Whether it’s a carburetor, a silicon chip or a new type of yogurt, throughout industry “Speed to market” is the major focus of a timely product development project and a successful business. Nowhere is this more crucial than in the Pharmaceutical industry where drug development takes around 12 years with average overall costs including marketing of around $2.25 billion per drug.
The right regulatory strategy is a key element in optimizing “speed to market” and planning your development with regulations in mind.
The PRI was formed 7 years ago to help its members navigate the regulatory situation for medicinal probiotics in Europe. In Europe the regulatory pathway for LBPs or “Medicinal Probiotics” is confusing. Whether you are marketing your product as a food supplement (companies and EFSA are constantly debating the validity of health claims for probiotics) or a medicine – there is little clarity about how to access the market with a probiotic product.
There’s clearly strong science that validates the taking of probiotics as a food supplement; at the PRI we fully support the work of our friends at the IPA. However, the PRI was created 7 years ago because the founders believed that the real future of these products is that of a medicine. Although our principal long term goal is to drive the creation of a new category at the European level for LBPs which will facilitate the future development of Microbiotic Medicinal products, we have already assisted several of our members to reach Stage III clinical trials.
The market outlook for Microbiome therapeutics is said to exceed $2.2 billion by 2025, and much of the investment we’ve seen so far has been in the US through companies such as Seres, Vedanta, Rebiotix, just to name a few.
Some important points to consider for American companies looking to gain a foothold in Europe:
- There are several established LBP developers with GMP pharma manufacturing status
- There already exist several pre-2001 products authorized as medicines
- there is a full supply chain already in place which would allow you to develop, manufacture and bring your product to market
The PRI is one of the few organizations in Europe that helps its members to navigate this difficult regulatory situation as well as discover the ever-expanding Microbiota & Human Health Industry, thanks to the continuous Partnering Platform and the annual can’t-miss event, Pharmabiotics 2018.
If you represent a US company in the Human microbiota industry looking to develop your European presence, the PRI can provide determinant expertise and insight for the European market.
Contact Richard Ellis, Business Developer, for more information.
Mobile phone: +33 661 245 717