Stepping Out in Oncology

Take a tour of UroGen Pharma President and CEO Liz Barrett’s Twitter feed, and you’ll quickly get a sense of where her priorities lay. Actually, just look at her Twitter name—@lizforacure—and therein is her motivation.

Liz Barrett

UroGen received FDA approval for its mitomycin gel for the treatment of low-grade upper tract urothelial cancer (UTUC). The product, marketed as Jelmyto, inhibits DNA transcription into RNA, stopping protein synthesis so cancer cells are unable to multiply. It was approved through FDA’s priority review, fast track, breakthrough therapy, and orphan drug designations, primarily for the reasons Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in CDER, said in a statement upon Jelmyto’s approval: “This is the first approval specifically for patients with low-grade UTUC and provides an option for some patients who may otherwise require a nephroureterectomy,” said Pazdur. “Due to substantial treatment challenges associated with the complex anatomy of the upper urinary tract, many patients need to be treated with radical surgery—usually complete removal of the affected kidney, ureter, and bladder cuff. Jelmyto gives patients, for the first time, an alternative treatment option for low-grade UTUC.”

Barrett, of Jelmyto’s approval, told Pharm Exec, “The patients with upper tract urothelial cancer were losing their kidneys. The FDA was extremely supportive and suggested to us that if we could save one in four, or one in five kidneys, that would be really meaningful.”

As it turned out, almost 60% of the patients in the Phase III trial had a complete response and avoided surgery to remove their kidney. Barrett credits FDA for working closely with the small company to provide advice and guide it on how the expedited process worked in recognition of the unmet need for these patients.

Jelmyto’s approval is a first step toward what UroGen is hoping its next compound in development will address in the bladder cancer space, which, too, features a landscape of unmet need. UGN-102 is currently in Phase II trials for non-muscle invasive bladder cancer (NMIBC), which, like Jelmyto, seeks to provide an option for patients besides invasive or recurring surgery. There are currently no FDA-approved drugs for first-line treatment of NMIBC; the three marketed therapies for NMIBC are only for adjuvant treatment.

The current standard of care for the estimated 80,000 patients per year diagnosed with bladder cancer is transurethral resection of bladder tumor, followed by adjuvant chemotherapy or, in certain cases, immunotherapy at the discretion of the treating physician. That tumor resection is performed under anesthesia in a hospital, and with a high disease recurrence even after the procedure, patients usually require multiple surgeries to control NMIBC over a lifetime, making bladder cancer one of the costliest cancers to treat in the US.

And it is among the reasons—patients’ needs and cancer complexity—that Barrett accepted the position of UroGen president and CEO in January 2019. Prior to that appointment, Barrett was the CEO of Novartis Oncology and a member of the Executive Committee of Novartis. When looking down the list of impressive achievements in Barrett’s resume, oncology is prominently featured. She was global president of oncology at Pfizer, and preceding positions at the pharma giant included president of global innovative pharma for Europe, president of the specialty care business unit for North America, and president of US oncology. Prior to Pfizer, Barrett was vice president and general manager of the oncology business unit at Cephalon Inc.

And here is where Barrett’s oncology story begins, over 20 years ago, in a convergence that now features more prominently in the pharma narrative—the consumer vs. the patient, where many advise pharma to view all consumers as potential patients, and pharma laser-focused on delivering medicines to the patients who need them.

Barrett started her career at Kraft Foods Group, then, after relocating to Philadelphia and obtaining an MBA from Saint Joseph’s University, she moved to Johnson & Johnson’s consumer products, and ultimately into the pharmaceutical side of the business with its Ortho Biotech unit.

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The transition from consumer products to healthcare was admittedly difficult because it was hard to do at the time, says Barrett, when not many people moved into pharmaceutical via her career pathway. It was more traditional for sales reps to start in pharma and then move into marketing. But it was a transition she very much wanted. While Barrett loved Reach toothbrushes and the importance of oral care, she says, “The type of impact you could have working on the pharmaceutical healthcare side was something I really wanted. And they wanted my experience with consumers and working with patients and consumers. Our industry gives us the challenges that exist in business, but at the same time, the work we do every day actually makes a difference. It gave me a purpose. And I haven’t looked back since.”

Barrett’s first experience on the pharma side was to lead J&J’s director-to-consumer (DTC) campaign for Procrit in HIV, the first patient population that J&J reached out to, and at a time when HIV was at epidemic proportions. “There were very few treatments available for those patients and they were very active,” says Barrett. “I really enjoyed the people that I worked with—the activism, the passion they had, and working very closely with patient advocacy groups.”

She took those insights and passion from the HIV community to help launch the first DTC campaign in oncology. “That was interesting because a lot of people said, no, it will never work. But it did,” says Barrett. Through those learnings and research, Barrett heard many inspirational stories from patients about how their medicine allowed them to enjoy the ordinary things in life. “With oncology, everybody you know is touched by cancer in some way; whether it’s family or friends or acquaintances, almost everybody knows someone that has died from or struggled with the fight with cancer. It drove me and I became even more passionate to stick with oncology,” she says.

Though five-year survival rates for many cancers have increased dramatically since Barrett entered the oncology arena, and the scientific developments have made amazing strides, she notes that oncology, by nature, is very complex. “They say that cancer is 150 different diseases, with multiple stages and every tumor is different,” says Barrett. “People often ask me about a cure, and even though my Twitter handle is @lizforacure, I, unfortunately, don’t know. I think we will have cures for cancer, but not one cure, because it’s multiple diseases rolled into one that we call cancer, and there’s much more that we have to learn.”

Concerns during COVID

Barrett joined a CEO roundtable in mid-May, CEO Leadership During the Pandemic, hosted by Pharmaceutical Executive and its parent company MJH Life Sciences.She shared insights around launching Jelmyto during lockdowns and the virtualization of physician education events, as well as the need for the use of real-world evidence in clinical trials. Again, her coupled interests of patient needs and educational outreach came to bear.

Liz Barrett speaks at Nasdaq headquarters.

“Our official launch was in June, and we were seeing patients coming back into clinics and surgery centers, we were seeing more patients come back into the healthcare system,” says Barrett. But that timeframe also occurred with COVID-19 resurgence in other geographic regions. While patients and healthcare locations strive to be safe and provide safe care environments, Barrett grows more concerned that patient safety concerns will affect diagnosis and a lag in discovery of potential cancers.

“There are reports emerging that skincare diagnosis is down 80%. So, if that’s basal cell carcinoma, maybe that’s okay. But if it’s melanoma, not necessarily,” she says. “The University of Nebraska Medical Center said that cancer treatments at their facilities have been cut in half, which suggests a 30% to 50% drop in cancer patients getting their prescribed treatment. We know that early diagnosis and early treatment results in the best prognosis, so this is not a good thing.”

Barrett refers to recent TV advertising of cancer centers informing of their safety practices and encouraging patients to not delay screenings or making appointments if concerned. “I think people are uninformed and they need to know that physician offices and hospitals are doing everything they can to keep them safe, and patients should not put off coming in,” says Barrett. As far as pharma’s role, she points to a continued focus on access to patients, as well as access to patient advocacy groups to educate and encourage people to participate in their healthcare. While these approaches need to vary by geographical and localized exposure to COVID, Barrett says UroGen is doing a lot via social media and through digital approaches, again, to encourage patients to get treated and have confidence they will be safe.

Bringing the past to present

Like many executives who have made the move from large pharma to smaller biopharma, Barrett has experienced the wearing of many hats, as well as resource realities. “Somebody the other day was trying to justify adding staff because, at his level, he shouldn’t be doing X, Y, and Z. And I responded, ‘I’m the CEO and trust me, I’m doing things I haven’t done in a really long time,’” says Barrett with a laugh. “The first time I went to the American Urological Association meeting, I had to figure out everything on my own, where I used to have someone taking care of all of that. Yes, you wear many different hats in this role, from finance, to legal and the balance of the day-to-day operations vs. building a long-term strategy for a successful, sustainable business.”

As the case for most executives, these responsibilities lead to challenges. Top on Barrett’s list of things that keep her up at night (besides her family) are entities or issues outside her or the company’s control, for example, the FDA. “You never know what they are going to think? We know what our clinical data looks like, and we know what clinicians think of the data, but will it be aligned with the FDA perspective on unmet need and what is necessary for an approval?” says Barrett. “Especially in a small company like ours, where we can’t absorb the same level of hits as a large company.”

Barrett also spends more time getting UroGen’s narrative correct to ensure investors are on board and understand the company’s mission and medicines, because that can be challenging if the investor sentiment isn’t correct.

And while in her control is the ability to ensure that patients have access to her company’s medicines, outside of her control is a patient’s response to screening or diagnosis decisions during the pandemic.

But, also true of executives who have gone from large to small companies, there is an excitement around the ability to fundamentally shape an organization’s direction. Barrett is no exception.

“Starting about 10 years ago, I would get calls to do this type of job. But I never felt I was quite ready,” says Barrett. “I think the experience that I had at Pfizer and Novartis really prepared me to be successful in this role.”

UroGen, based in New York City, employs 200 people, grown from the 70 when Barrett started there early last year. “The colleagues here at UroGen have a lot of experience, and everyone is so excited and passionate about being able to take this company to where we are now and beyond. That’s been the fun part for me…to come in and lead and shape the company. That’s one of the things, when I joined Cephalon years ago; I built the oncology business from scratch, which is very similar to what I’m doing now, and I feel fortunate to be in this position.”

While Barrett is outspoken about her passion for patients and describing UroGen and past company achievements, she doesn’t readily have an answer for the specific qualities she possesses that form the backbone of her executive record in pharma. “I can definitely say, I’ve never been very deliberate about my style. I’ve tried to remain true to who I am as a person,” says Barrett. “I grew up in a very blue-collar, middle-class family, and I was the first one in my family to go to college. My father taught us to work hard, be respectful, and do the right thing.”

In Barrett’s last review at Pfizer, her boss told her “you work by your values.”

“I never really thought about it like that,” she remembers. “And I think he’s right. It served me well; it’s also caused me problems because I can be very, very honest. But I’ve learned over time to be more tactful in my honesty.”

When it comes to Barrett’s teams and management style, she believes that honesty and courage are a major reason she’s not afraid to take bold approaches. “I challenge myself, but I also challenge my teams to always strive to do better,” explains Barrett. Recently, the executive says she received a text from a former employee she hadn’t spoken to in a couple of years, who was taking a new job. The text read: “I know I wasn’t always receptive at the time, but I just wanted to say, thank you. It’s only in retrospect that I can appreciate you pushing me to be the best person that I could be.”

“Wow. It was a nice text to get on a Saturday. Obviously, the work that I’ve done, in helping patients and having that impact on patients and being able to bring medicines to those patients is amazing,” says Barrett. “But at the end of the day, it’s also the impact I’ve had on the people that I’ve interacted with and the people that I’ve worked with. To me, it’s hard to get better than that.”

Lisa Henderson is Pharm Exec’s Editor-in-Chief. She can be reached at lhenderson@mjhlifesciences.com.