ADCs Ignited with Daiichi Sankyo Inc.'s Ken Keller - podcast episode cover

ADCs Ignited with Daiichi Sankyo Inc.'s Ken Keller

Jun 03, 20241 hr 4 min
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Just a few years ago, Daiichi Sankyo wasn't considered a player in the oncology therapeutics space, and it certainly wasn't a player in ADCs. But then, just a few years ago, who was? Fast forward to 2023, and we see an ADC arena that drove nearly $100 billion in M&A, licensing, and partnership deals, and a Daiichi Sankyo that can rightfully lay claim to lighting that fire. In fact, it was our guest on this episode of the Business of Biotech, Ken Keller, Chairman of the Board, President, and CEO at Daiichi Sankyo, Inc. who made the bold move to jump headlong into oncology armed with ADCs that, at the time, weren't exactly the darling of biotech. On this episode, Ken shares the story of his climb from "carrying the bag" all the way to the Big Biotech C-Suite, how and why Daiichi Sankyo pivoted from its roots in cardiovascular therapeutics into Oncology and ADCs, his reflections on the antibody-drug conjugate market, and a whole lot more. 


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Transcript

Matt Pillar

The Business of Biotech is produced by Life Science Connect and its community of learning , solving and sourcing resources for biopharma decision makers . If you're working on biologics process development and manufacturing challenges , you need to swing by bioprocessonlinecom . If you're trying to stay ahead of the cell or gene therapy curve , visit cellandgenecom .

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If you've been listening to the business of biotech for a while now , you may have picked up on the fact that I love a good story about driven young pharmaceutical sales reps who climb the ladder from carrying the bag and street-level business development all the way up to the C-suite .

Episodes 112 with Aviado Bio's Lisa Deschamps , and 167 with Orca Bio's , dan Kirby , come to mind as examples . I am Matt Pillar .

This is the Business of Biotech , and today we're talking with a guy who did just that in fantastic fashion , climbing the majority of his ladder with Amgen before taking the reins at Daiichi Sankyo , where he's been for the past 10 years and where he's been central to the company's embrace of , and leadership in , oncology and the antibody drug conjugate arena .

His name is Ken Keller . He's chairman of the board , president and CEO at Daiichi Sankyo Incorporated global head of the Daiichi Sankyo oncology business , and he's here with me today . Ken , welcome to the show .

Ken Keller

Matt , thank you very much for having me here .

Matt Pillar

I'm thrilled to have you here and you know I do love these stories . Young , young young folks like coming out of academia who have an interest in biotech and biopharma often ask me . They often ask me , like it happens more than you can imagine , like what should I do next ? Should I go get my MBA ? Should I go to work in industry ?

You know , what role should I , should I seek ? And my response is usually like all of it . All of it , like start somewhere and embrace as much of it as you possibly can . And stories like yours , you know they sort of embody that right .

They illustrate that you started , you know , at the base level , right Carrying the bag , like I said , and just embraced everything as you moved up the ladder at Amgen . And that's where I want to start . I want to kind of do a little bit of a retrospective on Ken Keller's career trajectory , if you will .

Perspective on Ken Keller's career trajectory , if you will . And I mean you know when I look at , when I look at CVs , I always hesitate to put an age on people . You know you look great , you look like a young man .

I mean it's terrific , but but we do need to rewind the clock quite a bit to go back to you know those days where you you business undergrad at St John's , a bit later in MBA at Loyal Marymount . So if you , if you roll the clock back to those days , what was your career intention then coming out of that undergrad and MBA experience ?

Ken Keller

Yeah , great question . So I haven't been called young in a long time so I think when you started . So I haven't been called young in a long time .

Matt Pillar

So I like where you started ? Well , I didn't , I didn't . I specifically did not say the specific years that you graduated from those programs .

Ken Keller

Well , it's hard for me to say this , but I graduated college from St John's 40 years ago this year . Yeah , it just doesn't seem . It seems like yesterday . Quite honestly , I wish I could give you a more profound answer than what I'm going to say , but what you said is just absolutely perfect and it kind of capsulates , kind of my career start .

When I graduated St John's I had an undergraduate degree in business finance and my dad was an accountant and I remember my dad telling me Ken , the salespeople understand how we make money . They bring business into our company . That's a great place to start and I think if you're in the finance world you probably have a little bit of the sales world envy .

I think my dad had that Because of his coaching . The only aspiration I had after college was I wanted to get into a company and start in sales so I could really learn the business from the bottom up . In terms of why I chose pharmaceuticals , I had two job offers back then .

One was entry-level sales position at a company called ADP and it was selling tax and basically payroll services . Then I had another offer from a company called Beecham Pharmaceuticals which went on to become SmithKline , beecham and then Glaxo . Why did I choose pharmaceuticals ? I knew no one in the industry . I didn't even know that pharmaceutical sales existed .

What made me choose that job was at that time I was driving around my family's old station wagon that had wood on the side . Nice and Beecham Pharmaceuticals gave me a company car .

Matt Pillar

Oh , so there was the cool factor .

Ken Keller

Right , I get a car I was all in and that was the depth of my thinking of pharmaceuticals and it was one of the luckiest decisions of my life . I'm a big believer , you know luck is important . You know making the right choices , obviously , but sometimes you get lucky and that really was a decision that shaped my entire life .

Matt Pillar

Yeah , yeah for sure . Did you like , did you right off the bat embrace uh sort of the life sciences role ? Um , I mean , was that , was that foreign territory like completely foreign territory for you ? I mean , coming coming out of college with a finance degree like ADP , you know ?

Hey , if you had landed there , very successful company could have gone a lot of places there too , and I imagine the nomenclature of that space might've been a little bit more familiar to you at the time .

Ken Keller

Absolutely . I think two things . One is I worked for a person his name is Tom Gebbia . Tom , if you see this , I haven't spoke to you in 35 years , but thank you .

I mean , that gentleman took me under his wing , he was the district manager , and he took me , and I knew nothing about pharmaceuticals , chemistry , the drug business , reimbursement , and that gentleman taught me so much , so I stumbled into the right mentor . Super important .

Second thing , though , is you very quickly learn that when you're bringing new medicines to , whether it be oncologists or primary care doctors , there is something incredibly special about doing that , and what I found is , back then we were selling three different medicines amoxicillin , an antibiotic , augmentin and a drug called Tymentin , which was an IV antibiotic , and I

met my wife through Tymentin . Literally , she was a nurse I was working at back then it was NYU , bellevue and the VA in Manhattan , and I was promoting Tymenton to basically the oncologist at this university . My wife was a nurse , and I met her there .

Actually , a friend of hers , the chief resident and fellow there , introduced us basically , and fellow there introduced us basically , and he didn't know my name , he didn't know Ken Keller . He knew me as the Tymentin man . That was the drug that I was promoting . He introduced this nurse to Tymentin man and you know that's how we kind of met .

But there was something that I just gravitated to . You know , when you bring a new medicine , something that you can see the excitement in the doctor's eyes when they say , okay , this is a new tool for me to help my patients . There's a feeling there that I would have never gotten from ADP and I didn't know that when I took the job . It was the car .

But to me , once you're doing something like that , you just never want to change . You always want to be bringing something new , something that changes the standard of care , something that excites the medical community . That's an amazing feeling .

Matt Pillar

Yeah , yeah , yeah , it was the car and eventually the wife . Talk about perks , right . Talk about making the right decision . Who knows who you might've met at ADP , but I'm surely not as interesting . As a , as a nurse , I mean that's fantastic .

So at some point in those early days you transitioned into Amgen and Amgen is where you stayed for quite some time and really exercised your ladder climbing chops .

Ken Keller

If you will Tell us a bit about your time there , so I joined Amgen as the first sales training class , as they were building out their commercial division , and I still have friends from that class . In that class we've got people like Dave Halal , who went on to become the CEO of Alexion and now he's a chairman and board of a number of different companies .

What was amazing about that time ? I started at Amgen in my 20s and I left when I was 50 . And so I grew up at Amgen . What made it so unique is it was one of the first biotechnology companies and it was a company that literally had zero revenue when I joined .

And any advice that I would give people if you can join a company that is entering a period of growth , that's going to give you so many more opportunities . And so when I joined , I started as a sales rep . I graduated to my destination job , a district manager .

I remember saying to my wife if you know what , if I can become a district manager , we've made it . Yeah . And I became a district manager . And then I had a unique experience . And I became a district manager and then I had a unique experience . I was offered an opportunity to go inside for a rotation a three-month rotation in marketing .

And I did that because the company said look , we want you to get some inside experience before you become a regional manager . I went inside and I met people . I started to work with clinical development , the idea of shaping a product and being kind of the architect behind what this product or medicine would look like . That was the place I was meant to be .

It was an addicting and a positive way experience . So after three months I had a goal , I had an ambition , I had a destination . I wanted to get into marketing and grow my career there I was . Amgen gave me the opportunity to be a sales rep and then I joined marketing full time , moved my family from the East Coast to the West Coast .

The moment they landed we were like this is where we want to be . Yeah .

Matt Pillar

It was beautiful , it was sunny , but so it says , the guy who's now speaking to me from New Jersey .

Ken Keller

I know , I know Life goes in a full circle , doesn't it ? One thing that was really important , though , and I think it defined who I was at Amgen from my entire career and even who I am today .

When I joined the marketing team at Amgen as an associate product manager , that team was filled with brilliant people senior pharmaceutical executives , people that were in a different league than me , at least in my mind and heart at the time . You know , they were from amazing schools , and I was the marketing guy who actually knew customers . That's who I was .

It was like , hey , we've got this young marketing guy , he actually knows customers , he's actually carried the bag , and that defined me and made me different within this group of amazingly talented people , and throughout my career , I've always used that as a badge of honor , and there's a little bit of a secret sauce in this , which is , you know from there , in

any therapeutic area that I worked in , or any drug , you look at all the market research in the world , but the secret for me has been developing a connection and a relationship with a handful of key opinion leaders and customers , whether it be for Enbrel with rheumatoid arthritis , or running the bone health business unit dealing with KOLs , from osteoporosis or

oncology , which is what I love . I have a group of customers that now I can pick up the phone right now , I can text them right now and they will get back to me immediately . And that's always been the secret of staying connected to what is really happening , because you can get lost inside .

You hire a lot of consultants to help you , you do a lot of market research but always vet that and pressure test that versus a few people that you really , really trust . Yeah , and you know that's been my kind of secret element .

Matt Pillar

You know , along the way , yeah Well , you're like the , the , the , the personality and sort of the personal relationships that you established , um , did they like uh , sort of a two-part question ? One did .

Did that instill the confidence in you at that young age , in an industry where you're surrounded by , you know to your point , some pretty heady people MDs and PhDs , right , you know , research scientists ? Did that establish personally for you the confidence that you needed to , you know , to not be completely out of your depth with those folks , one and two ?

At what point , like can you recall at what point you sort of realized , like , embrace that that confidence versus you know , I mean you can , you can try to swim out of your depth in this space , for , believe me , I do it all the time . I'm not .

I'm not a scientist , right , like , um , I love talking to people who are way smarter than me and teach me and our audience things , um , but I often feel out of my depth .

So at what point did you sort of like come to this realization that , hey , I've got a strength here , I'm going to embrace it and that's going to give me the confidence that I need to move forward ?

Ken Keller

Yeah , I remember the moment exactly . I was a product manager , maybe a marketing manager , at this time , and we were working on a drug called Nupagen , an amazing drug , a granulocyte colony stimulating factor that actually would stimulate the bone marrow to produce white blood cells and it would protect patients going through chemotherapy from getting infections .

So a first in class , amazing drug . And I was one of the people on the team and this drug had gone from zero to about a billion dollars at Amgen and it was stagnant and in fact the company at that time thought you know , we had peaked . This is what the drug's going to be .

I had an insight and it was something that came to me from going out with customers , listening to them , and then one day and I'll try to tell this really shortly , but I was looking at why there were some oncologists who were using Neupogen five , six , seven times more than other oncologists , basically in the same practice with the same number of patients , and

no market research could tell us why . You know we'd ask the question , no one could articulate it . But then one day I was at the West Clinic , which is a major oncology clinic in Tennessee , and I was speaking to a gentleman , dr Lee Schwartzberg and Lee is one of my confidants today , and you know , I just finally said look , I don't understand .

You're using this drug so much more than your peers . Help me understand it . We went to the charts , or he went to the charts , and we found that he was thinking about the drug in a slightly different way . This drug would increase white blood cells to prevent infection .

But for him it wasn't about a drug that would prevent infection , it was a drug that would allow him to deliver the optimal , the right dose of chemotherapy without having to dose reduce it and delay it . Right , and so think about this you're treating women with breast cancer and the .

The clinical data clearly shows , if you can deliver that full dose of chemotherapy and not have to reduce it because of side effects usually lower white blood cells you can give that woman a higher cure rate . So so , all of a sudden , the insight was well , let's not talk about this drug just to prevent infection .

Let's talk about this drug as something that enables you to deliver the optimal chemotherapy to give that woman the best chance of survival . And that was really our insight , lee's and mine .

And then we went back and we looked at how people were dosing chemotherapy across the globe right , and sure enough we saw some doctors that would just religiously do not lower the dose . We have to keep that dose at this level to give the woman the best chance for cure . And others just weren't doing that and so we brought that back .

We created an entire campaign around that and revenue grew over a hundred percent in 18 months . Now , to answer your question , all of a sudden I was not just the junior marketer with a sales background .

Matt Pillar

Yeah , not just moving , moving product , you were influencing .

Ken Keller

I became the guy that came up with this insight and , you know , with that came a lot more attention from management , but with that came a completely different level of confidence . That was when I'm like I can do this . I deserve to be sitting in this table with other people .

That's also what spurred me to go back to school at night , part-time , to get my MBA after I'd been out of college for 10 years because , I wanted to then do more , and so you know that that one spark just changed a lot .

Matt Pillar

Yeah , yeah , and I I don't want to give short shrift to that , that long period of time that you spent at Amgen , but , um , you know , for for , uh , for lack of having hours and hours to talk , I'm going to fast forward to the two , I guess , most recent roles that you had there before moving on , and that's going to lead into a question .

You are VP and General Manager of the Inflammation and Bone Health Divisions there most recently , but your time at Amgen gave you a lot of that exposure I was talking about earlier , to different modalities , to different targets , to different indications . Tell me a little bit about how you know .

One , how you made that happen , right , like how you , how you made that happen , that exposure to so many different arenas within , within pharma and biopharma . And two , how those exposures shaped your , I guess , your , preparation to become the leader that you are today of a major global biopharmaceutical company .

Ken Keller

Yeah , great question . The pivotal opportunity I was given in my career was actually one job . Before becoming the vice president and head of bone health and inflammation , I was given the opportunity to move to England and be the country manager for Amgen in the UK and Ireland and you know , there you run everything about the organization .

I was given that opportunity because I was not given a job that I wanted , right . So I was the head of marketing for oncology at Amgen . The head of global oncology came open . I wanted the job , I went for the job and I I wanted the job . I went for the job and I didn't get the job .

And the CEO at the time , kevin Schera , called me into his office and I thought he was going to give me the job . That day I did and he said , ken , I know you think you're going to get this job , but I'm not going to give you this job . And of course I was deflated . I said , well , kevin , why I've done this , this , this and this ?

And he asked me one question . He said , ken , can you name the number of stars in this organization that you created ? And the truth is , I was all about the marketing guy at that time . It was all about the brand , the brand plans , driving revenue . I was not about developing people . And so Kevin said I'm going to give you a different job .

I'm going to give you a job that you will fail unless you really embrace and understand that a leader's job is to help others be successful . And so boom , I was placed in the UK . Different products that Amgen had at the time , different healthcare system , different people and I could not do that job unless I honestly focused on people .

Matt Pillar

Yeah , people . And when you say focus on people , I mean to this point in your career you reference , like your focus on external people , relationships with customers and decision makers outside in the market . Nailed that right , Nailed that , Hit that square in the 10 ring . But now you're talking about internal , internal development of leadership and thought .

Ken Keller

Exactly , and the truth is that was not in my toolkit at the time . I framed success about coming up with the best business plan , the best marketing campaign and driving revenue and that's important . Right , that's our job . You got to do that .

But as you go up in the organization it really becomes your job is not just that , but it's helping people to be their very best . So I went to England , did three and a half years there . Then the job came open to run the inflammation and bone health business unit and it was at a time where that drug and that business was struggling .

So they needed a different lens and a different look at this and so I went back and I took that job with a . I came back a different person . You know . I came back as someone that genuinely I looked at my job as creating the environment and the culture within that group so that people could be their very best , where people could have fun in their job .

The group was a little demoralized at the time . They were a little beaten up , giving them new hope , inspiring them , changing people . So they're in the right positions and that opportunity allowed me to put kind of the new Ken Keller into play and really things started happening from there .

Matt Pillar

Yeah , yeah , that's pretty fascinating . So I mean you , you , you , that was a perfect answer to the two-part question because , you know , the second part of that question was like how , how that those exposures prepared you and it sounds like coming out of those experiences developing internal folks and creating stars .

You know , using your words , did that sort of inspire the confidence that it took to say , okay , like when it's , when it's time to leave Amgen , I think I'm ready to be the top dog .

Ken Keller

Yeah , it did , and because , more than anything else , you know being in different therapeutic areas . So by the time I left Amgen I had run the inflammation and bone health business unit . I led the oncology business unit .

I led a country in Europe that had other areas like nephrology , and you know I learned that what you need to do in any therapeutic area , you can learn the science . You know everyone can learn the science or enough to be able to do in any therapeutic area . You can learn the science . Everyone can learn the science or enough to be able to do your job .

But what you have to do is have your own way of building the organization , bringing people along , helping people and the company grow . If you have that , you can go anywhere , and you know that is what gave me the confidence to jump to Daiichi Sankyo .

Matt Pillar

Yeah , when you made that leap that's been about 10 years since you , so you , when you made that leap , you moved directly into the CEO role at Daiichi Sankyo .

Ken Keller

No , I went into . The first job was the head of business for the United States .

Matt Pillar

Okay .

Ken Keller

And then , about five years ago , I took over the CEO chairman job .

Matt Pillar

Yeah , yeah , all right . So I want to , I want to shift gears here , sort of transition into . You know that that five and 10 year period , the 10 year period since you've been with Aichi Senankyo and the transformation that you've sort of shepherded there , the company's evolved considerably , I think during your tenure .

You know the move into oncology and more recently the ADC space has been under your watch . So tell me a little bit about that . I guess just frame it up .

Ken Keller

We'll get into the details , but frame it up like what you walked into and what led to , like what sort of inspired you to start crafting and manipulating , to move into a different sort of area was literally a 100-year-old Japanese pharmaceutical company with an incredibly successful background in cardiovascular disease , based on drugs like omersartan , which is one of the

first ARBs on the market , drugs like Effiant , which is an antiplatelet so a very , very strong foundation in cardiovascular disease , a place I'd never worked . What really excited me about , about joining the organization was their intent to develop the next growth pillar for the company , which is oncology . And there is .

I've had the opportunity , you know , joining Amgen early especially , but then you know , working in different business units . There's something different about building an organization than joining something that's already built and you're just running it .

So the appeal was to build an oncology organization on the foundation of the cardiovascular strength , and when I joined , daiichi Senkiho had no oncology products , and when I joined Daiichi Senki , who had no oncology products , we had a few in the pipeline and that was the intent as expressed by the CEO , george Nakayama at the time .

What we have done over the last 10 years is we , our scientists , developed this antibody drug congenital technology and it really simply the concept of making chemotherapy smart to act like a heat seeking missile to the cancer cells . That concept's been around for decades . The first ADC was launched in 2000 .

Between 2000 and 2015 , most ADCs had failed as a category . People had lost enthusiasm .

But our scientists in Tokyo , they developed a new technology , a DXD technology , and that just opened up the door for a platform technology that we believed could yield four , five , six , seven different new medicines , and so the promise of that is what gave the entire organization the courage to say we're going to do this and we're going to go all in on it .

Yeah .

Matt Pillar

Yeah . So , before we get into some specifics around that ADC program , just generally , you know , I mean I think this will resonate with a lot of listeners who have worked in organizations where there's there's , you know , maybe a public or even internal conceptual embrace of some monumental change , some monumental change .

But then , when it's time to build the foundation of that monumental change , you encounter some maybe friction , some roadblocks , some challenges . When you're , when you're doing this into your point , 120 plus year old Japanese company that's rooted I mean grounded right Strong culture , there are surely going to be challenges , right ?

Like I mean there are surely going to be challenges , right , like I mean there are surely going to be challenges where you know , yeah , we want to do this , but there are going to be butts , you know . But you know , hey , let's pull back on the reins there a little bit . You know , tell me a little bit about that .

Like what , um , fundamentally , you know beyond , you know , without getting into , but we'll talk specifically about the ADC program but like , what did it take ? Or what does it take to say , listen , like we're going to do this , we're going to see this through . And when you face challenges , how do you deal with them ?

Like potential roadblocks or cultural , I guess , kind of stops . How do you work through that ?

Ken Keller

To transform a company around a technology that is different and new . Tons of skepticism . As I said before , adcs were looked at as yesterday's news . Here's what made it possible the C-suite and I'm talking about the executive management committee . There's like five people and you know , I'm talking about the executive management committee . There's like five people .

Those five people united together and their will , their conviction , made it happen . You can never transform an organization unless you get that support from the very , very top and that because it goes across the board of the company . The commercial part of it , quite frankly , is the tail of the dog .

When you're talking about changing a company complete company you're talking about getting the manufacturing organization to invest hundreds of millions of dollars before you know if you really have a product . Just think about that . That's incredible . You've got your development organization , your regulatory organization .

Everyone is making investments years before the drug will ever launch without a sure thing . You've got to get that conviction from the top . That's the first part of it . Then what you have to the the people at the top , they have to to frame for everyone in the organization what is in play and what's not right .

Because , as you can imagine , you know groups would come and say , well , we need to invest 50 million million to develop this manufacturing line . You can't do that if anyone thinks that this is a halfway bet . Yeah .

And so the CEO , the chief operating officer and myself , we made it very , very clear that this is going to be the future of the company and you know we wanted everyone to prepare and , you know , bet their jobs on this . Yeah , now the the question that people might have is how would you have the courage to do that ?

I mean , you're literally betting the company on on transforming it , and for us , everything changed when we presented the phase one data data these adcs looked great curing mice yeah a lot of mice in my time right .

the phase one data , though and this is what makes oncology so incredible this is a 120 patients , uh , metastatic breast cancer who who had failed four , five , six lines of therapy . So unfortunately , these people are in really dire straits . They really lost all hope In those patients . Our drug demonstrated a 60% response rate .

60% after all of that percent response rate , 60 percent after all of that , and we saw that internally and we thought we had something special .

But literally the CEO , the COO , other members of the EMC , we went together to where the data was presented and we saw the reaction and we gathered the thought leaders and they looked the thought leaders in their eyes and said what do you think of this ? Yeah . You know that was almost back to the very beginning .

You know being connected to the customers and when we saw what they , we saw their eyes and they told us what you have here is transformative .

And I actually think that single meeting it was at a meeting called ASCO and that room where there was maybe 10 investigators and the five of us that gave the leaders of this company the conviction to , in essence , bet the company- yeah , yeah , that's a super unique , I'm sure , and exciting I mean super interesting experience for a company , as I said , that's been

around for a long , long time , very well established .

Matt Pillar

It's almost like an injection , like a major injection of that biotech startup kind of feel like , hey , we're onto something here . Probably doesn't happen as often as you might think in companies like Daiichi Sankyo , um , the , the , the platform , the ADC platform that you mentioned . Uh , you know , cause , cause , the other thing at face value , at surface value .

You look at that time and , to your point , like the industry was still kind of stinging from the , the hope , and then kind of fall right Like the fall of ADCs , the fall of their promise . So that platform I mean the company must have known that it was onto something that was going to sort of revitalize this ADC space .

Otherwise , like that'd be even it's a scary enough proposition to say , hey , we're going to make this monumental shift . It'd be even it's a scary enough proposition to say , hey , we're going to make this monumental shift Even scarier when you're doing so on the heels of industrial scale failure for lack of a better word of the modality .

Ken Keller

Yeah , so the way this came about was there's a gentleman in our research labs in Shinagawa , tokyo , it's Dr Akatsuma , and him and his team they worked quietly for a decade on this ADC technology , and so , while others kind of gave up because you know , from the first launch there was only two other ADCs that had launched in 20 years they weren't very successful

, but what they did is they took this old technology and they revamped it and they made it new .

The technical part of it is they created a new payload and very quickly , what an ADC simply is is it's an antibody drug conjugate that is linked to a payload , a payload like a chemotherapy agent , and so , rather than the chemotherapy working everywhere , the antibody drug conjugate takes the cancer cell so that it could exert its cytotoxicity in the tumor

microenvironment . They created an ADC that had an eight to one antibody to drug ratio and a new , linker technology . So the entire ADC was new , and so it was engineered specifically to do a few things .

We saw the results preclinically and then we saw the results clinically , and the words that we used here at the company is we are going to create the world's oldest biotech startup . That's literally the words we use .

I mean , we were going to start a 120 year old biotech startup and you know , our bosses gave us the freedom to dream that big and to protect us , because you could never build an oncology division to work with the speed you need . And I'll give you a great example .

In cardiovascular disease , which was what we did , typically development is one or two clinical studies , thousands of patients , thousands of patients . That's cardiovascular disease . In oncology today we're running over 70 trials . Trials can range from 50 patients to maybe 500 patients , not thousands . Cardiovascular disease that study took seven years .

In oncology studies take a year , months , and so the speed , the amount of changes that you have to do , the mindset you need in oncology completely different than cardiovascular disease . So unless you really are able to protect that group , to be nimble , be flexible , be quick , you can never do it .

And and we purposely carved this oncology business outside from Daiichi Sankyo . Yeah . And it really has made a huge difference .

Matt Pillar

Yeah , yeah , just real quick question on the on the technology . You know , when I look at the ADC space , I mean you know today it's a very , it's a thriving development space , lots of players , and I'll get your opinions on that in a little bit .

But when you look at those players , many different business models , you know so many players who are just they're outsourcing the antibody , they're outsourcing the linker technology or they're outsourcing the payload .

Maybe they're , you know , maybe they're outsourcing all of it and putting it together on a platform , maybe they're developing one element of those three internally and outsourcing others . I mean there's very many permutations . Is the work going on there holistic , in that you're creating your own antibodies , your own linker technology and your own payloads ?

Ken Keller

So ours is a very all the linker technology and your own , your own payloads . So , um , ours is a very uh , all the linker technology right and the engineering part of it we own . We did it ourselves in our labs .

In terms of the commercial scale manufacturing , we use many different uh contract manufacturing organizations , so we've got people making the antibodies for us . We do the conjugation ourselves . So it really is . It's such a complex manufacturing process that in order to do it , you do rely on on outside manufacturing organizations .

Matt Pillar

We do quite a bit yeah but the science , the engineering is all daichi sankyo yeah , so that science and engineering is obviously foundational , fundamental . It's happening in in , in Japan . You've got something . We're going to move on it now To your point .

There's this monumental shift in the team , the rest of the team , right , all the folks who are supporting it clinically , you know , supporting the clinical trials , who are , you know , perhaps you know already working on some pre-commercialization efforts , and on and on and on .

So that requires some shift too , whether it's like taking the tools and people and resources that you have and manipulating them into this new arena , or bringing on new talent and resources . Tell me a little bit about that . Organizationally , what sort of HR and structural changes did the company need to make to ?

Ken Keller

accommodate the focus . You just nailed it and you asked me earlier what were some of the challenges . Building the team and bringing in the oncology talent early . Early was the biggest challenge Because , as you can imagine , who's Daiichi Sankyo in oncology ? Right .

No one , you know , no one in oncology knew Daiichi Sankyo and so early on it was difficult to attract the right kind of people . Now , now that's changed completely Right , as people have seen the success of this ADC platform . They've seen what our first drug in HER2 has done that people love and they flock to the next great big thing .

I mean people in oncology , I mean we live . What really rolls our socks up and down is to bring that next great drug to the oncology community . So once people saw the success , wow , all of a sudden everyone wants to be here .

That was not the case early on , and so you know , at first we brought in a handful of very talented people , but more so we wanted to recruit people that had the mindset to be a builder Right , and that's that's not a small difference . There are some people that have joined Daiichi Sankyo from very large companies who have everything in place .

They've been working in oncology for 30 years and they found it difficult to be able to do their jobs without everything in place , and so we were really thoughtful of bringing people in who believed in what we were doing but also had that build , a mindset that could build as they were running . So that's super important .

And the other part of it is great people attract great people , and so early on we were hiring for technical capabilities , but even more so we were hiring people that we believed could bring other people with them , and for the most part we got that right , and then success leads to more success . But that was that was a huge , huge part of it .

Matt Pillar

Yeah , give it . Give us a sense for the scale of that oncology effort now in terms of people and resources .

Ken Keller

So I was employee number one in the business unit . Today we've got over 2000,000 people working in oncology globally in over 55 countries and , like my direct reports , I've got people in Munich , I've got people in Tokyo , I've got people in the West Coast of the United States . I mean we really really are across the globe .

I will say one really interesting thing we did a lot of our hiring and building during COVID and I will tell you , COVID made us better , and here's why . And when you think about it , it won't be a surprise , but I'd grown up with this idea of you know , your staff , your people , need to be here in Baskin Ridge , New Jersey .

They need to be where the home office is Right .

Um , with COVID I didn't have that luxury and so because of that , I opened up my horizons and I hired people across the globe and I was able to get better talent , better talent , and you know , I wish I had learned that years ago , and so that was one of those unintended , really blessings and there's no blessings of COVID , but that opened up my eyes and it

actually helped us grow faster to be an oncology leader .

Matt Pillar

Yeah , yeah , for sure . You mentioned the , the criticality of the support of the C-suite when you're taking on a monumental pivot , get it , had it , I got that .

But when you look around sort of at the landscape of of players , stakeholders , shareholders , you know people who , people who you need to influence , who else kind of falls on that list Like what , what and who else did you need to influence to make sure that you know that that everyone was paddling in the same direction and and you know kind of lay the lay ,

the foundation for success .

Ken Keller

The three or four people and groups that are that have been my partners in this the entire time , and the people that you need aboard . First , you've got to have a chief financial officer who believes in the mission and is willing to make early investments and feel the pain in the P&L when you're building an oncology division from scratch .

There's a lot of investment and there's a lot of red early . If the CFO doesn't believe in that , it's not going to happen . Second thing is your HR person , your HR leader , and we have a chief people officer here at Daiichi Sankyo , simon King .

They've got to , in essence , be your right-hand person because you know they're the ones that are trying to help you attract the right people and the right talent . And you know you know you're going to have to build a team before you know the work can happen . So if you have finance and HR aboard , you're really on your way . That's super , super critical .

But then there's a third piece of it which I think I underappreciated early on , and that is when we started in oncology . We had another business , a specialty business unit the cardiovascular business . Specialty business unit , the cardiovascular business . And at a time when I'm saying I need more people , I need more resources .

I'm competing with the resources from the cardiovascular division and at first I really didn't invest enough time to help them understand what the potential was , what the future is , why they should be okay with me taking away some of their resources , and you know , that seems like a minor thing , but it's something that I could have done better with , because you

know , if you don't have that in the same place , you'll end up with a lot of friction .

Matt Pillar

Yeah , yeah , well , and I can imagine , I mean , in a situation like that , like it's one thing , if you're a small biotech and you're and you're reallocating resources from , perhaps , a product that is not reading out the way that you had anticipated , destined for failure , or the you know , I mean incredible market as it is foundational product . I mean that's .

I can imagine those challenges when you know we're not trivial .

Ken Keller

No , they really weren't . And you know , today I think we're in a great place , which is we've got , you know , two highly successful pillars of business . And you know , now people can can see the benefits of the investments we made .

You know , we've gone from zero to , basically , our run rate right now is over $3 billion a year in oncology , and so now people get it .

But you know , I guess my learning if I ever get an opportunity to do something like this again you know , really invest the time in the people that have the legacy and have built the organization and for us it was a cardiovascular group Make them understand that this is going to make us all stronger .

Matt Pillar

Yeah , all right , I want to shift gears for another minute .

I want to ask you sort of a philosophical question , and I'm probably going to paraphrase this , but I've read that you've said I'm going to read this when you have that spark of innovation and that opportunity that you believe in , be beholden to that opportunity , not the status quo I'm with you up to that point .

You then say if that new opportunity doesn't fit who you are , you've got to change who you are . That's the philosophical point . I want , want to , I want to , I want to press you on a little bit . You know , there's like a , there's a , there's a .

I don't know if it's a prevailing mentality , um , but you know there's this idea like stay true to who you are right . Like be , be , be who you are and find where you fit , and and . And this quote that I just read sounds a little bit contrarian to that .

It sounds a little bit contrarian like hey , if the spark of innovation and change that you want to make happen requires you to change you , change you .

Ken Keller

Yeah , yeah , great question . So for me , in the business of biotech pharmaceutical , what drives the company , the lifeblood of everything we do , is scientific innovation . It's that new product , that new medicine that can change the world , change the standard of care , transform breast cancer , like we've done within HER2 .

That's what we live for , and you know the idea . That's what is so rare . That great medicine is the unicorn , and so , to me , when you have that , that's what you need to follow , that's what you need to be beholden to too . I can make . There's many talented commercial people in the world .

Right , I'm telling you , commercial people can build a commercial model to fit a great medicine . That is a lot easier to do than to find that great medicine . You know , we've seen it time and time again . You know Merck , who is now our partner for three of our ADCs .

Merck , an unbelievable company in oncology today , right , built on a single product , keytruda . 15 years ago Merck was not thought of as an oncology company . Right , and you've seen this time and time again . I know , look at the obesity drugs today . None of that existed , you know , 10 years ago .

So I really do think the right way to do this is you follow the science , right when that leads you . Then you adjust the rest of your organization , because that is what's so rare , and you know , and when I say that you know , don't change who you are .

To me that's more about the values of the organization , who you are , whether it's in cardiovascular disease or oncology , the fabric of the organization , what are the behaviors that really are important to you . Those things don't change . But follow the science and when you've got something , change everything to bring that to patients .

Matt Pillar

Yeah , yeah , all right , good . So you know I'm going to ask you another , another challenging question , perhaps challenging change . Management , especially as it relates to HR , is not always sunshine and roses . No matter how great the idea or grand the gesture or true the intention , they're always going to be , especially in a large organization .

Folks who you just , it's like the difference between a horse and a mule the horse wants to please and the mule wants to lock its feet up and not be pulled right Like . So what of those folks Like what is your , what's your philosophy on ?

Like you know , they may bring great value to the organization in some capacity , but they're not willing to embrace a major , pivotal , you know , kind of change like that .

Ken Keller

Yeah , I mean , you know , we've had those experiences too . I've had those experiences . We've had those experiences too . I've had those experiences .

I think my approach has always been , you know , start with the mindset that you know everybody wants to do a good job because I really believe that's true , everybody wants to do a good job is to help people see what the future could be , to articulate clearly , definitively . Here's what we need from this group , or what we need from you .

Here are the expectations . So many times I've seen in my career where people don't come aboard or they go sideways , and the truth is , whoever that leader was , they didn't articulate what the expectations are . I always tell people you know , year-end reviews it's an open book test .

I'm giving you the answers along the way , and so many people you know they get their review at the end of the year and like I'm surprised , you know , I thought I was doing great . And so the leader , when you change things , needs to be very , very clear on what the expectations are , not only for the business results but also for the behaviors .

And what I've seen is when , when people resist change especially as here in Daiichi Sankyo , a lot of it is sometimes the business doesn't fit who they are as a person . I talked about speed and flexibility and nimbleness . You have to have that . You have to be willing to operate at the 80% level in terms of do I know this answer or not ?

You've got to make those bets . Some people just can't do that , and you know , unfortunately , teams will only grow as fast and as healthy as as each member of the team , and so if you do have people that are recalcitrant , they just can't get a board . They're just , you know , kind of locked in the past .

You know , you , you you've got to , you've got to move on right . Most people , um and in my career , uh , I I think I've gotten better at it Um , but I do believe that the answer to that is upfront . It's an open book test . Guys , here's , here's where we're headed , here's what I need from you and really having that dialogue .

Guys , here's where we're headed , here's what I need from you , and really having that dialogue , and so that's really important . But you cannot carry people . You just can't , and you always try to find the right thing for the person and help them along their way . Yeah .

Matt Pillar

Well , one of the things to be excited about if you're any of those people at every level of your team , is what I mentioned earlier .

To be excited about , if you're any of those people at every level of your team , is what I mentioned earlier and the fact that Daichi Sankyo's work in the ADC space sort of ushered in or even happened in advance of this explosion that we've seen now . Like I said , I mean it's just an incredible development arena is just insane right now .

So that's got to , that's got to be motivating in and of itself . Like , hey , we're in a hot , hot arena right now . So tell me about your perception of of that arena . Like when you look at the landscape again , even you know some of these new and emerging companies , the much smaller companies that are working on ADC development right now .

I mean it's got to be pretty mind blowing .

Ken Keller

The success that Daiichi Sankyo has had . It has absolutely ignited this incredible enthusiasm for ADCs . When we look at when we started working on ADCs in the you know about 2012 , 2010 , very few companies were doing research . As I mentioned , it was passe news . It was yesterday's science .

In the last 18 months there's been over 80 , been over $80 billion of M&A in the ADC space with Pfizer and Saddle Genetics and others . There are now hundreds of ADC programs there . So our success has ignited this incredible , incredible growth .

I do see a future where , wherever chemotherapy is used today , it is highly likely in 10 years that that will be displaced by antibody drug conjugants right . So I still believe we're only at the very , very beginning of what ADCs will look like in the future . The great news for patients is , you know , the more companies work on this technology .

I mean , science is beautiful . It just gets better and better and better . That's great for everybody . You know we've got to stay ahead of it and we're working on a lot of different new technologies and ADCs . But here's where we are today . So we've got one antibody drug conjugate on the market in HER2 . In just four years it has five indications .

It has not just replaced old ADCs , it's transformed how you treat cancer with indications like a HER2 low indication , which allows us to help 60% of all the women with breast cancer out there in a category that had almost no treatments before .

We just last week got a tumor agnostic indication , meaning this drug can be used for HER2 positive disease across the spectrum of cancer . We've got two other ADCs that have been filed with the FDA one that we expect to be approved this summer , one at the end of the year .

And we've got seven antibody drug conjugants , all based on this platform technology in the clinic today and all demonstrating impressive ability to shrink tumors .

So you know we've got a lot coming , but the beautiful thing is there are dozens of other ADCs that are also close to being approved , and I just think that's what makes oncology unreal in terms of excitement . New drugs all the time , new standards of care , better for patients , and you know that's what makes it great .

Matt Pillar

Yeah Well , you just answered the next question I was going to ask . I was going to ask you , you know you ignited the transformation industry-wide . Daichi Sankyo did , but that's you know in this business . You know that's not enough . You don't do that and then rest on your laurels .

So I was going to ask you what are you doing to differentiate from that crowded field now ? But I think you just answered it . I mean , you know the potential to have so many candidates in development and the potential to be looking at as many approved products as there have been in the past what 20 years you know in short order .

Ken Keller

Yeah , but yeah , one of the things we are doing to add to my previous statement is , oncology is all about speed of development Because , as you said , people are developing new drugs all the time and so , unlike cardiovascular disease , where studies take forever , how fast you do a study and how many studies you can do that dictates your competitive success .

One of the things that we've done is , in our first five antibody drug conjugants , we formed two partnerships One with AstraZeneca for our first two ADCs and then another partnership with Merck for ADC 3 , 4 , and 5 . Now why did we do that ?

The reason we did that is because we believe so much in the potential of this technology that we decided , if we kept these drugs to ourselves , we would only be able to bring this drug to a certain number of patients because we couldn't do all the studies fast enough .

And so we decided to partner with , quite frankly , the two most successful oncology companies last decade Merck and AstraZeneca .

So they're our partners today , and with them we're able to do three or four times more clinical studies and obtain , hopefully , three or four times more clinical studies and obtain , hopefully , three or four times more indications and help three to four times more patients than we could ourselves , and you know .

That's what you know , that's what competition not forces you to do . But if you want to stay ahead of the competition , being bold , being fast getting those studies done , bringing them to patients , that's what it's all about .

Matt Pillar

Yeah , that's a fascinating story . I've been abusive of your time . I feel like you know I if , if you didn't have other things to get to and you've got a lot to get to I could talk to you for the rest of the morning , but we'll we'll conclude with this what's next ? What's next for Ken Keller ? You know , a vacation , maybe a little break .

Take , take the wife uh , take the wife to someplace nice and warm I .

Ken Keller

I just took my , my wife , my three adult kids , my son-in-law and my three grandkids . We just spent a week in japan last week , so that vacation exhausted me , so I'm glad I'm back at work .

Matt Pillar

No , I know that feeling . I've not , I've not traveled with with quite that that tribe , but I know how . I know what you're saying about coming back from vacation and looking , looking forward to get back to the , the routine . So , yeah , what , what . What is next for you , though , in terms of your leadership there ?

I mean , you've given us a good outlay of what's next for the company . You know , corporate wise , what's next for you ?

Ken Keller

Yeah , I love what I'm doing right now and the way I see this playing out . In just a few years , Daichi Sankyo is going to be one of the biggest oncology companies in the world . Today , Daichi Sankyo ranks 15 in terms of global revenue and oncology . In just a few years , we'll be top 10 .

By 2030 , we should have six or seven ADCs on the market in over 30 indications across a dozen different tumor types . So I'm proud of where we are . But I got to tell you I've been in the job 10 years . I still feel like it's just a start and you know , as long as I had that feeling , I hope I get to stay in my seat . I'm in , yeah .

Matt Pillar

Yeah Well , I hope so too . You're doing great work and you're fantastic to talk to . I've enjoyed every minute of the conversation , Ken .

Ken Keller

Thank you so much for this opportunity .

Matt Pillar

Oh , thanks for joining me . So that's Daiichi Sankyo's CEO , Ken Keller . I'm Matt Pillar and this is the Business of Biotech . We're produced by Life Science Connect and available to hear anywhere you listen to podcasts and available to watch at bioprocessonlinecom under the listen and watch tab .

Subscribe to our newsletter at bioprocessonlinecom backslash B-O-B and , in the meantime , thanks for listening .

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