Innovate and Adapt: Shorla Oncology’s Path to Smarter, Faster Cancer Treatments

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 healthcare and technology bring hope of more effective treatments, the road from idea to impact is filled with challenges.

Sharon Cunningham is 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 three FDA-approved drugs in its portfolio, with three additional FDA approvals imminent.

“We’re a mission driven organization, led by our purpose,” says Cunningham. “Helping vulnerable patient populations is a privilege and I couldn’t be more proud 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 Shorla’s story.

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.”

Take for example, acute lymphoblastic leukemia (ALL), the most prevalent childhood cancer. The treatment for ALL can often be complex, and for the best outcomes, patients must have a steady, reliable supply of effective medication to improve their chances of successful treatment.

However in 2018 and 2019, the Arranon??(nelarabine) injection, one of a limited number of products used to treat these patients, suffered shortages. This became the focus of Shorla’s first product.

“We effectively expedited the development of a sterile drug product to treat T-ALL,” she says of Shorla’s generic formulation of nelarabine. “In doing so we removed both 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.”

Not only does this approach help cut down on the costs and risks that come with traditional drug discovery — it’s also speeding 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.

“While our products in themselves are innovative, we have also had to develop innovative ways to execute competitively and ensure speed to market.”

For example, while they started out developing products entirely in-house, they soon began acquiring and in-licensing products to both expand and de-risk their pipeline.

One recent highlight of this strategy was the acquisition of an FDA-approved oncology drug from a U.K.-based company. Shorla completed the acquisition 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. By combining in-house innovation with strategic acquisitions, Shorla has built a steady pipeline and growing portfolio, all in line with its mission to improve lives through science. This approach is fueling Shorla’s long-term growth, allowing them to fully leverage their U.S. infrastructure and seize new opportunities through both 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 U.S. state bodies.

However, Shorla has managed to turn 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 remembers. “The facility where the drug is manufactured in Germany needed to be inspected and FDA had suspended all overseas facility inspections due to the pandemic. This resulted in an 18-month delay in bringing our drug to market and put pressure on our cash flow.”

Shorla was quickly able to adapt and secure funding to maintain operations based on their network and the relationships Cunningham and Orlaith had fostered.

Lead with people in mind, harness tech for impact

Something all industries are currently facing is the need for 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 both strategy and technology to further their goals.

“In the future, I can see us leveraging AI and other emerging technologies to analyze data more efficiently, assist in the identification of new product development opportunities, assist in 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,” Cunningham says.

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About the Author

Mary Mack is a writer and digital content strategist. She earned her news-editorial journalism degree from the University of Illinois Urbana-Champaign and has a background covering arts, culture, food and entrepreneurship. She is a proud St. Louisan who enjoys cooking, reading and sharing the stories of interesting and inspiring people.