Summary

Amy DuRoss, co-founder and CEO of Vineti, sits down with Neil to discuss how the company’s platform technology addresses the unique supply chain management challenges of cell and gene therapy companies.

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Transcript

00:00
Danny Levine (producer)
All opinions expressed in this podcast by participants are solely their opinions and do not reflect the opinion of Bioverge Inc. Or its affiliates. The participants'opinions are based upon information they consider reliable, but neither Bioverge or its affiliates warrants its completeness or accuracy, and it should not be relied on as such. Nothing contained in an accompanying this podcast shall be construed as an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security by Bioverge, its portfolio companies, or any third party. Past performance is not indicative of future results. You're listening to the Bio Verge Podcast with Reallife. Yeah, we've got Amy Duras on the show today. Who is Amy?

01:09
Neil Littman (guest)
I am incredibly excited to welcome Amy to the show. Amy is the founder and CEO of a company by the name of Vanetti, which we'll get into in a minute. Actually, before founding Vanetti, amy focused on healthcare, new business creation at GE Ventures at Healthy Imagination. Prior to GE, Amy was the chief business officer at Navigenics. It was a genomics company that I believe sold the Life technologies. She was also a co founder and the executive director of Serum and Proposition 71, where I spent some time working. Amy and I did not overlap there. One of the reasons I'm so excited to talk to Amy today is she has such a long history in the field of regenerative medicine, cell and gene therapy. I think she brings a really unique 30,000 foot perspective to the field. I'm really excited to dive into her company, Vanetti, and what they're looking to do in terms of fulfill the promise of delivering highly personalized therapies to patients.

02:07
Danny Levine (producer)
I remember Amy from those days at Serm. What kind of visibility do you think that gives her into the types of issues Vanetti is trying to tackle today?

02:17
Neil Littman (guest)
Well, I think it gives her some critical visibility. She was one of the architects behind Prop 71. If you think about the promise of serum in Prop 71, right. At its core, the promise of serum funding was to deliver novel therapies to patients. My understanding is that's still very much what Amy is trying to do at Vanetti. She's just approaching in a slightly different angle, and she's going through trying to solve some fundamental infrastructure problems now at Vanetti, but the goal is still the same. It's still to deliver therapies to patients. Still her goal from her days at Serum still sounds like that's her goal at Vanetti. It's just a slightly different approach to how she's going about doing it.

03:03
Danny Levine (producer)
For listeners not familiar with Vanetti, what exactly does it do?

03:07
Neil Littman (guest)
Yeah, so Vanetti is a company that has developed some software, I believe it's enterprise level software to help control supply chain logistics for the delivery of cell and gene therapies. If you think about how you need to track a product, in this case, let's say autologous cell therapy, from manufacturing it all the way to the patient bedside and the infusion of that therapy. My understanding is Vanetti's technology platform helps to create unique IDs to track the cell therapy as the product from the manufacturing plant, essentially, or where it's manufactured, all the way to it being infused in the patient. And so this is all pretty novel. It's all relatively complex, and it's all very different infrastructure than what currently exists in the supply chain of delivering small molecules or biologics, for example. It's pretty complex stuff, but it's critically important in the delivery of more personalized medicines.

04:12
Neil Littman (guest)
Well, if you're all ready, let's do it. Hi, Amy. I'm incredibly excited to welcome you to the show today. Thank you so much for joining us.

04:23
Amy DuRoss (guest)
Oh, thanks so much for having me. It's delightful to be with you.

04:27
Neil Littman (guest)
Today we are going to talk about celangene therapies the promise of personalized medicine and dig into an area that people probably don't spend enough time thinking about. Although, given what's happened with the rollout of the COVID vaccines, certainly deserves a lot more attention than it gets. That's the complexity of the supply chain logistics and the delivery of complex and novel medicines. I'd love to better understand how Vanetti's approach and software is designed to drive and scale the delivery of personalized therapies within the Regene Med field. However, before we dive into that, you and I have some shared background from our days at the California Institute for Regenerative Medicine. We never actually overlap there, but you've been in the Regenerative medicine space, I think, for most of your career. I'd love to just dive into of your background, your experience within the field in general, and then what led you to the founding of Vanetti and the realization that there was a problem that needed to be solved.

05:27
Neil Littman (guest)
Thank you, Amy. It's a great background, and I think you approach things from a fairly unique angle in terms of bringing the patient perspective. You mentioned early in your career, what led you to be one of the architects behind Prop 71 in the creation of serum. Can you talk about having that patient perspective, the patient advocacy perspective, and how that has influenced what you're looking to do at Vanetti and what you've done over your career? Because I think that is a really valuable perspective that more people have these days. It wasn't as common five or ten years ago.

06:04
Amy DuRoss (guest)
Totally agree. Proposition 71 was the first initiative in history to really establish such a broad coalition of patient advocates and advocacy groups, along with leading scientists and academics and the industry partners we had. The primary focus was really for patients by patients. That's really where the founding group came together, was all around uniting support for patient focused research and then translation and then extension of that research into clinic. I do think the power of patients and we've seen other movements, notably HIV, breast cancer, it's just a phenomenal, rare disease phenomenal groundswell of patients taking ownership of the phenomenal just force of medical science than we've seen. Again, so many other paradigm shifting discoveries like CRISPR come into view. I do think that the particular point of personalization really brings into focus the role that patients play in a more meaningful and frankly, untrusted way than any other therapeutics area, because with autologous therapies, for example, the patient is the primary substrate for therapy.

07:30
Amy DuRoss (guest)
Excuse me. Patient equals product, equals process, there's this very interesting kind of differentiation and patient centricity that is also unprecedented. So I think it makes perfect sense. It's really aligned with form following function here, that patients are taking a front row seat and advocating for this phenomenal science and then its application to improve treatment of disease. I think that patients have found their voice. I think it's been true in the last five or ten years. I think Proposition 71 was just one piece of a mosaic of very forceful, out in front patients taking control to some degree of their destiny, which is their right.

08:21
Neil Littman (guest)
I think that's so true and couldn't agree more. I want to dive into a couple of things that you had mentioned, I guess, just so our listeners understand. You had mentioned the term autologous. Just for our listeners, could you compare or contrast this idea of autologous cell therapy versus allogeneic? There one area where Vanetti is more or less focused on?

08:42
Amy DuRoss (guest)
Oh, absolutely. So. I think in more common parlance, car t therapies, because they're now commercially available, number of them have been more popularized, perhaps. Principally what an autologous therapy is, it's a therapy that revolves around a patient's own cells. That's where the auto prefix comes from. Really essentially harnessing a patient's own immune cells, or T cells, to then genetically modify those cells, to turn them into assassins, if you will, reenter into the organism or the patient and then have those cells essentially do their work that they were set up to do, but in a highly targeted fashion. Autologous workflows versus allogenetic, which is when a donor cell is introduced again, genetically modified, so that it becomes an assassin cell as well. It just doesn't originate from the patient's own cells, rather from a donor cell. But the principles are similar. It's really taking the primary workhorse in the body T cells that defend us from disease and putting them to work in a much more targeted, much more efficient, deadly assassin way to eradicate disease.

10:09
Neil Littman (guest)
Obviously, this group of therapies are much more complex than, let's say, traditional small molecules or even biologics. Could you then talk about some of the complexities in terms of the development, manufacturing, the delivery of these types of selentine therapies, what's needed that it maybe doesn't exist today in large pharma or in biotech through the delivery of traditional small molecules or biologics.

10:37
Amy DuRoss (guest)
Yeah, absolutely. So, Neil, you started out this conversation of saying the supply chain side or the production and delivery of really groundbreaking medical science doesn't always get the same coverage or visibility as the underlying science itself. I understand that the science is absolutely flabbergasting. One of the things that I think our industry, particularly in the last five years, is really waking up to, if you will. And then I do agree with you. The COVID situation, both on the testing and vaccination distribution front, really burdened our existing broader pharma supply chain. I think there's been a renewed emphasis, even more so on improving the infrastructure overall, not just for our market here in cell and gene therapy, one of the fundamental paradigms that is different about cell and gene therapies versus. Every other therapeutic area that has come before is that the healthcare providers, the clinicians, the Aparasis nurses, the or surgeons and technicians who are administering to these patients are actually implicated in the manufacturing process.

11:53
Amy DuRoss (guest)
What that really means is there's this principle of good manufacturing, or GMP good manufacturing principle that is now it's really a compliance regimen that usually governs manufacturing facilities in our market. In celengene therapies, that GMP regulatory oversight is extended into clinic, and that is unprecedented. That is a new paradigm shift where you're actually asking clinicians to participate in manufacturing. Typically, clinicians order they requisition a therapy or a drug, and that drug is fulfilled outside of the hospital or clinic and then received and administered on site to a patient that just doesn't exist in our market. The patient is the patient centric approach to this medicine. Their healthcare provider is a participant in manufacturing. What that really means is you have a dependency in the supply chain that hasn't existed before. Therefore, the regulators, in their wisdom, FDA and their counterparts elsewhere in the world, have said to pharmaceutical therapeutic, or, excuse me, pharma companies, you must orchestrate this supply chain in a different way than in any other therapeutic environment.

13:16
Amy DuRoss (guest)
That really means you have to assign a unique patient identifier for every single process. Because, again, the process is the product. With autologous therapies were just talking about, or allogeneic therapies were just describing, the process is the product. In that paradigm, you really need to ensure there's a level of orchestration across the supply chain that only software can convey. It's actually the first time in the history of biologics that there is a regulatory requirement for software for commercial approval in a market. And that is really, again, to acknowledge. We have so much complexity where you're literally treating each patient individually, and you need to assign a unique identifier to that patient that follows the patient's care pathway and lifecycle for that therapeutic from the beginning to the very end and even post infusion. Because essentially we are modifying, genetically modifying parts of an organism or a patient.

14:26
Amy DuRoss (guest)
We always have to have that ability to tag back to a patient to ensure first and foremost that the right patient is receiving the right therapy at the right time. Because God forbid, Neil, if you get my cell therapy or I get yours, it could and likely would be a deadly event. Also to have that view and tracking capability over time so that as that patient continues in their life cycle, post infusion of a stellar gene therapy, we can monitor them, we can check on their progresses, and we can really use the information as that patient continues on to really supercharge future discovery. There's a whole realm of, frankly, new requirements that this celebrity therapy market is introducing that the old infrastructure and pharma really wasn't set up to deal with, particularly at scale. That's where companies like Vanetti and others are entering the freight here.

15:34
Neil Littman (guest)
I think it's really fascinating. I mean, as we know, well, just from the COVID pandemic, right, the infrastructure and the supply chain logistics, without that having being in place in a sufficient fashion, patients are never going to receive therapy, is never going to receive the vaccine. This is a critical point in delivering therapies to patients and patients gaining access. So, I know Veneti has developed, I think, what you call a personalized therapy management platform. Could you talk about what that is? It sounds like what you just described is part of this therapy management platform. For our listeners, could you describe about what that platform is and then how, if at all, it exists into existing workflow?

16:17
Amy DuRoss (guest)
Absolutely, it'd be my pleasure. The personal Therapy management platform I affectionately call my fourth baby because I have three children and I'm so proud to talk about it just as I am my human children. The personalized Therapy Management platform is a built for purpose enterprise platform as a service. What that really means is it's a fully configurable, fully extensible software platform that allows a level of flexibility and control and transparency into a workflow. What we do is this platform, the PTM platform, automates workflows at its core, assigns a digital chain of identity to each patient batch, to each product, meaning each therapeutic, again, back to that primary function of allowing for right patient, right therapy, right time, ensuring patient safety, but also really aligning the supply chain. That really means again, in addition to the healthcare providers, the clinicians I spoke about earlier, all of the cold chain providers, the specialty couriers, the hub managers, there are so many different stakeholders who are required to have frankly, a view into a single batch process, where, again, that chain of identity is the linchpin that allows for all of these different stakeholders to have realtime and right time supervision over the manufacturing and production line.

17:56
Amy DuRoss (guest)
That again, it only exists especially in a market like ours, which is unprecedented for its complexity, for all the reasons we've talked about. Again, because each therapy is specific to a patient that you really need to have transparency and control at every step of the process. I think the opportunity here is very interesting. Again, COVID has changed our lives, unfortunately tragically. I do think the learning opportunity on the relatively positive side is how can we take some of these learnings and apply them more broadly? The power of enterprise software, of truly configurable software, not customized software, but software that adjusts and adapts as workflows adjust and adapt and workflows adjust and adapt in our market by nature because of the individualized nature of these protocols. It's a huge opportunity, I think, where again, you've got a pharmaceutical sector. We sit at the bleeding edge of innovation in terms of the medical science and the mechanisms under the hood with CRISPR and all the other technologies contributing here.

19:19
Amy DuRoss (guest)
How can we take some of these learnings and then really spread them across the broader pharma distribution chain? Because that has been demonstrated here is having real deficiencies.

19:31
Neil Littman (guest)
Yeah, I totally agree with you. One of the questions that comes to mind is at what stage should companies be thinking about implementing this type of technology? I'll just make maybe a not great analogy, but as we think about manufacturing and CMC and as you said, the process is the product, there's often a tension for early stage companies to invest in manufacturing versus put all their research into and all their resources, excuse me, into racing towards clinical proof of concept. Oftentimes you're not going to achieve clinical proof of concept without investing first in the manufacturing process because you're going to have a more pure product, for example, which will increase the probability of you achieving clinical success. There's always that tension as you think about when companies should implement this type of technology. It preclinical, is it clinical, is it really reserved for commercial stage companies?

20:23
Neil Littman (guest)
I'd love to understand that a little better.

20:26
Amy DuRoss (guest)
It's such a great question. Again, when you have process equivalent to product, I think the way in which you're producing and delivering is inherently prioritized. It has to be. I think our rule of thumb to answer your question really directly, Neil, our rule of thumb is anytime you're in clinical phase with ten or more patients, you really need to introduce that the sophistication and control of a chain of identity platform. We work with customers who are in global commercial phase but who are also in phase one. Frankly, we are being asked to advise and even preind settings. Back to your fundamental question is how important is the process, how important is the manufacturing set up and system programming overall when again the primary meat and potatoes here is the actual mechanism of action. I think we're seeing that there's differentiation potential and there are real compatibility concerns as you move through the R and D life cycle and those are being called out increasingly with CMC call outs by FDA and others.

21:42
Amy DuRoss (guest)
They're counterparts more so than I would say the first wave of car T, the CGT 10, the Kim Ryze and the Escardias of the world. When we started our company, our first customer and really our collaborative collaborator was Kite Pharma and that was before they launched Yscarda. We were part of their BLA. What the leadership, the primary leadership and founding leadership of the Kite Pharma team understood, really, inherently was their whole manufacturing effort, their tech ops, all of their clinical operations. Everything was being all of the typical functions were being asked to not only participate differently, but align with one another in ways they historically in small molecule in other markets hadn't been asked to do. That really prompted, again, the founding leadership of Kai Pharma to say, look, we need to invest in ways not only to promote alignment across these historically disparate functions, but we also need to invest in what the build for purpose to support this alignment is going to look like, because it's just not on the market.

22:54
Amy DuRoss (guest)
We're just so new. I think they were rewarded for that investment frankly as they were brought under the Gilead umbrella. I do think it represents the forward looking, thinking, recognizing that the infrastructure is not set up to scale these therapies as it is today. It requires even more investment than we've seen to date. The world of closed loop manufacturing, there's a ton of investment there. The CDMO segment, it's still not enough. We still have a lot more work to do as an industry. I think that's fundamental recognition that not only is it more important than in other therapeutic areas to really understand that manufacturing and It system and the broader quality systems and how they're all going to interrelate, it's actually part of the value of the company to figure that out, invest in that. Part of it is along with the pure scientific discovery.

23:53
Neil Littman (guest)
Yeah, and I agree, I think that's really critical. You had mentioned Kite and Juno was another early developer of Cartes. We fast forward today, the selling gene therapy companies are really evolving almost at a breakneck pace these days. There's tons of capital flowing into the sector. It's really wonderful to see, but how does that affect what you're doing? How are you able to adjust your software, your business to the growing needs and growing demands of an industry that's frankly changing at warp speed?

24:25
Amy DuRoss (guest)
Yeah, well it's such a great problem to have. Speaking as someone who's been advocating for personalized immergenerative medicine my whole career, I'm just so honored and delighted to be alive at this moment in history. I do think that there's a huge opportunity here to invest in the pics and axes. More broadly, I think that you're seeing a conviction from the capital markets on therapeutic side and then very quickly also the realization that we can't consume this remarkable science without heavy investment on the infrastructure side. One of the key parts of really making sure we do tool our company here in our view as an enabler of a broader industrialization of this market is that we've made heavy investments. Our first instance, if you will, of the PTM or the Personalized Therapy Management platform was our kite instance. We built a go to market first version one to support yes Carta and a few other customers and really learned a tremendous amount with shoulder to shoulder with those partners and took a tremendous amount of investment into a much broader, much more sophisticated, enterprise grade global extensible configurable platform.

25:53
Amy DuRoss (guest)
We were very fortunate to hire Phil Calvin, our CTO, who built the salesforce platform last decade, was after selling one of his own companies into salesforce. Really understands extensibility configurability. Configurability really means the capability to not customize. Frankly, it means to change and adapt workflows within a modular enterprise environment so that as workflow adjustments happen, which are inevitable in our field, you absolutely will have adjustments even in commercial phase to the requirements to support these therapies. Rather than having to reinvent wheels in order to change and adjust to different requirements as they evolve, you can just configure them. You're all in a single platform. It makes it very simple and efficient to essentially keep pace with the requirement evolution. As we move through these products and we hybridize, that's what's happening more and more in our market. We're seeing a lot of mixing and matching of different mechanisms, PCVs, Nks, all sorts of things.

27:03
Amy DuRoss (guest)
You can't just have a static system. You have to have a system that's flexible and adaptable. Fortunately we have been able to raise the capital necessary to invest in the version two of PTM, which is the version that's live now and inherent in that architecture. Again, with our laser focus on this problem of automating chain of identity for these highly valuable, highly personalized therapies, we have lots more room for growth because we've been investing in the primary foundation of the platform. We're ready to kind of flywheel this on behalf of the industry. We saw a bit of a slowdown just because naturally in COVID the prioritization for COVID patients who needed ICU access continue to do so. Slowed down some of the protocols we support, but just delayed them by about two or three quarters. As you mentioned, the market is just unbelievably frothy and excited about supporting these therapies.

28:05
Amy DuRoss (guest)
We're in this interesting place where we're beginning to see a real uptick interest in participating in our platform, getting these products out there, making sure they're safe, working through all the clinical phases of development. So we're really excited and really optimistic.

28:24
Neil Littman (guest)
Amy, I want to pick up on a thread that you mentioned because I think you bring such a unique perspective to the field. The promise of regenerative medicine has been something, as you mentioned, you've been working on your entire career, really since helping to architect prop 71 in the creation of serum, which at its core, promise to deliver the types of novel therapies that we're talking about, right. That you are still working on to this day at Vanetti. I might put you on the spot here, but if you had a crystal ball with the caveat that all predictions are wrong, where do you see the field of cell therapy regenerative medicine going over the next five or ten years? Really even more specifically, if you had to guess, do you think cell therapies are going to be more widely accessible and used in the practice of everyday medicine in the relatively near term?

29:12
Amy DuRoss (guest)
Oh, I absolutely do. I think we're going to see I mean, I think the holy grail in our field, in addition to some of the rare disease focus efforts, is our tumor cell applications. We have a number of liquid tumor opportunities here, and they are developing rapidly. I do want to say one of the other. Again, I hate the term silver lining with the tragedy of the scale that we're seeing still unfold with the COVID-19 pandemic, the primacy of the mRNA platform in addressing COVID via the vaccine development. Again, that rapid cycle development, not only was it just remarkable science led by bioantech and pfizer and moderna and others, there are other folks, really, who've been working on mRNA for the last couple of decades, but the work has really come to a level of fruition, and again, urgent situations demand urgent solutions. We've just seen a remarkable cross collaboration, international effort to get these amazing, truly miraculous vaccines in place.

30:26
Amy DuRoss (guest)
I think there's some really interesting opportunities for mRNA. Specifically, we're looking at this companion opportunities with some of the other cell therapies. Can the mRNA vaccine approach also be booster? We still are struggling to understand why even in the v one of car t therapies, the autologous cell therapies were talking about earlier, some patients who appear to fit the profile have no efficacy. Many more patients are actually being cured, which is fantastic, but there's a growing body of evidence that suggests perhaps even an mRNA vaccine booster could be appropriate and helpful for some of the patients who aren't showing as much responsiveness to just the cell therapy administration alone. That's just one of a million opportunities, right? I'm so excited about personalized cancer vaccines about the neo antigens strategies. All of the science is just iterating in excess of Moore's Law. I have true conviction, just as I have from the early days of precerm, that there is really something here that is going to massively reduce human suffering.

31:41
Amy DuRoss (guest)
I think the other part of this, and you asked me about the outlook for the next five and ten years, I think that we do see a real continuity of funding coming forward for how to consume these therapies. Obviously where we play, we spend a lot of time focused in the supply chain. I do think that some of the sheer brain power that is being and the capital behind that brain power that is coming in and looking at vertical integration and really investing in some of those shop floor tools, and I think that my only hope in seeing a broad set of convicted partners with various core competencies is that we can, as an industry, respect those core competencies. Because I can speak from our own experience with just chain of identity, chain of custody as one slice of a much broader set of ecosystem issues.

32:37
Amy DuRoss (guest)
This is not for the faint of heart, right? We eat humble pie every day and I think we're continuously learning. You need to have that growth mindset in this marketplace because again, when processes, product and process is changeable and evolving, you're going to have to evolve alongside of it. The only way I see this really coming together in the next five to ten year time frame is if we can coordinate as an industry, respect those core competencies, merge those core competencies. There needs to be so much focus, laser focus on all of these various problems in the chain to solve and build for purpose. That's my only kind of call out to the industry for anyone who's listening today is great that we have the capital, great we have the focus, the science I'm actually just not worried about at all. I'm just so excited.

33:30
Amy DuRoss (guest)
I've like buckle up to see what happens next. If we can't figure out how to consume and extend and scale out the science, we won't see a market in an industry, we won't see a standard of care in the next five to ten years. I do believe we'll see it eventually because once you've unleashed the genie out of this bottle, it's going to find a way. I just think it can happen sooner if we could coordinate better.

33:54
Neil Littman (guest)
And, and to your point, Amy, I mean, I think what the Pandemic has clearly shown is that the industry is capable of collaborating and when the industry collaborates, things can literally move 100 x faster than what they ordinarily do. It is possible, and I agree, if we applied that level of collaboration and vigor to everything within healthcare, we would see tremendous progress much faster than we ordinarily would. So I. Would agree with your call out in terms of collaborating, Amy. I think we could probably spend the next two days talking about these topics. With that, I would like to just wrap up and extend my thanks for joining me on the show today and a really thoughtful and great discussion.

34:40
Amy DuRoss (guest)
Oh, Neil, thanks so much for the opportunity. Good luck with this series. I can't wait to listen to more of your recordings.

34:47
Neil Littman (guest)
Great. Thank you so much.

34:48
Amy DuRoss (guest)
Take care.

34:51
Danny Levine (producer)
Well, Neil, what did you think?

34:53
Neil Littman (guest)
I thought that was a wonderful discussion with Amy. I think we heard her talk a lot about the field in general, how it's progressed from the early days when she was architect behind Prop 71 in Serm to where the field is now. There's still a whole host of challenges. There's a lot of capital that's flown that's, that's been put into the space recently, which is really great. However, there needs to be investment in the supply chain, the logistics, the delivery of these types of technologies. You heard Amy say so many people pay attention to the science. That's the headline, and rightfully so. The science is sexy, but the nuts and bolts of how that science is delivered to the patient bedside is really critical. That's some of the maybe not as sexy stuff, but like critical stuff that Vanetti is working on. I think it was really nice to hear her perspective about how the software, the supply chain, the logistics, the infrastructure fits into the broader ecosystem and why it's so critically important.

35:54
Danny Levine (producer)
Supply chain management isn't something most people think about outside of the industry. What do you think we've learned from COVID about the supply chain?

36:04
Neil Littman (guest)
Yeah, I think we've learned an awful lot. I think we've learned from the COVID issues in terms of supply chain delivery of vaccines that it is critically important. Right. It's obvious that no therapies are going to be delivered to patients without the proper infrastructure, without the supply chain, without the proper tracking and logistics. That is, for whatever reason, it still astounds me that wasn't paid more attention to with the rollout of the COVID-19 vaccine. Right. That's something that Venetia is working on in the field of cell and gene therapy and that's going to be critical to the delivery of these novel therapies. Hopefully there's going to be enough forethought put into the delivery of these therapies that we don't run into similar issues. Obviously we don't have a huge urgency like we did with the COVID pandemic. Vanetti is trying to tackle some of these really critical issues because at the end of the day, if this stuff isn't right, then patients aren't going to be getting to therapies supply chain.

37:10
Danny Levine (producer)
Software is well established within industry and within the drug industry. How specialized is cell and gene therapy with regards to what phoneti is doing? What makes this different.

37:22
Neil Littman (guest)
Yeah, I mean, you heard Amy talk about this. The product itself is just very different than more traditional products, whether they're small molecules, whether they're biologics. In many ways, you heard Amy talk about this idea that the process is the product, the process of how the cells are manufactured is the end product. That's just a very different way of thinking, right? What we are delivering at the end of the day are living cells, which themselves act as the drug or therapeutic. So, as you can imagine, to try to deliver living medicines. It's just a very different proposition than what exists in, I guess, what I would call more mainstream or what has existed historically in the industry. It's not surprising, given how differentiated these products are, that they require highly specialized and differentiated infrastructure and supply chain to deliver them.

38:27
Danny Levine (producer)
I think many people who are excited by the potential of gene therapies and cell therapies often focus on the challenge of scaling up the science and the production. What role do you think Vanetti can play in that?

38:41
Neil Littman (guest)
Yeah, I think they play a critical role. I mean, people are very focused on the scale up, the scale out of manufacturing, and rightfully so. There's a lot of challenges. As you heard Amy talk about, the role that Vanetti can play can be relatively early on, even in clinical development, of a lot of these therapies. Because if you don't get that right as you're in the clinic, you're just not setting yourself up for future success. Just as people think about scaling up manufacturing, investing in that early on, investing in this type of infrastructure and the software that Vanetti has developed also seems to be highly critical early on. Once you're a commercial organization that's I don't want to say it's too late, but arguably it's too late to start thinking about that. You should have thought about that very early on, probably in a phase one clinical trial, for example.

39:32
Danny Levine (producer)
Well, until next time.

39:34
Neil Littman (guest)
Great. Thanks, Danny.

39:38
Danny Levine (producer)
Thanks for listening. The Bio Verge podcast is a product of Bioverge, Inc. An investment platform that funds visionary entrepreneurs with the aim of transforming healthcare. Bio Verge provides access and enables everyone to invest in highly vetted healthcare startups on the cutting edge of innovation, from family offices and registered investment advisors to accredited and non accredited individuals. To learn more, go to bioverge.com. This Podcast is produced for Bio Verge by The Levine Media Group Music for this podcast is provided courtesy of the Jonah Levine Collect.