Cell Therapy Advances And Biotech Leadership With Nkarta's Paul Hastings

On this week's episode of the Business of Biotech, Paul Hastings, Founding CEO and Board Member at Nkarta, an allogeneic cell therapy developer, talks about building off-the-shelf CAR NK cell therapies for autoimmune disease. Paul is candid about problems with clinical trial infrastructure in the U.S., what it will take to fix trial access (biotechs should actively facilitate patient access to trials and work with community health centers to establish new trial sites), and why biotech leaders have a responsibility to speak up about federal policies shaping the life sciences innovation ecosystem.    

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Transcript

Welcome And Guest Background

Ben Comer 0:03

Welcome back to the Business of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Paul Hastings, CEO and board member at Nkarta, a clinical stage biotech developing allogeneic natural killer or NK cell therapies for B cell-mediated autoimmune diseases. Encarta's donor-derived car in-key development candidate, NKX019, is unique among allogeneic cell therapies in that it doesn't trigger graph versus host disease and doesn't require immune suppression, and it can be delivered in outpatient community settings. In addition to his leadership at Nkarta, Paul is currently board chair at Specific Biologics and board member at Engene, and a previous board member at more than 10 other companies and trade organizations, including BIO, where he worked for over two decades with a stint as Bio's board chair from 2021 to 2023. His executive experience extends to CEO and board roles at OncoMed Pharmaceuticals, QLT, Axys Pharmaceuticals, and others. He's previously served in management positions at Genzyme, Synergen, which is part of Amgen, and Roche. Finally, Paul is active in several social patient and community advocacy groups, including the Youth Rally, Life Sciences to End Gun Violence Epidemic, No Patient Left Behind, OUTbio, the San Francisco chapter, and the Termeer Institute. I'm thrilled to have Paul on the show today for an update on Nkarta and a broader view of the cell therapy development space. And we'll also talk about the current landscape for biotech company creation and the impacts of federal policy changes and what industry leaders can do to sustain the innovation ecosystem. Paul, thank you for bearing with me through that long introduction. And thank you for being here. Well, thank you. I don't need to tell you anything about the company now because you did the whole thing.

Paul Hastings 2:01

That was great. Thank you.

From Crohn’s Patient To Biotech CEO

Ben Comer 2:03

Well, uh one thing that we like to do here on the business of biotech, Paul, is to start off with a little bit of background. And I'm not going to ask you to walk back through your entire career because we don't have enough time to do that. But I would like to know what brought you into life sciences uh initially. You attended the University of Rhode Island and earned a degree in pharmacy, and then I think went straight to Hoffman LaRoche uh after graduating. Did you plan to become a pharmacist initially?

Paul Hastings 2:35

Yes, I did. Um, and I did. I became a practicing pharmacist by working inside the drug uh discovery and development industry, and I used my knowledge of pharmacy to do that. Now, I I will take you all the way back to my teenage years when I was diagnosed with Crohn's disease, an autoimmune disorder. So that's one of the reasons I like doing what we're doing now in autoimmune disease. But I was so sick as a kid with Crohn's disease that our local pharmacist suggested to my parents that I go to pharmacy school because when I graduated, you know, I could work in his pharmacy, and if I needed to take time off, he would let me do that. And so that's kind of why I went into pharmacy. I was very science-oriented anyway. But once I was in pharmacy school, I realized, first of all, I had surgery and my life became full and my energy all came back after that surgery that was missing for so many years with Crohn's disease. But I started realizing that business and the business of pharmacy was what I was interested in, plus my experience as a patient, having gone through what I went through as a teenager with Crohn's disease, led me to want to work on drug discovery and development. And, you know, I started in sales and worked my way through a bunch of different areas. But but really what I say now, at the age of 66, by the way, uh, and I feel like I'm 66 going on 45, is that um, you know, what I really want like to do is take my experience as a patient and bring it to the industry, not just the patients in our industry, like the patient advocacy organizations, but the CEOs and make them understand that what we're all here for is the patient, not the other way around. And so I kind of take a holistic approach to our industry, having been through so many different companies. And now we're doing it, kind of want to do it, doing it the way that I want to do it, which is applying the patient first and what we do in discovery and development to develop and discover and deliver therapies for patients that are meaningful to them.

Ben Comer 4:35

Well, we have uh pharmacy in common. Um, I was a pharmaceutical technician, worked at a mom and pop pharmacy all through high school and college, and eventually parlayed that into a journalism job covering the life sciences industry. That's that's probably where our similarities end in terms of uh achievements. Uh, but that's where I was exposed to the industry uh as well. And I I I want to maybe start off with Incarta and what you're up to there. But before we do, uh, and this is gonna be a hard one maybe, but what is the biggest change, Paul, that you've observed about the life sciences industry since those early positions in marketing at LaRoche?

The FDA Shift Toward Patient Voice

Ben Comer 5:16

Wow, yeah, that is a big question.

Paul Hastings 5:17

Um, you know, I I I I'll take this back to the most impactful thing that I've seen was when Janet Woodcock at the FDA decided to make it an FDA initiative to work on patient-centric drug discovery and development. That really no, I worked at Gen Zyme where Henry Tremer, my mentor, was all about patience, and he was a unicorn back then, right? That he was all about patience. When the FDA decided that the patient voice is important, not just for discovery, but also for development and also approval these drugs, that's really when everybody paid attention to it. And I think Janet Woodcock was is and was the pioneer of this, reached out to a bunch of different patient organizations, in particular the Deshayed Muscular Dystrophy Patient Organization, to really help get these new therapies approved based on patient reported outcomes, not you know, these instruments, disease activity indices that that academics and bow ties have developed over the year, but real patient reported outcomes. And I think industry has paid a lot of attention to that. And I think now when when any one of us develops a drug, the first thing we think about is what does this do to the patient in their patient's own language, not in our language, not in the language of the clinicians, but in the patient's own language. And I see that as the biggest sea change ever, and I'm thrilled and celebrate that that is the case because even at the biotech industry organization today, I just came back from the bio board meeting two days ago. Um the focus of bio, a big focus of bio is patient advocacy. And I help stand that up at bio, but it's still going strong. And I think we got to remember when you when you go through when you get through all the other bullshit that we go through trying to figure out this administration and what they're all about, if you bring it back to the patient, you can do nothing but be objective about it. Right. And so I think that's the biggest change I've seen over the past 45 years. I started working in my early days on HIV therapeutics and on, you know, rare diseases and diseases people didn't know anything about. So training the general public and training even our companies about what is HIV, what is a rare disease, has been part of my backbone of growth for myself. But now it's it's it's like it is front and center. And it's it's amazing that it is. So I'm really pleased. The one thing about this industry I'm really happy about is this focus on patients and meaning that we're focused on patients, not just saying it, meaning it.

Ben Comer 8:00

I uh it's interesting what you say about uh Janet Woodcock, because you know, it as much as a company might want to bring those uh patient voices forward, use those uh as endpoints in clinical trials, if the FDA is not accepting and acknowledging these kinds of patient reported endpoints, it it it may not matter if the drug is not being approved. Do you so do you think that there are currently enough mechanisms, I guess, at the FDA to adequately bring those patient voices into review decisions? Oh, yes, absolutely. Yeah.

Paul Hastings 8:34

I I say the one thing the FDA is continuing to do is work with these patient groups and bring in pay uh we work with a woman here, Jen McNary. She was the Shane Muscular Dystopy mom of two boys. She's one of our patient advocacy uh people here at Ancarta. One of them died, the other one survived. The one that survived was on the Sereptotherapeutic, the one that died did not get access to that in early clinical trials. And she actually went to the FDA with a video of her surviving son. When he responded to therapy, he was actually able to walk in a wack-a-thon. Right? So this is a kid that was in a wheelchair who got this drug and was walking in a wack-a-thon while his big brother was pushing the wheelchair that he was supposed to be in. And she showed that to Jannah Woodcock in the FDA. She goes, How can we say this drug doesn't work? Here's a video of my kid. And this this started this uh videotaping uh evidence of patient-reported outcomes that actually helped get some of these drugs approved. Because when you just look at a disease activity indices, uh the ability to walk is one piece of a complicated disease activity index, right? But uh to see it uh is it's pictures and video say a thousand words, right? So so uh Jen right now is is a major voice inside the FDA, even with the changes that's happening at the FDA about patient reported outcomes. So, you know, that uh is sticking, that's important, it's important to the FDA, it's important to, you know, getting drugs approved. And I and I think and I think ultimately, you know, we've finally kind of gotten our heads out of our butts in this industry about the way we look at uh, you know, clinical trials and and outcomes of those trials that that are meaningful to patients. And maybe when we look at patient reported outcomes, these things aren't validated, they're not, they haven't been through the rigorous, you know, peer review that other instruments have been through. But just publishing what we're seeing gets people thinking about why these things are important and has a major impact on people when they look at them. So, you know, I think this is this is really part of the next number of years of our industry's development is to remember what we're doing here. Who is our ultimate customer? It's not a payer, it's not the government, it is the patient who receives the drug who then has an impact, or this drug has an impact on that patient. And it's the drug that succeeds or fails, not the patient in in in in their well-being. So um, I'm just really excited about that.

Ben Comer 11:07

Yeah, I don't want to take us too far afield, but because you brought up Duchenne, I I am curious about your read on the the Capricor decision, you know, the the the kind of re-review. Uh there was an adcom yesterday or or the day before. I I think the the patient advocates are in favor of approving that drug. We don't know what the FDA is gonna do yet. Um I and you know, you you can't extrapolate from a single case, you know, what's in the mind of the FDA, but I wonder if you have any read on that activity.

Paul Hastings 11:38

I I don't on that specific drug. I've heard about it, but I can't make an educated comment on whether it should be approved or not. But what I can say is giving companies and the patient groups the ability to have a hearing like that to be able to express what they've seen and how they've seen what they've seen, and to be able to do that in a forum where people are listening, that's what's important. Yeah. If that drug gets approved, great. If it doesn't get approved and there's a scientific reason for it not to get approved, that's the whole reason you want to have a panel like that. But to make sure that the right people are on that panel that are paying attention to the patient focus, to the science focus, to the practical focuses, to the, you know, activities of daily living that patients are able to do with or without that therapy, that's really what's important and that's encouraging.

NCARTA’s NKX019 Milestones And Data

Ben Comer 12:29

Uh let's talk about NCARTA. You've been CEO at Encarta uh for over eight years now, I think. Um what what's the next milestone that that you're working toward with NKX 019?

Paul Hastings 12:43

Data in multiple autoimmune diseases in our phase one two study by the end of this year. So definitive data that will tell us where do we go next. If we go to pivotal trials, where will we be going? And we'll have data, and again, we've announced this by the end of this year in one, two, three indications where we'll be able to say, hey, here's where we're going next. We're gonna do pivotal trials in these indications, and here's what the data look like. With you know, handfuls of patients with each disease with, you know, three, six months of follow-up data. You know, some cases one month, because as you enroll patients over the course of time, you only have so many months of follow-up. But um, but that's a real pivotal moment for our company. And and you mentioned me being the CEO for eight years. I've started EnCarta with our venture capitalists that started this company. So I was the first CEO, and it's been it's been an honor to to work in the field of oncology and now to pivot it to autoimmune disease. It really interesting for me is at the age of 66, this is the first company that I've run that's had an emphasis on diseases that also have affected me. So it's it's personal. It's really personal, and it's really wonderful to be able to work to be working in this space. So EnCarta is a labor of love, the people here uh that that have taken us to where we are today and and and to this very pivotal year for us where we're going to be presenting data at the end of this year, which will be very um telling in terms of where we go next.

Ben Comer 14:09

Yeah, I'm sure that must be a powerful uh motivating factor. Um is is lupus the the kind of are you considering lupus the lead indication, or are you exploring multiple indications uh at the same time? I guess I'm asking, you know, what what the data read that you're expecting will be on.

Paul Hastings 14:27

Yeah. So there is one study, N trust one, that is in uh lupus nephritis patients, and there's another study, N trust two, that's a basket study. Okay. And that has uh scleroderma, myositis, vasculitis, uh uh, and rheumatard arthritis as the indications that we're looking at there. So I'm not saying which ones, but a few of those indications will be the ones we will highlight. Those will be the indications where we've enrolled the most patients. The lupus area, I will say, is a crowded area. There's a lot of therapeutics in development in lupus. And there's, you know, one of the things I want to talk to you about is this is the way our clinical infrastructure system in this country is failing patients. Because there are so many patients out there that should be getting into clinical trials that are not getting into clinical trials because they're not part of the 5% that has access to academic medical centers. And lupus patients suffer from that the most. And that's unfortunate. Um but um, you know, uh, we'll we'll be announcing data in whatever indications we've enrolled the most patients and have the most follow-up in by the end of this year.

Ben Comer 15:33

All right. I'm gonna come back to the the clinical infrastructure piece and maybe get your recommendations on on what needs to happen. Um, but I I have a couple of other things I wanted to ask you about NCARTA.

Off The Shelf NK Cells Explained

Ben Comer 15:44

Um, and and one is that the uh NKX019 relies on healthy donor cells that are then engineered before patient administration. Um my question is if are are there enough donors to treat a U.S. population of 1.5 million, and I'm talking about lupus here, 1.5 million, I think, in the US, 5 million globally, and and you can use a different disease uh as a as an example if you like, but how do you scale up how scale that up? What does it look like?

Paul Hastings 16:17

That's a that's a wonderful setup question that you didn't realize you set me up for, but uh Ezra, you can you could have one donor that could be a universal donor that can make enough cells for the world population of patients, yes. So what you're so the concept of an off-the-shelf cell is that this cell therapy is like an antibody, it's like a pharmaceutical. You're not taking blood from a patient, apharesing that patient, and then um and then engineering that blood and then giving it back to the patient. You're taking blood from a donor or a set of donors, and you are making a master cell bank worth of cells that can then reproduce over and over again lots of material. So it that's purely off the shelf. So when you come, if you have an autoimmune disease, scleroderma, for example, and you go to your treating rheumatologist and say, and the rheumatologist says, Hey, I'd like to put you on the Encarta clinical trial for scleroderma, you're getting off-the-shelf cells. You're not being asked to give your blood to be able to then, you know, manufacture your own cells. You're getting cells from another donor. And those cells have already been made and they're ready to dose. So all you have to do is show up, thaw the cells, inject the cells. And you could theoretically have one donor that could supply the world. Now, you have multiple donors for different reasons, but um but no, this is a very rich um uh reservoir, if you will, of cells to be able to make an off-the-shelf, on-demand, ready-to-use therapeutic.

Ben Comer 17:56

Thank you for explaining that. I wasn't sure if it was like a one-to-one donor. I mean, I assume that it couldn't be, but yeah, that's uh that's you know, uh it does so it so the the scale.

Paul Hastings 18:07

Autologous therapies are one-to-one. The patient comes in, it's when you're taking from the yeah.

Ben Comer 18:11

But allogenaic, it's it's it's like a regular pharmaceutical, it's off the shelf.

Why Allogeneic Approvals Lift The Field

Ben Comer 18:16

Um I wanted to, I just, you know, there was uh uh a cell therapy, uh allogenaic cell therapy approved at the end of June, Orca Bio. Uh I think it's intended to help graph versus host disease in blood cancer patients. And I I only ask you about this because I wonder if there was anything surprising or or instructive uh about that FDA approval. It's not the same as as uh the the candidate that you're developing, obviously, but has some similarities. I I think the yes, absolutely.

Paul Hastings 18:46

I I and congratulations to Orca for getting that drug approved. And I call it a drug because they are drugs, right? These are cell therapies, but they're drugs. They act and look like drugs, allogenaic ones, anyway, not ontologous ones, but allogeneic ones. So so yes, that's that's great that that was approved. Um because the the recognition, if you will, and the knowledge of cell therapies is sporadic when it comes to uh you know the the physician community and even some of the pharmaceutical companies that want things that look like pills or injectables, right? Right. And so allogenaic therapies are like an ejectable, but there's still some awareness we need to work on. So any allogenetic therapy that gets approved helps everybody else, right? There's some recent data from another one of the companies that has all genetic NK cells. They're not engineered, but they're allogenaic. Great. The more data that's out there from other companies, the better. The more approvals, the better. Because at the end of the day, where cell therapy is today is where antibodies were 25 years ago. Nobody really knew where these antibodies are going. Are they going to become a mainstay of pharmaceutical company development? And they are. I think cell therapy will be the same, but awareness right now needs to be um needs to be enhanced. And these companies they're they're buying these in vivo Car T companies and whatever. You can you can see that the companies, the big companies, are starting to realize that cell therapy works and it works well and it works deeply. It penetrates where it needs to penetrate to get the therapeutic effect it needs to get. And I think ultimately cell therapy is going to be something that people just think of as another antibody, another therapeutic in the armamentarium of even some of the biggest companies in our industry. Gilead, for example, right? Yeah, right. Right? BMS, Navartis, they all have these. Lily, um, Genentech. Genentech recently announced, by the way, that while one of their um T cell engagers uh was being dropped on the portfolio, they have cell therapy and they're excited about it. And I was just telling one of their leadership members the other day at the bio board, thank you for saying that, because that helps the awareness of the industry to understand why they should be looking at cell therapy and cell therapy companies.

Ben Comer 21:10

Yes, especially when especially when big companies are are saying it. Uh, and I was curious about like awareness among the investor

Funding Reality: Data And Durability

Ben Comer 21:18

community. What what does the current funding picture look like for cell therapies? I mean, let me ask this a different way. Like, what do early stage cell therap cell therapy companies need? Uh, what do they need to do to survive into late stage development right now? Have good data.

Paul Hastings 21:37

I mean, uh one of our one of our colleagues and competitor companies in the NK space had some recent data, announced the data, raised $300 million. Right? So now that company is able to go into pivotal trials and complete its pivotal trials. And the investors who invested in them recognized the difference between the clinical outcome of that. That company sells versus other modalities. So investors, not all of them are aware of these cell therapies, not all of them are interested even in these cell therapies because they tend to go. Well, they don't tend to, I can't speak for them. People watch what pharma companies want to do when it comes to the emerging companies in our industry. And they say, if farmer wants this, we'll get behind it. And so the awareness, if you will, of the investment community in cell therapy, um, it was high when we first started. People were reporting out data, one, two patients, and people were getting all excited, market caps are going crazy. Now they're wanting to see data and durability of response. And I think that's good for us. And so what companies need to be successful is data, durability of response, good data in more than one or two patients, but handfuls of patients where we're showing some efficacy that's beyond what they're seeing with small molecules, T cell engagers, and other um allogenaic therapies. Uh I'm sorry, other autologous therapies.

Ben Comer 23:05

Yeah,

Allogeneic Versus Autologous Tradeoffs

Ben Comer 23:06

well, there have been more, I think, autologous therapies. Well, I know there's been more autologous cell therapies approved than allogenaic cell therapies, uh, but I remember, you know, not so long ago when everyone was thinking, you know, allogenaic cell therapies are really, you know, because they're off the shelf, uh, because of the you know, less complexity in administration, um, that that they would sort of lead the way. Do you think that still is going to happen? Do you think there will continue to be a place for both autologous and allogenaic? Or does it matter, you know, if one kind of beats out the other?

Paul Hastings 23:38

Well, first of all, we shouldn't be in the business of trying to beat each other out, right? Um, autologous therapies work and there's data that support that. Good for them, right? Yeah. So now there are, like with any drug, there are pros and cons of those drugs, right? So for autologous CAR T therapies, you know, particularly at autoimmune disease, these cells tend to expand over a long period of time and cause things like cytokine release syndrome and neurotoxicities. So the one area where we could provide a benefit over autologous CAR T is if we had a cell therapy that you could give, well, you didn't get cytokine release syndrome, well, you didn't get neurotoxicities. And so far in our autoimmune clinical trials, we have none of that. Zero, zero incidents. So if we're able to have the efficacy of the fantastic uh level that autologous CAR Ts have without having to aphore the patients, without having to put them through that, then we have a home run. But that's yet to be seen with data, with good efficacy, and with durability. And we're behind because these cells came along later. So now we got to show that. So if we can show that, we can be competitive with autologous CAR T's. And from my point of view, as a patient, I want patients to have access to everything: autologous therapies, allogenetic therapies, CAR T, CAR NK, T cell engagers, biospecific, small molecules, as long as they all work and um and patients have options. When have we ever had a situation with an autoimmune disease where patients had four or five options that they could do? And if they become resistant to one, they can go on to another. Never. So now we have that opportunity, and that's what I'm excited about.

Ben Comer 25:16

Uh, I want to get back to your comment um about uh clinical infrastructure, Paul. And you know, given your experience, active participation in the industry trade organizations, uh, I wonder what maybe uh what you could say about the the state of innovation broadly uh in the US and uh in terms of kind of what's going right and what's going wrong, and also talk to me about you know problems with with clinical infrastructure and and how they might be fixed.

Fixing US Clinical Trial Infrastructure

Paul Hastings 25:46

What is going right right now is that as a nation, we are recognizing that while we had the state-of-the-art clinical trial infrastructure for many, many years, we're losing it to China. Okay, that's number one. And we have to admit that they're kicking our ass, all right? They they're they're able to enroll multiple patients in clinical trials very quickly, um, report on our results. Why? Because they're focused on it. We lost the focus on clinical trial infrastructure. We got caught up in punishing academic centers for making political statements, taking away their funding. And so the clinical trial infrastructure is strained. And that when that infrastructure is strained, patients don't get enrolled, results don't happen quickly, we burn through hundreds of millions of dollars to do clinical trials. So it's not the academic institution's fault that right now the clinical infrastructure needs upgrading, but it does need upgrading. One way to do this, in my opinion, is to start working with community-based centers in disease areas where patients live in communities. So rather than have to send 95% of the patients that don't have access to New York or Boston or Philadelphia or Chicago to those cities, is to have community-based centers in their areas that actually can conduct clinical trial research. And when you hear from big academic centers that these small institutions can't do it, I don't buy it. I'm looking at centers now in the community that can do everything as well as the big centers, but what they do better than the big centers is understand who the patient is because it's their patient. It's the doc in that institution or in that clinic that know that patient because it's part of their practice. So if you can supplement the academic infrastructure, which tends to be big and bureaucratic and, you know, sterile, with more community-based centers where they're actually focused on treating their own patients, I think you then have a one-up on other countries who are trying to do this. And you're you're going to be able to find patients where they live, treat them where they live, provide services for them where they live. Like the simple, you know, when you look at what it costs to do a clinical trial in cell therapy, it's multiple hundreds of thousands of dollars per patient to enroll them in a clinical trial. So you could spend maybe $20,000, $50,000 on a patient by providing child care services, doggy daycare, um, fertility services for them, travel to and from the site, travel for their spouse. Right? These are infinitesimal costs that you can do to make it easy for them to get to those clinical trial sites in their communities or in those big academic centers. We do that now. It's a small cost compared to the rest of the cost of the clinical trial. But by making the clinical trial infrastructure patient friendly. So when the patient walks in the front door of the institution they're going to for their clinical trial, the person at the front desk, when the patient says, I'm here to enroll in my clinical trial, doesn't say what clinical trial. They say, Oh, yeah, I know that. Here's where I'm sending you. Go there, you know, get your labs done here, then go there. We're going to help you every step of the way. That's what companies need to do. That's what institutions need to do. And it's the company's onus to own that process and make sure that happens for the patient so they're not floundering about trying to figure out where their clinic is, where they need to get their treatment. Because, again, patients are giving up portions of their life to be involved in clinical research for us. So we have to own it. We got to work with them. We got to help them. We got to make this a process that is friendly to them so that they want to be involved in clinical trials. That's what we need to do to make our clinical trial infrastructure better in this country.

Ben Comer 29:39

And this is companies supporting these community center providers and community centers to actually conduct trials or helping get paid, helping, you know, provide patients what they need to actually get to where a trial may be happening, or both. All of the above. Yeah. All of the above.

Paul Hastings 29:56

So the one thing I will tell you that I always say to early stage CEOs and I share companies and boards of companies or early stage CEOs, is details matter. You know, this concept of servant leadership where you get out of the way and everybody just does their job and you trust that everyone's going to do the job, which of course you should trust people to do their job. But you need to be hands-on and you need to be, you need to know who's the investigator in my trial, who's the administrator of the hospital that the investigator works in. So if something goes wrong, you know what's happening and you can get in there and try to fix it. And and offer like there are some institutions that don't have study coordinators. Provide, you know, non-restrictive grants to those institutions so that they can actually get a study coordinator. It's an infinitesimal cost compared to the whole cost of the trial. And it helps the institution, it helps the PI as long as it's done the correct way, legally and within the boundaries of clinical trial ethics. And it all can be done. So many things can be done that people have said, no, no, no, you can't do it that way. Well, you can. You can actually re can actually reimburse patients for the amount of time they lose at work to go into a clinical trial. But nobody wants to go there. Everyone's afraid of that. But you actually can do it legally and within the confines of good clinical practice. So, you know, if you offer those things to patients and say, we're here for you, well, now they trust the institution of a clinical trial versus not trusting it. Their own community doc is the one administering therapy. So they trust the community doc. So it's again looking at this from the eye of the patient.

Ben Comer 31:32

Yeah, and maybe that community doctor is key because I there was a lot of excitement, you know, several years ago about you know, target Walgreens. I think even Walmart was proposing, you know, conducting clinical trials. And their whole thesis was, you know, we we already have these retail customers, we know them, we can get them into clinical trials. It didn't really work though. Uh, but I think maybe it's because those, you know, talk about sterile. It's a it's a different type of organization than uh a community doctor who you know may know not just the patient, but you know, their family as well.

Paul Hastings 32:08

Well, patients are people. People go to Target, people go to Walmart, people go to Costco, right? So why people get their I by the way, these glasses came from Costco. I get my eyes examined at Costco every year. Why? Because it's a third of the cost of going to a freaking optometrist in the Castro where I live. It's gonna charge me $1,000 for a pair of glasses when Costco charges me $25 or $100 or whatever it is. So I think the consumer is the customer. People need to understand how to work that. And I remember when the business of pharmacy started going from these mom and pop retail stores into CVS, Walgreens, et cetera, and then into Target and Costco. Remember, who is it important to be serving here? Is it our profession? No, it's the patient who's a person. Where do they go to get the things they need for their week? Right? They go to these big box stores to get their groceries, to get their pharmaceuticals, to get whatever. So so as a pharmacist, if you're working inside a Walgreens or a Target or a Costco, why not? Right? You can you can build a pharmacy there, you can you can have a one-stop uh place for patients to get all their needs. And so why not? Right? Whatever makes it easier for the patient as long as it's done within good pharmaceutical practice, good clinical practice, and uh people, people in the profession have great jobs there, they're treated well. By the way, Costco and other of these uh big corporations are are diversity, equity, inclusion um specific. They're still doing a lot of work there and they're treating their employees well. Why not?

Ben Comer 33:53

Yeah, except for Target. I think they've backed off some of that a little bit.

Paul Hastings 33:57

Well, they've backed off. Well, yes. Well, look, we can get into this whole subject of of what I think corporate leaders need to do, which is speak up. Yeah. But, you know, when I see people backing off, I I lose confidence in those people. Yeah, right. So so I if if I see the store that I go to backing off of what is important for people in this country, I'm gonna go away, but Costco's still doing it. I'm gonna go to Costco. You know, so it's supply and demand, right? It's supply and demand and it's it's it's consumerism.

Ben Comer 34:28

So there is you think there is a potential future then to doing some conducting some clinical trials in big box stores like that.

Paul Hastings 34:35

Well, I don't know that you can actually do a clinical trial, but you could certainly uh I mean, wouldn't it be great when patients have to go in for blood work if they could do it at Costco, right? I mean, you could you can get your flu vaccine, why not get your blood work done there? You they can hire a lab tech, right? All these like quests and all these diagnostic places, they're just little box stores inside clinical trial, you know, clinical um centers. So you could put one in a in in in in a in a retail pharmacy, why not?

Ben Comer 35:03

I uh I definitely do want to get your advice, Paul, on what biotech leaders should be doing and and how they can speak up and and you know what they should be speaking up about. And maybe a way to get to that is uh your stint as uh as bio board chair a few

Speaking Up: BIO, Policy, And Leadership

Ben Comer 35:20

years ago. I'm curious, you know, what you maybe learned from that job or what the hardest part of that job was.

Paul Hastings 35:27

Well, to be clear, it wasn't a job, it was a volunteer.

Ben Comer 35:30

Yeah, right. Yes, being on the board of the city. I'm sure it felt like a job. Yeah, sorry.

Paul Hastings 35:34

It does, it does feel like a job, yes. But I it's a commitment and it's a responsibility, in my opinion. This industry gives to us, we need to get back to the industry. And if you could be the head of the trade organization, the chair of the trade organization that helps the industry do what it needs to do and keep itself relevant, I think that's a good thing to do. So I believe these things are an obligation, not just a volunteer activity. So um, so what I learned from being chair of bio and what I continue to learn being on the board of bio is what is important to our industry, what are the important aspects of education on the hill, you know, making sure that our senators and and congresspeople are up to date on what we do, that they understand our industry, that they're getting appropriate messaging of what our industry is, not hearsay from others. Um one area that we all need to speak up against are these so-called pharmacy benefit managers. What are they providing to our ecosystem besides nothing other than being a middleman, right? So I do believe that as leaders, we have to take a stance. While we're being attacked by other industry organizations, we need to make sure that we are transparent about the way the pharmaceutical infrastructure and innovation infrastructure works. And part of that is unfortunately making sure that people know that a PBM uh is is is is is taking uh large percentages off what uh the insurance companies are paying for products and not giving it back to the patient. I think that's really important to know that. I think it's really important to understand what HHS and FDA and Department of Homeland Security and all the other groups within the administration are doing uh to and with and for the people who are our employees, right? So we're an eco we're an ecosystem of innovation. If we're gonna continue to have an ecosystem of innovation, it's probably important that we have an opinion about immigration. It's probably important that we have an opinion about, you know, people who come here to be educated and keeping them here versus sending them back to their countries like China to take what they learned here and just replicate it there in a much more efficient manner. So we should have opinions about that, we should work on that, we should be collaborative and cooperative in doing so, but we should be honest about how we feel about that and make sure that our voice is heard in DC and make sure that the people's voice and the patient voice is heard there as well. So not speaking up to me is cowardice, and speaking up to me is an obligation.

Ben Comer 38:15

What's the best forum for speaking up? I mean, is it is uh individual CEOs, you know, doing like going on television, writing op-eds? Uh, it should it be more behind the scenes, direct to you know, folks in power at the federal level? Like what what do you think is the most effective way that that leaders in the life sciences industry can speak up on on some of these issues?

Paul Hastings 38:38

Well, going to the going to a fly-in on the hill is not uh you know behind the scenes. It is very upfront and center. So I'm gonna say that, right? So I mean, you know, that's important. All of the above is important, right? Uh it is it is I'm not gonna compromise my standards or my ethics or pay to play for anything. I'm I'm I'm going, by the way, I I contribute to no PACs, I contribute to no well, I do contribute to some politicians, but but I'm not I'm I I want to see what people can do and and that they're doing the things that I think are important, that my spouse thinks are important, that we believe is the right thing to do before I give them a penny. Uh so I I like moderation and I like the ability to negotiate and work with the other side in the middle, not the far left or the far right. So so I I I just think it's our obligation to do all the above. So by the way, you don't need to be on CNBC or MSNBC or you know, heaven forbid Fox News or anything like that. Um, what you need to do is if you're asked, if they're you're called on to have an opinion, to have a goddamn opinion, right? And actually speak what you think and speak your mind and do it in as kind and gentle a way as possible by getting your point across what's important to you, what's important to your employees, uh, and and and why it would benefit people to do X, Y, or Z. So I think it's an obligation. And I think all of the above are what people should be doing. Hiding and not having an opinion about something, why be in leadership if you don't have an opinion about something? Right? That's my opinion. Yeah.

Ben Comer 40:21

Yeah. I mean, I I think the the the only rebuttal I could potentially see from leaders is, well, I, you know, I don't want to jeopardize, you know, my review at the FDA. I don't want to say something, you know, that and and of course that should never happen. Uh uh, obviously, you know, speaking uh, you know, an opinion about uh an issue should never change the science of an FDA submission. But uh, I mean I I I sense that there is a lot of people.

Paul Hastings 40:46

People had those fears, and and again, it is up to us to hold our politicians accountable for that. Yeah, like we shouldn't have to have fears about if we don't like what Homeland Security is doing, that should not affect how our interactions with the FDA are. And I'm not seeing that in my interactions. Yeah. So, you know, I'm seeing an FDA that likes cell therapy, that likes innovation, and that's working with us. I don't bring up to the FDA what I think about Homeland Security. You know, I don't bring up with Homeland Security what I think about the FDA. I think each one of these um uh uh departments or or or ventures or whatever within the government needs to be dealt with separately and objectively and with an objective lens. And so, yeah, I think, you know, to to to say I'm not gonna, you know, support my employees because I'm afraid of retribution. I mean, really? So by the way, anything we do is leaders, there are repercussions one way or the other. So we either take a stance or we're not gonna take a stance. But if we don't take a stance, are we really the right people for the job? I don't know. I'm not I don't think so. Yeah. I uh just uh privilege to be a leader, right? It's privileged to be a leader and you have to you gotta you want to you have to play you have to pay to play. If you want to play, be a leader and and and you people are looking to you to help lead, not follow.

Ben Comer 42:10

I I want to ask you about uh a couple of the groups that I mentioned uh in the introduction, um, Paul, but before I do before we leave the FDA, it my sense, and you can correct me if I'm wrong on this, is that there's been uh uh some stability now just in terms of personnel with Kyle Diamantis uh in the acting role and uh Kareem McHale as the acting head uh of Seber. I I won't ask you specifically about uh those two gentlemen, but what about um current policies at the FDA? Or are there any that that you're watching uh carefully or or that that you're concerned about, or or that you think you know the FDA needs to uh adopt yesterday?

Paul Hastings 42:51

Um all of the above in terms of watching initiatives. Okay. Um and I I I am encouraged by the fact that the gentlemen that you just mentioned are focused right now on making sure that we can put a drug into development and get it approved in as efficiently as possible. So I'm encouraged by that. How they go about doing that, jury's out. We got to wait and see what happens, right? I do know that one of the areas they're working with is academia to help speed up clinical trials. And to me, that's an oxymoron. Academia slows down clinical trials. We need to figure out a way to help academia speed up clinical trials. So that's that's a good initiative. But looking to them for solutions on how to make clinical trials faster, to me, it's a it's a little bit backwards. So I would look at community centers and community docs and say, how do we get these trials done? How do we get them done in an efficient manner? How do we make it easy for patients to have access? So I hope they focus on that, and I believe they are. So I think they're they're where they're trying to go is a good place. They're big, they're bureaucratic, they have to learn how to act like a biotech company, if you will, if you wanna if you want to do What China's doing and enroll patients quickly in an efficient, effective, and ethical manner. I don't know whether China's doing it ethically or not, but I don't see any reason to believe they're not. But if um you want to do all those things, you've got to think like an entrepreneur. And I think there's a focus there on doing that and making it an efficient organization that I'm very pleased with.

Ben Comer 44:21

So what about Yeah, sorry, go ahead. No, go

Mentoring New CEOs And Patient Advocacy

Ben Comer 44:24

ahead. I was just gonna say, what about integrating AI into the FDA? And and it and Carta, is is AI something you're leaning into uh at the FDA? Do you think AI is a you know a kind of key plank toward modernization? Um, how are you thinking about AI? AI is a tool in our armamentarium of tools. Yes. All right, well we'll leave that one there. There's uh I I honestly don't want to get too deep into that myself, uh, but I do want to ask you about the Termir Institute, which I believe you co-founded, uh, I think in 2023 or 2022, is that is that correct? I I did not co-found it.

Paul Hastings 45:02

It was founded by Henry's wife, Belinda, and she um built the organization and I am a member of its board. But um, but uh I'm very excited about what the Termir Foundation does because it speaks to your audience, it speaks to first-time entrepreneur CEOs, and how do we provide an environment for them to succeed?

Ben Comer 45:22

Okay, so it's like a leadership training kind of organization. Is that is that what it's focused on? It's a it's a peer-to-peer leadership mentoring organization.

Paul Hastings 45:31

That's right. So we read we we have these quote unquote Tremir fellows. They apply for fellowships within the Tremir Institute, and then I become a mentor as a board member. There are other former Gen Zime employees and former people that were friends with Gen Zime that are mentors to these first-time CEOs, and we help them through some of the issues they have. They they have someone to call and say, Hey, I'm facing this. What do you do when you face that? So it's a little bit like being board members of all these early stage companies, but you're actually helping them. And the the the institute provides grants to these people for some of their own research and some of their own development. And most a lot of these first-time CEOs are, you know, people who came up with an idea in their postdoc or in their academic institution who then decided to start a company. Um, some of them are just first-time CEOs that realize it'd be great to have some mentorship and to be part of an organization where there's a whole bunch of first-time CEOs working together and um, you know, socializing together and learning together. And so it's a it's a wonderful, wonderful um uh thing to do. Uh and it's got some great names behind it, like John Marigonori and Deborah Dunzier, and you know, just some really great people that are very successful biotech CEOs that are working together to make sure that the next generation of biotech CEOs has the same opportunities that we had. It's giving back.

Ben Comer 46:54

That's excellent. Um, the the other organization I wanted to ask you about is No Patient Left Behind, which I I believe was started by uh the investor Peter Kolczynski five or six years ago. Um you're what are they up to? What are you doing with that organization?

Paul Hastings 47:10

I'm uh advisor to No Patient Left Behind. I'm a proud advisor to No Patient Left Behind. I'm a very um big fan of Peter Kolczynski because the man cares. He he steps up, he has an opinion. He steps up, yeah. He speaks up and uh and he fights for the patients and he fights for no patient left behind. I mean, that was that was his his idea. So he's got a great staff there that works at No Patient Left Behind, and I help them wherever I can. They're a mini trade organization, basically. They're really their sole mission is that no patient is left behind, that we are actually looking out for the patients. And and so they have an opinion about what patients should have access to. And um, so working with them, it's been a pleasure. I'm gonna continue to work with them. Uh, and Carta is a member of No Patient Left Behind. You can, you know, pay membership dues and and be a part of the organization. And I think it's a great organization to be a part

2026 Goals And Closing Announcements

Paul Hastings 48:06

of.

Ben Comer 48:06

I'm running out of time with you, Paul, as I suspected I would. Um, so I'll just get one last question in here for you, which is what are your top goals for the rest of 2026? Uh, it could be goals for Ancarta, for for the industry at large, or or personal goals. I'll let you decide.

Paul Hastings 48:23

Yeah, well, data, data, data is my goal for 2026. And and to make sure that whatever data we present leads us to take our company to the next stage. That is the number one priority of my personal agenda, of my professional agenda, and my industry agenda for this year. Um, other things are making sure that, you know, uh we have an FDA that listens to um its constituents and does the right thing for patients. And I and I'm encouraged by what I'm seeing so far. And that we have a Congress that is understanding of our industry and is also speaking up for the um uh for their constituents, which are the same people that are our constituents that are our employees, right? So so those are the sort of the three top things that I'm looking to do this year.

Ben Comer 49:14

Excellent. Well, we'll have to leave it there. Uh thank you so much for coming on the show, Paul. It's a real pleasure speaking with you. My pleasure, Ben. Thank you. Uh as a side note to listeners, Paul is part of an all-star live panel that Life Science Leader is hosting, uh, and I'm moderating on August 20th at 11 a.m. Eastern. Um, Paul will join Ovid Therapeutics uh Jeremy Levin and Bio's um Senior Vice President of Science and Regulatory Affairs, Annette Beauregard, uh, to talk about FDA engagement strategies and best practices during a time of rapidly changing FDA personnel and policy. Uh listeners can uh register to join that event for free on the Life Science Leader website, or you can look for my post about it on LinkedIn. Uh for Business of Biotech, find us and subscribe anywhere you listen to podcasts, and be sure to check out our weekly video cast of these conversations every Monday under the Business of Biotech tab at lifescienceleader.com. We'll see you next week, and thanks as always for listening.