This week I’m speaking at the NIST (National Institute of Standards and Technology) Workshop on Standards for Microbiome Measurements held on September 9-10 in Gaithersburg, MD. Microbiome is a hot topic these days with scientists trying to understand how the flora of the gut can be modulated with supplements of healthy bacteria in order to achieve desired outcomes.
My presentation “Gut Microbiome Endgame: Ramping up cGMP Program Design to Ensure Regulatory Preparedness for Microbiome Products”, will focus on the many facets of working with microbiome products in the lab to move them successfully on to their next stage of product development. Included will be program design approaches, cleanroom engineering practices, characterization methods, stability options, and the expertise required to move to the next phase of a program’s lifecycle.
At BA Sciences we have seen expansion in this area of study and have proactively invested in the resources needed to accommodate that growth as well as keep current with regulations as they change. Documents such as EP 3053, the FDA Guidance for Industry documents on Early Clinical Trials with Live Biotherapeutic Products and Recommendations for Microbial Vectors for Gene Therapy play an important role to ensure requirements are met.
Microbiome is important for human health as it influences such things as nutrition, immunity, behavior and disease. By moving this science forward, we can make progress in things such as asthma, cancer, dementia, diabetes, heart disease, multiple sclerosis, obesity, and stress, as well as many other medical issues. Strides in this area of health are being made every day and we are gaining a better understanding of the important role the gut plays in our health.
Medicinal microbiome modulation is a fascinating topic that is really just starting to be understood, and it’s an area of research that will continue to gain momentum.