Working In Oncology
Working In Oncology

Episode · 8 months ago

Drug Development: How Do We Choose Which Unmet Needs Get Treated? w/ Jeff Bockman

ABOUT THIS EPISODE

Unmet need is a huge driver in the development of oncology treatments. But when it comes to choosing the therapies that “make the cut,” it’s not that simple.

What are the risks involved? Where has efficacy been demonstrated in the treatment area and type? And the timeless question: who’s paying for it?

Jeff Bockman, Ph.D. EVP & Oncology Practice Head at Cello Health BioConsulting, joins us to share his experience and break down the criteria and considerations of how therapies are chosen and developed.

Here are the show highlights:

- Who are the players and decision-makers developing therapies? (3:18)

- How developers decide which therapies to pursue (15:34)

- How the element of risk complicates the goal of pursuing unmet needs (28:20)

- Pipeline activity, precision oncology, and more trends in biotech (34:24)

- Why we’ll see more “engineering of biology” in the next 5-10 years (39:28)

Check out these resources mentioned during the podcast:

Dr. Bockman’s LinkedIn

Dr. Bockman’s Email

Cello Health’s Website



To hear more interviews like this one, subscribe to the Working In Oncology Podcast on Apple Podcasts, Spotify, or your preferred podcast platform.

You're listening to working in oncology, a podcast and video show that spotlights oncology practice staff and industry influencers who work behind the scenes to shape the future of oncology. The more knowledge the oncology community shares with each other, the more we all grow. Let's get into the show. Welcome to working in oncology. I'm your cohost, Alicia Evans. I'm joined today by Jeff Bachman, evp and oncology practice head at cellow health bio consulting. HBC is a leading strategic consultancy helping Biopharma inflect value with their early pre POC programs. Jeff, welcome to the show. Thank you, Lisa. Very, very honored to be here. Thanks. I am excited about our conversation today. I think a lot of our listeners are curious about what goes on behind the scenes of oncology drug development. So why is there funding for this treatment of one diagnosis versus another? Who makes these decisions and why? Right, I think you'll be able to shed some light on the subject. I hope so, Sam. So, before we jump into the show, can you tell our viewers a little bit more about you, your background and what you do. Sure. So I got to where I am through all hard work and and serendipity. So you know, I started in academia, did the PhD route, then the post doc route and then after that went to start up biotech, working in cancer and infectious diseases. My background was originally in infectious diseases and with that start of biotack for a couple of years it was one of the first scientists that to join it and the course of that got exposed to some of the financial and investment side of being an early stage biotech, gazing with some of the investors, etc. And then I left the biotech and stalled, started kind of consulting on my own and ultimately consulted to the legacy company of where I'm at now, which is defined health, which you know, was acquired. It became fellow health bio consulting. So but that that kind of shift was a lot happened. Stamps Right. It's not like I sat down and said, Oh, I want to be a consultant. Didn't even know what it was. So so it was really just a, you know, opportunism on my part connecting with, you know, the right company, a great group of people, particularly that the founder of the fine health who was now the executive chairman and really enjoying the kind of mingling scientific, clinical and kind of commercial elements that we do every day. I know, all the multitasking, right. It's never a dull moment. So many different agents and companies with different questions and concerns that we're working with across all different tumor types of cancer, as well as the work we do outside of cancer. So it's something that's a pretty broad range of experience there. Yeah, well, there even other diversions and digressions along the way, but you know, maybe we'll get to those later. So in the world of their P development, there are several different players in the process. Some names are were familiar with or some that weird but we're not. Can you help go over like who are the usual players? Who is making these decisions? WHO's developing these therapies? That's a that's the big question. So first of all I'd say is that, you know, the the industry, the Biopharma Industry, is made up of a variety of key stakeholders. Right there are the farm of companies, obviously, who most people know about, right the murks and the piasters and the prison Myers, etc. Roation in tech. And then there is a whole group of what we'll call the innovators. Not to say that Farma are an innovative, but much of the novel and New Drugs that they...

...are ultimately bringing to market are deriving from these biotexs. And that's the biotexs who are most of our clients, at least in ecology. And those biotexs obviously are funded by venture capital by and large, although these days, you know, increasingly also public money, because they can readily go to the mark it and raise quite significant funds during this past year and a half. And then, of course, you know, part of that ecosystem to are, you know, the regulatory agencies and the different COMP and of different countries at etc. But but if we think of it just more simply in terms of the funders, the DC's, the developers and ultimately the marketers farm up and then the innovators being the biotech that's kind of the kind of the tripartype core of kind of where the soul be gives and hopefully, and I think it's relatively true, you know much of what is being funded at early stage in these innovative companies is trying to address, you know, high unmet need areas. That's not to say that every one of them, you know, if they were to be approved, is going to change the treatment paradigm. Sometimes the important improvements can be smaller and incremental, but you know, mostly they are trying to look for, you know, where there are significant unmet needs, where you know, either in large tumor types that everyone knows about, where they're still unmet needs, like her too positive breast cancer, or much smaller, niche type of tumor types where, you know, maybe less attention has been paid, in part maybe because they're very challenging spaces to work in, like Glioblastoma or even some of the rare, rare star Comas, etc. So when we look at a typical therapy, can you help us track kind of the development process? So maybe you have popular medication or therapy like AK truer something. Can you help us check how these how it got to open out, it came to market? Oh, yes, well, yeah, at a high level. Yes, I think one of the more interesting things about Katruda is the fact that in many ways that was serendipitous and the sense that that was a program going on. I think within the organ on that was acquired by sharing plow. Didn't have much attention to sharing plow. But that I'm aware of and I don't want to miss speak, but as far as I'm you know, I don't think it was a high profile program at the time. Then in that's a startup, is that? Well, no, sharing plow was another large farm of company. And Okay, how it was acquired by MERC right, because there's a lot of MNA amongst large Farma. Right mark required sharing plow, fiser required part Davis Order Lambert. So you know a lot of that interlarge Farma MNA is very common. So you know MRK ends up with this sharing plow organ on program, you know, bumping around internally that you know, I'm sure had some strong campions. But you know, I would at that time when has to remember that the idea EMANO therapy of cancer, or it's also called now kind of emio oncology. You as I called for short io therapies for munal oncology. They were not the hot topic they are now. In in fact, back in the mid two thousands and certainly before that, they were pretty much for boating in anyways, because there's any because there had been so many failures. You know, the field of the people who were researching at that point were, you know, called tumor biologists to Mory, knowledgists that were kind of doing this, and the kind of the main programs that had been brought forward back then were mostly cancer vaccines, which were kind of developed with the framework similar to that idea developing, you know, infectious disease vaccines, which are, you really used to prevent infection. Very different this idea of trying to treat and...

...active cancer for all sorts of reasons that, you know, maybe we can go into leader of anyone wants to discuss offline, we can. But and so there were a lot of failures in this cancer vaccine space because I was mostly what was defining kind of immunotherapy then. Now there were a few approvals and success is one of them. Even was fearing plow, you know, in terms of interfere on Il to that was developed in you know, ultimately kind of really brought forth by Chiron, which that was quiet by artists, and you know, these had some glimmers of vary inting activity, particularly and like melanoma or renal sub personalma kidney cancer. But they were highly toxic, not very well tolerated. Only a small percentage of patients responded and any and smaller percentage responded really well. So you had a field for a long time that, you know, was defined by those few agents, interfere and Il to BCT for bladder cancer, and then just all these failures, mostly in cancer vaccine. So it wasn't until really like two thousand and twenty eleven when suddenly the world changed. Right, you had BMS has up Devo e volamp approved, you had Merks K Truda from Berlism at approved. You also had dendreon's cancer vaccine, provens approved. That of a niche player, but it's still, you know, generating revenue. You had your Voy, also from from BMS hit, the Luma Map approved. So now of a sudden you had these what are mostly annabodies to what are, you know, pe pdl one, that check one inhibitors. These are key proteins expressed, you know, on the t cell end or tumor, that are basically responsible for silencing the immune system. Right. So essentially what the cancer does is it creates a permissive environment for itself greets this emo suppressive environment that blocks the bodies kind of normal ability and desire to reject things that are wrong, whether that's, you know, a tumor are in beating bacteria or virus, and these Anna bodies basically unblocked that blockage and allow the immune system to see the tumor. And they, although they don't work in all cancers and they don't work in all patients. And I'll can sirs, and you know, some tumors they you know, work much better, like melanoma and RCC and lung cancer, than others where they, you know, really have minimal activity, like prostate cancer. They have created a massive seat change or a paradigm ship and how we think about treating cancer. So, you know, what work ms and all the others have done is what kind of Pharma generally does, as they invest a huge amount after first approvals in life cycle management. So merk has done an amazing job. They have, you know, I don't know, a thousand plus, probably more, ongoing clinical trials with Ktruda alone, mostly in combination, combination with Chemo and combination radiotherapy, combination with small molecule kindness inhibitors ending combination with other novel IO agents, including other IO and a body. So a lot of the news coming out of Asko, for example, over the weekend and through their part of this week will about other new targets besides pd one and PDL one, like lag three or tiget etc. These are kind of the next generation, you me know oncology targets. So that's a you know, sounds like a long story, but that's only a, you know, a little TV peek into that kind of the you know what it took to ultimately kind of bring that program forward? It took sciences who are true believers in kind of the value of the immune system in fighting cancer. It took the discovery of these particular targets. It was certainly, you know, lucky that some of these first targets proved to be as effective as they were, because, you know, some of the other ones haven't been. So, you know, Jim Alison got a little prose that there.

That yeah, certainly has been some. But so Jim Ellison got the Nobel prize for this, but many others contributed to kind of exploring that that. They're called checkpoint inhibitors. This checkpoint pathways and now they're kind of the foundational cornerstone of treatment, you know, either in a particular line or in multiple lines across many, many different cancers with, as I said, a huge amount of continued development in other tumor types, other lines of therapy, other combinations going on. Right now. There are at least six, I think, approved checkpoints. Now. Murk is the biggest one, followed by, you know, BMS has and then, you know, you've got fiser and Astra Zeneca, Rosanntec for Jenner on you others also, bet are that are out there, but it's it's competitive. But you know, the the behemoth in the room is Murks Cotruda, and yeah, that's when that we're most of us are familiar with and it sounds like there are continuing innovations in justice, just in Ktruda. It just think of true, but if I mean, I know, believe it. So there is a we're going to zation called Cancer Research Institu CRI, which was actually founded by, believe it was, of the daughter coldly Dr Coolie here at what ultimately became a Morislan kettering was considered to be really the what it would call a grandfather free, Grand Father Papa. Of do mean to therapy, because he was treating patients with what was called Klie's toxin. So that you know, but it was never and it was actually used after the sixty was never formally improved. But in any events CRI, you know, has fun to the lot of the key research as a not for profit foundation in Immuno Oncology, and they also do a lot of tracking and I think from their recent numbers of iron called correcting, there are probably threezero trials going on with, you know, all the different checkpoint inhibitors that there are. So the Truda, up devote, you know, Liveteo, Evencio, who am I missing anyway? So I mean all of the players, but by far the largest amount of clinical trial activity is with Murphs Co Truda. Understandable. So when we have so many different avenues, how do we decide our how does do the usual players, he's, decide which therapy to pursue? How do they make it? Is it just the question of all the money? Of course, said I mean without the money, I think could happen. But what other factors do they consider? So so many factors kind of going in to try to figure out what to bring forward and and the kind of the questions and the degree that these are explored and how deep and drawn certainly varies between whether that question is being asked internally within a large farm of company or whether it's see being asked by a biotech company. Let's start with the biotech company, since that's where a lot of the innovation, again, not all of it, but a lot of the innovation begins. Right. That's where a lot of the innovation in up to self therapy has been which is a burgeoning area, and there are, you know, a number of approvals already where team therapy began, by and large, and there are number of approvals there, you know, for you know, rare monogenetic disorder. So so the BIOTEX are kind of seen as the warehouse of innovation, if you will, and increasingly a large component of the pipeline, as it's called, the drug development pipeline, of large Farma is deriving from you know, external to the farm itself, so not from Pharma's own internal research. You know, I think it's obviously varies by company, but I'd in some companies it's fifty percent, maybe even seventy five percent of their pipeline is coming from external, you know, deals, either licensing and a program from a biotech or outright acquiring that the biotech right, like am Jen recently acquired, you know, company called five prime to get...

...some of their anibodies. Another programs. So when a biotech is trying to think about kind of what did the develop, part of that question depends on kind of what what they're res on Detra you know, what do they have? or I mean if they're a discovery company, a platform company, right, maybe they've got some novel interesting way to generate antibodies, which there are many. You've got a fire, right, well, all right, you can generate these anibodies. They may do some cool things that others can't. But how do you decide what's target? Right? There lots of targets. So that's one of the first gating things, right, because while the DCS like to find innovation, you don't want to be all about, you know, risk after risk after risk, pile on top of each other. So very often you will see biotext, in order to prove their platform but also to take some risk out of it, going after well established targets, many of which may already be approved right like her to amount of drug development around her to despite the fact you've got her Septin, you've got for Gina, you've got Ketsilah, you've got an here to WHO, you've got a number of, you know, multiple and they're mostly biologics, but they're also small molecules approved in the space, and yet they're still unmet need, particularly for advanced stage breast cancer patients. So you know, if you map where much of the activity is across follow the Biofarma industry against targets. I think her too is at the lead and then e gf are, which they are also approved drugs, and so you know, you do see a lot of attempts to de risk by going after these and well, it's kind of easy to say, Oh, we've got too many, we don't need anymore. That's just a meto type agents not going to be differentiated. In some cases, you know these can be differentiated and provide significant clinical value to patients. So that's kind of one of the first things that happens, particularly with really risky platform so an anabody is one platform. It's pretty well established. Most of those companies. Yes, they may go after her too, but they're also going after other novel targets, some of which have been more recently valided because there's been recent approvals, like Trope, to which there have been a recent ADC approval and a bye drug content approval. For the more risky the platform, the more likely there to go after these well validated targets. Like there are a lot of adoptive self therapy companies and mostly their lead programs are going after CD nineteen, which is approved for other self therapies, you know, and you know he's large to be selling foma in a cute pasidic leukemia. It's better because the everyone in the investors are very kind of scared of we're going to take a brand new novel unvalidated target, take a brand new unvalidated approach and put the two together and just double, you know, magnify our risk. So that's the first consideration as the target. And then, of course, is where do you develop it right? which indications do you develop in? And that thinking, you know, generally has to start even before you start getting early signals in early clinical trials, which, of course is going to more definitively tell you where to go, because you need to at least be thinking about where you might end up in advance of doing it. Can't just kind of wait around and just be react and then you're just scrambling right. So, and that's where we spend a lot of time with our clients. These are early stage, as you said, you know, helping them inflect value with preopes, pre POC assets. So helping him say, you know, I've got a novel platform. Should you go after CD nineteen or BCMA or her to or EGM, or should go after something more unvalidated and then, once having decided on the target or the May already have the target, which indications are best? If you're going after her too, sure you can go after you know, a number of different late line therapies and breast cancer, but her to is expressed in other doeur types like gas drink and even small percentages and other tumor types. So maybe the better thing to do is go for a niche approval in a percentage. But you know, a Mo likely defined some set of other tumor types that express, you know...

...where a subset of patients express or too. So those are all the questions that are kind of going on internally as well as you know, how much money do we have? What's our burn rate in order to prosecute that clinical trial development? What do we want to be when we grow up? Do we want to bring that drug all the way through to mid stage, face to development, or do we want to license it out or we to hope to get acquired, you know, early on? So you know. So there's there's true science and biology the target being asked about, there's clinical development questions being asked and there's kind of strategic like, you know, what's the trajectory for the company, all wrapped into the financial considerations of how much money do we have, how much could be raised, etc. So it sounds like it's a balance that has to be of all those different factors. Absolutely, it's a very delicate balance with a good healthy dose of luck. Ob You know, having, you know, experiences important, and that's one thing biotex have nowadays increasingly, that they didn't have, you know, as much of even, frankly, you know, ten or fifty years ago. was, you know, a much more mature season group of people leading the company. Right these are people you're out of farmap or who have been in one or multiple other biotex so they kind of know what's involved because, you know, it's one thing to choose these things, to choose the target, to choose the indication, to validate your platform, to start clinical development, but there are a lot of complexities around CEMC manufacturing for some of these agents. There's regulatory complexities, not just for us but differences between EU or, you know, Asia, etc. So a lot of different skill sets, you know, are required ultimately kind of bring these programs forward far enough and then ultimately, you know, to market. And so we did talk. We talked about biotech. What about some of the other players? How today are there? Is their process? There that process, similar problems, the similar it's obviously different. If you're a large farm up you're to say you're not concerned about money because you don't have infinite Castet, a bit more padded, a lot of money on hands. They invest a lot amount into R andd as a percentage of their their revenue. So they ask many of these questions, they ask them more deeply, they spend more time analyzing them. They even go outside, right. I mean, as big as these companies are, they often go outside for help doing things, everything from patient research to just kind of more kind of classic kind of market research, to you know, the big strategic questions that they need help on and so on. So that's why it's just just massive ecosystem of all these different players that are involved. Something we haven't really talked about is academia and how those efforts play into the pipeline. Why do you mention that? Yes, because this is an interesting and maybe even a little the sticking point, because many of the so I said that the innovation engine by large is biotech. They're generally not inventing it out of nowhere. Right. Generally biotech is coming out of academia. Where's that research for the those platforms or those novel targets? That's that are coming from all of us, the taxpayers, and I h funding, which is why it's so important to fund an AH. But also, at the same time people question, well, but you know, and I ain't just funding all this, what are we getting? What are we getting back? Now you know, when you ask that question, the ends, how you what time frame and how you answer. Right, ultimately we are getting back because we're getting these important drugs, but there are a lot of intermediaries along the way. So without getting into policy or other things like that. I mean our tax dollars in the coinsurance. Yeah, but at the end of the day, you know, it is within academia that the real engine of innovation. Now that gets taken within the biotech and it gets kicked up significantly and it gets formalized in order to, you know, enable it to be productive, to be credible to ultimately get approval right because, you know,...

...most academic labs, even though increasingly they are kind of starting to develop some drugs and bring them to you know, at least through preclinical they're not necessarily set up, you know, and don't have the expertise, you know, once you're kind of into early clinicals, although some, some are doing that certainly, you know, and that's where the biotech and then the form of companies come into play. But many of these BIOTEX are founded, you know, by either the entrepreneur scientists themselves or they're founded by, you know, a DC or early state BC, which there are a number that just go out and scout and say, Oh, you know, our team has found this really interesting cool mechanism or target or new platform at this university, and that could be you know, anywhere in the world, frankly, and you know, decides to build a company a round it. That's kind of generally how it goes. So if I understand correctly, so like the foundational foundations are usually set, or often set by academia. The foundation and researches often coming out of academia and not always, but often off it, and then generally goes to biotech and then to Farma and then to farm im though certainly, you know, there are biotexts that are already established that you know, will license programs or Ip or technologies from from academia. Right. So they've already started with something and they need to. They're either acquiring additional pieces or maybe something orthogonal. And Farma also does increasingly look early stage and and they're even groups within large Farma for doing kind of early stage investments. And most Farma have their own corporate DC group that are also making investments, you know, either investing in the lab and some type of early collaboration or investing or helping form a new code coinvesting along with more traditional, you know, BC's. That's atter us. So what I'm talking about is just that, you know, is it just a lace work. And yes, and there are many, many layers and many more new ones, as and complexities that to this. So often in practice, you know, the idea comes why is there a treatment for one diagnosis versus another? And I know we talked about reasons why, you know therapy, but can you kind of expand on that? It's a really complicated question. Part of its tide to what I already said about risk, right. So some of those, if you're choosing to take out some risk by going after a validated target, mostly that's going to take you to more validated indications which also, by definition, are also going to be more competitive, like breast cancer. The other thing. So the other side of taking risk out is not going into places where there is huge risk. So there are tumor types, and I'm not even talking about small niche tumor types right, because there are tumor types where only a hundred people have them or a thousand. Right. There's not not even orphan, it's Suborphan or sub suborphan diseases, and clearly these need to be addressed. They also need to be abreast when they're just, you know, not cancers, but just other very rare diseases, or I will put that aside for the moment. Even in kind of bigger, more wellknown tumor types, there has been a hesitancy to pursue because of the perceived risk that often cases is a real risk in these tumor types. So let's just take two. For example, Glioblastoma, very high on men need right, absolutely very poor outcomes, you know, andcreatic cancer another, very high on that. Need even bigger epidemiology than Glioblastoma, also very high on that. He again, you know, cases these are generally diagnosed late. Certain macreatic cancer mostly diagnosed late, good presentage or not per sectible. What do you do? Well, one could say, well, there should be more clinical development there, and there should be, but there's are somethings, little thing for the patient, that's...

...yes, and but there is a sizeable amount of clinical development there, you know. But part of the reason why maybe the amount is not as proportional to the unmet need. And I've done some mapping before and others have to. We're just kind of plot how many drugs are in development against either the epidemiology or against the actual unmet need. And I may need is best express either is one or by your survival. You know it parallels pretty well. But there are some, you know, kind of major places where there are gaps. But something like pancreatic or or Gbm, there have been a lot, a lot from drug film, all sorts of different mechanisms, all sorts of things that people have done and failure after failure. Now you know, I don't know that now we should go into the reasons for those there they're differing. First of all, GBM is very heterogeneous. It's not like one thing. So you know, given target, while it may work for a certain percentage of patients, you know may not work for all and since we may not know how to identify those patients up front, it means when you do a clinical trial your signals going to be drowned out and so the drug may fail. And for pancreatic cancer, you know also the biology is complex because bankrandic cancer basically builds this dance by Brot extroma around it makes it very hard for for drugs of any sort to get to the cancer. So for those in other reasons, you know they're both highly you know they have high kind of chemo resistance and other things makes it really hard. So we've seen annabodies fail, small molecule kind of snippetters failed, ex curation, chemo agents fail self, therapies vaccine meantime and again it in both these indications things have failed and when things fail that much makes it hard to convince someone to fund doing research in those areas. Now again, it's not like there's no research. There is a lot of clinical development in these areas, but perhaps not as much as there should be given their unmet needs, because of that overhang of the failure rate in those tumor types. So that is where foundations can be helpful, right. So there are many foundations that have been started, often by either survivors or family members. They may have well to do, you know, to begin with and can start the endowment. But you know, there's some great foundations out there in solid tumors, some of which are obviously well known, like can breast cancer, Susan Comen, etcetera, and you know, others in in Chemolignancies, like the my Aloma Research Foundation or Leukemia Boma Foundation etc. These are very helpful because part of their mandate. So I can speak more fluently to Luchemil and bomas designing AURASTA, work with them for over a decade. Part of their mandate is to find and where Biofarmat does not so go for the riskier things. So they're they're filling the gap. They're filling the gap. Yep. So that's what the foundations can do, is fill the gap, either by the tumor types that aren't getting as much attention as they should or the therapeutic approaches that you know, maybe they're you know, they're more swing for the fences. They're very high risk. That's not where VC's they want to fund or Farma wants to go. But if they were to work, you know, they could be, you know, groundbreaking. Thank you for that. s question that comes up and it goes to your mind off and like I wish, I wouldn't want to help this person. But what tools are there? What tools are available? So you work with so many iotext as a consult it. What trends are you seeing in yes, so one of the May not be the best metric, but it's a very tangible metric that one can use as you can look at pipeline activity, right. So where is the clinical mevelopment pipeline and you can also look at deals and you can look at funding. You know these things the money going. You see funding or series a funding, like where the money? Where's the money going? Either funding money or deal making money. That includes licensing and acquisition. So you know, over the past seven...

...plus years they're really kind of two big categories where investment has gone. Investment, start up, steal making, etcetera. It's precision oncology, right. These are targeted agents going to specific molecular changes, right, egfr mutations, ALC mutations, F gfr mutations, ECR able mutations. So while these are solidumor, because that's a very defined molecular target, you can define the patient population. You have a much higher rate of response because you're really defining who should get a given drug, and you actually have a much better kind of development tasks, right, because that we were as I gave in the kind of the counter example, negative example for Gbm or pancreatic you know you may not necessarily know who's going to be responsive and so your signal of those who are responsive maybe washed out in the trial, will redoubt negative. So that type of precision medicine, and we just literally had approval a few days ago, for from engine for their rass targeting agent. Rass had been like the big struggle for the biofarm industry for for decades, right. They couldn't drug it, and finally, you know, people found that there were some particular mutations within wrath that could be drugs. So now we have the first grasp drug from angin that going to prove just, you know, days or maybe a week ago. So precision oncology and then immano oncology. I mean then you oncology for period of time, say from like twenty fourteen fifteen through about two thousand and eighteen, with like probably two thirds of the highest value deals that were being done, meaning either the money up front that a farm I was going to pay to a biotech or the overall value of the deal, so including downstream payments, bilestones and etc. It's kind of equalized a bit over the past few years with kind of more of the precision medicine, you know, taking to its more balanced or like kind of fifty for these high profile deals. And it probably is true overall, and but even in the most recent analysis we've done for like, you know, this past the year to date or two thousand and twenty two year to day, looks like again kind of a lot more of a push towards the even own collency agents. Again. I mean people are very enamored of that, and with good cause, because, you know, tumors are very complex. There plastic, their heterogeneous, they change under treatment. Right there a little Darwinian experiments going on. So the minute you treat them that a tumors going to respond and counteract what you're treating it with. So it's very hard if you have, you know, one agent or even a tool kid of ten agents, to say, you know, I'm going to go against this, this foe that constantly keeps changing when I do something. The immune system is built for. That immune system is plastic, adaptive, heterogeneous, can change in real time just like the tumor. So in many ways it is the best matched to deal with a cancer and I think in part that's why, well, that's the kind of the biologic and clinical rationale for why people are and should be so interested in kind of harnessing immune system. I think the very practical reason is, you know, the trude is going to be the largest selling pharmaceutical product in a few years of any not just oncology period. So you know this is a very big category and you said it before. Chasing the money where the money is, people will go and they'll keep going and they'll go again and again. Sounds I can checks off all the boxes. Yes, the checkpoints in particular check off the boxes. So that's exty of best experience. So you might be the best person to answer this question. What are your predictions for the future of oncology, pharmaceutical therapy development and it? We've gone...

...over a couple things. So what do you think is in next frontier? So the next frontier, there are lots of famous quotes about predictions, hopefully wrong but but nevertheless. I think what they're the prediction that I'm going to make is less about what will definitively become the drugs of the future, but more about the types of approaches that I think are going to be heavily invested on and focused in over the coming by the ten plus years, and I think it's the idea of more engineering of biology to make the the therapies we use more multifunctional and perhaps more regulatable or controllable in the body. So whether it's a antibody that can be controlled externally. What does that mean? Well, that means that if you've got side effects with a certain anibody and you build in something that allows it to be active in one configuration, but when you give a drug it's no longer active. Right, you could give a small money or or the other way around. You turn it on and off in the same things being done with self therapies. So this idea of conditionally active and controllable, as well as targeting multiple things right, because we just talked about how plastic and diverse and Heter geneous the tumors are. So you know if you can, if you know you need to target her to and ultimately kind of three other key targets that become important when you know when you modulate her too and the tumor tries to escape, if you can hit her to and all those other targets at the same time, wouldn't that be pretty cool? Absolutely, so people are looking at ways to do that. You can do that with ten editing or things that are kind of like gene therapy. You could do it with certain types of self therapy. You can do it with RNA based therapeutics, you can do it with a certain multifunctional annum and a body or anibody like mom fules. Then you can build in that regular to the regulation that I talked about being able to kind of control that you have better quality of life, the safety for the patients, and so that kind of more complex or more refined engineering or bioengineering as I think where a lot of things are going. It's going to take a while to get there, but you know ultimately whether that means we're talking about some many type of robot. There was an interesting point counterpoint at a conference that I attend called and speak at Col I three hundred and sixty every February here in Manhattan, and that was one of the interesting kind of point counterpoints between two kind of luminaries and the oncology field was kind of where the future is and this idea of kind of robots, now that that doesn't mean they're little mini filicon base things that are but it, but the idea of robot being something that is responsive, that can do multiple things, that can change in reaction to changing environment. That's what's kind of meant and that's what I'm meaning. But this more complex and interesting engineering that is so exciting to be able to can you it control Scifi? But you know, there are people. You know, I think also of these are in the some of these are starting in the clinic right now to so, wow, that's so exciting. It's also, you said, it's already starting, that some of them are already going into the clinic. You know, the more the early generations of these things. Yeah, the first steps. Yeah, the first steps, but tune. Maybe we'll get to I hope. Yeah, and Anu Butts. Well, and they're you know, what's one thing too. So going back to that question of kind of why are certain cancers? Do they not have as many new drugs or powerful drugs? Is that a again, it's not for lack of trying. Like a third, roughly, of the overall biopharmaceutical pipeline. So, wherever that's coming from, wherever in the world, or biotech or Pharma or whoever, a third of that pipeline is cancer. That's a lot. That's a lot of drugs. That's like five thousand, six thousand, maybe more, drugs of all sorts that are being looked out to try...

...and treat, you know, sometimes a very specific, singular subset of one particular type of cancer and sometimes, you know, trying to go after every cancer. It's a very broad acting agent like the TRUDA. So again, it's not for lack of trying. May Not always be the right approach. It may always be the smartest approach. As you know, lots of other things complicate decision. Maybe it's not just a purely rational process to perhaps not lack of effort but lack of success, yes, and sometimes lack of focus, for sometimes getting trapped within a certain mindset. Right, like the immune system will never work, commune agents will never work. Right. That's a bid to stop there across. Getting away from dogma, you know, is something that is is harder than you should think in science. But maybe that's a broader conversation. Yes, that this has been a really great conversation and discussion. That any of our listeners want to reach out to you with any follow up question, students or just want to reach out to you at all. What's the best way for them to do that? So there's there's two ways. The way, the most likely that I would see easily and not accidentally miss, would be like reaching out be a linkedin right, a linkedin connection and messaging. They can also find my email if they go to challow health bio consultingcom to the website and go to the who we are and the BIOS and I think I'll be emails for everyone are there. It's just that I get so many emails that there is the chance that if I don't recognize an email coming from someone I don't know, either the SAM system will block it or I just won't see it because I get so many emails. So leave it. This appear into the ether. I've had them, so I will add the links to your linkedin and also the cello website here in the show notes for anyone who would like to follow up. Again, Jeff, thank you so much for joining us today. Alasia, thank you, it's been great talking with it. Take care of you to but you've been listening to working in oncology. To ensure that you never miss an episode, subscribe to the show in your favorite podcast player. If you're listening in apple podcasts. We'd love for you to leave a quick rating of the show, just to have the number of stars do you think the podcast deserves. Thank you so much for listening. Until next time,.

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