Persevering for Patients

Michael P. Bailey has learned many lessons along his way to becoming president and CEO of AVEO Oncology. But one of the greatest insights he’s gained is that perseverance pays. Perhaps his family’s musical background has helped teach him that. While everyone plays guitar, Bailey also plays drums, his wife and kids are vocalists, and his wife is also a keyboardist. As a result, he’s well aware of how dedication and commitment contribute to success on any stage.

Bailey grew up outside of Albany, NY. His father was a medicinal chemist at Sterling Drug, and Bailey was eager to follow in his scientific steps. But Bailey’s plans to become a doctor were derailed by the glamorous finance world of the 1980s. He attended St. Lawrence University, where he received his BS in psychology and economics. Though he enjoyed a successful career in financial consulting, Bailey still couldn’t shake his desire to help people through science. To be able to do that, he enrolled in the University of Notre Dame’s Mendoza College of Business to study international marketing, with the intent of building a career on the business side of pharma. Later in his career, he also attended the Harvard Business School Executive Education program for finance.

Bailey began his career in industry at SmithKline Beecham (SKB), now GlaxoSmithKline. There he was exposed to multiple facets of business, including marketing, strategic planning, analytics, and sales. But what he found most interesting was launching products, which combined all of those areas.

“Through my launch experience, I found out that it’s really important to bring the patient into the early development process,” says Bailey. “Having the focus of the customer versus just a regulatory or scientific consideration really makes a difference.”

In order to experience that, and on the advice of his mentor, Jerry Karabelas, who was executive vice president of SKB at the time and is now a partner at Care Capital LLC, Bailey started looking toward biotech, which seemed to integrate the development and commercialization processes better than big pharma. As a result, he joined Genentech, whose trailblazing antibody technology enhanced patient tolerability.

It was during his time at Genentech that Bailey started looking at his career on a macro level. Most of his experience had been in the anti-infective and cardiovascular space, areas of science that had made tremendous advances in extending patient lives. He thought about what the next big unmet health need would be, and the answer was clear—cancer. As life expectancy continued to increase, more people would have to face the disease.

Fighting the odds in oncology

Bailey left Genentech and shifted his focus to oncology, ultimately becoming senior vice president of commercial operations at ImClone Systems. This was his first test of perseverance. At ImClone, a poor initial clinical trial design for the colorectal cancer drug Erbitux ended in a negative FDA response. That snowballed into a very public insider trading scandal, when the company’s CEO sold the stock before the FDA announcement and he—and notorious investor Martha Stewart—were sentenced to jail. “As those setbacks occurred, I looked myself in the mirror and said, ‘Is this worth it?’” says Bailey. “I found myself sitting at a company that I wasn’t sure was going to be helpful for my career, and it forced me to look inside and say, ‘Why did I come here to begin with?’ The answer was because I believed in the lead product, Erbitux, and what it could do for patients.”

Bailey knew that the drug worked. He had the privilege of meeting patients who shared how it had changed their lives and he knew it was worth it. From there, he put his passion behind his work and pushed forward to devise a new plan. “I don’t think anybody sets out to be a turnaround CEO, but when you stumble on it, you have to step up to the challenge,” says Bailey. “Perseverance as a virtue is good, but there’s a fine line between perseverance and insanity. You really have to do your assessment, and I did that at ImClone. I knew that the drug worked, that it could provide benefits to patients. So perseverance was my call to duty.”

ImClone and its partners ultimately designed and performed another study according to the FDA recommendations, which proved successful.

Bailey’s time at ImClone was followed by another challenge as chief commercial officer and senior vice president of business development at Synta Pharmaceuticals, where in 2009, clinical trials for the cancer drug elesclomol were halted due to safety concerns. Roughly one year later, FDA approved resuming development.

Around that time, Bailey transitioned to chief commercial officer at AVEO, where yet another challenge awaited him. FDA denied approval for AVEO’s lead candidate, tivozanib, in 2013 due to a study design flaw that resulted in an uninterpretable overall survival result. The company decided to shelf the asset, but Bailey persisted, now in the role of chief business officer, and convinced his board of directors and Henri Termeer, AVEO’s chairman, to follow FDA’s guidance and invest in another study.

“I said, this drug works, it’s got huge advantages for patients,” says Bailey. “And then Henri asked me to be CEO and lead the AVEO turnaround. That was a very proud moment. Having the confidence and support of such a legendary innovator and leader was absolutely humbling.”

Eye on the prize

When it comes to product development and commercialization, every leader knows that challenges will arise and failures will occur. Accepting an executive role comes with that risk and leaders need to be willing to take it on. The key to success is to learn from the setbacks in order to help anticipate them in the future and mitigate any obstacles before they become problematic.

“If you have experience in developing and commercializing therapies, it makes you acutely aware of the many complexities and challenges that lie ahead,” says Bailey. “This is not easy business, what we do. It’s a long slog full of ups and downs, but at the end of the day, you have to believe you can make a difference, and you have to want to make a difference.”

What fuels Bailey’s patient-focused mission is the motto, by doing right, you’ll do well. “I think my mom told me that,” he says. “If you always do what’s in the best interest of the patients, you’re going to find success and your stakeholders will be rewarded. At the end of the day, that’s what we’re supposed to do.”

Bailey prides himself in fostering a culture at AVEO that is passionate about patients, collaborative, and fun. It’s not easy to expand a company amid a pandemic, but bringing people onboard has been facilitated by AVEO’s attractive culture and vision to improve the lives of cancer patients. In building a team of dedicated professionals, Bailey believes in actively listening to employees to elicit their insights and learn from them. He was once advised by John Johnson, ex-CEO of ImClone, to hire great people, give them opportunities, and fulfill their potential. “Johnson said, ‘If you’re a CEO, your role is chief enabling officer, not chief executive officer,’” says Bailey. “So provide opportunities to your employees, and you will reap the rewards.”

When Bailey interviews job candidates, he makes a point to ask them one specific question: Why do you want to come to this company? The response he looks for first and foremost is one that demonstrates a dedication to patients.

“If they don’t have the patient at the top, they’re probably not going to last long in biotech,” he says. “There have been plenty of mornings that I’ve woken up and thought my career was ruined, and I wasn’t going to create any value for stakeholders or myself. But what gets me out of bed and keeps me coming back is that loftiest goal of doing something good for the patients. That’s worth dusting yourself off for and making another run at it.”

Evolving with treatments

Since taking the helm at AVEO, Bailey has continued to fight for tivozanib, an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and other cancers. The drug currently is approved for the treatment of adult patients with advanced RCC in the EU, Norway, New Zealand, and Iceland, where it is known as Fotivda. In June 2020, FDA accepted the new drug application for tivozanib as a treatment for relapsed/refractory RCC and assigned a Prescription Drug User Fee Act target date of March 31, 2021.

When Bailey reflects on how the cancer space has changed over the years, he is amazed. It wasn’t long ago that physicians’ best resources were poison-derived chemotherapy treatments. Biologics and antibodies—which Bailey was involved with at Genentech—then rose to the top of the list. Now the focus is on targeted therapies and immunotherapies, which AVEO is seeking to advance.

“It’s really nice that I’m doing what I wanted to do in my career—stay on that cutting edge of improving patient’s lives who have cancer,” says Bailey. “It seems as an industry, we push the limits to try to improve overall survival, but with that, unfortunately, often comes additional toxicity. Then we try to manage those toxicities. It’s almost like an ecosystem in biotech where certain companies can take innovation and really push it, but there has to be a parallel process where we try to maintain those advances in efficacy in a better tolerated way.”

That is a major focus of AVEO. As immuno-oncology therapies are combined with TKIs, one of the challenges is added toxicity. AVEO is excited by tivozanib because it is very selective and seems to convey a more tolerable course of therapy. While AVEO awaits FDA’s decision on single-agent use of the drug, it is also working with Bristol Myers Squibb and AstraZeneca to combine tivozanib with their PD-1 and PD-L1, respectively, to capitalize on the survival advances of the immunotherapy in a better tolerated way. Tivozanib is also the first and only Phase III randomized study in third- and fourth-line oncology treatments. Boosting tolerability at this stage is important, because about 50% of patients in the third- and fourth-line setting decline additional therapy. “They choose to not continue their fight against cancer, and that is devastating,” says Bailey.

These patients cite two reasons why. One is that they’ve had enough toxicity with earlier lines of treatment and just want to enjoy the rest of their life without being sick from their therapy. The second is there hasn’t been a positive clinical study in the third and fourth line before tivozanib.

“Our mission is really focused on improving the lives of patients with cancer,” says Bailey. “The clinical trials are important, but we rely a lot on advisors, on the nurses and physicians who are treating the patients, and advocacy groups. Every time I speak to advocacy groups, I learn more about the patient experience and what we could do better as an industry to improve that experience. That’s really helpful in early development.”

After tivozanib, AVEO’s next most advanced program is ficlatuzumab, an HGF/cMET monoclonal antibody (mAb) inhibitor to treat head and neck cancer. Patients who have this very visible and debilitating cancer have a limited life expectancy and roughly 40% suffer from clinical depression. AVEO sees a great opportunity to improve the lives of these patients with ficlatuzumab and is researching its use in combination with Erbitux in current Phase II trials.

Another program that just went into the clinic this year is for AV-380, which is a GDF15 mAb focused on cachexia. Cachexia, which causes weakness and wasting away of the body, is one of cancer’s common comorbidities—50% of cancer patients suffer from this, and 30% are believed to die from the cachexia and not from the cancer. The potential for AV-380 goes beyond cancer and opens the door to potentially help patients suffering from other diseases where cachexia is a comorbidity.

“There have been no effective therapies for cachexia, but there are literally millions of patients who suffer from this,” says Bailey. “If you solve the cachexia, then potentially you could improve survival. So we’re excited about this program. This is so square to our mission.”

Continuing collaboration

As demonstrated by its partnerships with BMS and AstraZeneca, AVEO understands the strength of good collaboration. While different companies bring different expertise, capabilities, and resources to the table, it’s always important to choose partners that share the same vision. “A small company like ours has limited resources,” says Bailey. “If we want to start combining agents, we don’t have all of the agents we want to combine with. So collaboration has been a cornerstone to advancing our programs and our strategy. I’ve spent a large part of my career in business development finding and managing collaboration opportunities. In my role as CEO, we apply the idea that collaborations are truly a lifeblood to the company and to the industry as a whole.”

Industrywide collaborations certainly came into the spotlight over the past year, thanks to COVID-19. The response to the pandemic and the collaborations that ensued have been “a shining moment for the industry,” says Bailey. “It’s a very important statement to society that what we’re doing is really important. It’s hard, it’s risky, but it’s worth it in the end.”

Another silver lining of the pandemic has been the redevelopment of oncology therapies as COVID therapies. Though AVEO’s portfolio is not primed for this, the Canadian biotech IMV, for which Bailey is a board member, has a proprietary first-in-class delivery platform that offers a relevant application to COVID-19. “The company is actively developing a vaccine that we believe may overcome some of the resistance, durability, manufacturing, and distribution challenges that the first-generation COVID vaccines have seen,” says Bailey. “We’re encouraged and hopeful.”

Remote learning

Pre-COVID, Bailey listened to workers who wanted workplace flexibility by allowing all employees to work from home on Fridays. He believes AVEO’s collaborative culture is the cement that helps hold everyone together even when they are apart. Unsure of what schedules will look like post-COVID, Bailey imagines there will continue to be some sort of hybrid work arrangement.

Bailey himself appreciated his pre-pandemic time split between the office in Boston (Mondays-Thursdays) and his family home in Maine (Fridays-Sundays). “It is the absolute best of both worlds,” he says. “Boston is my favorite city in the world, and Maine is beautiful, with lots of things to do outdoors. We sail, ski, surf, and golf as a family—the common theme of these activities is that I can hold my kids hostage. I think they’re accepting of it, even as teenagers, because there are so many demands on my time, that when we get together for the weekends, we really enjoy each other’s company.”

Though COVID has presented many challenges, Bailey appreciates having been able to rediscover family over the past year. As he looks back at old photos of his family rocking out at Bon Jovi and Billy Joel concerts, he gets a little sentimental. “This year has been incredibly special for me—it’s my daughter’s last year before going to college, and I got to spend the whole year with her,” he says. “I think the core unit of the family has been solidified through this pandemic.”

Whether it’s a pandemic or a business setback, Bailey is a pro at meeting adversity with a positive outlook. “It’s not been easy,” he says. “I would be lying to you if I said so. But it has been rewarding.”

Update: On March 10, FDA approved tivozanib for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. It will be marketed as Fotivda by the end of the month in the US.

Elaine Quilici is Pharm Exec’s Senior Editor. She can be reached at equilici@mjhlifesciences.com.

Online Coverage

To hear more of Michael P. Bailey’s insights on the biopharma industry, watch video clips from the August 2020 Pharmaceutical Executive virtual closed roundtable titled “Pharmaceutical CEO Leadership: Image of the Pharma Industry” and read our coverage of the roundtable in our October issue.