From The Bench To The Boardroom with ImmunityBio's Enrique Diloné - podcast episode cover

From The Bench To The Boardroom with ImmunityBio's Enrique Diloné

Jul 22, 20241 hr 7 min
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While organic chemistry lectures caused many of his peers at NYU to wring their hands, gnash their teeth, and question life choices, then-19-year-old Enrique Diloné ate those classes for lunch. They inspired him to earn a Seton Hall Ph.D. in chemistry, and to go to work as a big bio research scientist. Along the way, Dr. Diloné got bit by the biotech business bug. It wasn’t easy. A whole bunch of MBA and executive learning programs at Rutgers, MIT, and Harvard, and many years of experience later, he’s Chief Technology Officer at Immunity Bio, which he joined in advance of the company winning FDA approval of ANKTIVA, its IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer, in April '24. On this episode of the Business of Biotech, we follow Dr. Diloné’s path from the bench to the boardroom, and learn how valuable that rare bridge between CMC and the executive offices really is. 

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Transcript

Matt Pillar

Want to get caught up on the latest , greatest bioprocessing equipment and solutions without putting in travel requests , flying across the country , spending gobs of money and time , getting harassed by salespeople . Of course you do Register for Bioprocess Online's BioExpo Live being held July 30th through August 1st .

This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device Conveniently . We've broken down the lineup into upstream solutions on July 30th , downstream solutions July 31st and quality analytical and data solutions on August 1st .

It's absolutely free to register for this series of short , digestible and interactive sessions . Just hit the link in today's show notes to register for BioExpo Live today .

Not too long ago , on episode 197 of this very podcast , I had a conversation with Immunity Bio Chief Medical Officer , dr Bobby Reddy , about the company's then impending first approval an immunotherapy called ANKTIVA that has since gained FDA approval in non-muscle invasive bladder cancer and one that offers many improvements over the current standard of care .

Beyond Dr Reddy's role in ANKTIVA's successful rollout , it was a meaningful conversation for me personally , given the role I've been playing in my dad's care for that very indication . I'm Matt Pillar .

This is the Business of Biotech , and on today's show we're digging even deeper into that success and the people behind it , with Dr Enrique , who's served as Chief Technology Officer at Immunity Bio since 2023 .

On this episode , we'll follow and learn from Dr Deilonet's transition from the research lab to the business side of biotech , how he did it , how his experiences put him in position to join Immunity at a pivotal moment , the roles he's been playing in the company's next post-commercial chapter with Anktiva , and the broad spectrum of follow-up programs the company is

pursuing in lung , colorectal and ovarian cancers , acute myeloid leukemia , glioblastoma , solid tumors , non-hodgkin lymphoma and HIV . Enrique , thank you for joining us .

Enrique Diloné, Ph.D.

My pleasure Matt .

Matt Pillar

That is an aggressive list of programs that I just rattled off . You have got your hands full .

Enrique Diloné, Ph.D.

Yes , we do , yes , we do . It's all in a day's work . It's all in a day's work .

Matt Pillar

All in a day's work . Yeah , yeah , we're going to get into that . I've got questions for you on that very aggressive pipeline that you guys are forming up . But I want to start by rewinding the clock a little bit . And you know , you and I had the benefit of a conversation not too long ago and it made me recall the story .

My son just returned from his first year , his freshman year , at Penn State University , and when he got , and when he , when he got home , I was we were having a conversation about his academic experiences and he said you know what he said organic chemistry is the leading cause of depression in state college Pennsylvania , which is which is where Penn State University

is . Um , he got through it . He got through it , but he said I mean , he said it was like a class like no other in terms of its impact , more often than not negative , on his peers .

You , on the other hand , told me that you ran circles around your peers in organic chemistry and that the experience there was one of many that influenced the rest of your academic and industry experiences . So tell us a little bit about that , like , tell us about that academic influence on your path to biopharma .

Enrique Diloné, Ph.D.

Well , matt , let me thank you for having me . I really appreciate the opportunity . I was I think I must have been 19 years old when I took that class . Yeah . And at the time that I took the class I was still thinking I was going to be a pre-med student and ultimately a physician , not thinking that chemistry would interest me all that much .

But when I started organic chemistry I very quickly switched to a chemistry major , which was not the case with most of the pre-med students , and I just enjoyed being in the lab . It was a little . It took me back a little bit . It's sort of finding your calling in a way which is a little bit nerdy , but but I I just enjoyed the laboratory .

I couldn't , I couldn't get enough of it . I , I the textbook piece and understanding and reading . The pre-med guys had a pretty solid grasp of that , just regurgitating a lot of the information . But actually going into laboratory and conducting , doing chemistry , that's what I enjoyed .

And many times my experiments would I I don't remember any one of my experiments failing when I was in in the laboratory . So , and some of them were pretty intense , um oxidations and the greenignard reaction . If you get a little bit of water in there , the Grignard reaction doesn't work .

So you know it was interesting and so I went back to my father and I told him I want to be a chemist and of course there was the ensued discussion .

Matt Pillar

Yeah , well , just for the audience's benefit , your father was a physician , wasn't he ?

Enrique Diloné, Ph.D.

That's right . My father was a physician . He was a pediatrician .

Matt Pillar

And he wanted that apple to fall close to the tree .

Enrique Diloné, Ph.D.

That's exactly right . That's exactly right . But then , once we had that discussion , he talked to some of his peers and he recognized well , you know . So chemistry is a good profession . And as it turns out , he influenced me still further , because then he told me why don't you at least work making medicines ? And that's how I actually wound up in pharma .

He convinced me of that .

Matt Pillar

And so that was how that happened . Was that convincing that inspiration to move into Florida and the influence of your dad before or after you earned your PhD ? I know you got your PhD in chemistry from Seton Hall , but did you pursue that PhD with the intention to move into medicine making ?

Enrique Diloné, Ph.D.

Yeah , I knew so at this point , when I was having that conversation with my father , I was still working on my bachelor's at NYU .

And once I graduated from NYU I knew I wanted to pursue additional degrees and somebody recommended Seton Hall University and I needed at the time I needed a small university , my environment , just from having been in the city for as long as I was . And so once I went to Seton Hall University I did my master's , but then I had to work for a little bit .

Somebody had suggested to me that I pursue my PhD . And again once I went to Roche at Hoffman LaRoche , I studied in the generics industry . When I went , when I graduated with my master's but very quickly moved to Hoffman LaRoche at the time their number one product was ceftrizone or Rocephin .

It was a cephalosporin and I've been working on cephalosporins for about a year . So I got into the company and the company ultimately helped me win my PhD .

Matt Pillar

Yeah , yeah , that's outstanding . And then those early , those early years . I mean you mentioned that you , you liked the lab , you liked the lab , you , you you you , you , you , you . You self-identified as a little bit nerdy , which , yes , I did . Yes , I did yes . I did yes , I did yes I did . Yes , I did yeah , so why not stay there ?

I mean , you moved into a business capacity in bio after spending those years at Hoffman , laroche and Wyeth in the science and research capacities . What inspired you to take a look at the business side ?

Enrique Diloné, Ph.D.

take a look at the business side . So I wanted a greater say on how products got developed . I felt when I was at Roche , I remember I got to a point where I felt I can contribute more . I know I can . That was a very strong urge and I really felt . After I had been at Rush for nine and a half years and I really felt like I could contribute more .

After I got my PhD I left Rush and went to Wyeth and they put me on a global team and I mean immediately . I was able to contribute to global drug development . Immediately I was able to contribute to global drug development .

So it was just a question of just understanding , for lack of a better word , matt , you just knew you could contribute further to the business , to just the aspects of developing whatever the asset was , as you got exposure , because at Roche I was in quality control , I was in pharmaceutical development and I was in drug metabolism servicing the discovery groups .

So I understood pretty broadly the whole preclinical aspects of drug development until commercialization in QC the technical aspects of it , not the biology . The technical aspects of drug development until commercialization in QC the technical aspects of it , not the biology .

The technical aspects of drug development , and so as I moved up the ranks , it just became clear to me I wanted more . And when I went to Wyeth , they put me on a global . They then taught me global drug development . They exposed me to colleagues around the globe .

I began to understand all the geographies and how to get drugs approved , basically how to work collectively in a multidisciplinary team to get drugs approved , and not just from the technical aspects of it , but also everything to do with that right . How do you relate with your team members ? How do you work with the process ?

There was a maturity emerging and then , very quickly , somebody plucked me out of Big Pharma .

Matt Pillar

Plucked you out of Big Pharma . Yeah , Lucked you out of big pharma . I want to hover just for another minute or two on the period where you began to feel as though you had more to contribute , and here's why I've made mention of this on the podcast recently on a few occasions .

There's a I don't I don't know if you're a Redditor , if you ever go on Reddit , but there's a subreddit called called biotech . It's a biotech subreddit and the I'd say the the bulk , if not , you know a good portion of the conversation on that , the user generated conversation , is around aspirational , you know it's .

It's it's lab employees and science , research , scientists who , who have , who have aspirations to move into the business side , and they're asking questions about it . How do I do it ? What path do I take ? What do I need to learn ? Who do I need to talk to ?

And I wonder retrospectively , now that you've got the benefit of wisdom behind you , when you first began to feel as though you had more to offer , had you been given the opportunity to offer successful in a , in a role that required , um , I guess , more , more , uh , directorial skill and more vision ?

Enrique Diloné, Ph.D.

That's a . That's an interesting question . Um , I think that there's no question that you have . I mean , a key learner inevitably is failure . It's just a key teacher . You know that you go through different kinds of failures , be that a product failure or a bankruptcy in a small biotech or whatever it is that just you just can't read about something like that .

You have to be exposed to that sort of thing . But even in the large companies , many times we had worked on products for many years , many years , and then it got to a point where , for whatever reason some of them were clinical or tox or there was a technical challenge you were told you're not working on this product anymore .

Yeah , and you asked me had I been , was I ready ? I , it's difficult for me to say to be honest , matt , it's just it's difficult for me to say definitively that I was ready for this or that .

I think there is an aggressiveness when you're young that sort of needs to be tempered so that that you know that eagerness and aggressiveness is directed positively when you're working , especially when you're working with other people and and everybody that , that , that I think a lot of people that have talent at some point think they're the smartest person in the room

. And then you come to terms and you realize that you know , even for all your academic credentials and everything else , the center of the knowledge of the universe doesn't revolve around you . So , but I think at the time I would have been ready if something had been offered to me that was appropriate .

And you know , it was just the case that that just didn't happen . I think many times , matt , when you come into an organization at a certain level , it's difficult for people to view you differently , even as you grow . Yeah , you know they still see it's like your parents , right , your parents always see you as their kid .

You could be president , but you're still my kid , no-transcript . And so it takes effort for people to make those transitions , and so usually I remember speaking at the time with several of my colleagues .

They told me , if you want to move up the ranks now that you've gotten your PhD , you have to go to another organization that views you as a PhD level scientist and doesn't view you as the entry level person that you came in as . And it's nothing there's . You know , it's just so .

That was the first really hit to my ego , that in industry that forced me to grow up . You know , it's just a matter of reality .

Matt Pillar

Yeah , did that ? Did that experience coincide or is that corollary with ? I wanted to get back to the comment you made about being plucked out of big bio .

Enrique Diloné, Ph.D.

No . So that was two years later when I went to Wyeth . I went in as not an entry level but a couple of levels above entry level , as a PhD scientist . They treated me really well . And then I was there for about a year and a half doing well , almost about to get promoted .

And then that's when a colleague from Roche called me probably one of the most influential people in my career Stephen Sapinski , and he called me , and he was the one that plucked me out of large pharma and gave me a tremendous opportunity . To this day I'm thankful to Steve for that .

Matt Pillar

Yeah , and what move was that ?

Enrique Diloné, Ph.D.

That was when I went to ITET . I went to a small New York firm focused on acute macular degeneration . It was ophthalmology and they were developing this very interesting drug . It was an oligonucleotide a pegylated oligonucleotide that was to be dosed directly into the eye for macular degeneration . We ultimately got that drug approved . That was a great experience .

I think I worked there for about three years under the iTech brand and then OSI bought them and I worked for an additional I want to say total of five years together between the two entities . So that was a great experience and gave me a lot of exposure . What was the role that you took there ?

So originally I was director of analytical development and quality control , so the bulk of my career up until 2010 was primarily focused on analytical chemistry in some capacity , you know , just developing the assays and the methods , working side by side with the process sciences folks to get the drug ready for the marketing application .

Matt Pillar

Yeah , was it at iTech . So help me out with the last time we spoke about achieving clarity around your lack of business acumen in a specific setting that inspired you to further educate in terms of the business side . Was that at iTech ? No , that was at .

Enrique Diloné, Ph.D.

Amicus At Amicus Therapeutics Okay .

Matt Pillar

At .

Enrique Diloné, Ph.D.

Amicus Therapeutics business side was that . Was that an ? itech that no no , that was an amicus and amicus therapeutics . Okay , yeah , but I make a therapeutics . I was , um this is around 2012 . I've come into amicus . Now I have technical operations . At the time it was very small but it was growing .

It was a growing area in the company and , um , I got promoted to vice president , which was I was elated . I finally made it to the executive ranks .

I was a head of a function and then I remember being in some of the meetings with the rest of the senior amicus leadership and they're just talking all these terms that I'm unfamiliar with , and a lot of it is just business jargon how to raise money , talking about NPIs and MPVs , discount cash flows , all these . How do you value that deal ?

How do you value this deal ? How the what's the bottom line on this ? You know the cogs ? I hadn't , I hadn't , I hadn't worried about cogs until then . All this is I'm worried about developing drugs , you know .

And so , um , that's when I finally did , I , I , I , finally , it came to mind that I have to go to business school , I have to do some formal business training and , um , and I remember the seminal moment came when I was at a PDA-FDA meeting in an elevator with this very competent person .

She was on the board of directors of PDA , Ursula Busey , and I knew she had a PhD and an MBA and I asked her what made you go for the MBA ?

And she said they were talking over me and I said , oh , so I completely related to that experience and that's when I decided I had to go for , and that's when I decided I had to go for , a business degree , which I ultimately did . So that was a fish out of water .

You really realize that when you go I'm sure there's a lot of people that can relate to this but you're going to school , thinking again now , after 20 plus years in the business , you're going to school and just all these different opinions and different points of view and different perspectives , having been in science for as long as I had been by that point ,

having been in science for as long as I had been , by that point again , it was another force moment to mature and realize .

You know you sort of , by this point you're not as shocked , because you sort of realize , okay , you know , this progression consistently humbles you that's just my opinion but consistently as you move up the ranks and you realize the complexity of the problems that folks work at the next level .

Matt Pillar

You just constantly realize how little you know , and then you expand again to fit that that level and then you move up again and so on yeah , yeah , and you and that didn't necessarily come come real easy to you , given that you had , uh , you had been studying in a , in a discipline where , um , scientific principles or scientific principles , exactly the business

side in there , you know , a plus B could be A1 plus B7 equals C , like there are just so many permutations and variables . Did you struggle with that a little bit ?

Enrique Diloné, Ph.D.

Of course , and you know , there were just like little snippets the professor . I went up to the professor because the professor was , he had an engineering degree and a doctorate in business administration , but an undergraduate degree in engineering . And I asked him you're an engineer , how did you adjust to this ?

And he said to me Enrique , the key thing to know is that in business , 80% is good enough . 80% is good enough , 80% is good enough . Think about that in everything you do in science . If you think 80% of overpasses are safe , is that acceptable ?

And so this is where it's just the ambiguity of business , I think , personally , I think always challenges technical and scientific professionals and when I see even physicians , some of the physicians in the field that I knew that went and got their business background , whatever that happened , to be an executive education or an MBA , even they told me it is very

difficult to make that transition and in some ways , man , you need that . You need that to succeed as an executive in pharma , because it's just a different way of approaching things and a different way of speaking to those business professionals when you're , when you're not speaking science or technical things .

Matt Pillar

I I think it makes you more effective yeah , well , I mean long-time listeners of the podcast know that I can go long on this topic . To transition from you know , and people might get tired of hearing it , but I never get tired of hearing it because every story has its own flavor .

You know , every story has its own perspectives and angles , but I don't want to dwell here too long . I do have one more question for you on this topic , though , and it's sort of a philosophical one . I'm just interested in your take on topic , though , and it's sort of a sort of a philosophical one . I'm just interested in your take on um .

You know , you , you mentioned that you , you love the lab and when you began to entertain the , the concept of , of going into the business side , you , uh , your , your expertise was in making medicine , developing medicine .

You know , when you make the transition into the business side and you have to gain expertise on running a business , keeping it profitable , maintaining , you know , maintaining the livelihood of your employees , running an apartment , organizational skills , as in the organization , is it a dangerous place , can it be a dangerous place , to potentially lose sight of the passion

around developing therapeutics and how do you maintain so ? Two-part question Is there ever a danger that , like , hey , now I'm a businessman and it's less about the therapeutic development , and how do you avoid it ? Like , what steps do you take , you personally ?

What does Enrique Dilon do when he wakes up in the morning to say , like you know , it might not just be about the bottom line today like we need to , you know , maintain our focus on the therapeutic . Does the question make sense ? I mean , yeah , it totally does .

Enrique Diloné, Ph.D.

It totally does . So I still remain close to the science . That's how I do it , that's the short answer For me , and even today , in my role in Immunity Bio , I am constantly talking science with folks and so . But the difference is and again this was conversations we had when I was in business school you need to be able to pivot . You need to be able to .

At one point you're talking in-depth characterization of a structural impurity for one hour with folks that are all scientists , and then in the next hour you're talking with the commercial operations team on supply chain and order to cash and all these other things , and you have to be able to compartmentalize the transitions .

But it doesn't mean that you've lost touch with the aspects that brought you to ultimately developing medicines for patients . Courage this I certainly did it proactively . Understand the business beyond the function that you conduct , so that you read about what the company is doing .

You understand the field of oncology , not like a physician , but to the extent that you can . So you remain grounded in what you're doing and why you are doing it , while at the same time , when you need to conduct business , you go and conduct business , and so I was able to do this , matt ?

I personally think for two reasons education , but there's also mentorship .

There were people who took me under their wing and showed me this , showed me how this is done , exposed me , for example , to a senior leadership team conversation where you just went all over the place and so you just absorb all this information and you don't realize at the time you are absorbing it .

But if you're intent , if you're present , you absorb it and when you move to the next position you remember all this . It all of a sudden comes out , and so there's that . But you have to have a , which I firmly believe this has helped me quite a bit . You have to have a mindset of continuous learning .

You have to constantly be open to just different things and be exposed and be a little bit unnerved sometimes about where you , about the path you're on . Yeah .

Matt Pillar

Yeah , very good . All right , you gave me a good segue . You mentioned immunity bio , so I want to kind of transition to that conversation . You joined immunity as chief tech officer last summer . That was in advance of Antiva's approval . So , multi-part question We'll start . We'll take them one at a time . One how did you come across the opportunity ?

What landed you at Antiva ?

Enrique Diloné, Ph.D.

So I was consulting for Immunity .

Matt Pillar

Bio . Oh , I said Antiva , didn't I ? I said what was consulting for Immunity Bio ? And oh , I said Anctiva , didn't I . I said what landed you at Anctiva ? What landed you at Immunity Bio ? You were consulting for them .

Enrique Diloné, Ph.D.

I was consulting for them . I was consulting . I understand CMC regulatory affairs in depth , and so that was what I was doing for them helping them with strategy , guiding them and that's how I got connected with the company .

Matt Pillar

So your initial consulting gig with them and , and the lead up to its approval , what was strategic about bringing you on in that consulting capacity ? And then what was strategic about bringing you on as chief technology officer at that particular point in time ?

Enrique Diloné, Ph.D.

the CMC aspects of the of the BLA just just needed that connection with a regulatory affairs expert . They they that that connection was needed , somebody to bring in not just a technical perspective about there's all because there were . I mean , bla is a complex projects and there was just a lot of know how around the BLA .

But I think there was there needed , someone sort of needed to just kind of distill what we were trying to do and sort of guide it , I mean in CMC and provide that distillation of what needed to happen to the senior leadership of Immunity Bio . And that was key . That was because I mean the senior leadership of Immunity Bio and that was key .

That was because I mean the senior leadership of Immunity Bio understood what needed to happen . They understood it was just a question of can somebody just sort of coalesce this strategy ? And I mean it was just a lot . The review was intense , I understood it and so what I did there with that was able to two pieces right .

I was able to first just gain the trust of the team because I wasn't going to come in and sort of you know this holier than thou mindset . I don't work like that , so I needed to just get to . Let me get the lay of the land and understand who knows what work across the team and begin to put people at ease with what Enrique is trying to accomplish .

And so I did that with the team , I did that with my manager and begin to put people at ease with what Enrique is trying to accomplish . And so I did that with the team , I did that with my manager and ultimately I did it with the senior leadership of Immunity Bio , which was key .

The folks , like the CEO , the chairman , the COO they eventually got to a point where , like this guy knows what he's doing , got to a point where , like this guy knows what he's doing , not just technically and regulatory , but he also has this , this calming influence of being able to sort of bridge , uh , the various disciplines and and um work with the senior

leadership to to get things done . Yeah , that that was and that's . Again it goes back , matt , I was taught all that I was .

Somebody took me under their wing and showed me how to work with folks in positions of power and even when you know more about this specific topic than they do , there's a certain way that these things need to be conveyed for people who feel at ease with you and then , ultimately , they make a decision whether to follow your advice or not as a consultant .

And that was another thing , that whole year that I consulted , expanded muscles and grew muscles that I didn't know I had . When you're a consultant , again , it's a different gig . You're not making decisions , but you want folks to have a very clear path and options for the decisions that you're asking them to make .

So that was the first piece , and then , ultimately , an opportunity opened up and I understood again after a year of work , fairly in-depth , on what needed to be done , and then I had the relationships to be able to work with those folks . It wasn't something that I was going to do alone and I knew it .

Matt Pillar

When you entertain the opportunity to become a full-time employee . Was there a part of you that was like I'm kind of enjoying this consultancy thing ? Like you know , I'm able to , like you said , flex and grow these muscles Ultimately , the decision-making power does not fall within me , but I like the guidance I can offer .

Was there a party that was kind of like ah , you know , I don't know ?

Enrique Diloné, Ph.D.

No , I actually felt the opposite . I , I , I wanted to be part of a team again . I really did . I felt , um , I really felt like I , because that was what I was used to . I was used to , Matt , when you work this hard on something this complicated , it becomes part of you .

Yeah , you know , you're so invested in success that you , and so that's how I felt . I was elated actually when they came and it was a surprise , but I , I said , hey , you know , I , I , and then I , I , I had laid out what I thought needed to happen and and very quickly , uh , kind of simulated into the company .

Matt Pillar

Yeah , yeah , that's , that's , that's awesome . Um , tell , tell me about the . You know , when you're invested in a project and you're invested in a team and you're invested in a company , and uh and , and you're making good progress and you're seeing light at the end of the tunnel , and then you receive a complete response letter . What's the ?

What's the prevailing , uh , emotion ? What's the prevailing into intellectual reaction ?

Enrique Diloné, Ph.D.

like , give me , give me some color on that experience I'm on your , I mean I the first word that comes to my mind is a is loss , yeah , but but not like you lose more , like just the sense of loss that you , you know , you , you sort of get to that point and you're sort of taken back a little bit at at at the outcome .

Um , so I had been , I had been in multiple marketing applications and I had worked on some that had not proceeded to approval , but it was primarily because something happened on the efficacy side . This was primarily a CMC thing , and so for me again , it went from loss to very quickly .

That same night , man , I tell you , that same night , immediately , my wheels began turning very quickly and just reading the whole thing and assimilating and making plans in my head , immediately , just immediately , I , you know you get a sense of loss , but then very quickly , as a pro , you sort of just put your hat back on and , okay , I see what we need to

do here and I see how we would craft that response and I understand , and so that was immediately the , but it took about .

Matt Pillar

I don't know 10 minutes to get there .

Enrique Diloné, Ph.D.

I can't wait minutes to it was just because you're shocked . You're in shock , sure , you're in shock . And and then all of a sudden , you know you get the document and you begin okay , okay , I understand , I understand what we need to do . And then , very quickly , you , and so immediately , of course , you huddle again .

Right , it's almost like you need another shot on goal . So you huddle very quickly and I had again Matt . I had the benefit of just having been through this before and assessing regulatory submissions and understanding CRLs and just being able to okay , is this surmountable or not ? What are the things we need to do here or there ?

And so all that played a role in my head and so , very quickly , we began to get back on the horse and get this done .

Matt Pillar

Yeah , I love 10 minutes . I was going to say I can't wait until my kids are mature enough to condense their time of sorrow after a loss or a poor test result to 10 minutes . Like I always tell them , as their dad , I always tell them you get a day , you get a day to be down Tomorrow , you collect yourself and you move on . I mean Enrique Dilon .

He does it in 10 minutes .

Enrique Diloné, Ph.D.

Matt , I mean , remember that I just couldn't afford to . I just couldn't afford to . I don't know if you've heard of Arnold Schwarzenegger . You know I can't be depressed , I'm too busy . You immediately pivot , you know I can't be depressed , I'm too busy . So you immediately , you immediately pivot . You know , you immediately pivot .

And what we need to know , what do we need to do ? And then so that's , that's the mode I got into .

Matt Pillar

Yeah , yeah , yeah and ultimately succeeded . Uh and uh and I I guess that's where I want to take the conversation next is um into a discussion around your , your role now , in terms of what role you play in the launch .

It's a brand new approval , so the launch and the maintenance of this newly approved biologic , as well as what your role is going to look like moving forward in terms of the , the pipeline that follows . But let's , let's start with with with Antiva , are you still playing an active role in ? Oh yeah ?

Enrique Diloné, Ph.D.

Yeah , is that the bulk of ?

Matt Pillar

your bulk of your responsibility .

Enrique Diloné, Ph.D.

Yeah , I would still say that the bulk of my work is still Antiva . Yeah , so with Antiva , you know , again , I , I , and again , what Activa allowed us to do is that it became and it always happens whenever a company has its first approval that approval becomes an opportunity to mature .

It just is For a company that's worked for a long time in clinical development . Immediately there's just things that begin getting flexed , muscles that begin getting flexed and areas of the company that you interact with that prior to that were sort of coming along but were not mature . And on the tip of the spear function commercial operations , accounting .

I mean , you have to do all this , you're a public company and everything else .

But now there's all these things that you have , all these processes you need to get into because of an approval right , and so managing the commercial business becomes an imperative immediately and typically in companies that have their first approval , there's various degrees of experience in the staff .

You know you're not in a Merck or a large company that has a strong set commercial arm . That you know . No , so that's a lot of what we had to do . Yeah , and I , I , I , I , you know , in in manufacturing operations but also working with my colleagues in other . You know the business units .

And then , of course , matt , very quickly fast enabling distribution and launch .

The approval is not where technical operations finishes right and we very quickly have to pivot to getting product ready for distribution and subsequently getting in the mindset of all the department heads that commercial operations basically begins to just take over your life , begins to take over your work life .

You still need to manage all the clinical development , but commercial operations , if there's anything with commercial ops , it takes precedence . Yeah , and that was , in my opinion , the biggest shift .

Matt Pillar

What are some of the ? I mean we could teach a college dissertation , I'm sure , on the tasks and responsibilities , or bringing in thought leadership in new areas , bulking up in terms of staff . What were some of the keys that are enabling the successful translation from approval to commercial success ?

Enrique Diloné, Ph.D.

Because that's a stumbling block for a lot of people . I get it . Success , because that's a stumbling block for a lot of people , I get it . The number one is the right expertise in supply chain . From an operations perspective , it is a function that is basically during the clinical years .

You're basically labeling , producing and labeling clinical supplies and distributing them . So that's what you're doing , and then you have to manage Immunity . Bio is vertically integrated , so we have all these facilities that we have to manage and all that . But then , once you get to commercial operations , the supply chain team is key .

There's just a lot that you have to understand insofar as distribution . You have to work on order to cash , order fulfillment , things like titles , 3pls , all these things that you could work a lifetime in clinical development and you never get exposed to them .

You're never exposed to that kind of thing , and so all those things related and then , of course , then what happens is supply chain sort of leads some of this right , but you need quality control , you need quality assurance , you need external manufacturing , all these other functions that need to understand the trivial things Matt , change , controls , deviations , whatever

it is . All these quality processes all of a sudden become limiting . Reagents move in a compliant GMP way , but you have to move the product in order to get that order fulfillment and all these other things that when you're over here , you're primarily concerned with avoiding drug holidays in any of your clinical trials . That's the key .

You want consistent supply of your clinical material Over here . It's more increasingly becomes a lifeblood of the company , and so that vision you need to make it very clear to folks so that they crystallize , because many folks have never worked in a commercial environment .

Matt Pillar

Did you have to bring on additional staff in terms of supply chain and quality , or were you able to work with the staff that you had that had been managing so ?

Enrique Diloné, Ph.D.

that's a work in progress . Yeah , that's a work in progress . You know it's , it's , it's again it's . It's inevitable that , um , yeah , some areas we have had to . We need this person focused on commercial or or , you know and and and of course you know , when you are at this stage of the company you get immediate buy-in .

I need somebody completely focused on Antiva in this business function . I can't have this person be worried about clinical supplies or anything like that , and of course it immediately happens that and of course it immediately happens . So , which is again it just , you know , I people understand the urgency .

Yeah , and unless you've worked in commercial operations , it's difficult , matt , development folks don't have the typically don't have the same level of urgency . In my experience , yeah . You know , because it's just , the timeframes are just longer .

Matt Pillar

The timeframes are longer , the work is I mean not that the work is , you know , urgency there's like an urgency continuum right , Exactly right , the urgency , the long know urgency , yeah , there's a , there's a . There's like an urgency continuum , right , like the exactly right . The urgency , the long-term urgency is there .

The patient , you know , the urgency to create patient benefit is , is certainly there , but , um , there's not necessarily a dollar figure or a , a survival aspect that's imminent .

Enrique Diloné, Ph.D.

But like in this , in this commercial capacity , Yep and quarterly earnings , yeah , wall Street , immediately , all these things . So it's okay . So that's the , and I understood that , I understood that that was coming , and so that was another key transition for us .

Matt Pillar

And so far so good . So far so good . Yeah , it's early , yeah , it'll be great to watch . I mean it's early . But in this short timeframe since approval and you know I mean a lot of this work the preparation happens , I'm sure , before you know . When the writing begins to appear on the wall , you start to mobilize .

But in the short time since the approval , looking back on that short period of time , are there any like specific pieces of advice that you've already , maybe from lessons already learned that you would share with someone in your role for the first time ?

Enrique Diloné, Ph.D.

the key is , the devil is in the detail . For launch , and especially with a company that has never launched a product , there needs to be this again .

The CTO needs to be involved at a fairly detailed level with the various business units in manufacturing and quality and supply chain to make sure that everything is meshing , that everything is moving , and be aware of any specific bottlenecks .

Many times , Matt , it's not anything that anyone is doing , it's just something a process that was created under clinical development and under manufacturing operations for commercial does not make sense anymore .

There's something that and it made complete sense while you were in development , but now it doesn't , and so we ran into that a couple of times , but we were able to work through it because we all work together very intently at a very detailed level .

So my advice for any CTO that is going through this for the first time make sure you are in the details and that you understand the flows of what needs to happen when to get your product launched .

Matt Pillar

Yeah , Beyond Activa . I can't let this conversation go any further without referencing what I said early on about this aggressive pipeline that comes in beyond NACTIV , and you know we don't need to get into great detail around clinical progress in each of those programs .

The overarching question is when you have the responsibilities that come with this commercial rollout and then behind that you have this beautiful , as I said , aggressive , stacked pipeline of potential , what's your obligation to what comes next ? and how you know how do you balance . I mean , how do you , how do you balance your ?

You know 47 hours per day that apparently you're working . How do you appropriate your time and attention appropriately ?

Enrique Diloné, Ph.D.

So , for somebody said to me in the company that I'm drinking from a fire hose right now , which , yeah , it's typical at this stage , having been with a company less than a year . I think I crystallize it in a very simple way , matt .

We are focused as an organization , in manufacturing operations , in making sure that our patients have high quality product at the right time , at the right place in the right quantity , and so that's key , that's the key , and so it's a question of how do I work with my direct reports to make sure that I'm aware of each of those aspects in the portfolio that

we're managing , and also I work with the CEO , the COO , the chairman , to make sure that we all agreed on exactly what are we trying to accomplish for the year to support that pipeline , and is it possible for us to do it with the resources we have ?

But , yes , my responsibility is manufacturing , so we manufacture all the products of the company of Immunity Bio , whether internally or externally , of immunity by , whether internally or externally , and so for that I am constantly , constantly in in updates , meetings , reviewing reports , reviewing regulatory submissions , but it's driven primarily by what I think are what I

know are the priorities for the business unit , and and that reflects what is a priority for the company , and so that , and , matt , I preach this constantly to the group that mantra of this is our focus for this year .

Overall , the number one objective is to continue to provide products for all our patients , but underneath that , there's yearly metrics that we have to meet , and I just stay focused on those metrics and so that's how I manage it , and so you have to do it this way , because in my opinion it has to be systematic . So that's how I do it .

Matt Pillar

Yeah , how often do those those priorities ? I mean you've been in biotech for quite some time now , so you know I'm talking immunity , bio and previous , you know beyond , how often are you reassessing and perhaps adjusting those those priorities ? I mean it's gotta be depending on the , the market .

There's so many , so many factors , right , depending on the market and and the patient population and the competitive landscape , priorities often shift and change . Is it ? Do you have to be on your toes in terms of like ?

these are our priorities for this year and maybe six months down the road we'll be like ah , you know we're going to we're going to shift that priority a little bit .

Enrique Diloné, Ph.D.

Well , but then , yeah , but there's also processes that we've instituted to keep track of this , formal and informal , to make sure we are aligned with where the company is going , and so it's a constant thing . It's a constant thing . It's a constant , constant conversation many times .

And what happens many times , matt , is that there's conversations on my level and maybe one level below and they don't go any further because we're just assessing things Right . Yeah . And you know , you're , you're , you're assessing various things . Okay , are we going to pursue that ?

And there was a little bit of a flurry of activity around a particular indication or a market or something , and it takes place , you get pulled into it , but then two or three weeks later now there was a decision not to move forward with that . So you have to be judicious in what you bring to your staff so that the staff remains focused . Yeah and so .

You , you , you , you . But as a C-level executive , you just have to go with the flow on that . You have to . It's part of the armor that you have to have built in order to succeed in this role .

Yeah and so , um , and I'm doing the same thing for the folks that report to me my and so , and I'm doing the same thing for the folks that report to me my direct reports . It's the same thing . But what I say is the staff . It wouldn't have helped me when I was an associate scientist at Roche to understand all the strategies that we're pursuing .

I just needed to do my testing . I needed to do my testing and remain focused , and so that's sort of the mindset that I've sort of created within manufacturing operations , so that people are focused on what we need to do for the day Now . Do I still talk about the high-level objectives ? Yes , the high-level objectives , yes , the high-level objectives are here .

And then , once in a while , matt , if you need to shift and accommodate the actual plan , that's done systematically .

Well , this trial or that trial didn't give us what we needed , so we're going to pivot to this and then we work it in a very systematic and very open so that folks understand what is happening and it's just oh , I see , I see , okay , so we have to adjust that direction and instead of making this , we're producing that .

Or instead of doing that submission , we're working on this other submission . Yeah , but you know , so that's how we do it .

Matt Pillar

Yeah , all right , we're running a bit short on time here , enrique , so I got just a couple more questions for you and then we'll wrap things up . Sure , if you're looking at sort of your immediate , short-term future in terms of what's next for you in immunity bio , um , what , what does that look like like ?

What's , uh , what's , what's going to keep enrique's plate full for the next , you know , I don't know six , eight , twelve months and beyond ?

Enrique Diloné, Ph.D.

so I mean it's it's still going to be activa . Yeah , it's , it's . It's additional indications in additional territories . We got it approved in the US . We just announced in the shareholders meeting that we're going to IMA . We're going to IMA with Prudentiala .

So that's a huge endeavor , yeah , and then there's additional indications that we are pursuing , and then there's additional indications that we are pursuing . So that continues to take , and will continue to take , quite a bit of my time and quite a bit of the team's time to be able to go through that .

But there's also metrics that we have for the other products , for the other platforms , specific things that we have committed ourselves to . We're in the middle of those right now . They're very intense and so we have to get those done , and so I'm again keeping my pulse on those things . Just constantly discussions on a daily basis .

Man , yeah , to the point where we understand what is happening on the manufacturing floor , you have to you go that far and so , um , you know , it's just what you have to do .

Matt Pillar

I lied , I lied . I have more than two more questions for you because you brought it up . You brought up the move into the , into EMA . You good on time just for a few more minutes ? Sure , sure , all right . What do you have to do to tool up to uh , to go do business in in Europe and and uh and approach the EMA ?

Enrique Diloné, Ph.D.

Uh , do you have consultants on the ground over there ? Have you hired , like EMA , you know , people with EMA regulatory experience ? Is that something that you bring to the table from in Europe in order to be successful ? So that's part of what's happened .

What is happening internally with a lot of with the marketing application is that there's , just now , more people that need to get up to speed with the product , and that's a big thing for me From a CMC perspective .

I need to make sure that the folks that ultimately are going to go and help us get the marketing application approved from a CMC perspective have the background . Matt , it takes months to be ready for something like that , and so that's one of my big priorities right now . I have to get the team ready for that application .

By the time the application is sent , it's too late , and so that's part of what we're doing now . That's a very important preparation that we're doing and , as usual , the Europeans they have their own spin . It always happens .

Matt Pillar

Well , that's why there's an FDA and an EMA and not an FDA and EMA . Yeah , it's okay . All right , it's all good .

Enrique Diloné, Ph.D.

It's all good , it's just a different take , but it's all good , I quite enjoy it . I quite enjoy it .

Matt Pillar

Yeah , very good . Okay , so then , looking a little bit further beyond , I would say not that I'm going to ask you to pick a favorite second child , but are there any programs of the many at Immunity Bio that have you perhaps excited more than others or that you're very much looking forward to working on once ? Anktiva is a self-propelled machine , dr .

Enrique Diloné, Ph.D.

I mean . So Immunity Bio has a great vaccine platform Ad5 vaccine platform for cancer and there's just very fertile ground there . I'll say that , and that's something that I'm personally very excited about . And , of course , also the cell therapy . The cell therapy business is uh , again , it's . It's a very interesting business .

How close you are to the patient and how quickly that needs to be turned around , the , the logistical challenges , the um , it's simple things , matt . How do you release those things quickly so that you can dose the patient quickly All these things are things that have me very excited and we're working on right now .

I mean , it's just and that was one thing I didn't say that at the beginning , but I'm sort of a jack of all trades in CMC . I've done every modality , and so that was another thing that excited me about Immunity Bio . It was just a good fit .

They didn't need somebody who's solely focused in a particular technology , but somebody who was able to move around in the various technologies that they have in their portfolio . So , yeah , and so we're doing that now and again on a daily basis , matt .

Oh , enrique , today we have to do this on this product , that on that product , and this on this other product , and you just go through your day . Sometimes my I mean I'm sure you know this , but my day is booked from beginning to end with meetings on 10 different topics , and so you just need to keep your head and go through each one of them .

That I learned in small pharma that jump of just managing and wearing so many hats and giving advice , sometimes making decisions . Other times you're not the primary player , it's a process scientist who understands better , way better than you , specifically what needs to happen with that chromatography column , and you just have to question and guide him to the answer .

Well , I still love drug development . I love it .

Matt Pillar

I can see it in your eyes . I was thinking , as you were just kind of wrapping that thought up , I was thinking , like this guy thrives on the diversity of the challenges at hand , uh , and I think that takes a special personality .

Um , and training , I mean you , you know you talked about the training , you talked about the , you know your commitment to uh , to , to improving in areas where you needed to improve , uh , but but I think I think , underneath all that , I mean you're , you're a special guy who's doing special work , and I and I and I can appreciate , I can appreciate just

watching you as you speak , the way that you uh , the way that you thrive on it . So , thank you , I , uh , I I mentioned that that I had Dr Reddy on the show , uh , several weeks ago , several episodes ago , uh , I believe it was one 97 .

He , you know , he know , he , he appealed to my emotions as well , just for the very work that you guys are doing , cause , as I said , I've , I've my , my father has been successfully working his way through NMIBC for for a few years now . So I just want to take a minute to thank you guys again for the work that you're doing .

Enrique Diloné, Ph.D.

It's awesome work and I want to thank you guys again for the work that you're doing .

Matt Pillar

It's awesome work and I want to thank you for your thoughtful and contemplative responses and transparency to my questions today . You've been a good sport .

Enrique Diloné, Ph.D.

Thank you , I appreciate it , matt . I really appreciate the opportunity .

Matt Pillar

We'll have you on again . You're one of my favorite companies now because of this emotional soft spot I have . We'll get you back . Thanks a lot . I look forward . I have .

Enrique Diloné, Ph.D.

So we'll get you back . Thanks a lot , I look forward to it .

Matt Pillar

So that's Immunity Bio Chief Technology Officer , dr Enrique , I'm Matt Pillar , and you just listened to the Business of Biotech . We're proudly supporting Bioprocess Online's BioExpo Live , which kicks off very soon , on July 30th , and runs through August 1st .

It's three days of virtual programming on all the latest and greatest upstream , downstream , quality , analytical and data solutions , and you can register for any one or more of those sessions for free at the link in the show notes of this episode Register today . We'll see you there and in the meantime , thanks for listening .

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