Democratizing Cell Therapy Through Regional Manufacturing | Amy Hay (Part 4/4)

Intro - 00:00:06 Welcome to the Biotech Startups Podcast by Excedr. Join us as we speak with first-time founders, serial entrepreneurs, and experienced investors about the challenges and triumphs of running a biotech startup from pre-seed to IPO with your host, Jon Chee.

In our last episode, Amy shared how she navigated one of the hardest transitions of her career, leaving MD Anderson after twenty years, and turned it into an opportunity to launch her own consulting firm, Evolv, bridging academic medicine, pharma, medtech, and digital health. If you missed it, check out Part 3.

In Part 4, Amy unpacks her time at Varian Medical Systems, where she brought a different perspective to a sales-driven organization by focusing on building cancer programs rather than just selling equipment, and how that approach helped her to navigate the Siemens Healthineers acquisition. She also breaks down her transition to CTMC, where she leads business strategy for a joint venture between MD Anderson and National Resilience that is accelerating cell therapy development by providing manufacturing, regulatory, and clinical access under one roof. She reflects on the state of the cell therapy market, why business model innovation matters as much as scientific innovation, and how aligning incentives through milestone-based contracts and equity stakes can de-risk development in challenging fundraising environments.

Jon Chee - 00:01:52 Talk a little about CTMC's mission and focus. What is your guys' North Star?

Amy Hay - 00:01:57 Yeah. So as I mentioned, CTMC was kind of incubated—to use an appropriate term—in MD Anderson with this idea of: we've got this incredible science and researchers, but it takes us forever to get anything through the process, through the hierarchy, much less getting commercialized. I mean, that's a difficult process, though there are clear examples of people that have done it and done it incredibly. But we want to make that value proposition wider and for more people.

So there was this opportunity to purchase lab space by a pharmaceutical company called Bellicum that was, unfortunately, at the time, going out of business, and it was right in the Texas Medical Center down the street from MD Anderson. Anderson used that moment in time to join forces with Resilience Labs to create CTMC.

The vision behind it was, just as I said, how can we bridge between academic and industry? How can we help enable more early-stage biotechs and early-stage researchers to get into the clinic as fast as possible in a capital-efficient manner in order to get clinical proof of concept? I always say it's like multiple shots on goal. We want to get as many companies that we believe in—in their science—to the point of getting into the clinic for testing to see if this therapy is going to work for patients. Because as we all know, the desert is full of carcasses of biotech companies that didn't work for whatever reason—not even just the science, sometimes for the economics or the commercialization.

So that was the basic premise. CTMC started out with a few MD Anderson researchers who wanted to take their research out of the academic environment, kind of more in Phase 1, Phase 2, and start to develop them into later-stage assets at CTMC. In addition to that, I think the beauty of the business plan is that it was geared toward attracting early-stage biotechs. So early-stage biotech companies who really wanted to engage with a manufacturer that wasn't in the business of just providing a widget.

And I don't mean that flippantly at all because none of these are widgets. None of them are simple. None of them are easy, no matter where you are as a manufacturer. But at CTMC, part of our approach is we want to co-develop. We want to partner with you because we want to, at a very early stage, work with you as a biotech company and make your process sustainable and commercializable. Because if you do that early on, you can make very good decisions. If you wait to do that until a later stage, it can financially cripple you.

The same goes with making the right decisions around regulatory. Investing in regulatory expertise upfront can really pave your entire trajectory for the next few years as you go through Phase 1, 2, 3, and to commercial. CTMC has been in existence for over three years now. At the end of year two, they were able to actually show a profit, which is, quite frankly, pretty remarkable. And it was really based on this value proposition of: we can accelerate your timeline to clinic, we can reduce your capital burden, and really be that support mechanism.

So a lot of our early-stage customers or partners are biotechs that have three to five people in them. They're the scientists, the brains, the brilliance, and we do everything else. We partner with them on regulatory. We provide logistics support. We get them into MD Anderson and into the clinic in less than a hundred days. We really are kind of everything you need in order to partner. So that means that these early-stage biotechs are not going to have to invest their capital on a regulatory consultant, on a CRO, and all these other things that not only cost money, they take time and often distract these brilliant men and women who were inventing these new technologies from the science, which is where we need them.

The center is—you know, as I said, we've done eight INDs. All have been approved ahead of schedule. We've got an incredible team with not only expertise in CAR T but also even a lot of development in proprietary reagents and TIL therapies.

Right now, part of me coming in about a year ago as the Chief Business Officer was to set the course for our future, and that's really what attracted me. In order to do that, what we are operationalizing now is completing the total buildout of our current infrastructure so we can seamlessly provide not only Phase 1 and Phase 2 cell therapy support, but Phase 3 pivotal studies and also commercial. By doing that, we're just extending that value proposition and reducing the risk even further. And we've been able to demonstrate with a lot of our customers their increased ability with this approach to raise capital in really challenging markets.

Jon Chee - 00:07:40 That's amazing. And if we zoom out a little bit, from your opinion, what is the state of the market, and how are you guys disrupting the status quo to achieve all this?

Amy Hay - 00:07:51 Yeah, that's a great question. I say that the market is tough right now. I mean, I am always on the optimist side, so I kind of think that we're moving in the right direction. The clouds are parting. We're not there yet, but the clouds are parting. And the science just continues to grow and evolve.

If you believe in the science and your passion is there—but I will say that we do approach things differently that I think have disrupted the market. It's interesting, your question, because this last year we were working on actually launching a new website and really trying to focus on our mission, our vision, and our values. In our mission statement, I was a big proponent of using the word "disruptive." Many people looked at that and said, "Oh, we don't like that word. It's negative." I was like, "No. It's exactly what it needs to be." If cell therapy is going to be democratized, if we are going to make an impact on a global scale, we've got to disrupt this market. We've got to change it. And we ultimately kept it in our mission statement because I think it's an important part of who we are.

We do all those normal things. As my boss would say, we don't pipette faster. We don't have magic. But it's the entire approach to how we not only work with biotechs but, on the business side, how we are able to create the right incentives. I say that purposely because when I look at early deal structures with Phase 1 and Phase 2, I don't think in my head, "What is the price per batch, and how can I maximize that to my benefit as much as possible?" What I think about is, "Okay, what's our goal?" Typically, in our early-stage clients, our goal is: file an IND, get approval, get it in the first patient, and see if it works.

So instead of focusing some of these early-stage contracts on "what's your raw material cost, what's your suite fee, what's your labor cost," and developing a very pay-as-you-go approach, we like to step back and say, "Okay, we want to partner with you." Yes, we have to pay the liability. Yes, we have to pay for our materials. But let's put a milestone fee on IND submission and IND approval. Let's put a milestone fee on first-in-patient. So sometimes that means we have to take a little bit more risk, but we do that with partners that we are truly partners with and we're trying to co-develop.

It also means that we have the ability to oftentimes take equity and look at being a part of it. I personally really like that because I think when you're going to capital markets, especially in difficult times, and you can say that my manufacturer has equity in the company and they are also just as aligned in making us successful as we are—that's a good sign. That's the right storytelling that is so necessary in the current cell therapy market and raising funds.

Jon Chee - 00:10:54 Absolutely. And I think when talking about innovation, it usually revolves around scientific innovation or the latest AI model or something like that. But there's also business model innovation and deal structuring innovation that unlocks value and alignment. I love what you described as: how do we make it so that we are all rowing in the same direction here? We want to make sure that you hit that milestone. And, yes, we'll take more risk during that period where we're not at the milestone, but you know that we are doing everything in our power to get there. And that's where you want to be, too.

That creates that alignment versus exactly what you said: "Alright, I'm going to really just optimize for this shorter-term view where I'm going to charge as much as I can and extract margin," when you should be more in value creation mode than value capture mode at that point. I also like the idea of having someone like CTMC that's downstream from the early, maybe two scientists in the preclinical. Showing that we have downstream buy-in is a massive way to signal to the markets that we're taking the whole thing into consideration here, not just our specific viewpoint of the really early stage. So I love that. What does an engagement with CTMC typically look like?

Amy Hay - 00:12:25 Just like an electronic medical record, there's not just one version, right? I think that's actually the real beauty of it. We literally tailor these programs to what the needs of the providers are. So on the early-stage side, we try to co-develop and optimize and also get into clinic as fast as possible.

One of the value propositions of working with us is through our partnership with MD Anderson. We've set up a system with them where we can very easily get into clinic and connect biotech leaders with researchers and clinicians at MD Anderson. And that's that important marriage. That's the thing that has to happen. Because if you're on a biotech side, you might be a brilliant researcher with the next big thing. But in order for that to be translated into the clinic, you need a clinical partner who does clinical research, who can identify the right patients who would benefit from this.

Through our relationship with MD Anderson, we're really able to bridge that gap, create these synergies, and also get into clinic in under a hundred days, which is very difficult. On top of that, Anderson, because of its size and scope and expertise—I mean, they see 50,000 new cancer patients every year, so your volumes are just tremendous. Even in early stage, where oftentimes your points of patients needed in trial are anywhere from 10 to 30, Anderson typically can enroll those patients very quickly because of just the volume of patients they see.

Those are typically your early-phase contracts. In those agreements, we have a very large and incredibly expertise-laden group of process development who are deep scientists. They work with these researchers almost on a hand-to-hand basis to try to make what they've developed scalable and even better. And an area in which we have a lot of expertise in-house is TIL therapy. I bring that up because many of our staff are actually in our own labs creating our own proprietary reagents that can be used by our customer base in order to really accelerate their assets from Phase 1 all the way through.

Jon Chee - 00:15:04 Wow. I am kind of seeing this through-line from the earliest days. It's putting the right people on the bus. That's where magic really happens, and then finding alignment through all that and how do you get the one plus one equals 10 or more. You mentioned a lot of the folks that work with you are on the smaller side. What is an archetypical partner customer of yours that can really find value and benefit from working with CTMC?

Amy Hay - 00:15:35 The nice thing about that is that it's expanding. So in our first year or two, it was really the smaller early Phase 1, Phase 2 that was the sweet spot. What we have learned is that as you start building that funnel of biotechs and researchers, they want to continue on this trajectory with you because, in cell therapy—just by its very nature—this is a very complex, personalized process where the patient is actually part of the supply chain.

I think that is where we've made so many missteps in manufacturing and other locations because we try to approach cell therapy like just another modality of cancer care, and it is not—just like theranostics or radiopharmaceuticals, another area where the patient is part of the supply chain. So because these truly are personalized therapies—not just saying that they're personalized because they're for you, no, they're personalized because they're made from you—they're made literally from your cells. That changes the dynamic of that supply chain. It not only adds in logistics and risk, but it also requires this chain of custody. That chain of custody is sacred.

So as this year we have expanded into pivotal trials and commercial, what we found is you are de-risking even further the process for our biotech partners. Previously, when we didn't have the capacity and the ability to provide pivotal trials, companies would go through Phase 1, Phase 2 with us, and then they'd need to tech transfer to another facility, which adds in cost, time, risk, and money. We had circumstances where that process did not go smoothly because, again, these are very complex therapies.

So what we have really focused ourselves on is how can we provide end-to-end services all the way from early clinical candidate selection to commercialization. De-risk, reduce the time, decrease the cost. That's the value prop. So now we have quite a few current customers and partners who are at that inflection point of moving from stage two to pivotal. Those are much larger contracts. Those are contracts that involve more patients. Those are contracts that extend over periods of years. As you know, in your early stage, a lot of those contracts are 10 to 30 patients over a year or eighteen months. Your pivotal trials agreements often are 300 patients, 200 patients, and it could span three years and require a very high level of integration with our regulatory team to make sure that these hurdles are met and are not costly missteps that can, quite frankly, bring many biotechs down to their knees.

Jon Chee - 00:18:52 Yeah. Putting myself in the shoes of having to get so far and then have to tech transfer that thing out—you're like, "Oh my god. This could make or break us right now." And you guys saw that this is a need that we need to address, and now it makes a lot of sense that it's end-to-end. So there's this level of consistency and continuity where you don't want to just put it up to chance. "We can't put this up to chance that we've worked too hard to get this all the way to this point."

When you're thinking about CTMC as its own firm, how are you thinking about building with end-to-end? Are there new developments on the horizon? Are there other aspects of the business that you're looking to evolve? How do you see this unfolding in the next one year, two years?

Amy Hay - 00:19:46 Great question. And, again, kind of brings it back a little bit full circle. Going back to the point that I mentioned about the patient being part of the supply chain: even in our current footprint—and we're very fortunate, on one side of our building we have seven clean rooms that are fully up and operating, and we're just opening up four more large ballrooms that will do our pivotal and commercial—but even with that, in Houston, Texas, we probably have a capacity of about a thousand batches a year depending on whether the CAR T or TIL and their duration.

That's a thousand batches a year. Just think about the number of people who might benefit from cell therapy. You can read online anywhere from 35% of cancer patients to 50% in the future would benefit from cell therapy. If you just do the high-level math, we can only do a little tiny piece of what's needed out there.

So one of the large areas that I'm spending quite a bit of time on is: how do we democratize cell therapy? How do we share our knowledge, and how do we develop manufacturing centers that are regional in nature and can manufacture locally in order to really start to provide access in places that don't have it?

Here in Brazil, we just announced last month what we call our Network Alliance, and Albert Einstein is part of that. We're transferring our knowledge to them. We're sharing with them our master batch reviews. We're sharing our standard operating procedures. We're inviting them to come to Houston and spend six months or a year with our team—process developers, quality people, manufacturing people—through the entire process.

In addition to that, we're providing them access to materials that oftentimes in many countries are hard to come by. For example, in many countries, they don't have viral vector labs. So you need that vector to help carry that cell therapy. You can purchase these from companies; they're very expensive, and it takes a long time because you're on a list like everybody else. Well, we have our own viral vector lab that's segregated on a top floor where we reserve that for our partners. So if you need a viral vector, in 30 days we can make you one and send it to you. So we're trying to do things to not only transfer the knowledge but also equip these locations with the products they need to invest in the research and the science, but also locally manufacture.

I'll give you a great example that speaks to me in Brazil. There are different techniques for cell therapy. Some of the therapeutics that are even commercially available in the United States in CAR T use the material from the patient, and without freezing it—in a fresh way—they engineer it to transfuse it back into the patient. Well, when you're not freezing it and you don't have that intermediate spot, you can't send that somewhere. It is a living cell therapy. So if you don't have local manufacturing, you can't even provide that therapy because there's not a moment where you can ship it to the United States or to Europe and then have it come back.

Right now, the commercial products that are here in Brazil are all cryoproducts, which is fantastic. But in order for a patient to get that in Brazil, you have to go have your apheresis—your material taken out. It gets frozen. It then gets shipped to the United States or to Europe. Your cell therapy gets made, and that duration could be anywhere from, depending on the process, 10, 20, 30 days. Then it gets sent back to Brazil and infused in that patient. While, yes, this works, you can imagine the cost, the complexity, and the time. Many patients that would benefit from cell therapy don't have that time. They simply don't have that time.

So, personally, just from my passion standpoint, I believe in the incredible value of cell therapy, but I also am driven by the fact that this has to be regionally manufactured in order to get the impact that it could have. So that's a big focus this next year for us. We've onboarded Albert Einstein as our first member that I'm very proud of. We have strategically looked across the globe and tried to identify locations where we think the greatest need is.

I'll maybe share one there: Australia, as many people know or don't know, has the highest incidence rates of melanoma cancer. And TIL therapy has shown incredible curative value in melanoma. There's one cell therapy on the market that's commercially available for melanoma, and that is not readily available. And there's not local manufacturing using TIL in Australia, even though they had the highest incidence of melanoma. That, to me, is a real need. We have a lot of biotechs focusing on solid tumor and melanoma being the one that we've proven works, that we know this works, but yet we're not manufacturing TIL in Australia. We gotta change that. Period. End stop. So how you change that is I think you partner with the leaders in science and innovation in Australia, you share your knowledge, you share your expertise, and you allow them to use that to accelerate providing that therapy locally.

Jon Chee - 00:25:57 I love that. And it reminds me of your proton days. It's like finding where the need is the most. "Who can directly find value from this?" "Let's go straight to the source here." And also, it's kind of like your mission statement of being disruptive. It's like, "We gotta do things differently. We can't be shipping these things. The status quo is not sufficient."

I love that because it really is finding the alignment, finding the folks that need it, addressing the unmet medical need, and really just going straight to the source and directly addressing it head-on. So I really love that. And, I mean, I'm super pumped about hearing the CTMC journey. I can't believe that you've achieved all this in two to three years. Talk about a speed run. Just like time is of the essence. We're compressing everything. But, exactly as you said, we have no time to waste.

First off, I just want to thank you so much for sharing all of your insights and your journey. I've learned a lot having this conversation with you, and I know all the listeners out there will also find tons and tons of value. I love something that you said that really stood out to me: make time to give back. You can always give time. In the very early days, you're kind of just trying to sponge as much as I can, but I love the philosophy of giving back. Being in the Bay Area, you see this culture of giving back that just creates this momentum and community where the learnings continue to compound.

Something that stood out to me was—I feel like sometimes companies can be... look, I get there's confidential things. Like, there's secret sauce to certain things. But going out there and trying to—it's kind of the tide raises all boats. That's kind of what it seems like you guys are doing. We got some knowledge that everyone could benefit from. The problem is big enough that there's room for all of us here. We don't have to have a completely hoarding mindset around this. Let's try to get everyone upskilled.

So, anyways, things that I'm going to take away from this conversation is all those lessons and then some. So thank you again for being so generous with your time. And in traditional closing fashion, we have two questions for you. So the first question is, would you like to give any shout-outs to anyone who has supported you along your way?

Amy Hay - 00:28:35 I would say actually three. The first person who's always believed in me, no matter when he should or shouldn't, has been my husband, Colin Hay. He is the one that has [supported me] my entire life since I've met him back in 1992, the first day of college when I knocked on the Pi Kappa Alpha fraternity house door because I thought I needed an appointment. He has always believed in me. He has never ever doubted who I am and what I could be, and I think everybody needs that person.

And the other two have been my strongest mentors that are not due to my job or my position. It's due to who I am as a person and who they are. And that's Henrique Neves at Albert Einstein, who has constantly been my mentor and my advisor and, oftentimes, the person telling me that I needed to be patient, and I needed to take a moment and allow the people around me to get on board.

And the second is my mentor and still closest friend, Dan Fontaine from MD Anderson, who very early in my career said, "Amy, you know what your problem is?" And I said, "No, boss. What's my problem?" And he said, "Your problem is that you're in a bike race, and you are sprinting ahead of everybody else. And you're pedaling as fast as you can, and you don't stop for water, and you don't stop to sleep. But you know what? The only people behind you—the only thing they're seeing is your backside. You gotta slow down. You've got to extend that bridge and pull those people forward."

I remind myself of that every single day. Take a moment to pull someone forward. Take a moment and a pause to take a deep breath and pivot. Because on those days when you have to pivot, the harder that pivot is, probably the sweeter that success is going to be.

Jon Chee - 00:30:38 Absolutely. I literally was just thinking about—I was like, "Oh, man. I was so impatient." Thinking about some decisions I made recently, I'm like, "God. I could have just waited a little bit longer." And I think you were describing how it can be difficult to kind of stew in uncertainty.

Amy Hay - 00:30:56 Mhmm. It's an uncomfortable smile.

Jon Chee - 00:30:59 Yeah. Super uncomfortable. I think I will continue to struggle with that, but that's where my impatience stems from—like, I need certainty. Even if it means the certainty is the least optimal decision, I'm going to get that. And my mentor also kind of reminded me that inaction here is probably better. Like, you actually by doing nothing, you're setting yourself up. Just do nothing for a moment. And I'm like, "Gosh. I gotta put a Post-it note somewhere to just pause, like, wait for a second."

Amy Hay - 00:31:29 I have one actually on my computer at the office because I still struggle with that. And quite honestly, sometimes, no response is the loudest response of all.

Jon Chee - 00:31:41 Yeah. It's like I think there tends to be this bias towards action, and it's always grinded into you. Like, you need to always be doing.

Amy Hay - 00:31:50 Sometimes you just need to let the world revolve. Let the world revolve for the day. See what happens tomorrow.

Jon Chee - 00:31:56 Exactly. And then last question for you is: if you can give any advice to your 21-year-old self, what would it be?

Amy Hay - 00:32:02 Patience and grace. Give yourself a break. We're all human. And always come from a perspective and believe that other human beings—whether you agree with them or disagree with them, like them or not like them—believe that they're coming from a good place. There's so much skepticism in our world. We have so much false news and ugliness. Come from a place where you see the good in people and allow yourself the space and the grace to learn from your mistakes.

Jon Chee - 00:32:36 I love that. And something I was thinking about: it takes just as much energy to assume the worst as it does to assume the best, so just might as well assume the best.

Amy Hay - 00:32:47 Less emotionally exhausted.

Jon Chee - 00:32:49 Yeah. Exactly. And you'll be less stressed out. Like, it's a less stressful reality. You're just like, "Let's just assume the best here." So I love that piece of advice. It's hard for sure. Absolutely hard. Not easy, but definitely worth reminding yourself when you're kind of working with someone and thinking about the other side.

Well, Amy, thank you so much. This has been really fun. I guess we're a little bit of a ways away. If you make it out to JPMorgan or something like that, I'd love to grab coffee with you.

Amy Hay - 00:33:15 I will be at JPMorgan. I'd love to have a coffee or whatever.

Jon Chee - 00:33:18 That'll be awesome.

Amy Hay - 00:33:20 Okay. Well, good. Looks like I'll pencil that in. I'll send you a note.

Jon Chee - 00:33:23 Yeah. I'd be so pumped to just be able to sit down with you. And I also didn't realize you're in Brazil right now, so that is truly amazing. Thank you again for making the time while in Brazil. So thank you again, and I hope to see you soon.

Amy Hay - 00:33:37 Okay. We'll see you soon, and thank you.

Outro - 00:33:41 hanks for listening to our four-part series featuring Amy Hay. From her early days in Dallas to patient advocacy at MD Anderson, raising capital for proton therapy in the wake of 9/11, building global oncology networks, and now accelerating cell therapy development at CTMC. Amy's story shows how resilience, cultural adaptability, and a relentless focus on patient impact can shape an unconventional path in oncology innovation. If you enjoy the show, please subscribe, leave a review, or share it with a friend.

Join us for our next series featuring Judy Chou, President and CEO of AltruBio, a clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory diseases. Before founding AltruBio, Dr. Chou served as Global Head of Biotech and Senior Vice President at Bayer Pharmaceuticals, where she oversaw the development, manufacturing, and distribution of the company's more than $3 billion product portfolio and led over 2,000 employees across six sites in the US and Europe. Under her leadership, Bayer successfully launched Jivi and Eylea, and she led the organization's transformation from traditional biologics to advanced therapies, including cell and gene therapies.

Dr. Chou has spent over twenty-five years in drug development and bio-manufacturing with significant milestones at Genentech, Pfizer, and AbbVie, where she became broadly recognized for breakthrough technologies in analytical characterization and accelerated product development. With a PhD in biochemistry, cell biology, and neuroscience from Yale University, postdoctoral training at the Max Planck Institute, and executive education from Harvard Business School, Dr. Chou's journey from big pharma MVP to startup CEO demonstrates how deep scientific expertise, operational excellence, and bold leadership can drive innovation in autoimmune and inflammatory disease development, making this a conversation you won't want to miss.

The Biotech Startups Podcast is produced by Excedr. Don't want to miss an episode? Search for the Biotech Startups Podcast wherever you get your podcasts and click subscribe. Excedr provides research labs with equipment leases on founder-friendly terms to support paths to exceptional outcomes. To learn more, visit our website, www.excedr.com. On behalf of the team here at Excedr, thanks for listening.

The Biotech Startups Podcast provides general insights into the life science sector through the experiences of its guests. The use of information on this podcast or materials linked from the podcast is at the user's own risk. The views expressed by the participants are their own and are not the views of Excedr or sponsors. No reference to any product, service, or company in the podcast is an endorsement by Excedr or its guests.