with with biotech companies and it's a great area to be, to be doing business in the biotech field.
Matt Pillar:I noticed that live on air you actually annunciated Maryland Is the way that you were saying it earlier, before we started recording, sort of an insider's thing.
Andrew Lees:Yeah, yeah, it's Maryland. I'm from Boston originally and we do pronounce words strangely, but you can say Maryland, all right.
Matt Pillar:Well, andy. Steve, thank you so much for joining me. Like I said, we'll do it again down the road. I appreciate it, but in the meantime I'll let you get on with your day. Andrew's got three other companies to run today, so we'll thank you.
Andrew Lees:Thank you very much, much appreciated.
Steve Lavezoli:All right Thanks.
Matt Pillar:So that was Fina Bio Solutions' Dr Andy Lees and Scorpius BioManufacturing. Vp of BizDev and client partnership, Steve Lavezoli. I'm Matt Pillar and this is the business of biotech. We're produced by Bioprocess on line. If you like listening in on conversations with biopharma, medicine and dealmakers like Andy and Steve, subscribe to the Business of Biotech podcast, sign up for our newsletter at bioprocessonlinecom backslashbob and be sure to leave us a review and let us know how we're doing. And, as always, thanks for listening.