Emerging scientific developments have shown that microbiome-based medicinal products do not only represent a paradigm shift in human medicine, but also in veterinary medicine.
With the global initiatives to curtail the indiscriminate and irresponsible use of (last resort) antimicrobials in the treatment of human as well as animal illness, proofs of concept continue to emerge on the potential of using microbial solutions. In certain animal pathologies for which, similarly to human, few alternatives are currently available for treatment, the body of knowledge acquired by the PRI on researching, navigating and the use of human microbial medicinal products could be highly valuable to companies who are also developing potential live microbial based veterinary medicines.
For both companion and livestock animals, these new types of products represent/are perceived as a more natural and sustainable solution by animal owners.
We want to see if there is interest for a collaborative approach to developing guidelines best suited for live microbial products. The current EU (including biological) guidelines, are not always applicable to microorganisms and/or derivatives of microorganisms for potential use as veterinary drugs,
explains Dr Bernadette Okeke, Global Director, Government and Trade Affairs and Senior Adviser, Regulatory Affairs and Compliance at Lallemand Animal Nutrition/Lallemand Brewing.
These guidelines would help companies developing Microbiotic Medicinal Products for animals to do so in a streamlined/efficient manner. Trials run in the correct way should significantly reduce the cost and time it takes to get approval for such products.
Dr Bernadette Okeke adds.
Thus, the PRI intends to hold an Exploratory Meeting in London on July 10th, 2019 in order to assess if stakeholders in or interested in the field of animal medicine would choose to participate in such an initiative.
As the PRI has been heavily involved in ascertaining the regulatory pathways for microbiome-based medicinal products for potential wide ranging applications in human medicines, it seems like the only natural path to also use the wealth of knowledge and experience to further similar initiatives on the research, registration and potential use of MMPs in Veterinary medicines in the EU market and beyond.
said Joseph Simmons, Business Development and Member Services for the PRI.
During this meeting the PRI would propose to address the following points with those stakeholders present:
- How could the knowledge acquired by the PRI with regards to human applications also be applicable to veterinarymedicines?
- Would the industry be interested in the application of the PRI strategy to Veterinary Medicinal Products?
- Would the industry be interested in any support from the PRI?
- What are the win-wins that the PRI has achieved for human medicine applications with regards to MMPs and what are the other goals in their projections; how can some of these apply to veterinary medicine and what is the potential benefit for the veterinary industry?
If, at the end of the meeting, those present should wish to pursue such an initiative, the intention is for the PRI to commence work with all interested parties in order to support them in the clarification of the regulatory landscape for registering microbiome-based drug products (in addition to mutually agreed initiatives that will facilitate the development of MMPs) as veterinary medicines in the EU.
If you are interested in joining the initiative, please contact the PRI to express your interest.