It’s hard to find anyone whose life hasn’t been touched by cancer. In 2022 alone, nearly 20 million new cases were diagnosed globally, leading to 9.7 million deaths worldwide.
And while advancements in health care and technology bring hope of more effective treatments, the road from idea to impact is filled with challenges.
Sharon Cunningham, EY Entrepreneur Of The Year™ 2025 Ireland winner, on a mission to overcome some of these challenges, co-founding Shorla Oncology in 2018 alongside Orlaith Ryan. The company focuses on specialty oncology drugs tailored for underserved patient populations, particularly women and children, working to fill critical gaps in cancer care and bring innovative solutions to those who need them most.
The company currently has four FDA-approved, commercialized drugs in its portfolio, with a growing pipeline of further treatments.
— Sharon Cunningham share
“We’re a mission-driven organization, led by our purpose,” says Cunningham. “Helping vulnerable patient populations is a privilege, and I couldn’t be prouder of our team as we realize our vision of improving lives through science and innovation by making existing oncology treatments better.”
And while her work is — intentionally — specific, all executives can learn from Cunningham and Shorla’s story.
Build with intention: a career designed to make a difference
Before co-founding Shorla Oncology, Sharon Cunningham laid the groundwork for a purpose-driven career. After earning a degree in finance, she trained as a chartered accountant with PricewaterhouseCoopers (PwC), then moved into the pharmaceutical sector — drawn by its potential to impact lives and offer long-term stability. She joined EirGen Pharma as a management accountant and quickly advanced to Head of Finance, earning her executive MBA along the way.
“I come from an entrepreneurial family, and I always knew I would run my own business eventually,” she says, adding that as a child, she had several business ventures, including a tea shop and a library.
“From a career perspective, I wanted to spend time in practice and industry and gain as much formal education as possible to maximize my knowledge and skills, build an industry network and ultimately enhance my credibility to ensure success.”
Focus on the few: meet the needs of the overlooked
Unlike many larger pharmaceutical companies that often focus on broad-spectrum cancer treatments, Shorla Oncology identifies specific areas of unmet need in oncology, including drug shortages and inadequate treatments for specific patient demographics.
Then, Shorla reimagines the formulation of existing cancer drugs, focusing on improving the efficacy, safety and accessibility of these treatments for patients often left behind by traditional offerings.
“Drug shortages frequently threaten childhood cancer treatment and pose a significant public health concern, says Cunningham. “They have a significant impact on patient health outcomes, leading to delays in treatment or substitution with less effective therapies when the preferred drug product is not available. This adversely affects outcomes such as disease progression and survival.”
— Sharon Cunningham share
For example, patients with acute lymphoblastic leukemia, the most prevalent childhood cancer, need a steady, reliable supply of effective medication to improve their chances of successful treatment. One of the limited products to treat these patients suffered shortages and became the focus of Shorla’s first product.
In expediting the development of a generic form of the drug, Cunningham explains, “We removed the financial and emotional burdens placed on patients who are forced to purchase costly alternative treatments or cease treatment if no alternatives exist.”
Innovate smarter: cut risks, not potential
Shorla’s focus on formulation re-innovation enables the company to mitigate barriers associated with traditional drug development.
“New drug development carries significant risk and cost,” Sharon explains. “By taking established and proven oncology treatments and doing something novel or different with them to address key areas of unmet need, we can create differentiated, superior products.”
This approach helps cut down on the costs and risks that come with traditional drug discovery and speeds up the approval process, allowing it to better meet the demands of the market and the rigorous standards of the U.S. Food and Drug Administration (FDA).
“While our products in themselves are innovative, we have also had to develop innovative ways to execute competitively and ensure speed to market,” she says.
In addition to developing products in-house, they now acquire and in-license products to expand and de-risk their pipeline. For example, they acquired an FDA-approved oncology drug from a U.K.-based company in October 2023 and launched the drug in the U.S. just two months later, in record time.
“This approach has become our strategy for long-term growth and revenue optimization,” she says. Shorla has built a steady pipeline and growing portfolio, all in line with its mission to improve lives through science and innovation. This approach is fuelling Shorla’s long-term growth, allowing it to fully leverage its U.S. infrastructure and seize new opportunities through development and partnership.
Build resiliency through relationships
Operating in a regulated environment like pharmaceuticals comes with inevitable hurdles, including the complex approval processes and ongoing quality audits required by individual state bodies in the U.S.
However, Shorla has turned these challenges into opportunities by fostering collaborations with key opinion leaders and advocacy groups, building a reputation for delivering innovative treatments aligned with high-quality standards. This has helped the team overcome substantial challenges.
“There have been many times when things haven’t gone as expected, most notably during the pandemic when we were awaiting FDA approval of our first drug,” she says, recalling an 18-month delay in bringing the drug to market that put pressure on the company’s cash flow.
Shorla was quickly able to adapt and secure funding to maintain operations based on their network and the relationships Cunningham and Ryan had fostered.
Lead with people in mind, harness tech for impact
All industries need a more personalized, unique customer experience, and Cunningham believes that cancer treatment is no different. She sees the focus increasingly shifting to treating the patient, not just the disease.
“Pharma will have to respond to this, incorporating effective companion diagnostics and biomarkers to optimize clinical benefit,” she says. “This targeted approach will create a competitive edge.”
Shorla Oncology’s patient-centric approach aligns closely with this vision, and the team will continue to use strategy and technology to further their goals.
“We’re leveraging AI and other emerging technologies to analyze data more efficiently, assist in the identification of new product development opportunities, serve project progression saving on time and resources and ultimately support in expediting drug development,” she says.
As Shorla Oncology continues to expand, its focus on innovation, patient-centered solutions, and strategic growth provides valuable lessons for any leader navigating a complex industry.
“Accomplishment to me means reaching as many patients as possible, it’s all about impact” Cunningham says.
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