Lucy Tanner: What do you see as the biggest difficulty within outsourcing clinical trials at the moment?

Industry Expert: Well, the biggest challenge within our company is getting the funding to do clinical trials because undertaking them is not something we can do ourselves. We look to outsource all of the clinical study and getting the funding to carry them out is tough.

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LT: What practical steps can people take to overcome this barrier?

IE: To date, we have not carried out any clinical trials. However, what we have done is look to collaborate with second parties. We applied for a grant from the EU and there were several participants. Ideally, one of them was a company that carried out clinical trials. When looking to attain funding it is crucial to build relationships and fortunately, a local company gave us the chance.

However, they had limited capabilities, and so instead of continuing with the study, they recommended an Italian company to us. From there we made contact with that company in Rome and we established a very productive relationship; we had good conversations and they satisfied all of our business needs. Therefore, we submitted an application but the problem now is there’s tremendous competition for these grants within the industry and many companies find it difficult to gain funds.

LT: How else could you attain funding and grants? Are there any other means or practical steps companies can take in order to secure it?

IE: Yes, there are two main channels in which you can receive grants. This can be either from the government or alternatively, a private agency or foundation. However, they will only invest in studies that are of interest to them. More often than not these are cancer or disease trials.

However, another source of funding is from investors, people who are willing to invest in the company. There are opportunities to present and pitch your developments with the aim of attaining their financial support for your clinical trial. Yet again, the competition is very tough in this domain.

LT: Are there any further challenges in securing funding?

IE: What makes these challenges increasingly difficult is the fact there are always a greater number of companies requesting funds, rather than giving funds. This creates a lot of competition for each dollar or euro you can get and subsequently, makes it harder to obtain. You have to be able to convince and outline to an agency or investor that you have not only a good chance but a better chance of succeeding against every other company. How it works is that each company is benchmarked against another in terms of their operations and success, which again makes it tougher. Another issue is that if you have not made a lot of progress with your product development or had little success, it is even harder to reassure investors that your study will succeed.

Naturally, investors are cautious of where they put their money because there is usually a lot of risk involved with clinical studies. Sometimes their investments go particularly badly. Therefore, low risk studies are deemed more favorable. The agency will get frustrated if they do not see results that you promised and this will give you a bad reputation. The solution lies within understanding how we can win funding again in order to secure our long term goals. How do we differentiate ourselves? How do we get people to invest into us?

LT: Very interesting, thank you. Lastly, what would you say your top priority is at the moment?

IE: Right now, as discussed previously we are looking to raise additional research and development funds. Without clinical trial approval, the implications will mean that you only achieve incremental growth. You can have excellent results with sales, but until it has attained clinical approval, you have nothing to show and this is difficult. Essentially, we need the funding to do this from agencies or investors.