I would say that the microbiome is
an emerging field currently. It has huge opportunities of product development in the field of health,
in particular. In this sector from
a regulatory perspective we can consider several possible
statuses for those products that can be developed
as drug products but also as food products under several status
such as biologic products, small molecules, food supplements. We can consider a broad range of applications. All those statuses will depend upon
the number of characteristic of the products which are the form of the product,
its indications, the target population that will be considered and all those parameters
should be considered in order to define what is the appropriate status for this product. We have seen companies which
had to delay the launch of their product because of non-adequate initial positioning which has consequences
on the futher development of the product. So the first step
and our first recommendation is to carefully choose and identify the optimal passway
for microbiome related products. Currently the regulatory framework
for these products is not specifically adapted
to microbiome products. We have a drug regulatory field
and a food regulatory field, but each of them will present specific
challenges in the field of microbiome all along the development passway from the quality assessment of the product, from the non clinical and clinical assessment in terms of safety and efficacy
on the human population. So all of these challenges
will need to be specifically anticipated for microbiome products
and we are currently missing specific orientation from the authorities
because this is a new topic and there is no specific
regulations on the topic yet. We’ve seen a beginning of evolution
in specific in the US which developed specific
live bio therapeutic products status which is specifically
applying to probiotics. This is a guide line
that we can expect to follow and that we can consider
even for the EU market as a broad indication, even if it’s not
an official EU authorities requirement. We can expect further orientation
from the authorities and what can be done is
to try and consult the authorities as soon as possible
to discuss these specific issues all along the product development. Even at an early stage,
it can be positive to exchange with the authorities to discuss
on a better way and a better approach that would satisfy them
in terms of requirements for the development of the product, actually quite similarly to
what has been done was ATMPs. This is an approach that should be considered
really specific to each products. There is no ready to go plan
for these products and you need to consider really
what are the characteristics of your product, where you want to go
in terms of development, what is your target,
what is your market, and all of these parameters
should be considered in order to establish the most
appropriate roadmap, I would say, and to anticipate the specific challenges
that will have to be faced in terms of development. And anticipating those requirements can also turn into an advantage
in terms of competition and what is your access to the market. So our recommendation for
what we’ve seen in the past is to clearly identify as soon as possible
the most appropriate status and roadmap for microbiome related products, can they be food or drugs, and depending on the status
we would recommend, of course, identifying the most appropriate roadmap
and identifying as soon as possible the specific challenges and
the specific steps of developments that will have to be challenged
in order to have the easiest and the optimal passway
to access the market more easily and more efficiently.

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