A microbiome describes the collection of microbial life (microbiota) that inhabit a specific environment, and include microorganisms as diverse as bacteria, yeasts, fungi, archaea and viruses. In man, these organisms are resident primarily in the gastrointestinal tract, but also occur on the skin, genitals and in the lungs. Although the extent of the relationship between microbiome and human health is not fully known yet, our understanding improves of the role these microorganisms have in the development of pathologies such as obesity, gastro-intestinal diseases, depression and allergies, the possibility now exists to address these, and other, health challenges from a new perspective. This includes the development of new foodstuffs to maintain beneficial gut flora, as well as the development of new drugs that offer more targeted possibilities.
Microbiome products are typically designated as prebiotics, probiotics or postbiotics, however, these are not regulatory product categories. Applicable status may vary depending on the product intended purpose (including target population, claims, etc.), composition, route of administration, Mode of Action. They can either be drugs, LBPs, biological medicinal products, functional foods, food/dietary supplements, devices, transplants or tissues & cells. Some are specific to microbiome products (e.g. FMT) while other also apply to other types of health products.
Key challenges encompass:
- Identifying cause-effect relationships
- Being able to restore a “healthy” microbiome when such microbiome is not well characterized
- Navigating the moving and multiple potential applicable regulatory frameworks as no harmonized approach is in place
Main considerations to keep in mind if you are developing a microbiome related product:
- Microbiome products can fall under several regulatory statuses, in both the food and medical arenas
- Their intended use, target population, presentation form, composition, mode of action and route of administration will be key in determining the corresponding status
- Both drug and food pathways and associated regulatory statuses present specific benefits and constraints and will be directly related to the complexity, costs and timelines of development, and to the further marketing opportunities.
VCLS contributes to the development of products within a comprehensive range of regulatory statuses, including drugs, biologics, ATMP, medical devices, FSMPs, Food supplements , etc. We have a solid track of experience in various therapeutic fields including infectious diseases, inflammatory diseases, immunology (including allergies), metabolic disorders, oncology with common applications in the gastro-intestinal tract, skin and gut-brain axis.
What VCLS can offer:
Early product positioning & Strategical development planning
- Identification of eligible regulatory paths, within the food and therapeutic arenas, as well as in the cosmetic field
- Re-qualification risk assessment & Identification of critical product features
- Target Product Profile (TPP) definition
- Assessment of optimal positioning based on subsequent development needs and risks
Regulatory activities implementation
- Definition of optimal regulatory roadmap for international market entry
- Critical analysis of regulatory development plans
- Eligibility assessment & application to accelerated development pathways and authorization programs
- Support for request, preparation and during meetings with Competent Authorities at key steps of product development: Informational meetings, Scientific Advices, pre-IND meetings
- Author, review and submission of authorization / notifications regulatory dossiers in key global markets
Learn more about our Regulatory Strategy & Submission service
CMC, Nonclinical and Clinical development support
- Gap analysis of available CMC, nonclinical and clinical data in view of critical regulatory submissions
- Definition of individualized nonclinical and clinical development programs, protocols design