Michael Bailey got his start in biopharma sales and marketing a few moons ago , kicking off his career at GSK before making a move to Genentech , where he was group manager of cardiovascular programs , and then Iclone , now Eli Lilly , where he was senior VP of commercial operations .
Vp of Commercial Operations Collectively , those three stints comprised the first 16 years of his career and during that climb he worked with and led teams that notched up a lot of antibody wins Erbitux , ceramda , androderm and Nesatumumab , among them .
He joined Sinta Pharmaceuticals , which since merged with Madrigal , before he became chief commercial officer at Aveo Oncology in 2010 , chief business officer there in 2013 , and now CEO since 2015 . That tenure brought another win in Fortivda in the advance of multiple more more late phase antibodies that are in the commercial preparation queue today .
While Michael has many winning credits to his name , he's also faced and overcome a lot of adversity along the way . I'm Matt Pillar , this is the Business of Biotech , and on today's show we're digging into some of the stories of commercial perseverance with Aveo Oncology CEO Michael Bailey . Michael , welcome to the show . Thank you , pat .
It's a pleasure to have you here and I'm glad you made the time for us , and I want to get into some biographical info on you . We're going to kind of shelve that for a minute and get right into the quick of the discussion here , if that's cool . You know , looking over your CV and your wins column , so to speak , it's impressive .
I mean , a biotech builder can go a long time , a lot of years , an entire career maybe still making fantastic contributions to the space , to the science , but go winless to the space , to the science , but go winless . You've played a hand in what , from my perspective , looks like an above average number of commercial successes during your career .
And the first thing I wonder is like , as you traverse , you know kind of navigate your career , are you keeping like a wins-loss column somewhere ?
Are you keeping like some hash marks somewhere along the way ? First of all , matt , again thank you for inviting me to appear on your show and you know , like everybody , I've got memories of my successes and and failures . I think I'm probably better known for my failures , although I have logged up quite a few successes .
But the reason I'm better known probably for my failures is that it's what you learn from those challenging experiences and I think that's what people are looking for is in this business . You're going to run into those kind of challenges and you know , one of the things I think my experience provides is just how to work your way through that .
With that , I was extremely privileged , as you mentioned , a lot of wins to work on some amazing , amazing products and I know all of these serve to improve the lives of patients . As you mentioned , at SmithKline Beach I led the launch of Androderm , which is our first testosterone product .
I was on an Augmentin commercial team and if you have kids everybody knows Augmentin or Otitis Media Sinusitis . We did a major repositioning initiative on that . In addition , I had an opportunity there to do a rotation in the field where I got to launch Relafin , which was for arthritis .
So I got to see kind of a lot of different perspectives , stages in product life cycles . As you mentioned , I went to Genentech .
There I worked really in new products where I think it was really important to bring the customer to the development process , and I worked on a next generation thrombolytic called TNKs that was ultimately launched and , as mentioned , worked at Imclone for their first launch , which is always an exciting event at a company Herbitux and then their follow on Nest 2 Map .
Herbitux went on to be a blockbuster . So you know , that was a pretty exciting event . But as far as my most recent success is with Aveo , but it was preceded by a significant setback and again , those are the things you really remember .
But , you know , overcoming that setback and kind of charting a path forward , which included not only securing funding for additional pivotal studies but ultimately getting the first product approval for the company and a subsequent launch in 2021 .
And , just not to make it even more complicated , we launched in the middle of COVID and you know , despite I'm very proud to say that despite launching in the middle of COVID and despite the setbacks earlier , I believe we executed on a flawless launch and were ultimately recognized by ZS as one of the best launches of the year . Follow that on with .
This success caught the eye of LG Chem , who ultimately became our parent company , and they were looking for a proven ontology commercial organization to acquire , and I feel like that this is one of my biggest and most proud accomplishments , if you will , which is the resulting deal , which I've defined as a kind of win-win-win .
So if you can get a win-win , that's great , if you can get a win-win-win , that's amazing . And let me describe what I mean by a win-win-win . We wanted to develop our pipeline . We didn't have the funding or the investor advocacy , if you will , so LG was willing to provide that .
So we really won for the patients because we're moving our important portfolio forward . My team , my employees who got us to where we are , we're all retained . So it was a win for the employees and was one of the fastest growing stocks in the year that the acquisition occurred . So our shareholders won . So a really nice win , win , win for everybody .
Yeah , that's outstanding .
I'm curious and I've asked this question of biotech builders before who have been in similar positions , having come from big bio and been on big teams that you know , having played a hand in the launch , the commercial success of therapeutics and big bio , and then moving to biotech and taking a small company , a small team that perhaps had , you know , those investor
challenges and more , and winning there too , Contrast those for me , like personally , for you and for your team , the feeling , the , the , the , the feeling , the , the , the sense of accomplishment , um , you know , contrast that between big bio and biotech .
Well , I would say that the biggest contrast is in biotech . It's uh , it's survival . Um , where I'm big pharma , maybe it's growth and share price and some of those other things .
So , you know , when we set out as kind of the turnaround of AVEA , we had a small team we called the go forward team and there's 20 people down from a company that was roughly 260 people and our strategy , you know , top line , was to survive and that you know .
Obviously part of that is survive while we're progressing our agent to through the clinic and then ultimately to the patients . But I would say that's the biggest thing .
There's an incredible amount of stability that you know , I think big pharma affords because they've got a huge portfolio of products where most of the small biotechs are going to be one product and it's a do or die .
You've got to make the right decisions , you've got to be fiscally responsible to maintain that kind of lifeline or that runway to be able to achieve the clinical results from your study . And you know , like I said , I think big pharma has a little more of a luxury there .
You know , as I think about the LG collaboration , we have the best of both worlds now because we operate as a biotech . So there's a lot of kind of innovation , excitement , a lot of , you know , nimbleness , risk-taking , ability to do all those things .
And now we have this parent company , lg , who's got incredible financial security and that works as a safety net . So I feel like we've gotten to the best of both worlds the biotech spirit with the stability of a big farm .
And I would say you know , I've been in this situation before when I was at Genentech , when Roche came in and had acquired them , but they let them live that spirit of biotech that really , I think , creates innovation and advances science .
Particularly when you're , you know , with Genentech pre-Roche , when you're at Mclone now Aveo , pre-lg acquisition . What is it that I mean ? To your point , when you're working in big bio , failure is the norm across the board . Whether you're a big bio , biotech , in this business , the losses almost always outnumber the wins .
The losses almost always outnumber the wins . But when you're in small bio and you don't win , you know , when you encounter a setback , when you kill a program , when you need to pivot , it can be deflating . I mean just human to human , it can be deflating .
Right , what keeps you as the leader in those organizations motivated to keep moving forward when things don't end well and when they don't end well in small bio , they can end well , you know , in a pretty dramatic or they can end unwell in a pretty dramatic fashion .
Yeah , so first , I would 100% agree this is tough business a high rate of failures . Your losses are going to outnumber your wins . Hopefully they won't outweigh your wins , and I think it's kind of ties to how you deal with your losses .
But one of the things we have to keep in mind and I always remind my employees and they remind me is that it's a privilege to work in this industry . We're doing something incredible that's going to touch countless lives , change families' lives , extend life , and that's a really important thing . And I don't think there could be a better job in the world .
And that's my personal opinion and I believe that I share that with most of the people who dedicate their careers to this type of patient-focused mission . And that concept of mission , I think , is really important . Because I want to get back to your specific question what do you do when you have a setback ?
And I think the simple answer is you focus back on why we're doing what we're doing . So you know , as I thought about taking this CEO job after a major setback in the company , I asked myself kind of , what are the reasons I'm doing this ? And the first thing is always got to be patience .
We're doing this because we think that what we're developing is going to improve the lives of patients . Then , on top of that , there was a career aspect of it . First time CEO , that's a wonderful thing . And then you know , if you're really successful in biotech , there's a tremendous amount of opportunity to generate wealth .
Well , you know , if I think about all those three things through my career , through this you know this journey of being a CEO there's been days I woke up and said my career is over , I have just made the worst mistake of my life and that's the personal insight I was looking for , Michael .
Yeah , and there's no way I'm going to make any money here and you know my shareholders are going to hate me and all that . But but you know , the thing that got you out of bed was saying I believe in the product , I know the data , we just have to get through this and make it happen .
And you know , that's the kind of thing that really gets a team that's mission focused , moving forward . I kind of think about it as the heart and the head . The heart is that you know that mission focus and we really want to make sure we're doing it . But the head part of this is really important .
We have to make prudent decisions and we have to make thoughtful decisions . We can talk more about kind of philosophies about making decisions , but one of my philosophies is all about know the data , do the homework , listen to your advisors , listen to your employees .
The whole concept of diversity that you know we hear a lot about to me is diversity in thought , and that diversity in thought comes from diversity in race , gender experiences , religion , all those kind of things .
But it's the idea of getting that full kind of 360 perspective on the important challenges that you're facing and listening to those , and I think , too often people listen to themselves and not to others , and that can create kind of , if you will , limited thought process .
Yeah , just for context and clarity , you've referenced a couple of times now a setback at Aveo . Can you share a little bit about that , what that setback was ?
And I'll start with setting up with . I had two kind of major setbacks and the similarities were actually uncanny and I think getting through the second one was a result of having gone through the first one . So when I was at Imclon , we got an RTF for the first drug .
So when I was at Imclon , we got an RTF for the first drug , erbitux , when it was first filed , and that was largely because , I think , there was a lack of active listening .
The FDA was saying , hey , I got concerns , da-da-da-da , but I think the team at the time was listening and saying I want to hear what I want to hear , which is this is green light , full speed ahead . They filed and then they got an RTF . Ultimately , you know , that was a very important period of time in my life because a lot of people left the company .
As you might imagine , the company had gone down . There was a lot of bad press that went along with that . But you know , if you looked at this honestly , it was clearly a drug that worked that had a bad study designer In this case it was just not adequate study designer and not adequate data to be able to get the FDA approval .
Long story short persevering through , we ended up launching the product and ultimately sold the company , as you mentioned , to Eli Lilly for $7 billion . So that kind of failure turned into a success . Now fast forward to May of 2013 . I've just recently joined Aveo as a chief commercial officer .
The data reads out it met its primary endpoint , but there was a study design one-way crossover , not to get into too much detail , but that confounded one of the secondary endpoints that the FDA was very keen on , which was overall survival . So we didn't show what we hoped to show on the overall survival .
Long story short , we ended up getting what's called a complete response letter , as many of your biotech listeners would understand what that is and what a major setback .
So at that point , our global partner exited , just literally dropped the contract on the door and said we're done , and then the management at the time decided to shelve the product , and I really did not necessarily agree with that .
I actually moved to a chief business officer , tried to spin the oncology products , including to boson , which was the one that got the complete response spin it out .
But long story short , in about 2020 , 2014 , I had really crafted , thought about all that had happened , acknowledged the mistakes that were made and tried to look beyond this failure to identify a clear path forward for this really important drug that provides efficacy combined with tolerability .
So , again , square in our mission of improving the lives of patients with cancer , and that's really what really motivated me was this was something that was aligned with our mission , and we owed it to the patients to bring this therapy to them and provide a product option that does provide both efficacy and safety .
So in 2014 , after being chief business officer for about a year , I shared my proposed strategy with the board and ultimately , in 2015 , I was appointed CEO of Aveo .
So , kind of , instead of folding up on Ptivda , we decided to focus on the mission set out , on what we knew was going to be an arduous path to raising capital , executing on another phase three study , which was the TiVo 3 .
And then ultimately launching and God knows , we could never have anticipated that we'd be launching into in the midst of a global pandemic where you can't actually see your customers . So , yeah , it was , you know , obviously in the end , grateful we didn't fold it Um and .
But I'll be the first to say it wasn't an easy journey , but I will say it was worth it . And you know , and another important thing , one can say , gosh , he got lucky and we did . I'm not going to deny that .
But at the same time , I firmly believe luck favors the prepared mind and our little go forward team of 20 people were prepared to take on all the challenges we had to take on and we got to where we needed to go .
Yeah , I mean in that anecdote alone , those two anecdotes , those two stories collectively shed a little bit of light on any number of challenges , some preventable , some completely unforeseen . I mean , you talk about COVID like there's a challenge that nobody saw coming and at the end of 2020 and all of a sudden in 21 , everything goes to hell in a handbasket .
Looking back on that , you know , looking back on the things that can influence success or failure , the things that you know more pointedly can indicate imminent failure human biology , funding , competition , the regulatory environment , as I said , unforeseen things like global pandemics , pandemics .
Looking back , if you were going to advise our audience on some of the things that maybe are foreseeable , that are the most formidable challenges a biotech leader might face , I mean , is it even possible to say well , you know there's a handful of things that are . Is it even possible ?
to say well , you know , there's a handful of things that are Well , you know , it's funny when you start thinking about . You know what are the things that a biotech executive is challenged with ? Well , you know , there's all the know that you better know your market , you better know the data , you better know the science .
But you know , at the end of the day it really comes down to two people and you know , having the right people around you , keeping them motivated , especially as I mean , look , this is a slow moving business . You do a phase three study .
It can be three years where you're sitting there waiting for the card to turn over , years where you're sitting there waiting for the card to turn over and you've got to . You know , really be driven during that period of time while you're waiting in the uncertainty . And then you get , you know market dynamics that come in , financial concerns .
You've got competitive news that comes out . So again , I don't mean to be too simplistic , but it comes back to really refocusing people on the mission . You know , someone very wise once told me , as you're in your CEO role , every opportunity you get to state the mission , which is to improve the lives of patients with cancer .
I think I probably said it a half a dozen times already and I apologize for that , but it rolls off the tongue Something you should never apologize for that .
But it rolls off the tongue Something you should never apologize for , right .
It rolls off the tongue and it is truly , you know , the thing that keeps people focused , because , when you start getting distracted about a variety of things , then you know it's easy to lose perspective . And when you keep that simple perspective in place , you're going to be in a much better position .
The other thing , you know , look , as a CEO you kind of feel every bump in the road . So you know it's important that you keep what . What I refer to and it's actually one of our core cultures is realistic optimism . Actually , one of our core cultures is realistic optimism .
Nobody wants to hear you say , oh , everything's going to be all right , don't worry , as you're going over the edge of a waterfall . But you know , keeping that realistic optimism , transparency , being able to share with your employees the risks , the challenges that we have and understand what we need to overcome them , I think is really important .
The other thing again and I'll kind of put the CEO hat on is just gosh , there's so many stresses in what we do , and one of the things that I do kind of two things to try to manage stress . One is I try to keep a good work-life balance .
Part of that is trying to be healthy , at least get some exercise , do something other than just working 14 , 20 hours a day , which you absolutely could do as a CEO and the other thing is have fun . I learned that at Genentech .
The work hard , play hard , mentality , but a good laugh , a couple of beers with your colleagues , those are the kind of things that just make it say , yeah , this is OK , I feel good about what I'm doing , I enjoy the people I'm with . So it's important , you know , as a CEO , to set that tone . I wear shorts .
I just put my jacket on for this , but I wear shorts to work and Hawaiian shirts just to kind of make sure everybody knows . Hey , what's really important is the work we're doing . Enjoy yourself on the journey , on the journey .
Yeah Well , you didn't have to put a jacket on on , on , for us , likely , that's . I appreciate that you did , though you look great . Um , I don't want to , I don't want to , uh , belabor the , the , the failure questions , Um , but and and we'll , we'll , we'll turn it towards winning here shortly , but a couple more on on this , like at Avail .
I mean , you , you could have , you could have folded , you could have folded , you could have , you could have , you know , even gone down with that ship and then and then jumped on another . Plenty , of , plenty of biotech CEOs do it . You know , a company goes down , they , they see it to the end and then they pop up on another one . Um , you , you didn't .
In this case , you know you fought for what you thought you should fight for . Um , ended up winning that battle . But when it is time to fold , how do you know ? You know , like you know , you got to know when to fold , hold them , you got to know when to fold them .
Yeah , what goes into , what goes into your calculus when , uh , when it's when it's time to fold ?
Yeah , I don't think that's a simple answer . I know I have a tendency , but it's funny because I'm actually exploring this in a book I'm reading . I don't know if you've come across Quit the Power of Knowing when to Walk Away by Annie Dukes . No , I haven't . It's an interesting exploration of how we decide to persevere or when to quit .
Annie Dukes actually was a professional poker player , so you know she uses the term when to know when to fold them as as you've referred to , the Kenny Rogers analogy applies Exactly , exactly . And , and you know , here's the other thing she explores and I think it's really interesting .
I would encourage anybody to read it and it would make my , my executive assistant , really nervous when I ordered the book because she's like are you quitting ? I said no , I'm just trying to understand when it's the right time to quit , and I'm not talking about your job .
But you can give up on a project or move on to the next thing and I think that's the genesis of your question . But you know , one of the challenges , just in society , you know , quitting is looked down on . How many times your coach , whatever , your father , your mother in growing up say don't be a quitter , get back in there , just keep going ?
And she takes an interesting exploration into . You know , in life and in business , quitting can often be the right decision , the best decision , and you know I'll just make it concrete for you . The two couple examples that stuck with me from her book was Muhammad Ali decided to continue to keep fighting and trying to get regain the title .
Another is you know the folks who have summited or was quested to summit Everest and decided not to turn around , just to keep going , even though you know maybe the bad weather is coming in and ultimately it costs them their lives . So there is a good time to quit and a bad time to quit .
You know , in my personal experiences , I've been incredibly fortunate that you know , in taking a step back , reflecting on the situation , being very , you know , candid and objective . And part of that , as I think I mentioned earlier , it's acknowledging your mistakes .
You know , what's one of the hardest things I think people have is that I made a mistake and that's why we're in this situation . But we can fix that mistake , we can take another course to overcome it , versus just saying I'm going to shove this aside and hide it in the closet because I don't want to acknowledge a failure .
So I think the key thing is really being objective . I think it's understanding the complete situation . You got to do your homework . I mean , I spend a tremendous amount of time reading clinical studies . I'm not a scientist , but there's a tremendous amount of value .
I take a lot of time reading books about competition and how to ultimately be successful in a variety of arenas . And then , probably most importantly is , I talk to a lot of smart people and I listen to those smart people and get their perspectives , and it's not just the winners .
You go out and say I'm going to go find that winner , the guy who has never missed on a swing , but those are not necessarily the people that you're going to learn from that are going to benefit you when you're faced with the challenges . It's you know . Look the failures in the face and learn from them .
Yeah , when we talk about failure in biotech and biopharma in general , I think there's a I don't the general . I guess proclivity is to talk about clinical failure . But in recent years we've seen some multi-billion dollar post-commercial failures , right Like multi-billions of dollars in sales projections , and the product just fizzles after it's been approved .
After that , you know that quote unquote finish line has been realized . You've had experience with multiple commercial successes . Um , so I guess the question I want to get at there is like post-commercial failure and and you know , there there are case studies upon case studies written about what went wrong .
You know , when everything was going right , what went wrong once the commercial finish line was achieved . In your experience , what are some of the factors that go into the post-commercial win or loss ? You know , conquering a market versus falling apart after billions of dollars were invested and billions of dollars in sales were projected .
And how do you obviate for a post-commercial you know , a post-approval meltdown ?
Yeah , well , let me just start by saying commercial launches are incredibly complex and I think you have to have an appreciation for the challenges and the complexity of that . You know I'll go back to my Imclon days .
I remember first presenting my strategic plan to , you know , basically the board , which is largely scientific folks , and you know I think the feeling was , oh , this is a great drug , it's going to sell itself .
And you know we talk about issues and you know reimbursement , you know awareness , education , just to name a few kind of common issues that you have to overcome . And I remember having to change the way I presented the issues . You know , and I started everything . The drug will sell itself if the physicians and patients get reimbursed .
The drug will sell itself if the physicians are fully aware of the data . The drug will sell itself if we are positioned distinctly from our competition . And it was just that nuance and it's true . I mean , if you've got a good drug , people are aware of it , they can get access to it and it's providing an advantage .
I think there's a certain momentum that goes along with that . But all those other things you can't take for granted , and one of the things again it goes back to you know , know the data , know the risks , know the science and it's you know as a commercial person . One of the things we pride our group on is that we know the data cold .
And you know not just our data but we know the competition's data , and that's critical to be able to find those little opportunities to distinguish yourself and then ultimately match that up with a patient population that can benefit the most from it .
And you know , that to me is how you sell it's utilizing evidence-based medicine , utilizing the data , utilizing the science . But the other important thing that I think people don't consider enough is just the changing clinical scientific landscape .
You need to be looking 10 years down the road because if you need to take a turn or make a shift or an adjustment in your development program , it's going to take you three to five years to be able to do that . It's like turning a battleship . You can't just , you know tomorrow , say okay , now , this is our new position . It just doesn't work .
You have to . You know . I firmly believe you have to support that with the evidence-based medicine . So you know again , being a student of the markets , being a student of the science , again goes back to talk to people who are creating the future and understand where it's going to go and anticipate .
So many of the failures that you see in the marketplace are just some . You know are situations , in many cases , that they just didn't anticipate that the world was going to change .
You know it goes back to the Xerox kind of story not to but just to make it concrete that you know they didn't anticipate the change in the world and you know that applies for pharmaceutical biotech marketing too .
Yeah , yeah , we tend to use the word . You're talking about turning around a battleship . We you know it's convenient to use the word pivot , but there's really no pivot Like . Pivot implies we're going to make an about face and instantly be moving in a different direction . That doesn't work that way .
You know one of the things I mean we're doing combination studies , and so you know part of that turning that battleship has to do with , you know , engaging with . So one of the key elements of , I think , success is to actively be out there looking for collaborations with the other companies who have innovative science .
Yeah , all right . One last question about losing , and then we'll talk about winning . We'll turn it into a happier conversation . Uh , when , when you , when you do have to fold , when you do have to lose , what's , what's your best advice on on doing that smartly ?
Like , yeah , there's there's a right way to do it in the wrong way and there's probably a whole lot of in between , but what's your advice ?
Yeah , no , you know , three things come to , kind of come to mind that I think about . You know , losing smartly . First one is fail fast . Time is money . One of my favorite bands , rush , geddy Lee said if you choose not to decide , you still have made a choice .
Kind of get into analysis , paralysis or just afraid to again kill a program that they kind of start to acknowledge may not have a future . And the longer it takes to make that decision , the more it costs , and not just financially but from a distraction for the company . I mean that is an important thing . The second thing I'll say is do the right thing .
And again , if you want to fail smartly , act with integrity , because when you fail it's always better if you did the right thing versus failing at trying to do something that you shouldn't . And I'll just give you a very practical example of that . Whenever we get to an impasse and these are business impasses what do we do in this situation ?
And there's one what may cost more money ? One may take more time ? I always ask my team to step back and ask the simple question Again , this is going back to that mission focus what's in the best interest of the patients , and it is remarkable how clarifying that statement or that question is in making these decisions .
Now , you know , it's not a guarantee that if you make the decision that's in the best interest of the patient , that it's going to come out the way you hoped it would , that it's going to come out the way you hoped it would .
But I'll tell you , as I said , I would much rather have made that decision and be able to sleep at night by saying we did the right thing , we did it for the right reasons . That's really , I think , important .
And then the last thing , and this is kind of we just have a situation like this that I don't know how often this comes up , but if you can design a win-win , then you win . You know , either way this thing goes , and I'll give you the example of what I'm talking about . And again , I don't know how often these come up .
I've seen it once or twice in my career where there's real opportunity to do this . But for us , we took the Tavozinib and we wanted to move into the second line following IO combinations , right ?
So one of the big questions that was being asked in the scientific community is can you keep IO on board If you had prior IO , is it okay to then treat again with IO and in this case in combination with a VEGF TKI , in our case TiVo . So we set out on a phase three study . We call it a Tenevo 2 study , and this study , the way we designed it was .
Again the question was adding a PD-1 to a TKI . Does that actually add additional value ? So the study design we did is we put our drug in both arms , so it's Fetivda versus Fetivda plus Nivolumab , which is BMS's drug . We did a clinical collaboration following a PD-1 combination . So one of the questions is does Nevo add anything on top of Tevo ?
But the other side of that win is we get a great data set , evidence-based medicine that we've been looking for as a single agent following IO combinations , which is the new standard of care in first line . So you design a win-win , one could say . If the study doesn't work out , you say that it failed .
But you failed very smartly because you had the results from the control arm . So that one , like I said , I don't know if that's out there all the time for everybody to take advantage of , but you know , be creative and try to think out of the box . Thinking of win-wins is a lovely place to be .
Yeah , engineer yourself and design yourself into a win . In other words , exactly yeah , very cool , yeah . Now we'll turn the tide here and talk about winning . We just talked about commercial failures and some of the things that cause them .
The last time you and I had a chance to catch up , I remember you telling me that you do not like to follow the quote unquote commercial playbook . You know , like if you went to Bill Belichick and you said , you know , you don't need that , you don't need that playbook .
You know , throw that out the window , let's just play football , you know he'd look at you like you had three heads . So I'm going to give you an opportunity to explain what you mean by that .
Sure . So just to familiarize listeners , commercial playbook is literally you can buy them from consulting groups and they're about four inches thick and they have every single thing you're supposed to do when you launch a book . It's very prescribed . When you launch a drug , it's very prescribed .
I believe personally that the commercial playbook has become a bit bloated and you know it's almost the 80-20 rule . You know you're going to have certain things that are going to give you huge return on investment or huge bang for the buck , and then it's going to just continue to get diminishing returns as you continue to spend money .
And I honestly think one of the things at least what we've kind of tried to embrace in a small biotech is let's be as efficient with our spend . So again , just spending towards the whole commercial playbook probably not going to be able to afford it , and you're going to certainly waste quite a bit of money .
And I think that's one of the challenges that some of the pharma companies have is that they end up spending because that's the way we've always done it companies have is that they end up spending because that's the way we've always done it . I firmly believe that every situation is unique and , as such , launch situation as such , it requires a tailored approach .
Perfect example going back to Fatibda and COVID , I mean throw the playbook out the window . How do you launch a product when you can't actually get in contact in person with your customers ? And that's been the model for , you know , 100 years . And now , all of a sudden , there's no personal contact with your customer . What do you do that ?
Well , you know , look , we had already had this kind of mindset that every situation is unique . So as we were faced with that , we found it kind of second nature to say let's build a tailored plan to launch in COVID , and I think that served us well , as evidenced by the recognition we got as one of the best launches of the year .
One of the best launches of the year . So you know , that's that's what I mean by don't you know ? The playbook is not something that you want to rely on .
But now let me just say this I don't want to completely dismiss the value of a launch playbook , because I will tell you personally and you know I expect this of my teams is to look through the playbook and make sure you're not missing something .
That's , to me , the value of the playbook is there's again , I mentioned , it's incredibly complex launching in pharmaceutical in the US in particular , and if you miss a critical item , you will pay for that down the road .
So the playbook is not the here's all we're going to do , but it's let's make sure we're doing the stuff we're going to do , but it's let's make sure we're doing the stuff we're supposed to do . That's the way I look at it .
Yeah , yeah , Uh , in in keeping with my probably bad football analogy , I dropped Bill Belichick's name . I don't even know what he's doing these days , Right , but uh , in keeping .
In keeping with that analogy , nonetheless , uh can you give any other examples of times where you and your team have called audibles to adjust , to make an adjustment in the face of adversity , like the COVID example you gave ?
Yeah , I mean , I think the COVID is just such a wealth of experience and I feel very privileged to have gone through it and then you know , more privileged to have been successful . But it was it's probably one of the biggest high stakes audibles you could call because , gosh , we were deciding whether we were going to launch this product ourselves .
You know , I mean that that was an important decision and it certainly would have been easier just to hand it off to a big pharma company , but we were committed to building a world-class oncology organization . In order to do that , you get to launch products . But I'll just give you some examples .
So we were starting to build the sales force around the time when COVID started to set in and we sat down and we said , okay , you're not going to be able to access your customers in person , so you can't just have you know salespeople that you know have a successful track record , but rather you have to also have to have people that have relationship because
you know recognizing you're going to have to make a phone call , do an email and you know you don't know that person , you're not picking up the phone call , you're not answering the email . So you have to have these relationships and so you know we're going into launch . We don't have tons of money but we said this is worth spending the money .
So you know we had to pay a premium to get those people , but we felt it was that important to make sure that we had to pay a premium to get those people , but we felt it was that important to make sure that we had not only you know the top performing salespeople , but also people with those kind of relationships that can open the door , and it was very
successful . The other thing was you know everybody's done non-personal promotion . You do speakers programs , you do these kinds of things , but this was a whole nother dimension . What do we do now that you know we've got to compete for this kind of non-personal promotion , that's , quote unquote omni-channel type access to our customers ?
So you know , we worked very quickly to lock up key channels on that , recognizing that this is going to be more competitive the further we go into this pandemic , and we were very successful in doing that and I think we got our message across to our customers , which ended up helping them make the right decisions for their patients .
Now I will tell you this just doesn't stop after COVID . If you truly believe what I believe , which is this idea that every situation is a unique situation that requires a tailored solution , then you got to continue this . It's kind of we're hardwired to say what's the next thing , so stay tuned . Ai is going to be incredibly cool .
As we get into commercialization , we're already using some AI techniques and you know artificial intelligence is one of the core competencies of our parent company , lg . They have the ABCs artificial intelligence , biotech , and then clean energy .
So we're right in their sweet spot , and I think that gives us again an advantage over some of our contemporaries in the industry .
Well , you just cracked open a can of worms that we don't have time to dig into . I mean the AI angle to dig into . I mean the AI angle , specifically your mention of AI in the context of , you know , pre and commercial activity . I mean that's super interesting to me . Can you give us and I don't want to put you in a position .
I'll give you a great example . So we can through the big database you know , claims databases you can watch , quote , unquote , watch . The systems can allow you to understand , based on certain activities and prescriptions , supportive care , et cetera , et cetera . A huge amount of data .
You can identify when a patient is going to progress and then need an X line of therapy . We can send a kind of a flag to our salespeople and say Dr Smith has a second line patient , kidney cancer patient , who's received XYZ before and is likely to progress based on this artificial intelligence algorithm . It's not perfect but it's cool Sure .
Yeah , not perfect , but data that's more readily available thanks to the tool than it otherwise would have been .
Yeah , and we're getting a pretty good success rate on that . And you know , look , that's the . It's like going fishing off and you know , if you , if you don't have that kind of sonar to be able to see that there's actually fish around , you could sit and fish in a place that there's no fish for a really long time .
So we're sending our people to fish in a place where you know we , we can see that there's a need for what they've they're bringing to the table .
Well , you got to . Uh , yeah , now . Now I'm going to tag onto your fishing analogy real quick . You got to trust the technology , though , because you , you , you bring that up and it , it , it . It makes me recollect a story .
I , I , I used to spend a lot of time fishing with an old timer who , when we started using you know fish finders , he would scoff at them and say those things are , they're programmed at the factory . You know they're showing you fish that programmed at the factory , but it's an important point because you do .
There are a lot of folks out there in our space who don't necessarily trust the technology . You've got to know where the data is coming from and trust that it's doing its job .
And look , you've got to be willing to be a pioneer . That's it . I mean it's . You know it's not going to work all the time , and there's , you know , there's definitely a learning that goes along with the artificial intelligence . So , you know , we keep feeding back information that they keep spitting it out .
We keep feeding back information that keeps spitting it out and hopefully we get to a point where we can really be in a place to again provide solutions to patients when they most need it .
Yeah , very good , we're running short on time , michael , I feel like I could talk to you all afternoon , so I'm going to ask you a few more questions and wrap things up here . I want to make sure I give you an opportunity to tell us what's coming down the pipeline there at Avail .
So tell us about what's in the pipeline , like what's coming down the pike here and how you're I guess , maybe share some strategy around how you're navigating them towards more W's in the W column .
Yeah . So I'll just kind of recap that the Tenevo 2 study . We hope to be presenting the results of that again , a phase three study with tavozinib in combination with nivolumab versus tavozinib in kidney cancer following prior IO systemic therapy . So that's hopefully going to be presented at an upcoming scientific meeting .
I mentioned a little bit about the importance of the LG collaboration and the support that they've given us to allow us to move forward with our second most advanced program , which is Ficletuzumab , which is an HDFC med inhibitor . We're studying that in combination with my old friend Erbitux in head and neck cancer .
So I'm probably one of the oldest commercial people in head and neck cancer I've been about 20 years . But we're really excited . An incredible amount of unmet need . These patients are in dire need of effective therapies . So we're running a phase three study in HPV negative patients , which is a poor prognosis subset of the overall head neck population .
And then behind that we've got AV380 . This is our anti-GDF15 antibody which we're studying that for cachexia , which is a muscle wasting that's associated often with cancer . And if you think about Steve Jobs and near the end of his life he had really lost a lot of weight he probably didn't die of his cancer . He probably died of his cachexia .
There's no effective treatments , so this is a kind of first in class antibody that was developed internally . We're really excited to be moving that forward to try to tackle that significant unmet need .
Yeah Well , good luck on those programs . Great , great progress . And I'm kind of bookending this with stuff that I normally do up front . You know , these episodes usually sort of follow an arc of like let's get to know Michael , and then let's get to know what excites him and what makes him tick , and then let's learn his pipeline .
I'm going to ask you this question here towards the end , because whenever I look at my guests you know educational backgrounds and career trajectories I always pick out questions where I see interesting inflection points or where questions or gaps remain .
And when I look at yours , like going way back to your undergrad , psychology and economics , and then an MBA in international marketing , which you know- I mean the biotech leaders that I've interviewed come from every walk of life you can imagine , but this one in particular doesn't scream .
You know , this guy's destined for a career in biopharma and leading biotechs , so I just got to hear at least the short version of the story that got you into biotech and biopharma , as it were , in the first place .
First of all , I'll acknowledge I'm definitely a unique individual . I get told that all the time , so I am not exactly your typical CEO pedigree or background et cetera . But look , it is interesting . And unlike my kids now who seem to be laser focused on what they want to do in their lives , I did a little more meandering in my career choice .
In fact , my father was a lifetime research scientist , so I've been exposed to the pharmaceutical industry through my entire upbringing and he was always very proud of what he had accomplished when he'd come home and that was exciting for me to see that .
So I started to have a love for science and I actually started my career , or my college career , wanting to be a doctor . That's how I set it out . But this was in the 80s and if you remember the culture in the 80s , you know greed is good . Greed of the 80s really kind of directed me towards finance and Wall Street and that kind of stuff .
So I pursued that , did that for a couple of years and , frankly , found that I was kind of missing , felt like I was missing something . I missed the science . I felt like I could do more to feel good about what I did every day my example before . I would have just had I can make money or this would be good for my career .
I didn't really have that patient as that focus to keep you going when you had bad days . So I went back to school really to follow my father's footsteps to go get my MBA and pursue a career in drug development . But I , you know , recognize that drug development is not just science , it's also the business , and so I felt like that I could .
I could bring that part of the equation to the table . I was very fortunate to have an opportunity to work in London while getting my MBA and at SmithKline Beecham as an intern and then was able to parlay that into a job at SmithKline Beecham coming out . And it was a very fortunate time .
Jerry Karabellis had started this kind of innovative , if you will , very high-profile management development program . We had two people in each class . The other guy was Ron Square , went on to run Array , sold that company to Pfizer for $11 billion .
But he and I went through this program , spent about five years and we got the opportunity , really , really privileged , to be rotated around to a variety of different things .
I mean , you know , got right out of business school launching the product I mentioned earlier , uh , working on flagship products , getting an opportunity to go out in the field working on managed markets , that uh was all all very exciting and you know , I'm very fortunate to have had a mentor like uh jerry Jerry Carabello's to , to give me that opportunity .
And then the rest is just history .
Yeah , well , we're fortunate , uh , that that's the path that you went down . I mean , you're doing great work , have done great work , continue to do great work . Um , and I appreciate you coming on the show .
I'm going to ask you to to to wrap things up with some advice for the guy or gal who's in the shoes you were in back in the early 90s and maybe has some opportunity , like you did , to pursue a path in biotech , but isn't sure which path to pursue or how to pursue it . What advice would you offer ?
Yeah , it's more common than you think and I think you know people come into the industry and one of the things the beauty of being in a biotech is you get that exposure to a lot of different things , and we've given the opportunity for people in our organization who come in in one role and then want to switch to another .
So that , I think , is a great opportunity . But the key thing here is get as much out of all those experiences as you possibly can . Said another way , don't take any shortcuts . I see a lot of people who feel like they need to be progressing faster than they're progressing and I think you can miss out on some great experiences .
Bringing things to conclusion , I mean you know doing some for six months and then saying I checked that box is is very different from actually you know doing it for two years and you know having that complete experience . But I think I shared with you the lifelong friend who's now an executive coach , a guy named Gerald Mosley . He put it .
He defined it as the five E's of life and career . So I actually gave him the fifth one , this one teens are for excitement , so it doesn't really have a lot to do with career , but it has to do with having fun throughout your life . 20s are for education , 30s are for experience , 40s are for equity and 50s are for enjoyment .
And if you play your cards right you can follow that continuum . But again , I see lots of folks in their 30s saying , oh , I haven't made millions of dollars , I haven't had the big win , I haven't gotten a senior vice president title .
Just take your time , get the experiences , build a foundation and then you can stand on top of that foundation into your 50s and 60s and really enjoy it . I personally am 58 . I'm having the time of my life . I'm really enjoying what we're doing and I think I can say that because I've had a lot of experiences , I'm not afraid of failure .
You know , there's very few things and I'm knocking on wood right now . There's very few things I haven't seen , but I'm sure there's more in store .
So so stay tuned . Yeah , that's fantastic . Some of the most transparent , genuine and valuable insight . I think that we think that we've entertained on the business of biotech . I'm thankful you came on , Michael .
Thank you for having me .
So that's Aveo Oncology President and CEO Michael Bailey . I'm Matt Pillar . This is the business of biotech .
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