Q&A: Cathal Friel, Open Orphan

CRO Open Orphan is a leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. It comprises two commercial specialist CRO services businesses — hVIVO and Venn Life Sciences — and has offices in London, Dublin, Paris, and the Netherlands. It IPO’d on the London and Dublin stock exchanges in June 2019.

The company was co-founded by Executive Chairman, Cathal Friel, also co-founded Amryt Pharma in 2015. Prior to Amryt, Friel founded Fastnet Oil & Gas. He was a finalist in the International category as part of the EY Entrepreneur of the Year 2020.

Here, Friel talks to Pharm Exec about how Open Orphan is distinctive from traditional CROs and the company‘s role in the UK’s COVID-19 human challenge study.

Pharm Exec: Open Orphan classifies itself as a “niche CRO” pharmaceutical services company. How do you differentiate yourself from a traditional CRO?

Cathal Friel: Open Orphan is the world leader in vaccine and antiviral testing using human challenge clinical trials. Using our state-of-the-art facilities location in London, and our subsidiary hVIVO, we have been able to study respiratory diseases such as the common cold, influenza, RSV, Malaria, and COVID-19. Our biggest differentiator from a traditional CRO is the amount of human challenge models we have completed.

In which therapeutic niches does the company operate?

Cathal Friel

We operate in the infectious and respiratory disease market. It is a growing market that is quickly gaining momentum especially with the pandemic. The infectious disease global market is projected to increase in value to $154bn by 2025, growing at a CAGR of 7.9%.

In recent years the company has implemented a growth by acquisition strategy. Can you details on those acquisitions and comment on whether this strategy is unique within the CRO space?

Prior to Open Orphan acquiring hVIVO and Venn Life Sciences, neither company was making a profit. By acquiring these two companies, we were able to establish a clear business strategy, and are now turning a profit. This is especially unique in the CRO space as small CROs are typically merged into larger companies, but with Open Orphan, we have kept Venn Life Sciences and hVIVO as standalone entities.

How do you determine which programs to engage and how do you prioritize them?

We have eight challenge studies and growing numbers of challenge studies having added Malaria in recent weeks and about to add TB, strep and pneumococcals as well. This will bring us to double digits and we are always happy to engage with customers on respiratory challenge studies in a range of COPD, RSV, Asthma etc.

How is Open Orphan’s role in the development of COVID-19 vaccines influencing that drug development sector?

The onset of the COVID-19 pandemic has not only directly brought in contracts for COVID-19 human challenge studies on behalf of the Government, but it has also ushered in a heightened awareness of the need for vaccines and treatments against other infectious diseases. This wave of change has already been seen, with Open Orphan winning 27 new contract wins across 2020 compared to four throughout 2019, with the majority of the new wins in 2020 coming in disease areas such as RSV and influenza, which were previously underserved by the pharmaceutical and biotechnology industries.

Could you provide detail on your coronavirus challenge study and your partnership with the UK Government?

The COVID-19 human challenge study aims to provide valuable insight into the biology of the virus which causes COVID-19. This knowledge will improve the ability to manage the virus and deliver a range of treatment options in the future. The study is being funded by the UK Government, and has already been expanded due to the valuable information that is being discovered.

What milestones are you anticipating from this study?

We are confident that this study will provide vital information in treating those infected with COVID-19, and will be a key part of creating the next generation of COVID-19 vaccines and anti-virals.

Three volunteers have completed the study with no safety issues and the data will be published in a scientific journal.

Is this a model you plan to implement in the US?

It would be valuable to implement this model in the US and other parts of the world and we are having active conversations at this time.

How has your role at Open Orphan evolved since the 2019 IPO? What makes you passionate about your work and the prospects for the company?

The company has grown substantially since the 2019 IPO and with that has come greater responsibility. Acquiring hVIVO and Venn Life Sciences required me to be strategic so that we could create a leaner, more efficient business with no excess costs while turning both companies around. It was risky, but we were successful.

Additionally, in June of this year Open Orphan spun-out Poolbeg Pharma. Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a novel capital light clinical model which enables us to develop multiple products faster and more cost effectively compared to the traditional biotech model. Poolbeg aspires to become a “one-stop shop” for big pharma to find Phase II ready products for development and commercialization, and is already making leeway with its first-in-class, Phase II ready, repositioned small molecule immunomodulator for severe influenza, POLB 001.

What makes Open Orphan’s corporate culture unique and how does that impact the business?

We are a multicultural company and have offices in Dublin, London, Breda and Paris. One of our main goals is to make sure our employees are taken care of and feel safe in their working environment — all of our staff have the ability to work remotely from home, have access to extensive company learning initiatives, health and CRS initiatives. Our team also have an open line to me and the executive team, and we operate in a flat corporate structure so that team members feel empowered to make decisions. Open Orphan is made up of the brightest minds in the industry and ensuring that we are supporting our employees has brought us the success that we have today. We truly would not be where we are today without them.