With three FDA-approved cancer drugs under their belts and more on the way, Shorla Oncology founders and EY Entrepreneur of the Year finalists Sharon Cunningham and Orlaith Ryan show how Irish pharma businesses are going global.
Shorla is among 24 Irish finalists who have been named for the EY Entrepreneur of the Year Awards which take place in November. Currently in its 27th year in Ireland, the programme works to recognise, promote, and build a supportive community around Ireland’s high-growth entrepreneurs and is considered one of the strongest programmes globally.
Since its inception, the EY Entrepreneur Of The Year Ireland community has grown to a tight-knit network of more than 600 alumni who harness each other’s wealth of experience, with three quarters (75%) conducting business with one another. Together, the EOY alumni community generates revenues of €25bn, and employs more than 250,000 people across the island of Ireland.
“By all means aim for the blue sky, but make sure you have the ammunition and the fuel you need to reach for the sky”
In the past 11 months the finalists have engaged in a strategic growth programme which includes a week-long CEO Retreat in South Africa.
Made in Ireland
Started in 2018 by Sharon Cunningham and Orlaith Ryan, Clonmel, Co Tipperary, business Shorla focuses on developing oncology drugs with a focus on rare, orphan and paediatric cancers.
Together with a strong team of 35 scientists, clinicians and an extensive industry network, the company has an advanced pipeline of innovative drug products to treat a number of unmet patient needs.
Last year the company raised $35m in a series B funding round led by Kurma Partners and with participation from existing investors Seroba Life Sciences, various Irish, US and Canadian family offices and Enterprise Ireland.
The funding will enable Shorla to accelerate the growth of its oncology portfolio by advancing its pipeline, bringing therapies to market that will address drug shortages, and improving the preparation and application of oncology medication.
Cunningham and Ryan met when they both worked for EirGen Pharma in Co Waterford. The experience provided the co-founders of Shorla with a front row seat to building a business that was subsequently acquired by a multinational.
It was a pivotal formative experience, giving the pair a grounding in finance and regulatory affairs, scaling a business but also the hard work of getting a product patented, FDA-approved and to market.
Shorla (an amalgamation of the founders’ first names) in recent days achieved FDA approval for JYLAMVO, an oncology autoimmune drug for pediatric indications. This is the only oral liquid methotrexate to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.
A chemical connection
Shorla founders Orlaith Ryan and Sharon Cunningham in the lab
The young business has established an outpost in the US in the vital life sciences hub of Cambridge, Massachusetts, which is led by Sharon Cunningham.
“Orlaith and I joined EirGen around 2009 and we lived through various transactions and the whole evolution of that company from a start-up with a handful of people to when the company was acquired in 2015. And that’s really where we got our inspiration. It was a very entrepreneurial company with two founders.
“When it was acquired in 2015 [by OPKO Health] we both got itchy feet and we craved that entrepreneurial environment again and wanted to set up our own company in the field of oncology; taking existing drugs but doing something different or novel to make them better in some way. We decided that the US would be our initial and main target market.
“And hence three years ago during the pandemic I decided to relocate to the US to set up our US office ahead of our first commercial launch. Fast forward eight years from when we started we now have three FDA-approved drugs in our portfolio, two of which we are currently selling in the US market and we have three additional approvals imminent in the next six months.”
EirGen’s drug product manufacturing facility in Waterford has since been acquired by Horizon Therapeutics for €54m.
Orlaith explained that one of the main areas of focus is on making cancer drugs easier to administer to patients. “Caregivers and patients face challenges and we are creating alternative formulations to make them easier to take such as making them more flavourable. It takes out a preparation step that may be a pain point in the hospital or home setting.
“So that’s our focus and mission: to really address areas of unmet need for existing treatments that are limited or inadequate for the target population.”
Both Sharon and Orlaith come from different professional backgrounds but with skillsets that when combined make them an unbeatable force.
“Sharon is a chartered accountant and I’m a biochemist. I would have mastered regulatory affairs and my area of focus is on product development and getting regulatory and especially FDA approval. Sharon would be an experienced accountant familiar with fundraising in the pharma industry, ensuring we realise the product opportunities, make them viable from a commercial perspective and building the commercial infrastructure required.
“We’re probably quite unique in that we develop and commercialise products. Often companies in our sector do one or the other, but it was something we have really focused on. We also work closely with doctors and advocacy groups who give us support and we want to deliver on our commitment to them in getting our products to market.”
Orlaith emphasised the importance of the experience she and Sharon gained at EirGen. “I think coming from a start-up company that was very successful did give us the confidence and inspiration. We had the tenacity and the can-do attitude to just roll up your sleeves and take products and make them even better. That was how we operated at EirGen so it wasn’t a significant change to apply that way of working to our own company.
“Obviously we took on a lot more risk as founders but very early in the process we attracted the right investors who were very strategic in terms of our approach to manufacturing and whatever else we needed to make it a success and realise a commercial product.
“So we definitely had confidence and if there was something we didn’t know we sought that expertise and partnership early on.”
A level playing field
While pharmaceuticals, like tech, can be a male-dominated industry, neither of the founders felt daunted or discouraged in anyway. “I don’t think gender has ever presented a challenge. We got opportunities based on merit.
“I don’t want to gender stereotype, but the female skills of multitasking and being detail-oriented helped us navigate a lot of challenges. We didn’t encounter any gender challenges and were given the opportunity to prove ourselves and hopefully blaze a trail for more female founders in our sector to follow.”
After eight years of working together both Sharon and Orlaith are also young mothers. The level playing field they found in pharma should be the same in every industry, Orlaith says. “Every opportunity should be equal and every outcome should be the result of hard work and commitment and ultimately reaping the fruits of your labour. I’m all for more female founders and leaders and I’ve no doubt there will be many, many more into the future.”
In the early days of Shorla, the founders drew on supports such as those offered by the Local Enterprise Office but also a combination of their contacts in the vibrant life sciences industry that has grown up in the south-east of Ireland.
“We were fortunate in that we had a proven track-record that we had built up in EirGen. As we grew as a company we got support from Enterprise Ireland who genuinely do have a global ambition.
“Obviously you need investors who are familiar with pharma companies and the process and timelines involved. We were able to secure our funding with Irish investors and with European investors early on.”
The world class pharmaceutical industry that has developed in Ireland from an indigenous and multinational perspective has made Ireland the centre of the world for pharma product development. But opening an office in the US has also worked to Shorla’s advantage.
“As Sharon said, we have two more FDA approvals un the coming months ahead, and really it’s to replicate that and continue to bring products that address key areas of unmet need. We want to be very strategic in the types of products that we bring to market, and to ensure they ultimately get to patients. So it’s our goal to scale and grow, to build our commercial footprint in the US, and then hopefully take the products to other territories like Europe and to the rest of the world.”
In terms of fundamental business lessons learned over the course of eight years, both Ryan and Cunningham agree that a business plan forms the central nervous system of achieving ambition; albeit a business plan that needs to be occasionally augmented.
“The idea needs to be underpinned by a sound business plan,” Ryan said. “In our business it’s about the key structures. We operate in a highly regulated environment and you need to have your ducks in a row in order to be able to realise your idea into an operational plan.
“That was something that we benefited from through prior experience that really stood to us. By all means aim for the blue sky, but make sure you have the ammunition and the fuel you need to reach for the sky.”
Being nominated for the EY Entrepreneur of the Year Award brought the Shorla founders into the orbit of other successful Irish entrepreneurs, both fellow nominees and alumni. “It’s been almost a year-long process,” says Sharon. “Our interactions with fellow founders have taught us loads. It has been a really positive experience.
“We’ve met loads of like-minded people, it’s a phenomenal network. For me it has taught me to step back and reflect on the journey, how far we have come and reimagine what the future looks like.”
Orlaith adds: “Every time you open up the WhatsApp group you find that someone has acquired or sold a business, that something big has happened almost every week. That has been really inspiring, but also very encouraging. It gives you confidence that if you stick with it and follow through you can do anything.”
Main image at top: Orlaith Ryan and Sharon Cunningham of Shorla Oncology
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