From left: Orlaith Ryan and Sharon Cunningham. Image: Shorla Pharma
Our Start-up of the Week is Shorla Pharma, which is developing treatments for children’s and women’s cancers to make them more accessible.
In 2018, Sharon Cunningham and Orlaith Ryan started Shorla Pharma, a Tipperary-based pharmaceutical start-up focusing on women’s and paediatric cancers.
Cunningham is a qualified chartered accountant, while Ryan is a chartered scientist and biochemist. They worked together in senior roles at EirGen Pharma in Waterford, before deciding to start their own healthcare business.
Shorla Pharma now looks at where existing oncology treatments are limited, in shortage or inadequate for the target population.
Cunningham, who was named Ireland’s Best Young Entrepreneur in 2019, told Siliconrepublic.com that the team’s aim is to bring “accessible, affordable and life-saving treatments to patients” while providing a significant clinical impact.
The market
Cunningham said that Shorla Pharma’s products are the result of work put in by scientists, clinicians and commercial strategists who have experience in the areas of drug development and the commercialisation of niche cancer treatments.
“Our customers are prescribing oncologists and, ultimately, cancer patients. We work closely with the prescribing clinicians and key opinion leaders to ensure our products solve unmet needs, will be prescribed by the oncologists and reimbursed by the payors.
“We have received a letter of support from a children’s cancer group at a leading international children’s hospital and we have already been to the US regulatory authority, the FDA, with our first two products which will launch in the US next year.”
‘The ultimate goal is to establish a reputable brand and continue to solve problems in oncology’
– SHARON CUNNINGHAM
The company has been working on active substances and applying novel changes to the formulations, which Cunningham said can “enhance or improve” the existing formulations. One of its products is the redevelopment of a children’s cancer drug from a difficult-to-swallow capsule into an oral solution.
“Novel changes include creating ready-to-dilute sterile presentations to remove compounding steps and improve drug product stability or palatable oral solutions to improve patient compliance and safety,” Cunningham said.
“The ultimate goal is to establish a reputable brand and continue to solve problems in oncology and orphan diseases, ensuring we bring products to market that are clinically impactful.”
Orphan diseases are diseases in small populations or with low incidence rate, often more prevalent in developing countries, such as tuberculosis, cholera, typhoid and malaria.
Challenges
Naturally, there are plenty of challenges that come with setting up a company that focuses on cancer treatments. While the co-founders had experience in product identification and development from previous roles, navigating the US market for niche cancer drugs was a new hurdle.
“We were prompted very early on to validate our product ideas,” Cunningham said. “Simple but effective questions deducing how our products are different to existing products quickly screened the product developments we would invest in and take forward.”
According to Cunningham, the products were then validated by experts and clinicians who looked at the potential impact of Shorla Pharma’s solutions.
“Risk of competition was also a challenge we needed to address early on in the business; the pharmaceutical industry is highly competitive, coupled with increasing pressure on drug pricing, particularly in the US,” she added.
“Having a solid intellectual property and regulatory strategy ensures protectability and market exclusivity, as the majority of products being developed by Shorla Pharma will qualify for orphan designation.”
Start-up scene
Shorla Pharma is based alongside a cluster of pharmaceuticals businesses in the Questum acceleration centre in Clonmel.
Here, the start-up’s founders have availed of a number of supports from their Local Enterprise Office and Enterprise Ireland. Cunningham said that Shorla Pharma has taken advantage of Enterprise Ireland’s supports for women-led businesses.
“To address the underrepresentation of women entrepreneurs in Ireland, Enterprise Ireland has developed a number of supports specifically for female entrepreneurs,” she said.
“From our experience, Ireland has much of the infrastructure in place to foster a sustainable start-up culture, with early-stage investment available from Enterprise Ireland and a steadily growing venture capital and angel investor community.”
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