“We are hoping that they will suggest informal discussions as a step before giving a firm decision on a dossier,” said Lonza representative Ulla Freitas. Her company has just had the exciting results of two human studies on ResistAid. These indicate its benefits in improving immune defence, but of course following the last EFSA ruling, this cannot be claimed in Europe. However, in the US, Asia and the Far East, ResistAid has great potential.
Stéphane Postic, CEO of scientific and regulatory consulting agency Naturalpha, spoke on how companies are changing in their approach to scientific studies: “Their questions are more precise and they know what they are aiming at now,” they said. They also know that the recruitment of the correct target population for a study is essential to acceptance by EFSA. This can be challenging, as these groups don’t always exist. Perhaps there is no group large enough of those over a certain weight and not on any medication, for instance.
Naturalpha believes it usually takes around 2-6 months to organise a trial, although this can take as long as 12 months.
“We have our innovation centre in Lille located next to the hospital there, and have discovered that a multi-centric approach works best. We work with 50 of the biggest food companies in the world on a variety of food topics, ranging from chocolate and fibre to lycopene and tomatoes and many more.
“We are seeing greater interest on meeting EFSA rulings from companies based in Southern Europe such as Spain, Italy and France. Our database gives us 7,000 people to choose from for our clinical trials, and here, appropriate population and pre-clinical validation is key. What we aim to do is to demystify the regulations and make achieving EFSA approval a little easier.”
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