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Ep. 23 Jason Foster on Scaling Indivior, Leading Ori Biotech, and Solving the Real-World Bottlenecks Holding Back Cell and Gene Therapy
35 Plays1 month ago
This week we are joined by Jason Foster, CEO of Ori Biotech to talk about the future of CGT and why scalable strategic manufacturing is in a make or break moment, his experience scaling Indivior from 5 to 1,100 people culminating in a £3B exit and the powerful culture behind that growth, the Bluebird Bio acquisition and what it means for CGT investment today, and why he is deeply optimistic about Ori Biotech’s automated, closed platform. A must-listen for anyone building, investing in, or scaling the next era of biotech.
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Transcript
Introduction to Sparktime and Hosts
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Speaker
Welcome to Sparktime, where biotech's thought leaders, investors, CEOs, and industry experts break down the evolving story of life sciences. Hosted by Danny Stoltzfus and Will Riedel, two scientists and strategic communicators, we dive deep into how biotech leaders can shape the narrative, win investor confidence, and communicate breakthrough science in ways that truly resonate.
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From
Biotech Leaders and Industry Insights
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emerging trends and cutting-edge technologies to what investors and partners really want to hear, we go beyond the usual echo chamber, bringing you fresh insights, unexpected perspectives, and the strategies that set biotech's top players apart.
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If you want to sharpen your corporate messaging, decode industry shifts, hear from voices shaping the future of biotech, and get inspired, then you're in the right place. Let's get into it.
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Today,
Interview with Jason Foster: Scaling and Leadership
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we had a fascinating conversation with Jason Foster. He told us everything about the culture that allowed his former company, Indivior, to scale from when he was employee five all the way up to 1,100 employees. He spoke about the Bluebird acquisition and and how that affects cell and gene therapy investment right now.
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And he went all the way to advice from his grandmother at the end of the episode. So be sure to stick around and listen to this conversation. This was a really fun one. Today we're joined by Jason C. Foster. Jason's held leading roles in consulting healthcare and technology companies for over 20 years in the US, UK and Europe.
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He spent 10 of those years building in Divior, which exited in a 3.5 billion pound enterprise value listing on the LSE in December 2014. twenty fourteen Jason is currently CEO and Executive Director for Ori Biotech, a cell and gene therapy manufacturing technology company with offices in London and New Jersey, which raised a $100 million dollar Series B in December 2021.
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Jason also serves as a non-executive director of London-based health tech startups Grip Able and Credentially, as well as Oxidaparty, an Australian healthcare data platform and Hystrix Medical AG, a Swiss B2B marketplace for medical products.
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As the managing director of health equity consulting for the last six years, Jason's advised private equity and venture capital funds, family offices, accelerators, and health tech startups. In addition to his work at HEC, Jason is a strategic advisor to Joyance Partners, a venture partner with Hambro Perks, and active in mentoring health tech startups as co-chair of the Tech London Advocates Health Tech Working
Career Journey and Leadership Philosophy
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Group.
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Jason also volunteers as a trustee for the UK registered charity, Painkiller Addiction Information Network, or PAIN. So Jason, it's fantastic to have you here. How are you doing today? I'm doing great. It's a sunny day in London, ah Friday afternoon, so I can't i can't complain. and We don't often see the sun over here, so it's a little bit unusual.
00:02:44
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That's my understanding is that England's known for being a little more gloomy and especially in the London area. good news. It's also sunny here in Pittsburgh, which is equally unusual. So we'll celebrate that together.
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My wife's from Pittsburgh, actually. We're a family of Steelers fans, if you could believe believe it. yeah You would be surprised how many people that we talk to that have a connection to Pittsburgh. So very cool. Yeah.
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All right. So Jason, i before we can talk about what what's coming next, we want to start way back in the beginning. And I want to hear a little bit about your career because it's been really dynamic. You've done so many different things, including consulting, healthcare, tech across multiple regions.
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So tell us about that journey. What do you think in that process of transitioning, you really took away as key moments that shaped your leadership approach? Wow, a trip down memory lane. Yes.
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I mean, I i guess you know my i was in um
00:03:43
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You know, my first venture into startups was in 2000 in the dot-com bubble. um I was kind of relatively relatively newly out of university and, you know, all these exciting things were happening. You know, sock puppets were raising billions of dollars and then all seemed very, very sexy.
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So went to my first startup, which, you know, imploded within 10 months. But, you know, it's one of those things where you sort of get the bug of of building something interesting and the dynamism of a startup and,
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um you know I couldn't really shake shake the memory. you know went Went to business school ah to maybe legitimize myself in the in the next phase, but I wanted to get into healthcare. care I sort of spent my first job was in healthcare care public policy in Washington, DC.
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um And I saw the sausage getting made in DC, which is pretty ugly um if you if you see it um close and personal. But what you realize is actually, you know of course, you know in retrospect, it was obvious. But at the time, I was a starry-eyed you know college graduate and went to Washington DC to to change the world. But it's really the private sector that's driving change. you know the The public sector is reactive, particularly in the government.
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So I decided to go back and get a ah real degree and at Columbia, did business school there after studying political science undergrad, which was good for nothing. But I managed to make my way to New York and did two years of business business school.
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And then, um unfortunately, 9-11 happened and the whole economy sort of turned on its head. So I've sort of seen you know three cycles, you know the 2000.com bubble burst. I saw the 2008 financial crisis as an operator, which we can talk about as well.
Culture and Growth at Indivior
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And then you know the post 2021 implosion that we all are living through, still living through the the effects of. kind of shaped shape that experience. Ultimately, what I learned myself learned about myself and in those various stepping stones were I'm excited building things. It took me a while to realize that, but actually the thought of building something meaningful and lasting that has an impact on the world and on people um is a kind of inner purpose that I have and consciously or unconsciously sought out in many of the roles that I've been in over the last you know two decades.
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But that kind of, I've just, I don't do very well in large bureaucratic, slow moving organizations. So a little bit more dynamic, the ability to build something important and lasting and ultimately having impact, positive impact. you mine Mine has been focused in healthcare, which is relatively easy to draw a straight line to, to the kind of human impact of what we do.
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Those have been kind of the red threads as you look back in retrospect of the career of the last 25 years. Yeah, kindred spirits here in building something meaningful, especially for patients. So I'm glad we're all on the call together.
00:06:38
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I want to think about that a little bit, you know, in in in building something big that impacts patients. And you spent, Jason, a decade helping build Divior. You focus first on marketing and then on European operations.
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The company ultimately exited with a three and a half billion pound valuation. So and I'm curious, what were some of the biggest challenges in scaling a company to that level that you faced? And what lessons do you take from that experience into your role now at Ori Biotech?
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One of the most important lessons I learned in that experience, I was employee number five in that business. yeah um Ultimately, over 10 years, we grew it to over 1,100 people in 37 countries. So it was an incredible scale-up experience. and But you know one of the most important lessons I took away from that was the the the power and the importance of culture.
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um Building a culture that is resilient, that's um supportive, that's aggressive in a good way, you know proactive, like moving forward, doesn't accept you know things barriers that stand in our way, doesn't accept ah bureaucracy, um the importance of talent density and making sure you've got the right people in the right places.
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Those are some of the lessons that I learned there that I've carried with me throughout. I mean, I think people... and generally underestimate, particularly you know investors and and those that have sort of grown up in big companies. They see process, they see you know big marketing budgets, they see scale as differentiators. And I would argue that actually it's the people that underpin those things that ultimately are the differentiator.
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And the culture that you build around the business that enables those people to do their best work and to remain passionate about what they do is one of the critical success
Challenges and Adaptation in Different Markets
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factors. And Divir, I saw both sides of the coin. So from employee five to 400 in the US, we were 400 people in four years.
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um scaling at that quickly to that level, um but being able to hold on to the culture that differentiated the business and really drove outsized performance was something special to observe. And you know I think it was one of those companies, actually for many years after leaving that company, I kept our core our core guiding values in my wallet because it was just one of those things that I believed in so much. It just seemed like that was the that was the home for those principles and it should stay there even though I was no longer with the business.
00:09:05
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and you know and And it had some unusual ah guiding principles. Things like assume others' actions are well intended was one of my favorites. um you know When you get that email that's kind of short and sharp and it feels you know more cold, trickly than warm, fuzzy,
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You know, maybe you just say, well, maybe that person's, you know, in a hurry or they're in rush or they're dashing for a train and they just want to give a message. Maybe they're not trying to piss me off because that really pissed me off. You know, it was some of these things. And, you know, of course there are things like honesty and integrity at all times and patient focus. But, yeah you know, some of these things are, have proven to be valuable lessons in life, not just in in building a business. So, um you know, when we went to kind of from five to 400, that was still very present and you could feel the culture and the business.
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And then as it continued to grow, some of those things got diluted over time, unfortunately, as is often the case with businesses that scale into the hundreds and then thousands. It becomes much more process driven, much more, you know unfortunately, often run by the lawyers and the compliance team. It becomes more difficult to do what's best for patients. And especially if you're a publicly listed company, it becomes even more difficult. so um It was an important lesson for me as an individual, like where I want to be and what kind of environment I thrive in, but also you know how you get the most out of you build the best environment for your human resources to deliver the best result.
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And that's one of the things I've certainly taken with me post-Endevier to Ori and to the other organizations that I work with today. Yeah, i I'm a little curious. I'm realizing that you're speaking to us from London right now. I am. And of course, you're in cell and gene therapy. And so i'm curious, what brought you over to the UK originally?
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and And now you've ended up in sort of the hub for cell and gene therapy. I'm not sure why you assume that I'm not British. I mean, maybe it's the accent. Get me away. Right. um Yes. No, i I actually moved over to London in 2010 with Indivior. I was employee number one or two and in the European business. And we and that's what brought you Exactly right. Yeah. So we we've had ah I had two startup experiences in the same company on two different continents. So we built the business in Europe to about 200 people, 250 million and in sales um from from the ground up. So you know very different being an American in Europe and adapting to
00:11:24
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you know the differences of doing business in in Munich and Madrid and then Milan all in the same week. So it was a pretty exciting exciting time. and I learned a huge amount. you know We american aren our Americans aren't known for our tact.
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We generally have big boots and then don't listen very well, which you know ah serves us well in some ways, but not in others. So in this case, I tried to shut up and listen, which which was a good strategy.
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um But you know just that kind of... The ability to adapt the model and my own you know business operating system to ah different cultures and and different places and different business contexts was was hugely valuable thing. and And London's a great city. im I think it compares favorably to New York and and all the other great cities of the world. Absolutely. We've had a ah great time raising our family here. My kids are now 17 and 14. One was born here, the other one was two when we moved, and they both have very posh British accents, even though my wife's from Pittsburgh and I'm from Richmond, Virginia. so
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Well, I have the opposite problem, Jason. i moved to Pittsburgh from Australia when I had a two-year-old and nine-month-old. And they're now very brave seven and six. And I also have a three-year-old and all three that have this horrendous Pittsburgh accent. And I'm like, oh no, what have I done?
00:12:46
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and I was going to say that doesn't sound like a Yinzer accent to me. That's ah that's definitely not native. Yes, no no definitely not native. um I moved here about six years ago now for the opportunity of working in the States and being in the biotech industry. So,
00:13:01
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Very you good. Yeah. And I just wanted to say, like, at the end of this podcast, Will and I will always talk about the most valuable thing that we've learned from talking to our guests. And for me, I can already tell you what it is, is that concept of always assuming that people act with with the best intentions. And i think I'm inherently very quick to be frustrated and judgmental of people that are rude to me via email.
00:13:27
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And Will can attest to this because he's heard me rant about it for years now.
Ori Biotech's Innovations in Cell and Gene Therapy
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And um i really and i all that happens is I end up frustrated. So i i really really value that insight and I'm going to continue to try and hold on to that as I move forward. That's so true. because There's a really great strategy, which is to angry type out the really the like the nastiest response you can possibly figure out.
00:13:48
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And then you walk away and then you delete it when you come back. and You kind of get that frustration out. But yeah, no, I think... if you If you look at it through the filter of of the best intent, it definitely helps yeah yeah smooth that process.
00:14:02
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Perfect. So let's like talk about something completely different now and go back to the cell and gene therapy industry because my understanding is that at Ori, you're tackling one of the biggest bottlenecks in the industry, which is the manufacturing process. So can you help me as a non-biologist but chemist understand what is the core problem and how is Ori working to solve it?
00:14:26
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Well, I'm going to do this in the only way I know how, because I'm a marketer. I'm not a biologist or chemist either. so Perfect. I'm going to give you the but layman's version because that's all I know. But ultimately, and and cel gene therapy, we have an absolutely incredible modality. like We are literally curing cancer and rare diseases. And these are often intractable diseases that don't have good treatment options.
00:14:49
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um We take, in the case of, let's say, blood cancers, CAR-T therapy is probably the best known of the cell therapies. It's the one that your your listeners may know if they don't know anything else about this field. um yeah And they've been widely approved and used in hematological tumors. So I think leukemia, lymphoma, multiple myeloma, these kinds of things.
00:15:10
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ah Most of them yeah are used at the end of the treatment path. So last line therapy by industry parlance, they try everything else, chemotherapy, bone marrow, stem cell transplant, they throw the kitchen sink at it, nothing works.
00:15:23
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Then ultimately at that point when the patient probably has weeks or months to live, not years, they try CAR T therapy. And for many of these diseases, 90% of the time,
00:15:35
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The patient is cured of cancer at that stage. Now, my jaw hit the floor when I heard that. I'm like, literally, what? Tell me that again? It's slower now this time. I mean, it's incredible. The clinical efficacy and the safety profile of these products is almost unmatched. We've almost never seen anything like this before.
00:15:54
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And that is great news for humanity. That is an incredible scientific breakthrough. We now have ah ah therapeutics approved for other indications beyond just blood cancers. So one was approved for melanoma, ah one for synovial sarcoma, which are the post-solid tumor indications.
00:16:12
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But actually, it's being studied much more broadly in autoimmune disease, things like MS or lupus, in cardiovascular disease, and even in things like type 1 diabetes. We may be able to cure these kinds of of ah diseases using cell therapy interventions. So that is the that's the great news is that we are living and literally in a golden age of science and these kinds of fears are possible.
00:16:34
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The bad news, which unfortunately tends to certainly now overshadow the good news is we're just really not able to deliver to patients. And this is the the dichotomy we find ourselves in, which is what is the point of having a cure for cancer if patients can't get access to it?
00:16:51
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There isn't really a point. It it becomes a grand scientific experiment. And so on the back of that incredible science, we saw an incredible boom of investment in cell and gene therapy around 19 to 21.
00:17:05
Speaker
I think over $100 billion dollars was invested cell therapy alone, like just in that one niche in the in the larger biotech. $100 billion would be an incredible sum. And most of that was using the old biotech playbook, which is you know you get good safety and efficacy in the clinic, you then flip the asset to big pharma or you sell it you partner it, you know somebody like a Pfizer or Novartis or of those big companies buys it, you make a lot of money, you ride off into the sunset or you do do it again another time. And that's the kind of biotech model and has been for for several decades.
00:17:38
Speaker
When we tried to do something similar with cell therapy, you know following that same playbook, we found that actually, unfortunately, the assumption that we could make these products at scale prove has proven to be false.
00:17:51
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We have the ability to develop them. We have the ability to manufacture them at very small scales you know for a clinical trial maybe. But we don't have the ability to scale manufacturing such that we can deliver lots of doses to lots of patients for an affordable price. So these products often cost somewhere between half a million dollars to $5 million dollars per patient.
00:18:14
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That's per patient dose. yeah And that, you know, it's not just the headline price. Like if you say I'm going to cure, you know, X, Y, D, Z disease, it may very well be worth $5 million. dollars But the the ability to, for the pharma companies to recoup the investment, it costs them $1 to $2 billion to develop a product. And, you know, as you know, only 7% of products make it out of pre-clinical development to commercial. So, you know, that means 93 out of 100 products that they're going to try and develop are going to fail. So when they when they get one that makes it to to the market, they need to be able to pay back that investment for all those other products. And the economics of cell therapy are unfortunately broken today. We just can't make affordable products.
00:18:58
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ah You may have been following the story with Bluebird Bio recently, you know, one of the pioneers in gene therapy. three approved products that all work very well.
00:19:09
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They're all very clinically effective, they're safe, ah but they're very expensive. And the economics of those products just don't work. And ultimately, no matter how hard the team there tried, I think at one point that business was worth over $10 billion. dollars About a month ago, it was sold to Carlisle for $30 million. dollars And that, I think, is that kind of rise and fall really, unfortunately, neatly sort of describes where we are with the industry. it's We've got great clinical safety and efficacy, but we don't have the commercial viability model.
00:19:43
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sorted. And so because of that, Selangene is out of favor with investors. They're sort of looking skeptically at well, this next product, can you know what's what's the reason to believe that the outcome is going to be different for this than it was you know for the last several? So Ori really plays directly in that space. We are not a biotech company in that we don't develop therapeutics.
00:20:06
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We have developed a manufacturing platform that allows products to make it into the clinic more quickly, to make it to approval and commercial scale more seamlessly.
00:20:17
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ah So we can, just as an example, we can drive the throughput of your manufacturing process up by 10 to 50 fold. So we can make 10 to 50 fold more products for half the cost.
00:20:30
Speaker
And if you can drive cost of goods down by 50% while driving throughput up by 50 times, you've got a ah very much more interesting economic proposition for these products. And so that's ultimately what we're trying to do. And a couple days ago, we na be announced partnerships with some of the leading CDMOs in this space. So it's People like Charles River Labs, CTMC, Elevate Bio, KinCell Bio, these are some of the leaders in cell therapy manufacturing.
00:20:58
Speaker
We also have a partnership with one of the big pharma companies that has a commercial CAR-T product, as well as some of the leading academic centers like MD Anderson down in Houston.
00:21:10
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So we're trying to demonstrate with those partners that we can actually make this next generation of products much more affordable and accessible, not just approvable from a regulatory perspective.
00:21:23
Speaker
Yeah. such Well, it's such an exciting time to to sit down with you, Jason. I mean, a few big partnerships and such an incredible technology that Ori is bringing forward and so well needed. As you said, the the old playbook does not work for selling gene therapy.
00:21:41
Speaker
um And that reminds me that in a previous conversation we spoke with ah Jeff Baker, the former deputy director of the FDA, um about improving manufacturing processes.
00:21:53
Speaker
um and And that conversation was largely for biologics. But ultimately, you know he told us that people tend to view it as a very non-sexy process. It's it's like perceived as a cost rather than an opportunity to add value to the process. and Along the same line, we've spoken with some earlier stage clients who haven't yet taken the opportunity to strategize their manufacturing process.
00:22:16
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um And I imagine you have a lot of thoughts about that from your perspective. you know Can you share any comments or advice for listeners around when to start strategizing that manufacturing process? You imagine correctly, I've got a lot to say about that.
00:22:29
Speaker
I think ultimately, you really can't start too early. If you're in pre-clinical development, R&D or translation, but certainly by process development, you should be thinking about manufacturability in your target product profile.
00:22:44
Speaker
You need to have written a target cost of goods, a target through annual throughput, you know what line of therapy you intend to be, how many patients you want to treat. Because really, it used to be, as you said, in biologics, it's now, or small molecules, manufacturing is boring.
00:22:59
Speaker
It's not sexy. It's it's been figured out. it's ah it's It's a commodity. So if you can get a product that's safe and effective, we know we're going to able to make it. That's not true in cell therapy. what What happens is we get sexy products that are very safe and safe and effective, but then we can't make them, and the whole thing explodes.
00:23:14
Speaker
And the worst outcome, people say to me, well, it's risky to try and you know tinker with the manufacturing process, or it's risky to try a new platform. I'll tell you what's most risky is to do the same thing over and over again and expect a different result. We're not insane here, even though that is the definition of insanity.
00:23:30
Speaker
um the The risk is to go forward on a lab scale process using lab scale tools and say, oh we're going to fix that later. We're going to do better than you know BMS did or Gilead did after they've spent $15 billion dollars setting up their manufacturing process and delivered a thousand doses last year for some of their products. So we've got ah a patient tracker on our website that tracks how many patients get treated.
00:23:58
Speaker
ah Because really the the data is not available anywhere and it's it's a relatively unscientific method. We take you know revenue and divide by price you know every quarter, but at least it shows us the trend. And if you look at the trends, Kimraya from Novartis was the first approved product.
00:24:14
Speaker
It was approved in 2017. Last year in 2024, so basically eight years post-launch, they treated 1,000 patients. Now, I can demonstrate very clearly, I'm not a Pharma BD&L person, but I can guarantee you that when Mayan licensed that product from Penn or when kite bought or a Gilead bought Kite for $12 billion, they didn't expect to be treating a couple of thousand patients eight years after launch.
00:24:38
Speaker
you know This is this is a economically it's an economic disaster for these companies because they are spending billions and billions of dollars and not delivering these products to patients. so Whether you as an early stage company think you can do better than that, I would suggest you can't and you should be thinking about how am I going to make a product that's not only safe and effective, but commercially viable. And and really the point, and and I don't but place the blame on i do place the blame on on venture investors, but I don't place the blame on anyone else because I think The venture investors are the ones that are driving management teams to get clinical data as fast as possible. Get into the clinic, get us a signal, let us know if we've got something here, because that's the old playbook.
00:25:18
Speaker
But that playbook doesn't work, and they need to realize that that playbook doesn't work. Management teams responding to that because, of course, they are. Those are their investors and their and their board members. We need to take the less risky path, with it which is let's assess commercial viability early in the process before we get into the clinic.
00:25:37
Speaker
And let's decide how we're going to get to the appropriate level scale, the appropriate appropriate cost of goods, because ultimately, no one wants to be the next bluebird. you know I mean, Adaptimmune announced earnings this week.
00:25:49
Speaker
Their stock halved, you know, that's not, there's no good news there. You know, they're, they're having, i mean, they're doing well, but you know, it's not flying off the shelves and you know, it's just not fast enough. Things don't go fast enough. We think, you know, if you were to leverage the benefits of the Eero platform, which is what our platform is called, you could shave three years off the drug development timeline for a cell therapy.
00:26:12
Speaker
If I can save you three years, that's a massive benefit. A massive benefit. And that's three years of of costs you don't incur on your process and people you don't pay and buildings you don't pay the rent on.
00:26:23
Speaker
So there is a massive benefit to thinking through this early. like before you get into the clinic. It's not too late. If you're in phase one, two, you can absolutely think about this challenge. But once you get into phase three and get approved, it all becomes just too hard ah to deal with. And ultimately, you're sort of doomed to failure if you don't address this early, and by at least you know early in the clinical process.
Economic Viability and Investment in Biotech
00:26:46
Speaker
You just set me up perfectly for the next thing that I want to ask you, Jason, which is I 100% understand and hear you and agree with you on everything that you just said. And you're not following the playbook while following the method you just outlined. So when it came to doing your raise in 2021 of 100 million, what were you telling investors at that point? And how did they react to it? And ultimately, you know how did that what you said to investors then those key messages how did that shape the trajectory of what you're doing now
00:27:19
Speaker
It's super interesting because I think you know in these boom and bust times, you know perception matters so much. you know the The attitude of people, selling gene therapy was sexy then. So it's a good news story to say, like we can just scale this know into massive you know numbers and the numbers go you know big in a hurry and everybody's happy and everybody makes returns and you know everybody's on board.
00:27:41
Speaker
So it's kind of a good news, let's do more of a good thing story. And I still believe that story, but the because the investor perception is so different now, it's, you know, prove prove it to me because i just believe this is a huge disaster and how do I maybe mitigate risk? And it's sort of a negative filter that people are looking at it through.
00:27:59
Speaker
It's a more of a show me mentality, you know, should show that you can do something different. Nothing has changed from, you know, 2019, 2020 around the safety profile these products, the efficacy profile these products. We have more of them approved. They're still demonstrating credible clinical results.
00:28:15
Speaker
What has changed is that no one's broken through on an economic model that works. And so now, I mean, unfortunately, you know i know a lot of people who are early at Bluebird. i think you know patients are getting massive benefit from their products.
00:28:28
Speaker
I'm not at all happy with you know the the fate of that company. And and I hope you know the if we can be part of the solution with the Carlyle team and helping to turn those products into commercially viable products, we'd love to do that.
00:28:40
Speaker
But ultimately, you know the the bad news in the industry actually proves the point. It proves the point that I'm trying to say, which is the model's not working. We have to do something differently. We can't just keep doing the same thing and hoping that something different happens. So ultimately, these kinds of bad news, quote unquote, stories are are sort of sort of good for the for the point that we're trying to make, which is change is necessary.
00:29:03
Speaker
We can't recycle the old playbook anymore. ah But i do I have a full faith and belief that cell and gene therapy is a viable modality if you approach and tackle these issues early.
00:29:16
Speaker
And I think we we will see that as we move forward in the next generation. And when Iovance got approval last year, i don't know if you you follow that company, but they're the first tumor-infiltrating lymphocyte TIL product.
00:29:29
Speaker
um And you know I'm hugely happy for them and for the industry. We know the team there. um They and Autolus who got an approval in November, there's kind of three companies that got approval for novel cell therapies last year.
00:29:42
Speaker
But unfortunately, those products have been in flight for 10 years plus. And so they are wedded to those same platforms, those same manufacturing modalities. that all the other companies have used. too they didn't Unfortunately, we just didn't get there in time to be able to help to help those companies. But I'm very concerned that those companies are going to suffer the same outcome that you know some of these other companies have because they just don't have that differential mechanism to drive towards a better economic
Technology Adoption Challenges in Healthcare
00:30:10
Speaker
model. So, you know, we're working very closely with several phars therapy developers, several CDMOs, and a lot of academic research centers so that the next generation were able to very clearly demonstrate ah not only, obviously, the safety and efficacy story, which is required, ah but also that economic model and that commercial viability that will be required for successful products that can reach patients at scale.
00:30:34
Speaker
Right. Yet another argument for considering manufacturing early in the process. Please, please, If I can beg your audience, please, like let us give me a ring. And if I can't help, I will definitely tell you, but at least let's have a conversation because I'd love to just be able to have the discussion.
00:30:51
Speaker
Yeah. Well, Jason, beyond you're deeply involved in in health tech as an investor, an advisor, and and a board member. I'm kind of curious, are there some common threads you see in the companies that do successfully scale and maybe some early warning signs of challenges that can appear for these companies?
00:31:10
Speaker
Yeah. I mean, I think you if you look outside of therapeutics development where there's a relatively clear roadmap, I mean, clearly, you know if you're developing a therapeutic, you're not going to be generating revenue for seven to 10 years. It's a different, it's a totally different model. But if you look outside of that and you look at enabling technology space for Ori is, or you look at what's broadly called med tech or health tech or whatever, I don't think we really know we talk about when we're using those terms, but digital health, I could throw a bunch of other ones in. We're sort of generally sure.
00:31:39
Speaker
I'm not talking about, you know, medical devices or or pharmaceutical therapeutics, but everything else in between. I think there are some sort of common threads at least or or things that you would,
00:31:51
Speaker
take on as learnings. I've been and involved actively investing in the field for the last six or seven years. i sit on the board of four companies that are dotted around the landscape and in various ways. um you know I think the change management process that is involved in selling technology into healthcare care is greatly underestimated, the difficulty of that.
00:32:12
Speaker
um i think you see a lot of technologists come into the space and just assume that the best technology will win and that technology sells itself because it's so great and it does all of its stuff. And you know I see when I talk to entrepreneurs, I you know i won't curse on your podcast. i don't know.
00:32:30
Speaker
It's family friendly. But I say like they don't care about your technology. No one cares about your technology. What they care about and is the value that it brings that particular individual. doesn't solve enough of their problem. that someone's willing to pay for it. So what I most often see is that the solution is too narrow.
00:32:46
Speaker
So even if you solve that one singular slice of this of the problem, there's problems left and right of that that will sort of a prevent the buyer from getting the value that you fores perceive your solution to but to provide because they don't really understand the value chain. They don't really understand the workflow.
00:33:02
Speaker
So that's one of the most common mistakes along with an overfocus on just technology for technology stage, which again, people don't care about. The other thing that I notice is a very common theme is a lack of understanding of the incentives within the healthcare care system.
00:33:19
Speaker
um So in the US, as we all know- 100%. In the US, s healthcare care' is a business and people are trying to make money and and that's relatively straightforward. I can understand you know how I can help a doctor yeah practice be more efficient or ah health system make more money or do things more efficiently.
00:33:36
Speaker
And that you know is hard, but at least it's relatively straightforward. In public payer systems like the UK or Europe, us most of the rest of the world, the incentive alignment is terrible.
00:33:47
Speaker
you know You have people that would be using your technology that aren't the payers. So there's a lot of people who can say no in the system, there's very few people who can say yes. If you're a clinician in the and NHS, you can love a technology to death, but it doesn't matter it mean it's going to get adopted unless you can go through the procurement system and the finance team. And so really, you know people say follow the money. It's like really understanding where...
00:34:11
Speaker
the impact of your technology, the benefit gets accrued, and where the payment needs to come from. And getting those two things as close together as you can, aligning those two constituents as closely as you can, is absolutely critical.
00:34:26
Speaker
Because I have seen hundreds of very good technology solutions, maybe thousands, and that you know on their face look like, god this is a no-brainer. like this This makes tons of sense. And for all kinds of reasons, it's bogged down in the healthcare inertia in the systems and the not invented here syndrome and the, it's not my problem. like There's all kinds of these challenges that ah tend to prevent adoption in the healthcare system. And it's totally different than even other highly regulated industries like FinTech or you know clean tech and energy and and these things that
00:35:01
Speaker
Healthcare is its own beast and it is very unlike the technology adoption curve that you see for other you know types
AI and Machine Learning in Biotech Manufacturing
00:35:09
Speaker
of technologies. And and people, you know obviously, AI and ML are huge buzzwords at the moment and the kinds of things, the kinds of use cases that are being explored in healthcare. care I think are very, let's call them rudimentary. It's sort of, you know, you have an AI note taker taking physician notes so the physician doesn't have to do it. Like that makes sense. That kind of efficiency gain, it's a small step forward. You know, if you're trying to transform the way electronic medical records work or you're trying to transform processes in healthcare, care you got to be ready ah to have a long time.
00:35:44
Speaker
Very long change management sale process. These are very long sales cycles and it is a change management sale. It's not a our widget is better than their widget sale. That just doesn't work in healthcare. care Yeah.
00:35:56
Speaker
Interesting that you you kind of went in the AI ML direction because we we talk a lot about that, ah Will and I, and there's a considerable convergence of tech and biotech happening right now. And I would say the pace of that convergence is continuing to accelerate.
00:36:14
Speaker
And especially with AI entering both manufacturing and clinical development. So, How do you see this, from your perspective, weaving through cell and gene therapy? I mean, we touched on it a little bit in terms of the the payer systems and the healthcare systems, but what about cell and gene therapy specifically?
00:36:37
Speaker
um There's a couple. I mean, I think emerging use cases that are, let's say, the low-hanging fruit from my perspective. I mean, I think... We operate usually mostly in autologous cell therapy, so making a personalized dose for an individual patient.
00:36:52
Speaker
And in that world, we are taking a highly variable input, right which is a patient's cells, their immune cells. and we're putting it through a standardized process. right So GMP, again, i'm not ah i'm I'm not an expert in anything. I'm a jack-of-all-trades, master of none. But my my layman's understanding of GMP is we validate that we're putting the same input into the same process, and then we validate that we got the same output. That's the rough kind of explanation of GMP.
00:37:21
Speaker
Well, what we're doing in cell-in-gen therapy is we're putting a variable input into the same process. And lo and behold, we often get a variable output. And that is not that is not good for anyone. I mean, yeah the failure rates in GMP manufacturing and cell therapy can reach 25%.
00:37:40
Speaker
you know One in four doses. If you had a 25% failure rate in small molecule manufacturing, you'd be fired in 10 seconds. Literally, that manufacturer's head would be on a stick in the office. like It would just be ridiculous. ridiculous so But this is accepted you know right now as as you know about as good as we can do because, unfortunately, that dynamic of variable input standard process equals variable output some of the time is sort of where we're at.
00:38:07
Speaker
And what I would argue is actually what we need is adaptive manufacturing. So we give the system, you know, a system like the Eero platform, which we developed parameters in which it's its able to adapt.
00:38:20
Speaker
So we don't say you can go crazy and do whatever you want. We say, if these things happen, you're able to do this or that, you know. So this is... the very first use cases for a bit of ML where we see the system sees something happen 10 times and then 100 times and then 1,000 times and eventually it learns, okay, when X happens, we do Y. And then maybe it gets expanded beyond that into multivariable you know predictive models, which we've started to build that we can handle lots of different inputs and lots of different you know unseen eventualities. but
00:38:53
Speaker
At the current moment, the regulator isn't that comfortable with adaptive the concept of adaptive manufacturing because it goes it basically violates the core tenets of GMP, right? Because you're not doing the same thing every time, which is what you're supposed to be doing.
00:39:06
Speaker
So what we have to be able to demonstrate is actually by doing adaptive manufacturing, we can get higher consistency on the output. So we can get ultimately what they care about. Is it the same safe and effective product that comes out every time? Because that's really what they care about.
00:39:21
Speaker
They don't care so much about how you got there. But in historically, the method that we discussed, same input, same process, equal same output, has been the way in which they ins ensured that same output is achieved. So we just need enough data to be able to demonstrate that it's safe and effective to do adaptive manufacturing in an automated fashion. In today's, you know but prior to Eero, the ah automation technologies that existed weren't capable of doing so, and nor would they should they have been trusted to do so.
00:39:52
Speaker
But I think as we move forward you know over the next three to five years, you'll see more and more of this. And and I would actually argue we're already doing adaptive manufacturing. What we call it is deviation management.
00:40:04
Speaker
and've got yeah yeah Something happens we didn't expect in the process. We call over smart person and say, this is what happened. What do we do now? Smart person says, do this and and make a note in the batch record. And that's what we do. And that is adaptive that is the definition of adaptive manufacturer. We're responding to an unexpected input, ah but we trust human beings, I guess, rightly or wrongly, to make the call versus machines. And so I think at some point that will switch because ultimately there just and aren't enough of those super smart, experienced people to be hanging around a manufacturing facility to be answering those questions because they just there's just not enough of them around. so
00:40:42
Speaker
we will get to a point where we trust the system to do these some of these things. And that for me is one of the low hanging fruit use cases of kind of AI, ML applications.
00:40:53
Speaker
The others are are really on the drug discovery side. You start to see, you know can we actually identify opportunities for targeting different types of diseases in different ways? And that's something that is a very quantitative approach.
00:41:07
Speaker
method where you would identify new receptors or new targets or new whatever. And I think that's ah that for me is is ripe for ai disruption. You can just screen so many more data points and so many more get so many more insights using a model and in silico model versus you know going into a lab and injecting a bunch of mice or rabbits or whatever it is you're doing.
Ori's Eero Platform and Future Goals
00:41:30
Speaker
Right, right. Well, Jason, you spoke a bit about some partnerships that have been formed recently and other exciting things that are are going on at Ori, but we'd love to hear what you're excited about in the coming year and whether that relates to OriBio or anything in the biopharma space. What are you looking forward to?
00:41:48
Speaker
I'm super excited about ah this year because we've just launched the Eero platform. So we are now a commercial organization, which you know god God forbid we start making revenues. mean, would be Sorry about that. That was not a good place to be if you're a startup, but you know hopefully if you want to be a going concern, that's ah it's a necessity.
00:42:07
Speaker
ah So we're excited about that. And I'm a commercial guy anyway, so this is book i my you know this is my bread and butter. I'm not an R&D scientist where we've been the last and four years, so very excited to...
00:42:18
Speaker
to put the technology in the hands of experts at, you know, MD Anderson and and CTMC and Elevate Bio and some of our other partners and, and see what they do with it. Cause I think ultimately that was, that's the whole reason we've, we've developed it and then it works so hard to get it to where it is, is to get it the hands of our partners.
00:42:34
Speaker
Uh, and ultimately, hopefully fingers crossed at the, uh, by the end of this year we'll have been, uh, put into our first clinical trial and the very first patient will be treated with a product that's manufactured on the Euro platform. And that will be a massive milestone ah for the company and something that you know our founders were working for towards for a decade.
00:42:53
Speaker
So that's a very exciting milestone ultimately. and And I do also hope that you know within the next, let's say, year, and don't know that it'll happen in 2025, but within the next year, my hope is that we'll be able to demonstrate this commercial commercial viability case.
00:43:10
Speaker
you know Because the the biggest disaster you know for humanity in this context would be if we abandoned cell and gene therapy as a modality and said, you know what, it was just a glorious you know scientific exploration, but it just never really you know proved out.
00:43:25
Speaker
I think we've demonstrated very clearly that clinically these products perform incredibly well. And there's lots of rare diseases and other you know intractable diseases that don't have good treatment options that can be cured or at least you know dramatically improved by these therapies. So it would be an incredible shame if we were to abandon the modality and wander off into something else. So my hope is that you know by, let's say mid-26, we've got a very clear business case for how you know addressing commercial vi viability early will lead to cheaper products, more available products, larger scale production, more higher quality, you know more consistent production.
00:44:06
Speaker
so that the investors will see the the potential again for cell therapy and and come back into, I don't know if we need a hundred billion dollars and in a year or two, but, you know, certainly a higher level investment back into the industry would be useful. And, um you know, I think there are other approaches like in vivo, you know, you shoot some, infuse someone with a,
00:44:25
Speaker
a vector of some kind, and it goes in and does all of the stuff inside the human body, which sounds incredible, and I hope for humanity that we figure that out. ah But my guess is that that is a good 15 to 20 years away from from widespread application. I mean, these things are difficult. you know If you look even on autologous therapy where we are today, first products were approved in 2017.
00:44:47
Speaker
That means they worked on those products for at least 10 years before that, and probably another 10 doing you know early research. We're probably 30 years in that kind of to get where we are today and autologous
Personal Insights and Career Lessons
00:45:00
Speaker
therapy. So what's to make us think it's going to be that much more efficient with actually arguably a harder problem to solve? with it within even more Exactly. So I think you know my advice is and and my hope is that we make autologous cell therapy work because it clearly has benefits for patients.
00:45:16
Speaker
And hopefully Eero plays a ah positive contributing role to that. Well, we hope so too. And it sounds like a really, really exciting year of growth and milestones coming up, Jason. So very cool. Thank you for sharing.
00:45:31
Speaker
And I want to kind of wrap up our discussion today with a question that we like to ask our guests to just kind of get insight into kind of how they tick. And the question I want to ask you today is, you know, we often get given advice, right, when we're younger or we're not really listening or from people that we don't want to hear it from, like I'm thinking my parents, for example. Yeah.
00:45:55
Speaker
But, you know, at some point in our life, we realized, oh, damn it, that was actually really good advice. I didn't realize it until just now. So I'm really curious, you know, if you reflect back over the years, like what's the one thing someone told you that you wish you'd known sooner? Because it it really was actually very valuable insight.
00:46:17
Speaker
Yeah, one of the things that I've learned along the way, and i don't know if I should credit my grandmother for it. She definitely was was one of the people who told me this in a different in a different way. But you know my advice would be to say, don't worry about it so much.
00:46:32
Speaker
who and just go for it. There's always this decision paralysis of, well, what if this happens or what if that happens or what if it doesn't go well? And we feel like we need to tightly control future outcomes, which are beyond our control.
00:46:47
Speaker
like if we If we face the reality of it to say, like you know you don't have any control over what's going to happen to you in three years or five years or 10 years, you the best thing you can do today is make the best decision with the information you have.
00:47:00
Speaker
And my advice on that is to say, take the risk. Ultimately, every good thing that has happened to me over my career has been the result of me taking a risk when you know I'm relatively risk averse in the whole scheme of things. i mean, you wouldn't know it by maybe looking at my career path, but you to say, i think when I took the leap, you know when we got the offer, just you know as an example, well, start even before that. I left a very stable job with the US government on Capitol Hill leave for a startup in 2020 and that lasted 10 months and blew up. And you know on his face, you'd say, well, that wasn't a good outcome.
00:47:37
Speaker
But actually that experience and living through that and realizing that actually having your employer fail around you isn't terminal and you can rebound and and learn a lot from it, was ah that was a great experience. And that was worthwhile, you know having that failure, and especially early. And then you know when the next one came around, you had a little bit of those learnings that you took with you and um yeah I would say just don't worry so much about trying to manicure and and manufacture the outcome that probably isn't controllable anyway.
00:48:08
Speaker
you know my My advice would be take the risk. Be resilient. If it doesn't work, just know that that was a stepping stone to something else that's going to be bigger and better and and more interesting. So um I think you know growing up in a relatively conservative, yeah know we all think about the milestones that we want to do. I was an only child and a people pleaser and spent a lot of time with adults. So I wanted to present the image that was expected of me and do the things that was were expected of me. But ultimately, you know I've realized at this point, ah just turned 50, so maybe I'm getting a bit sanguine or nostalgic about you know going entering this phase of my life. But you know it's the ah you know my biggest fear is is living an inconsequential life.
00:48:51
Speaker
you know Ultimately, our time on this earth is very short. And you don't want to get to the end and realize, shoot, you know have the regrets or the they say the things you regret are the things you didn't do. yeah And I guess that's ultimately it. is Take the chance, take the risk.
00:49:05
Speaker
If it doesn't work, you're going to be okay. And look for the next opportunity. And I think that will lead to the most fulfilling and the best outcome for most people. Love that advice. Yeah, too. It really, really, really resonates with me. And If I ever make it to London, which I haven't yet in all of my travel, we're going to meet up and talk about that over some beers.
00:49:26
Speaker
Love to. Love to do it. Or if I make it Pittsburgh, I'd love to have an icy light and we'll have some pierogies in it. Oh, yeah Yeah. Let's do it. Well, Jason, it's been such a pleasure having you. So thanks for joining us. Thanks for having me. It's been great chatting with you guys. And if anyone wants to reach out, I'm um out there on LinkedIn and other places, Jason C. Foster, and you can find me. And I'd love to talk to entrepreneurs who are doing cool stuff. And if I can help, I'd love to.
Key Takeaways and Future Directions
00:49:50
Speaker
Thanks, Jason. So I have this tendency to assume that everyone that sends me a really short snippy email is just like 100% a jerk. But I think what I'm going to take away from this conversation from Jason is that, you know, I should probably just assume that they have good intentions and they're just really busy.
00:50:07
Speaker
I fully agree with that, Danny. i think I think we should both take that going forward. And I i love that Jason was talking about the culture at Indivior when he was employee number five and they scaled to 1,100. And you know i think simple ideas like that really carry forward um and and help create a culture where people feel valued and appreciated.
00:50:30
Speaker
of course things are going to happen and people get upset but maintaining ideas like that is is so important so i love that uh jason brought that up obviously indivior was such a successful scale i mean i can't even imagine five to eleven hundred people in in that short of a time you know i i do agree with him that that that's he's right that's something that a lot of people investors included may overlook and underestimate the value of that just in general i'm amazed at how they held on to that culture with such a rapid scale what did you think Well, I think if they have 1,100 people, there's probably a lot of really short snippy emails getting sent around. No doubt about that. Yeah.
00:51:06
Speaker
Yeah. But in all seriousness, I can't even comprehend what it would have taken to maintain a culture that is positive and you know actually made people want to stay in the company when you grew that much in that short amount of time. So kudos to Jason for his part in that.
00:51:22
Speaker
Yeah, well, one of the other aspects we've been discussing a lot on the podcast recently, and I can see it going forward that we'll continue to discuss it is cell and gene therapy. And of course, that is driven by not only the huge amount of investments there have been and the number of companies around, but also the ah recent, let's call them um failures um in the space and um you know disappointing news like like the news we heard about earlier this month and what Jason brought up of of you know Bluebird being sold for a very small amount.
00:51:51
Speaker
um And of course, we hear a lot of chatter about that and about cell and gene therapy. um You know, what I envision is is a lot of maybe generalist investors thinking that, well, this is really a tainted space.
00:52:06
Speaker
But maybe what we actually saw was some sort of FOMO bubble with um cell and gene therapy in in recent years. But In reality, there is a lot of good scientific work that's been done there.
00:52:19
Speaker
And I think people like Audrey Greenberg, who we interviewed last week, and um Jason Foster, who we just discussed with, are showing that there is a way forward. And um I think the next few years, we're going to see some really exciting developments.
00:52:33
Speaker
Yeah, I mean, you know, you can you could interview like 100 people on this question of whether cell and gene therapy is like a good place to invest. You'd probably get 50 people that say yes and 50 people that say no. And I mean, you know, we see both sides of that coin with the people that we talk to. So...
00:52:51
Speaker
you know I agree with everything that Jason said and you know the comments that you just had as well, Will. One of the aspects that Jason was was talking about in bringing cell and gene therapy or cell and gene therapies to market was you know the playbook that we've used for biologics and for small molecules, the making, the scaling, you know having a lot of patients, having a lot of doses and those doses of medication being affordable.
00:53:16
Speaker
That just doesn't work in cell and gene therapy. And i you know, honestly, I just thought Jason spoke to that so eloquently. Dani, what do you think? Maybe from a marketing perspective, what did you think about that?
00:53:26
Speaker
Well, hang on a sec. Before we get to my thoughts on the marketing, I want to give you my thoughts on the chemistry, given that's my intimate understanding, right? Like, think about it. Like, if you make a small molecule, like that's been made at scale of like, you know, metric tons for decades. So that feels so easy to replicate, right?
00:53:44
Speaker
But I think about like making a biologic at scale, like that feels like that must have been a big challenge to overcome, right? So I feel like there must have been some change in the playbook between, you know, like when biologics came on market and, you know, really started to scale and escalate. Like I'm now curious, like well what what happened in that transition from small molecule to biologics that we can look back on and take those learnings and accelerate forward into cell and gene therapy. And I mean, I'm sure Jason's thought about this as well. And I probably should have asked him when he was on the line with us.
00:54:19
Speaker
But I feel like, you know, there's probably some lessons that have been learned that we can just go back and look on and refresh our memories of what we already, we know how to do. So that was what I i thought about when we had that discussion and that, you know, with that train of thought going on. And in terms of the marketing perspective, yeah, it's like a logistical problem or an operational problem. And, you know,
00:54:42
Speaker
we we What we should do is get our our good friend Jeff back on to talk about that some more. because I was just going to say that, yeah. It seems like he would have some great thoughts and could build upon this conversation with us. And I'm going to write that in my notebook.
00:54:58
Speaker
Yeah, I'm sure our listeners remember our conversation with Jeff Baker and we talked a lot about advanced manufacturing today with Jason. Of course, we talked about adaptive manufacturing. i would love to hear um Jeff's thoughts on how companies can can really put that into practice because, you know, as he spoke a lot about, the agency cares about whether something is safe and reproducible.
00:55:21
Speaker
um And the company can show that. And so, you know, I think putting these two thoughts together leads to an interesting conversation. Let's get Jeff back on board. You know, now that you you talk about adaptive manufacturing, I was also thinking about that with from the perspective of adaptive clinical trials. So we we've talked with multiple clients about this concept. And, you know, you think about it, like that's still...
00:55:45
Speaker
under strict regulatory control, right, a clinical trial. So if we can really adapt clinical trials and, you know, make them real time and respond to the data that's being seen, I don't see why we can't ah take that strategy and bring it into the manufacturing
Closing Thoughts and Future Episodes
00:56:01
Speaker
world as well. Like, I mean, I know I'm not the one having to do it, but, you know, if you just kind of make that dotted line comparison, it doesn't seem like, again, that there's lessons learned about how to adapt clinical trials that we could bring forward into manufacturing. Yeah.
00:56:14
Speaker
Yeah, that's an interesting thought. Well, as always, thanks to our listeners for tuning into Sparktime. Looking forward to diving in with you next time as we continue to explore the ideas, the innovations, and the thinkers driving the next era of biotech.