Emma Taylor

– Abstract –

Challenges in Microbiome Therapeutic Development

Despite the overwhelming data that microbial therapies can impact clinical disease, evidenced by the success of fecal microbiome transplants, translating these approaches into meaningful and reproducible therapeutic strategies remains a challenge. There still remains an industry-wide dependence on antibiotics and there are many company-specific challenges in working with live biologic material, namely relating to securing intellectual property, identifying optimal candidate strains, developing a GMP manufacturing process, establishing a regulatory strategy, and designing clinical trials.  I hope to shed light on how our company, Naked Biome,  has navigated many of these challenges in developing a topical live biologic therapy for acne.