
Introducing Clinical Trial Blazers – Pioneering oncology trails with AVEO’s Michael Bailey from Clinical Trialblazers. Follow the show: Clinical Trialblazers In this episode of Clinical Trial Blazers, Michael Bailey, President and CEO of Aveo Oncology, shares his insights on the evolving landscape of oncology trials and their impact on patient care. Join host Alberto Grignolo for a thoughtful conversation on the challenges and innovations shaping the future of clinical development. We hope you enjoyed this week’s episode of Clinical Trial Blazers. Please take a moment to rate and review this podcast wherever you listen. Special thanks to our production partner, Wonder Media Network. Our producer is Brittany Martinez, our editor is Maddy Foley and our production assistant is Joia Putnoi. DISCLAIMER: Please note, this is an independent podcast episode not affiliated with, endorsed by, or produced in conjunction with the host podcast feed or any of its media entities. The views and...
Loading summary
Alberto Grignolo
Hello and welcome to Clinical Trial Blazers, a podcast by Paraxel Biotech, where we explore the human stories behind breakthrough clinical research. In this series, we'll dive deep into the world of clinical development, connecting you with leading voices across biopharma and biotech to hear about the decisions, risks and accomplishments that define these trailblazers legacies. Together, we'll explore the pivotal choices, bold risks and remarkable achievements that that defined these trailblazers legacies Uncovering the heart, grit and ingenuity driving the future of scientific innovation. I am Alberto Grignolo, your host on this journey. Whether you're an emerging leader in biotech or someone curious about the future of clinical trials, this series is here to inform and inspire you. In this episode, we'll hear from Michael Bailey, President and CEO of AVEO Oncology, a company dedicated to advancing targeted cancer therapies. Marco, it's a pleasure to have you joining me today and very much looking forward to our conversation.
Michael Bailey
Thank you.
Alberto Grignolo
Alberto, could you begin by introducing yourself and telling me a little bit about your background in biotech?
Michael Bailey
Sure. Well, thanks, Alberto, and I appreciate you all having me on the show today. I'm Michael Bailey. I'm the president and CEO of AO Oncology, which is an LG chemistry company. I started my career in big pharma, actually at SmithKline Beecham in London and moved to Philadelphia, was in a wonderful program there for about five years. After that, I moved to Genentech and that was my first kind of foray into biotech. And I have to say, I really never looked back after that. And I'll tell you why. There's a couple things about biotech that I think are hallmarks of biotech. One is they see the importance of bringing the customer into the development process earlier. And you'll hear this as kind of a theme that, you know, the regulators are going to be an important customer, but really, at the end of the day, we're trying to bring therapies to patients that we serve. The second thing I find about biotech is more responsive and nimble. I think more of a willingness to listen to different perspectives where I think, unfortunately, the large infrastructure and the organizational decision making in big pharma can make that more challenging. And then the last couple of things is one, I think a major hallmark of biotech has been innovation. And we all know that large pharma to a large extent has relied on biotech to bring that innovation forward. And I think that plays an important role in our overall ecosystem. Last but not least around biotech is I Think there's a propensity to have more fun in biotech. And that's certainly something that I strive to do to try to keep that life work balance.
Marco
Take me back to when you realized that you wanted to pursue the path that led you to where you are today. You are a biotech CEO. That's the apex of the profession, if you will. Was it all intentional from an early age or was it accidental?
Alberto Grignolo
Maybe serendipitous? How did you get here?
Michael Bailey
I get this question all the time. And the bottom line is I didn't set out to be a CEO, but in my career I always was very intrigued with the importance of the strategic planning, clinical strategy, financial planning. These are aspects that I are real core to the direction that an organization goes. And obviously, you know, they play a major role in the overall CEO role. Through my career I took every opportunity and I would encourage everybody who may be listening on this to do this and that is get exposed to as many different parts of the organization as you can. Certainly in a CEO role, I'm not a CMC guy, for example, but I had enough information and experience to be dangerous there. And I also always kept in mind, you know, really defer to the subject matter experts on areas of technical expertise that you can't be everything to everybody, you just can't. There's too much to know. And so you really have to rely on your team, your advisors, the good people within the organization. And when I was asked to become a CEO of aveo, I honestly didn't know if I was prepared at all, not to mention to become a turnaround CEO. But one thing about me is I don't like to fail. And, and if I'm going to do something, I'm going to do it a thousand percent. And in this case, as I said, nobody really sets up or plans to be a turnaround CEO. But when the opportunity presents itself, you really have to step up because in those circumstances it's truly a do or die.
Marco
Many people, particularly when their career is very advanced, give credit to mentors and role models in their early phases. Are there any role models and mentors that benefited you in your career throughout?
Michael Bailey
Yes, so many. I mean, too many to mention. I'll touch on one kind of early and one later. Early on, Jerry Carabellas, who was the sponsor of the program, I was at smithcon beach and really very simply taught me to focus on really the key driving factors, you know, if you will, seeing the forest for the trees. The example I'll give you is I Remember putting together this very complex forecasting model to present to him and the leadership team. And he's in his office, and he took a napkin out, and he wrote down here's four key variables that are gonna drive this business. Flipped it over to me, and he was within 10% of my very complex model. And that really spoke to me, the importance of really focusing on the key drivers for the business. There's so many different factors. You have to really try to keep them in context kind of later on, I would say. Mike Bonnie was a, you know, a very influential person in my career as I became CEO. He was a coach for me, and he helped me with things that, you know, very candidly, if you're not a CEO, you don't get exposed to as much. And that is, how do you manage your board for success? Having them really provide you with the kind of input that you need. As importantly, making sure you're giving them exactly what they need. The other thing Mike Bonnie helped me is more kind of the soft part of managing a large organization or multiple people. There's lots of leadership challenges that arise as a CEO. One simple thing that Mike taught me was something I think we all know, but we often, I think, don't practice as well as we should, which is clearly getting the right people on the bus is important, but just as importantly is getting the wrong people off the bus. And, you know, I think we can all kind of reflect back on our careers and say, I tolerated that person. That's not fitting in with the culture or just not up to the challenges that you're faced with. And I think it's important to kind of either move them into a place where they can succeed or just move them off the bus.
Marco
That's right.
Michael Bailey
My general rulers, you know, mentors are critical, but don't overlook the opportunity to really learn from everybody you interact with. I mean, it's amazing the gems you can take away from a hallway conversation with someone who you may not think is the person you should be going to for guidance. But just people's common sense I think is helpful to listen to.
Marco
You mentioned Mike Bonnie a couple of times. I believe he was, among other roles, the CEO of Cubist.
Michael Bailey
That's correct.
Marco
Am I right?
Michael Bailey
That's correct.
Marco
You talked about leadership, so I'd like to ask straight out, what type of leader are you, and how do you inspire the people that you work with?
Michael Bailey
Wow. I'm going to try to boil this down to a word. I would say, in a word, genuine. I feel like I'm a genuine leader and that what you see is what you get. I don't like politics. I don't like playing the game. It was funny you talked about becoming a CEO. The last thing in the world I wanted to be was ever would be a politician. And then, you know, to a certain extent as a CEO, there's a lot of politics. So it was inevitable. You asked about, you know, how do you inspire people at work? And I'm not sure I inspire people as much as I've organized a team who's inspired by our mission to improve the lives of patients with cancer. Every opportunity I get to try to build on that mission and communicate that in everything to do. And the last thing, you know, I think that has helped me is that I sincerely try to have fun along the way. And I think people prefer to be around people who are fun and people who are kind of not happy and miserable in general. So don't forget those kind of common sense things.
Marco
I remember years ago, you were recovering from the flu or a bad cold or something, and we were talking on the phone, and I said, how you doing, Michael? And you said, my superpowers are back. So I want to ask you, what are your superpowers?
Michael Bailey
So in a nutshell. And my wife makes fun of me all the time on this, but she's helped me define this. And I would say my superpower is I don't dwell on the bad things that happen to me or the company. And by doing that, I find I'm more optimistic and happier. And there's a positive attitude that tends to rub off on the people around you. I'm not saying just ignore the bad things that happen. Learning from the setbacks that you have is absolutely critical. What I'm just saying here is don't carry those bad days around like a wait, really. Just make sure that you're focused on what you need to do. And that's usually around the mission or the vision.
Marco
Let me take us a little deeper.
Michael Bailey
Now.
Marco
You and Aveo Oncology have endured a long, challenging, successful journey to where you are today. How did you personally navigate that journey?
Michael Bailey
Well, that's a big question, Alberto. I'm going to use my concise card on this one. And I would just say simply, one day at a time. Take it one day at a time. Always keep focused on the patient. In our case, which is our mission, always think about what's in the best interest of the patient. This is a little tool we use, actually, with my management team, and that is when we come to A crossroads or a loggerhead on a decision, we just take a step back and we say what's in the best interest of the patient? And unbelievable level of clarity comes from that. The example we had the TiVo 3 study and we didn't have a lot of money, so we were getting reimbursement for the control arm drug. And the second we heard that patients were having problems getting access or getting reimbursed, we made the decision despite not necessarily having, you know, excess funds to be able to throw at this. It was the right thing to do. And so it was a very clear decision.
Marco
Yeah. For clarity for our listeners, tell us a little bit about TiVo. TiVozenib.
Michael Bailey
Yeah. So TiVo is our now commercialized product. We got approved in March of 2021. This was the first approved product for the company. It's a VEGF receptor inhibitor. Hits very selectively, very potently. VEGF 1, 2 and 3. Our indication is in patients who have received two prior systemic therapies in a metastatic setting. So we're very excited about it. The kind of special sauce for the Tavosinib or Fotivda is the brand name, is really that it's very effective as well as well tolerated, which is very important to patient experience.
Marco
And we'll get into the clinical trials a little bit later in our conversation. But first let me ask you about something that every biotech CEO has to worry about, and that is money. Over the years, you have been instrumental and very successful in raising financing for AVEO Oncology. So I'd like to ask you, how did you prepare to ask for capital and what obstacles, if any, did you encounter?
Michael Bailey
I'll just hit the obstacles. It's kind of everything you can imagine you're going to get hit with. I mean, macroeconomic as well as specific challenges for your company with the clinical trial. So you always have to be prepared to pivot. But with that said, I would say a couple things that I think are critical for raising capital successfully. One is a well thought out and realistic and achievable plan. Then we need to effectively communicate that plan at the end of the day. I mean, I had some experiences in sales. I had a rotation that I did in sales, which was really unbelievably valuable to me because pitching for capital is selling. It's a sales call. I mean, it is what it is with any kind of sales. You have to have credibility, integrity, transparency, you know, not only just talking about the big opportunity, the upside, but being realistic about the challenges. I will Say investors can smell BS a mile away and you don't want to be in that space. And the last thing with regard to raising capital that I found incredibly valuable was listening to investors. These are smart people, MD, PhD, MBA. I mean, you know, they are among the smartest people you're going to run into in your careers. And if you ignore their hard questions, you'll be doing it at your own peril. Because I've found investors are anticipating the challenges that you're going to have, sometimes better than you do. And so I really found it important to listen to them carefully, staying for.
Marco
Another moment on the business side of things. A couple of Years ago, early 2023, Aveo Oncology was acquired by a Korean conglomerate, LG Chem. How have you managed working through two cultures that are really quite different to help advance the interest of patients, which, as you mentioned, is your core mission. So how are you navigating these two cultures? And frankly, did you have to learn any new skills?
Michael Bailey
Yeah, so the acquisition of LG was an incredible upside for us as a company. They've really committed to investing in our pipeline. And it really kind of comes from what I'll just refer to as a shared or common mission and vision. We were very much aligned on that. And that's if you're in a strategic negotiation and you and the company you're talking to see the world very differently, it's probably not going to be very successful, or they're probably going to come in and get rid of all your people and follow their own mission. So it was really important to us that we shared that common mission and vision. The mission being improving the lives of patients. The vision was to be a leader in this space, getting to cultural norms. I mean, every time there's got to be cultural sensitivity. I've been in global business in partnerships with Japanese companies, European companies, and you also always have to be as sensitive to kind of some of the cultural norms and differences. I'll give you some examples with lg, and I think these are more or less common. But one of the things that I've found is they're very polite. It kind of translates into being less direct. They refer to it as beating around the bush. So that just requires you to be a very active listener and ask clarifying questions to make sure we're, you know, you understand what feedback or information they're giving you. The other thing, you know, they're very much financially focused. They're very precise as a culture, I've found. And so it's important for us to be as diligent as possible and really have our financials buttoned up in our planning and our spending well thought out. But I would say the other kind of common cultural norm is they work hard and they play hard. And that's very much kind of how I've been raised, certainly in the biotech space. And so the chemistry was immediate. We just, we had, you know, it was clear what we needed to do and we had a lot of fun along the way.
Alberto Grignolo
Great.
Marco
Let's get to clinical trials. Since this is the clinical Trial Blazers podcast series, tell me a bit about your clinical trial journey in oncology. At avail, certainly.
Alberto Grignolo
But also earlier in your career, as.
Marco
You mentioned, did you blaze uncharted trails or did you follow more traditional paths? I know it's a big question, but how do you think about that?
Michael Bailey
Yeah, I think simply answering the question, probably a mix. But, you know, a couple things that I think are important. One thing is phase three are a big deal. Phase three investments are among the biggest investments that a company will make in their journey to bring therapies to patient. They're expensive, they're risky, but we can do things along those lines to try to reduce risk. One of those things, you can do what everybody else does do kind of a me too study. I'm not a huge fan of me too studies in that, you know, it's too big of an investment to not really advance the scientific community, advance the care of patients. So to your question, I prefer to blaze new trails. We've kind of defined blazing new trails is addressing high unmet medical needs. And if I, if I go to last, three studies that three of our programs working on. One was TiVo 3. We went into patients who are basically refractory to everything, so they were third or fourth line patients. There was some skeptics that said, these patients unfortunately are too far gone. You're not going to be able to benefit them. So to us, it was a really important question. Can we help these patients continue to fight their fight? We're currently doing a phase three study with our HGFC MET antibody, which is called Ficlatuzumab. The study is called the FIERCE head and neck study. Once again, these are patients who, their therapies have failed. I should say they don't have a lot of treatment options. And if you think about head and neck cancer patients, cancer's tough enough to deal with head and neck cancer. Often they have to see their cancer, their caregivers have to see their cancer every day. I think the Statistic is something like 40% of all head and neck cancer patients have clinical depression. This is a real unmet need and there's not been a lot of research there. There's not been a lot of advances. I'm very pleased we're at fast track status from the fda, which means that they understand the need in head and neck cancer and they're willing to help us. And our last program that I'll reference in this is AB380. It's an anti GDF15 antibody. No therapies are effective in cachexia. We're trying to treat cancer cachexia. There are other possible applications for this outside of cancer, but for now we're focused on cancer cachexia. Again, throughout some statistics, 60% of patients with cancer get cachexia. Cachexia is that wasting syndrome. If you remember Steve Jobs in his later years before he died, yes.
Marco
Right.
Michael Bailey
And then 30% of patients with cancer die of their cachexia. So real unmet need. There's really no effective therapies. So we're going to try to blaze that trail.
Marco
To use your term, you've been in the industry in several companies for a long time. Can you talk about when it comes to clinical trials, what have been your highest highs and your lowest lows? In other words, did you ever consider just giving up?
Michael Bailey
Yeah, so I'll just take a high level shot at that. Any positive phase three is a super high. You know TiVo 3, which was, you know that turnaround study that we did as a company as the first phase three I did as a, the CEO after raising capital and being able to kind of go back to your investors and say we did it and go back to the patients and bring them a therapy that could really change their lives. On the other side of that, any phase three failures is super low. And TiVo1 was the first study that we did at Aveo. I joined after the study had completed enrollment, but it read out during my tenure. And was it a phase one study?
Marco
TiVo1?
Michael Bailey
Was it TiVo3? TiVo1 was a phase three study in first line kidney cancer. Thanks for that clarifying question. But any failure in a phase three especially has major impact on the company. Your access to capital, your credibility as a leadership team, all those things you have to deal with. So one thing, kind of a cheat that we try to do whenever we can is a win win. And as you start to get a bigger portfolio, win wins are more possible for us. Our win win we designed was just read out recently was Tenevo 2. It was a combination of nivolumab plus our drug Fativda or TiVo versus TiVo alone in the second line setting of kidney cancer following IO therapy. So why is that a win win? Well, the goal of the study, objective of the study was to show that the addition of Nivo 2 of VEGF, TKI, in our case Tivo, added some value following IO. In fact, it didn't. So it was a very important study from that perspective because about 20 to 25% of all patients were getting sequential lines of immunotherapy with very limited data. So this was a study that was important to change practice. But for us, it was a win win because it allowed us to get a large data set in a contemporary setting of patients who had gotten an IO doublet or an IO TKI combination therapy in the first line. And we were pleased with the data that that control arm produced. And ultimately that can help direct therapy. And then you ask about, do you ever consider just giving up?
Marco
Yeah. Quitting?
Michael Bailey
Yeah.
Marco
Well, is that a word?
Michael Bailey
Yeah. No, no, no, of course. And Alberto, I'll say what I always say is there's a very fine line between perseverance and insanity. So, you know, as in life and similarly in business, there is a time when it's, does it make sense to keep going? You know, doing the same thing again and again and expecting a different outcome is not, is not very logical. But, you know, there's always giving up should be an option. And a lot of people talk about killing programs early. You know, kill it early is a, is probably a really good concept. As you think about earlier stage development, you don't drag it out till it gets into hundreds of millions of dollars in development where you're just kind of praying for something good to happen despite what you've seen in the past.
Marco
Can you think again, going deeper and deeper? Can you think of specific experiences, cases that highlight the challenges and successes you faced in clinical trials? Any cases that come to mind that are particularly emblematic, I'll kind of turn.
Michael Bailey
That on its head a little bit and say, what are the lessons learned from those different things? And I would say, the thing is, listen very closely to the FDA. So I was at McLone Systems when Irbitux was first filed and we got a refusal to file because of the study design that was there. And, you know, I think there was an obvious gap between what the company was hearing and what the FDA was actually saying, because you should never be in a situation where they say this is just not acceptable and then not Too dissimilarly with TiVo One, we got a complete response letter. We went all the way up to the time of getting ready to launch. Lots of expense effort that went into that. Could we have heard the FDA's message that this was problematic? We had done a one way crossover that had confounded the overall survival, which was an important endpoint for the FDA and it was an important endpoint for all of us. But could we have done a better job of listening? So listen closely to the fda. Much to the chagrin of, of my regulatory people, I always insist on going to the FDA meetings, not necessarily to say anything, but just to listen and have a different perspective. The second kind of lesson learned in clinical trials design is always consider the customer, the patient, the competitive landscape, not just the regulators. I think too often we're very keyed in on, okay, what do we need to do to get this drug approved, when at the end of the day, the bigger part of the lifecycle for this product is to be actually delivering it to the patients and meeting their needs. So you really want to make sure that you've got a clear value proposition for the patients, even though it may not be as important for your regulatory document. I think a perfect case in point is like quality of life or patient reported outcomes usually not allowed in the label, but could be really important to a decision maker. And then I mentioned kind of competitive landscape. But again, going back, do you do just what everybody else has done to get the drug approved, or should you be measuring things that are going to differentiate you in the marketplace? And those are, I think, always important factors. The other thing to consider is confounding factors. And again, the case studies here for us are subsequent or prior treatments that they got. So for TiVo1, the way that it was confounded was basically a differential set of subsequent therapies in different geographies. So that was something that I think should have been considered a little more carefully as we were going forward. And then, you know, Tenevo 2, there's five or six different combination regimens you can get prior to where our setting was. So really understanding what the impact is and designing a study to be able to tease out any differential outcomes you might see. I would say the fourth lesson learned is try to reduce risk where possible. We've designed our fierce head and neck study, which I made reference to, and we put in interim analysis as a way to kind of reduce risk. And so, you know, clinical trial design is not just heading up two drugs head to head and say, roll the Dice and let's see when it turns over. But you can design into your studies ways to try to de risk the program down the road. And then my last thing is kind of stack the DEC in your favor whenever possible. I've been involved in clinical trials where, you know, investigators are saying, oh, I've got a large population of patients who are, you know, don't qualify for your study because they have terrible performance status. And although that feels good to let those patients come into the study, often it increases the risk of your study. And I've been in situations where, you know, the population of, of poor performance status didn't do well and the good performance status did great. But at the end of the day, you have to look at the total data set and unfortunately that was a setback for the company. So think about the patient population. Try to, as I refer to, stack the deck in your favor wherever possible.
Marco
You mentioned going to FDA meetings. It's been common accepted wisdom in the regulatory profession, where I spent most of my career, that you never take your CEO to an FDA meeting.
Alberto Grignolo
They'll only cost.
Marco
Right.
Michael Bailey
Trouble. Yeah, I usually put the zipper on my lip and throw away the key and I just listen. I put my ears on big.
Marco
Okay, so you were not a troublesome CEO at meetings with the fda?
Michael Bailey
Well, that. Not that anybody told me to my face, but okay.
Marco
Would they tell you?
Michael Bailey
Of course, of course, of course.
Marco
Have you ever felt that the world or the circumstances were absolutely stacked against you? If so, how did you stay motivated?
Michael Bailey
It's a real privilege to work in this industry. I mean, so on the worst days, I'd rather be doing this job than some other more challenging jobs in our kind of ecosystem. With that said, I've faced my share of challenge. And the thing that really gets me out of bed is really, again, going back to that mission, focus or the patients. When I took the job as CEO, I said, this is wonderful. I can actually drive to getting this study done for the patients we serve. But on top of that, wow, great opportunity. A first time CEO, that's kind of rare air. And then if we're successful, there's some certain financial rewards that can come from it. Well, I will tell you that there was more than a handful of days where you got up and you said, I have ruined my career and I am certainly not going to make any money. But I have to get out of bed today because the patients really depend on it and we're doing something really important. So those are the kind of things I would say the key things to stay motivated. If you ever hire someone and they don't mention in your discussion with them in an interview that a reason to want to be at your company is to help patients, then they're probably, I mean, certainly here at aveo, they're probably not going to fit in with. And like I said, this is a tough business. I mean, unprecedented failure rates. So you've got to have a higher.
Marco
Calling to close out with your career journey. What is your next area of excitement?
Michael Bailey
Well, professionally I'm absolutely committed to making ABEO LG a leading oncology company, leading global oncology company, which is our vision. And there's a lot obviously we have to do. I'm really excited about the clinical trials that we have ongoing and the readout of them. But I'm also excited just to be part of this oncology community. And we're very excited about a month that we always rally around and that is Kidney Cancer Awareness Month in March. So please do Visit us at abeo oncology.org, follow our initiatives there. We've been working very closely with advocacy groups and again, keeping that patient focus. As far as what am I really excited. Our business is pretty slow when you think about it. You start a trial and trial and three years later, maybe four, you get to read it out. So my anticipation rises over those years as you get closer and closer to that readout. And that's what I'm really excited about, is bringing new therapies to patients.
Marco
Great message to end with. Michael Bailey, President CEO of aveo. Thank you so much for your time today. Your deep insights, so illuminating. Thank you so much for a wonderful conversation.
Michael Bailey
Thank you, Alberto. It's always a pleasure.
Alberto Grignolo
Thank that's it for this episode of Clinical Trial Blazers. Michael, thank you very, very much. Really loved hearing your insights on the evolving landscape of oncology trials and the impact on patient care. I think your point about taking it one day at a time and keeping the focus on the patient will resonate really well with many other biotech leaders. That's what it's all about, after all. We hope that today's conversation offered valuable perspectives to you, the listeners on navigating the challenges of clinical development while staying focused on delivering what means the most to patients their health. Stay tuned for more episodes of Clinical Trial Blazers, where we will continue to explore human stories behind the ideas and innovations that are shaping biopharma and biotech. And please do take a moment to rate and review this podcast wherever you listen. Clinical Trial Blazers is created by Park Cell Biotech tech and hosted by me, Alberto Grignolo. Special thanks to our production partner, Wonder Media Network. And thank you for listening. Until next time, stay curious and let's keep pushing the boundaries of clinical research.
Podcast Summary: Clinical Trial Blazers – Interview with Michael Bailey, President and CEO of AVEO Oncology
Podcast Information:
Note: While the episode is part of "The Great Detectives Present Dragnet" series, this particular segment features an insightful conversation from the "Clinical Trial Blazers" podcast, hosted by Alberto Grignolo, with guest Michael Bailey, President and CEO of AVEO Oncology.
In the episode titled "You Might Also Like: Clinical Trial Blazers," host Alberto Grignolo engages in a comprehensive dialogue with Michael Bailey, the President and CEO of AVEO Oncology. The conversation delves into Bailey's extensive background in the biotech industry, his leadership philosophy, navigating the challenges of clinical trials, and his vision for the future of AVEO Oncology.
Michael Bailey's Career Path: Bailey begins by sharing his career trajectory, highlighting his transition from big pharma to biotech. Starting at SmithKline Beecham in London, he later moved to Genentech in Philadelphia, which marked his entrée into the biotech sector.
"One of the things about biotech that I think are hallmarks is the importance of bringing the customer into the development process earlier... more responsive and nimble, more innovation."
[01:13] – Michael Bailey
Motivation for Biotech: Bailey emphasizes the agility and innovative spirit of biotech companies compared to larger pharmaceutical firms. He appreciates the focus on patient-centric development and the dynamic environment that fosters rapid adaptation and creativity.
Path to Leadership: When asked about his journey to becoming a CEO, Bailey describes it as a blend of strategic opportunities and personal determination rather than a premeditated plan.
"I didn't set out to be a CEO, but in my career I always was very intrigued with the importance of strategic planning, clinical strategy, financial planning."
[03:07] – Michael Bailey
He underscores the importance of gaining diverse organizational insights and relying on a strong team to navigate the multifaceted responsibilities of a CEO.
Role Models and Mentors: Bailey attributes significant influence to mentors throughout his career, particularly highlighting Jerry Carabellas and Mike Bonnie.
"Jerry Carabellas really taught me to focus on the key driving factors... Mike Bonnie helped me with managing my board and the soft aspects of leadership."
[04:55] – Michael Bailey
He stresses the value of leadership coaching and the critical lesson of having the right team, emphasizing the importance of both bringing in the right people and making tough decisions to move out those who don't fit.
Genuine Leadership: Describing himself as a genuine leader, Bailey avoids office politics and focuses on authenticity.
"I would say, in a word, genuine. I feel like I'm a genuine leader and that what you see is what you get."
[07:40] – Michael Bailey
Inspiring Teams: Rather than seeking to inspire directly, Bailey focuses on organizing a team united by a shared mission to improve patient lives. He believes in fostering a fun and positive work environment to maintain high morale.
"I've organized a team who's inspired by our mission to improve the lives of patients with cancer... I sincerely try to have fun along the way."
[07:49] – Michael Bailey
Resilience and Optimism: Bailey identifies his ability to maintain optimism despite setbacks as his "superpower." This positive attitude helps cultivate a similar outlook within his team.
"My superpower is I don't dwell on the bad things that happen to me or the company... a positive attitude that tends to rub off on the people around you."
[09:07] – Michael Bailey
One Day at a Time: Bailey emphasizes a patient-focused approach, advocating for decisions that prioritize patient interests to provide clarity in challenging situations.
"Take it one day at a time. Always keep focused on the patient... what's in the best interest of the patient."
[10:03] – Michael Bailey
Clinical Trials and Product Development: He discusses AVEO Oncology's flagship product, TiVo (tivozenib), a VEGF receptor inhibitor approved in March 2021 for metastatic patients who have undergone prior systemic therapies. Bailey highlights TiVo's efficacy and tolerability as key strengths.
"TiVo is very effective as well as well tolerated, which is very important to patient experience."
[11:07] – Michael Bailey
Capital Raising Essentials: Bailey outlines critical strategies for successful capital raising, including having a realistic plan, effective communication, maintaining credibility, and actively listening to investors.
"Pitching for capital is selling... credibility, integrity, transparency... Listening to investors."
[12:08] – Michael Bailey
He shares insights from his sales experience, likening capital raising to a sales call where honesty and responsiveness are paramount.
Navigating Cultural Differences: Following AVEO Oncology's acquisition by LG Chem in early 2023, Bailey discusses the importance of shared mission and vision in harmonizing differing corporate cultures.
"We share a common mission and vision... cultural sensitivity is crucial."
[14:11] – Michael Bailey
He elaborates on adapting to LG's cultural norms, emphasizing active listening and meticulous financial planning to align with their precise and polite working style.
Blazing New Trails: Bailey advocates for innovative clinical trials targeting high unmet medical needs rather than conducting redundant "me too" studies. He highlights current projects addressing refractory patients in kidney cancer, head and neck cancer, and cancer cachexia.
"Blazing new trails is addressing high unmet medical needs... patients who are refractory to everything."
[16:44] – Michael Bailey
Risk Mitigation in Trials: He shares lessons learned from past trials, stressing the importance of listening to FDA feedback, understanding patient and competitive landscapes, designing studies to reduce risk, and carefully selecting patient populations to improve study outcomes.
"Listen very closely to the FDA... consider the customer, the patient, the competitive landscape."
[23:36] – Michael Bailey
Highs and Lows in Clinical Trials: Bailey recounts the emotional highs of successful Phase III trials, such as TiVo3, and the lows of trial failures, which impact capital access and company credibility. He underscores the necessity of perseverance balanced with strategic program termination when necessary.
"Any positive phase three is a super high... any phase three failures are super low."
[19:56] – Michael Bailey
Maintaining Motivation: Despite facing significant challenges, Bailey stays motivated by the mission to help patients and the personal fulfillment derived from leading impactful clinical trials.
"The patients really depend on it and we're doing something really important."
[28:36] – Michael Bailey
Vision for AVEO Oncology: Looking ahead, Bailey is committed to establishing AVEO Oncology as a leading global oncology company. He expresses excitement about ongoing clinical trials, upcoming data readouts, and continued collaboration with advocacy groups to enhance patient care.
"I'm really excited about the clinical trials that we have ongoing and the readout of them."
[30:08] – Michael Bailey
He also highlights the anticipation surrounding trial outcomes, emphasizing the long-term rewards of bringing new therapies to patients.
The episode offers a deep dive into Michael Bailey's leadership and strategic approaches within the biotech industry. His emphasis on patient-centric development, innovative clinical trial design, and maintaining a positive organizational culture provides valuable insights for emerging biotech leaders and enthusiasts alike. Bailey's commitment to improving patient lives and navigating the complexities of clinical development underscores the pivotal role of leadership in advancing scientific innovation.
Notable Quotes:
"Biotech sees the importance of bringing the customer into the development process earlier."
[01:13] – Michael Bailey
"What you see is what you get. I don't like politics."
[07:49] – Michael Bailey
"Don't dwell on the bad things... focus on the mission or the vision."
[09:07] – Michael Bailey
"Take it one day at a time. Always keep focused on the patient."
[10:03] – Michael Bailey
"Pitching for capital is selling... credibility, integrity, transparency."
[12:08] – Michael Bailey
"Listen very closely to the FDA... consider the customer, the patient, the competitive landscape."
[23:36] – Michael Bailey
This detailed summary encapsulates the key discussions, insights, and conclusions from the interview with Michael Bailey on the "Clinical Trial Blazers" podcast. It provides a comprehensive overview for listeners who may not have had the chance to engage with the full episode.