The Infrastructure Behind Bringing New Therapies to Market: A Conversation with Melissa Marlowe

Speaker A: Welcome to this special series of the Commons recorded live from the floor of the Bio International Conference in San Diego, California. At the Commons we explore the people, ideas and places shaping our future. And over the next 11 special episodes, we're turning our attention to one of the most compelling bioscience growth stories in the country, that of Phoenix, Arizona. Across this series, we'll sit down with leaders from research institutions, healthcare systems startups, investors, philanthropy and economic development to better understand what it takes to build a world class innovation ecosystem. Phoenix's rise has not happened by accident. It is being driven by intentional partnerships, long term investment, entrepreneurial energy and a shared belief that breakthroughs in bioscience can create healthier communities and stronger economies. From translational research and commercialization to talent, capital and the power of place, these conversations will explore how an ecosystem comes together and what other regions can learn from this journey. Thanks for joining us for these special episodes. I'm your host Thomas Osha and this is the Commons coming to you live from San Diego. Our special series of the Commons coming to you live from the Bio show floor at the Bio International Convention continues. You can hear all of the people who are coming by the Phoenix, Arizona booth here. And so we apologize for the noise, but we'll more than make up for it from the content of our conversation today. And speaking of our conversation today, my guest is Melissa Marlowe, who is the VP of Clinical services and biotherapies lab at Vitalent. Melissa, welcome to the Commons.

Speaker B: Thank you.

Speaker A: You know, it's interesting that long before biotech became ah, a global industry, blood organizations were solving complex problems around collection logistics, testing, storage, regulation and patient access. Right. Few organizations illustrate that evolution better than Vitalin been around for 70, 80 years. Going back to the 40s in Phoenix I think you were the salt, uh, River Valley Blood bank. But today you've grown into one of the nation's largest, not only nonprofit blood and biotherapy organizations, but you have advanced services that now stretch the country. So that's a lot to take in. Why don't you tell me a little bit about Vitalent today?

Speaker B: Thank you for that fantastic introduction. Uh, we do have still our headquarters in Scottsdale, Arizona and we do have a national footprint across the majority of the country with a focus not just on the blood products, but also on the advanced services that can help expand our access to different, uh, cell therapy and advanced therapies into broader regions where they might not have had access if they were not co located directly with a larger academic or research institution. So that footprint and partnership that is built on top of the network of blood banks and locations that we have had over our lifespan. We are able to capitalize and build on those relationships and use that network to be able to add the access to those areas that might not have been reached before.

Speaker A: And really adding that access just brings all of this, all of these advances in healthcare, bringing them closer to the patient. Right.

Speaker B: You hear in the news an uh, almost daily basis about new clinical trials and new cell therapies, including CAR t therapies. And those are difficult to get access to if you are not near a larger center that might not have some of the infrastructure you need to be able to handle cryopreserved cells. You need to have um, clinicians who have been vetted and accepted by those clinical trials or by those biopharma companies to be able to offer those services. And some of the smaller regional hospitals may not have the expertise or the infrastructure available to support those therapies. And those are the locations where we have been able to partner with those groups and provide those services.

Speaker A: So if I'm somebody in, let's say a smaller community, not one of the, the, not Philadelphia that has 200 uh, cell and gene therapy companies kind of sitting around u City square, but I'm, I'm in a smaller community, then I can work with my talent and get those therapies just as if I were sitting in a big city hospital.

Speaker B: There are a lot of partners that we have been able to work with to be able to provide those services, to be able to store those cells and hold them until they are ready for them to be sent back to their facility for infusion into the patients and to be able to provide that trusted and licensed partner that will allow those biopharma companies to release those products, uh, without having them have to build all of that infrastructure at each site.

Speaker A: So that infrastructure really is complex. I mean the behind the scenes are exceptionally complex. The infrastructure as you say, needed to preserve these cells, exceptionally complex and expensive. So uh, give the listeners a little bit of appreciation what happens behind the doors.

Speaker B: So just the physical facilities that are required to even receive these products, you're receiving these dry shippers that may come from anywhere across the country and be able to handle these liquid nitrogen shippers in a safe way and then have the facilities set up that if you need to take these into long term storage, you have large liquid nitrogen freezers that allow you to store these products in the vapor phase at ah, colder than 150 degrees Celsius. And to have the infrastructure so that these are monitored freezers to be able to know if there's any issue with the liquid nitrogen source or the temperature in those storage containers. Because these are completely irreplaceable products. You do also need to have, um, staff who are well trained to be able to handle these safely and to make sure that you are pulling these cells out and packaging them in a very rapid manner to be able to protect the integrity, uh, of these cells.

Speaker A: It's one thing to manufacture a pharmaceutical. If a batch is bad, you throw it out and you start with another batch. But the very nature of the cell characterizations, the very nature of the fact that these are therapies derived from our own cells, you are right. They are irreplaceable, aren't they? You mess up a batch, you've messed it up.

Speaker B: Most of the products at this point are autologous, so they are collected from the patient for the patient. So there is not another 10 of these off the shelf to be able to go back to. So every time we handle a bag of the frozen product and the cells, this is something that you have to treat as one of a kind.

Speaker A: Does that go to the kind of culture you need to create around the company to do this? This is mission focused work.

Speaker B: It is. And I think that's part of why our staff tend to be very long term. They really enjoy the fact that they know their work on a daily basis is saving lives every single day. It's not the same as some of the laboratory work where you have ID numbers on a tube of blood and you may have hundreds or thousands of them pass through your hands on a daily basis. You know who you're working for and who you are working to save and to treat.

Speaker A: Do you think that goes back to your pedigree as a blood bank?

Speaker B: I do. And also the community aspect of it as well. That that's why we really enjoy being able to help provide the access to these advanced therapies into locations that are, uh, where our friends and neighbors live. And it may not be, you know, the largest academic center, but how do we help provide that to a broader network and to a broader swath of the people that we want to be able to impact.

Speaker A: So you call it a network, but it really is one of the most complex supply chains there is in health care, isn't is?

Speaker B: And when we talk about the number of people to have a successful transplant or to have a successful infusion of these therapies, you're not talking about a handful of people. You are probably talking at least 100 people who have touched this along the way, um, whether you're starting at the very beginning of the process from the physicians and the nurses that are caring for that patient, the collection of the cells, the apheresis product that is necessary to be able to start any manufacturing, all of the logistics along the way as that is being moved from location to location and then as it goes into the laboratory for processing and then shipped off again to the biomanufacturer and then the return visit back to our laboratory before it is held for distribution and then back to the treating facility and the nurses and the doctors that are caring for the patient at that end. This is an entire team of people that are required every step of the way to be able to make this be successful.

Speaker A: It sounds as if there's also a lot of innovation that the public never sees describe some of that.

Speaker B: A lot of it is taking a network of things that individually may be a very simple process, but just the complexity of the timing that's necessary and the communication is really critical. There can be a very small window sometimes for having these therapies be the most, um, efficacious for the patient. So you have a very small window in which to do the manufacturing and then to return the product back, uh, to the laboratory and then to return the patient their cells for the infusion.

Speaker A: So how are these biologics, how are these advanced therapies changing our world?

Speaker B: So they are providing opportunities for patients that have taken on multiple different therapies that have not provided them, um, success in being able to go into remission. And so this has provided the opportunity for patients who have, they call it clinical failure. Um, of these different therapies, they failed three or four previous regimens before they are eligible for some of the car t therapies that are out there at this point. And, you know, this can take them to a longer term remission. And we tend to try to avoid the cure word, but to take them into a long term, um, status where

Speaker A: they are disease free, no evidence of disease. So are we going to get to a world where these therapies can be moved up rather than be therapies of last resort?

Speaker B: There are exciting studies that are out there and they are, um, different therapies and different diagnoses are now starting to see these moving to, you know, from fourth line to third line to, um, coming relatively in the next couple of years, you know, second line. So you're not having to go through as many therapies, which definitely can cause Stress on those cells. You know, you have someone who has been through rounds and rounds of chemo and other biologics before they have now collected the cells and trying to, uh, have those grow and generate a new product. It can be very challenging because these cells have been taxed and are not the healthiest.

Speaker A: You have multiple locations. You have locations in Phoenix, right? Including at 8:50 PBC. I think you're in Connect Labs there. You're in Pittsburgh. You had mentioned. Are there other places? Uh, you are. And how should city leaders and life science leaders across the country view vitalent and your presence in their markets?

Speaker B: As we work across different markets, there are areas that we have focus, um, based on the locations and the need in those particular regions. Uh, so we do have cryopreservation and storage laboratories in Allendale, New Jersey and also in Tempe, Arizona. Uh, we are actively building one in Denver, uh, Colorado at this point that will be operational in early 2027. But we also have across that whole continuum of services, uh, that are necessary to support advanced therapies. We have apheresis capabilities for the collection of the initial cells that are needed for those patient therapies to even start and move into the manufacturing. Uh, those are, can be available across, um, more than 20 states.

Speaker A: So you're really also bringing a talent and a skill set to some of these communities. Correct?

Speaker B: There are opportunities that we are bringing based on the experience with the collections capabilities, with the handling of the cells from a particular standpoint, whether or not it's the cryopreservation and the shipment and logistics of these cryopreserve products and the support for getting these to the bedside and the special nature in which they have to be handled to make sure you have a viable product for infusion.

Speaker A: So when I hear Pittsburgh, I always think of transplant. It's one of the things they do real well. And that's an area you're getting into as well, isn't it?

Speaker B: We also have a hidden gem in that area, which is our, uh, coagulation and, uh, hemophilia center. And so in that area, that's one of kind of the hidden additional aspects of Vitala that is well known in that region. But as you go outside of that area, um, that's something that could provide additional services and support for those sort of critical patient care.

Speaker A: Are there other opportunities that are emerging around cell and gene therapies? In other words, by the, by the bio processing or the storage or the cryo, Are there other directions that technology goes?

Speaker B: There are Additional studies that are looking at you know, the opportunity to not have all of the therapies be autologous based on know um, you know, donating for yourself. There are opportunities looking at the uh, autologous off, more off the shelf product that a variety of different trials and studies are working on at this point and we have the opportunity to help support some of those as well. That would be an amazing step forward in being able to provide access to a broader population of patients and you know, that may not be able to donate to themselves. There's also looking at things that um, whether or not you're able to do some generation in vivo, uh, so that you are able to have those therapies, um, when you're in the hospital, have a treatment in the future, it would be generating those cell therapies um, while you're in the hospital and you're not having to send cells off someplace for manufacturing. But those are under development at this point.

Speaker A: So does it give you an advantage to be at 850 PBC literally just down the street from Translational Genomics, our

Speaker B: scientific development lab is uh, what is building out those capabilities at that site. So having that location close to that group is a fantastic opportunity to be able to work on other projects that might be aligned working with some of the other groups in the Phoenix area.

Speaker A: So what does the future of blood centers look like? And as I was looking at the website I noticed you had an innovation center. So tell me a little bit about what those are doing.

Speaker B: We do also have a different research group. Um, we have a Vitalent Research Institute and we have um, the Vitalent Innovation center and those are not in Phoenix but we uh, have the Vitalent Research Institute is in San Francisco and so they are working more on the traditional real scientific research on m. Um most of the areas are focused on transfusion medicine but there have been a lot of breakthroughs related to the different testing to make sure that we have a safe blood supply and how to make sure that you have increased viability and safety and potency in those processes products. Our Vitalin Innovation center which is in uh, Denver, Colorado is kind of that bridge from the bench to the bedside where they can be working with more of industry to be able to take some of those ideas and help with the translational work to take them from true research to more of the bedside and end users.

Speaker A: So following up on the importance to transplant, are there other things that are happening in transfusion medicine that that Vitalin is providing to its customers, patients, partners?

Speaker B: Well when you think about biotherapies and what all that can include transfusion and transplantation, blood and marrow transplantation are really the original biotherapies.

Speaker A: They really are, aren't they?

Speaker B: So we do have a system of HLA laboratories that support both solid organ and bone marrow transplant programs. We have locations in, uh, Spokane, Washington, Sacramento, California and Phoenix, Arizona. And those provide support for a variety of programs in those regions. In the Phoenix area, we work very closely with several different programs that are lung, kidney and heart transplant programs. And those are incredibly critical in the timing and the, uh, urgency of the support, especially when you are looking at some of the deceased donor work.

Speaker A: What's the coolest thing you've seen at the show so far?

Speaker B: This is my first year attending.

Speaker A: Okay.

Speaker B: I tend to go to a lot more of the technical conferences. I think this has been fantastic. Walking around the exhibit floor. I feel like we are, uh, in the epcot of Bayo. Being able to go to some of the different exhibitors, uh, from both different countries around the world and different, uh, states within the U.S. uh, just seeing the variety of different services that people are either offering or interested in setting up in their locations has been exciting. And just the energy in the room. Everybody is really excited to make connections and to further the opportunities in, in their part of the world.

Speaker A: So if all these people walked out of here knowing one thing about Vitalent, what would you want it to be?

Speaker B: I think the opportunity to be able to bring. Bring some of the services that they don't have to build everything themselves. Um, when you look at the footprint of what we have available for where Vitalent sits in the country, they're the opportunity to partner with us and not have to build everything on your own.

Speaker A: Final question. What's on your playlist that, uh, you're enjoying today?

Speaker B: So it's a wide variety of things. I have two adult children with a really wide variety of musical tastes. So, uh, we go everywhere from, you know, uh, K pop to, uh, hardcore heavy metal. As far as the Taste for My Children. So we, uh, go to a lot of concerts. So recently went to, uh, Bruno Mars and Ed Sheeran in the last month and, uh, go to Zach Bryan in another month.

Speaker A: Wow. All right, so you have a big summer music ahead.

Speaker B: We do have a big summer.

Speaker A: Wonderful. Well, thank you so much for being here at the Commons. Thank you for bringing us up to date on the great work that Vitalent is doing both in Phoenix and around the country and have a great show.

Speaker B: Thanks for a great conversation.

Speaker A: The Commons is a production of Wexford Science and Technology, llc. Views and opinions expressed are solely those of the host and guest. To view additional material about today's episode, submit questions or story ideas, or learn more about Wexford Science and technology, please visit www.wexfordscitech.com thecommons. I'm your host, Tom Osha. Thanks for listening.