Clonmel duo develop innovative cancer drugs

The takeover of the company they worked for by a multinational led to Orlaith Ryan and Sharon Cunningham leaving secure, well-paid jobs to set up their own pharmaceutical company. ThinkBusiness talks to the duo on developing innovative therapies that focus on women’s and paediatric health. 

What made you decide to set up your own company?

We both previously worked for EirGen Pharma in County Waterford. We were extremely fortunate to be part of it from the beginning. It was a really inspiring and confidence boosting journey for us. EirGen went on to be extremely successful and was later acquired by a US multinational. At that point, having both reached the top of our respective careers in finance and regulatory affairs, we decided the multinational space wasn’t for us and agreed to set up something together. 

How did you identify the gap in the market? 

We identified the market opportunities we saw and it was different to the model EirGen had. We spent two years working on our idea and really validating it. We have a lot of experience in the development of oncology products but while a lot of the pre-existing chemotherapy is extremely effective, there are always ways to make it better and we saw that as an opportunity, particularly in women’s and paediatric cancers. We had lots of ideas and went on to validate them with opinion leaders and clinicians, primarily in the US – our initial target market. We saw an opportunity to work on pre-existing treatments to make them better. We call it re-innovation.

“We decided the multinational space wasn’t for us and agreed to set up something together”

What products have you improved upon?

One of our products is for paediatric cancer. Treatment is currently only available in a hard capsule. Besides swallowing difficulties, caregivers are having to open the capsule to mix it to try and get a child to ingest it. It is dangerous to do that because you could be compromising the dose. We’ve created a palatable oral solution that makes it easier for children to take. It’s in the development stage. It will be on the market in 2022 in the US initially, and Europe soon after.

We have other products in the pipeline, all at different stages. Another one is for breast and ovarian cancer. We are creating a ready-to-administer version of an injectable drug to make it more stable and less time sensitive. The existing version has to be made up and administered immediately. The reworking doesn’t require a lot of mixing steps. It’s a technically challenging process but clinically impactful.

Founders Orlaith Ryan and Sharon Cunningham say their first product will be on the market in 2021

Did you feel that the focus on women’s and paediatric health was lacking?

In some areas, it is. That’s why regulatory authorities give incentives to companies that develop drugs in that space.  Particularly in the paediatric space, it is a smaller market hence Big Pharma may not always be inclined to develop drugs for it. We are women and have children, so it was an area we wanted to make improvements in. 

“We saw an opportunity to work on pre-existing treatments to make them better. We call it re-innovation”

What were some of the challenges of setting up your own company and how did you overcome them?

During the initial phases, the main challenge was funding. We invested our own savings into the business and did some consultancy work on the side to support ourselves. We secured funding via Tipperary Local Enterprise Office but there was still a gap. In order to determine how we were going to bridge it, we engaged heavily with strategic investors, we made sure that our business plan was ready and that our strategy was going to make a strong impact commercially. 

Another challenge is embracing change. We had lots of ideas when we started but when we took them to the clinician, all of them weren’t viable. You have to be open to making difficult but important decisions, knowing what not to pursue, as well as pursue, because ultimately you will get the best business plan and product attention as a result of being discerning. 

How did you work out your business plan?

We worked on it for two years – at night and on weekends while we were working in EirGen together. Business plans were a large part of what I did in my job. I had fundraising experience from EirGen too. We knew we needed to be transaction ready at any time, so we structured our systems and processes with that in mind from the outset.

“The paediatric space is a smaller market; hence Big Pharma may not always be inclined to develop drugs for it”

What was the funding process like?

Getting funding is never easy because you have to go through the due diligence process. Our investors were strategic in that they knew the environment. From a regulatory perspective, they were supportive and accepted that there could be delays. They also brought a network with them, which is very important. Our strategic investors continue to open doors for us and make introductions. It’s that business development piece that brings it all together for us.

Access to the right money is challenging because you need to know what’s right for you and the business. Fundraising never ends, we are always thinking about the next phase. We are continually fuelling our pipeline with new ideas, which brings financial requirements too.

What are some of your high points to date?

We took our first product to US health regulators in June and had a very positive outcome from that meeting. That was an extreme high because it validated that we were on the right path. Securing funding was an extremely high point because it gave us the platform to take the company to the next level. Clinically, we have established collaborations with a large children’s oncology group in the US. Being able to work with such established clinicians in paediatric medicine is extremely rewarding.

“You have to be open to making difficult but important decisions, knowing what not to pursue, as well as pursue”

How do you see the future of the company?

We are fundraising at the moment and hiring our first employees. Our aim is to build a core technical team of around 14 highly skilled people by 2021. We are continuing to fuel our pipeline. Our first product will be on the market in 2021. We want to continue to make meaningful improvements to standards of care and ultimately enhance patients’ lives. 

What advice would you give to others thinking of starting their own company?

Be organised and prepared and know your area very well. Stick to what you know initially and have the right advisors on board. Surround yourself with the right people. Everyone will want to give you advice but take it from those who actually know the industry you are going to operate in and have been successful. 

Don’t rush into setting up a business. It’s really important that you get all the education you can and experience you need. Build your network, don’t underestimate the value of your network, because you’ll need it. Don’t be afraid to take risks but make sure they’re calculated ones.

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Interview by Olivia McGill

Published: 20 December, 2019