Apoyo en ciencia reguladora de microbioma para proyectos precompetitivos
Referencia RDRFR20230912001
Caduca 01/09/2024
Resumen
A French non-profit association offers pre-competitive European research projects its unique microbiome regulatory science expertise for translational excellence in the research and development of microbiome-based health innovations (probiotics, FMT, LBPs, diagnostics, phage, biomarkers). The Association is seeking to join projects and/or propose its services to improve projects for regulatory compatibility, support research/industry interface, and training for regulatory science principles.Información adicional
The French non-profit Association is the Europes microbiome regulatory science expertise centre. Its purpose is to support the development of innovative health products emerging from microbiome science, by bridging stakeholders in industry, academia, and EU regulatory representatives. It works to educate and contribute to the conditions of success for future health innovations emerging from microbiome science. Since its creation in 2010, the French Association has worked to clarify the specific technical and scientific requirements for the development and registration of microbiome-based health innovations. Today its expert position within key national and EU regulatory and standards bodies offers its partners and Members unique insight into the future European regulatory framework for microbiome-based health products.
Regulatory awareness and societal impact are key evaluation criteria for funding in EU R&I and CSA projects in the microbiome field, These points are becoming increasingly relevant; microbiome science is such a transversal aspect of host biology that microbiome-based health innovations can translate towards diverse applications, which places the importance of regulatory science and impact even earlier in the development continuum. As the microbiome field is relatively young and still taking shape, researchers and innovators are faced with a lack of harmonization in basic terminology, a need for the standardization of analytical methods and tools, and no microbiome-dedicated guidelines for product development or evaluation by regulatory agencies.
The French non-profit Association is searching to join EU microbiome research projects in need of regulatory science expertise. The French Association has several years experience in EU project participation and over a decade of experience in interacting directly with European regulators and standards agencies on microbiome development and innovation questions. The Association has over a decade of experience in organizing and executing internal working groups which bring together a diverse array of industry and academic stakeholders while striving to find consensus on common pre-competitive challenges, and have contributed to key regulatory science publications (ie regulatory requirements of probiotic-based medicinal products vs. probiotic-based food products, safety assessment of LBPs, regulatory framework for fecal microbiota-derived therapeutic interventions
).
The French non-profit Association is also offering fee-for-service expertise to pre-competitive applied microbiome research consortia, such as (but not limited to): review and optimization of project design/deliverables for compatibility with regulatory framework(s), regulatory science missions for academic/industry partner interfacing, microbiome regulatory science training for applied microbiome research and biobanking organisations.
The French non-profit Association actively supports industry stakeholders involved in the development and commercialization of microbiome-based health innovations (medicinal products, diagnostics, nutritional interventions).
Advantages and innovation
The French non-profit Associations collaborative approach has helped it to achieve a unique Expert-position among industry stakeholders, scientific/clinical societies, and national and European regulatory bodies. This expert vision and experience translate throughout all of the Associations work and is thus a benefit to each of its members and project partners/clients.
Framework program
Health
Call title and identifier
EU microbiome research projects
Submission and evaluation scheme
Anticipated project budget
Coordinator required
Yes
Deadline for EoI
01/09/2024
Deadline of the call
31/12/2024
