Aqua Agenda webinar: Making waves

Getting it right at the start

If somebody has a product which they’re looking to take through the regulatory process, what are the key things that they really need to take account of at the outset?

 

Catherine Albert advised: “One of the most important things to consider is the different countries that are going to be involved in the licensing or the use of this product.

 

“Where does your company sit in the world? Who do you think might make this product for you? In which country will it be made? What country will you test it in? For instance, you might be in Norway, but you could be using Onda to test your product in Canada.

 

“Also, in which country will your product be registered? Products aren’t always registered in the same country that they’re sold in, necessarily. You might have to have licences in several countries.

 

“So all of these different countries play a role in the regulatory process.”

 

She added: “It becomes very complex when there’s so many countries involved, and if you don’t get alignment up front from all the different regulators and health authorities in the different countries, you might spend some time doing some great research, but then it’s not accepted by a different country.”

 

Michael Fontaine agreed. He said: “The key is to plan ahead. The country in which you’re intending to register your product will have its own particular framework of regulatory requirements for data that need to be submitted.

 

“There’s no point just starting on your development journey without having a clue about what that might entail. If you don’t have a plan, you’re heading for disaster.”

 

Onda’s Nasif Sarowar advised: “Keep the scientific plan simple. More often than not, scientists like to make things complicated.

 

“But complicated science sometimes does not bring the message that regulators need to see.”

 

It is also important to be aware of where there is some flexibility in regulation and where there is not.

 

As he put it: “Not everything is negotiable.”

 

Michael Fontaine warned that smaller companies, in particular, tend to underestimate the complexity of the regulatory process.

 

Where do companies starting out in this field often slip up?

 

Pawan Agrawal stressed that it is important to recognise that the early stages of research are just that, and there is a lot further to go at that stage.

 

He said: “They may think they have proof of concept, so now they have a product. It’s far away from that. Once you have proof of concept, then the journey starts.”

 

Catherine Albert commented: “People who come from academia and from universities are always thinking outside the box, and they have very complex ideas. But they need to narrow that focus to: What do we really need? What data do I actually need to license this product in whatever country I’m trying to sell it?”

The international perspective

What’s the best way to go about making sure that your product is internationally ready? And should you go for the low-hanging fruit first? Should you go for the fastest regulatory regime with the lowest hurdles, or is it actually more important to get a licence from a regime that will be accepted everywhere, even if it may take you longer to get that acceptance?

 

Catherine Albert said: “There’s a mutual acceptance of data across many countries in the world, especially for safety studies, or the GLP [good laboratory practice] standards.

 

“If you run a study in one country, then generally another country will accept that data.”

 

One of the factors driving agreement on this was a mutual desire to reduce the amount of animal testing required for a new product, by avoiding the duplication of tests.

 

“So,” she said, “if you have a well-run study, and the study design is aligned between the different countries, you will only have to run that study once.”

 

Pawan Agrawal agreed, adding: “If you have a plan to market your product in many different countries, it’s better to meet the requirement of the country which has the strictest requirements.”

 

Of course, much depends on the strategic vision for the business. As Nasif Sarowar pointed out, Onda also has clients who are very much focused on just one country, so if they do not have plans to seriously market their offering outside Norway, for example, they can afford to focus on Norwegian regulations.

Commercial awareness

 

One question from the audience was: can you sometimes have a product that passes all regulatory hurdles but flops in terms of sales?

 

This is indeed a danger, advised Michael Fontaine.

 

He said: “It’s not just about understanding your regulatory process, you also need to understand what your target market is. What are the limitations that will prevent the adoption of certain technologies within a given marketplace? You need to understand all of these things.

 

“If you don’t have all of that wrapped up into your development plan at the outset, then you run the real risk of registering a product that ultimately nobody wants.

 

“And the other side of that is not just about what the market need for it is, it’s also what the expected price point for a product is within that marketplace.”

 

He added: “You might have a registered product that might be selling at the correct price, and there might be no competition in a particular field, but if you don’t have a distribution network as well, then you’ve got a problem.”

 

Onda has a business development team to help guide customers through these issues, Catherine Albert added.

 

One consideration is that not all aquaculture sectors are as advanced or as profitable as high-end species like salmon. A solution for another fish species might address an important need, but if that industry does not have the resources for it yet, the time for your product as a commercially viable proposition might not be right.

 

In these sectors it might be the intervention of, for example, a philanthropic foundation or international aid body that makes innovation viable.

 

A key lesson is that an interesting avenue of research for a scientist does not guarantee a viable product at the end of the process.

 

Michael Fontaine commented: “Having been a scientist myself, I have gone down that road of painful experience of realising it’s not just about the science!

 

“Academic or early stage start-up companies can be focused on the proof of concept, and on getting the registration, but there often hasn’t been much thought given, once I have that registration, to how am I actually going to distribute and sell this product?”

 

It is also worth bearing in mind that some innovations relating to aquaculture relate to devices or processes – like a humane stunner or a pumping system for transporting fish – rather than veterinary or pharmaceutical innovations. In this case the questions of fish welfare are still important, but will be handled by a different set of regulators and regulatory hurdles.