Regulatory Guidance for Microbiome-Based Therapeutics
To my fellow microbiome enthusiasts,
Earlier this month, the newly established Microbiome Therapeutics Innovation Group (MTIG), a coalition of organisations leading the research & development of FDA-approved microbiome-based therapeutics, provided an important statement on the current regulatory frameworks for FMT treatments*.
Following this assessment, coupled with the 2017 publication of the U.S. Regulatory Considerations for Development of LBPs as drugs*, we understand that staying up to date with the current regulatory guidance for microbiome-based therapeutics will be critical to the clinical development and market approval of these breakthrough treatments.
That’s why at this year’s 4th Microbiome Movement – Drug Development Summit, we have continued to put the spotlight on this critical topic, with agenda highlights including:
- Edna Termilus, CBER Medical Officer at the FDA who will present an important update on the clinical and regulatory frameworks for LBPs, with an emphasis on filing INDs and CMC considerations during development
- Thomas J. DesRosier, Chairman of the MTIG Board and EVP, Chief Legal Officer & Secretary at Seres Therapeutics who will provide an update on current MTIG strategy that is helping build a collective voice to enhance the regulatory success of microbiome-based therapeutics
- Jim Weston, SVP Regulatory Affairs at Seres Therapeutics, Edward Burd Head of Regulatory Affairs at Rebiotix, Susan Stewart, SVP Regulatory Affairs & Quality at Kaleido Biosciences and Edna Termilus, CBER Medical Officer at the FDA be sharing the stage as part of our exciting panel discussion reviewing how microbiome drug developers can build clear regulatory guidelines to accelerate the approval of microbiome-based therapeutics, with an emphasis on LBPS
Access the latest event guide for further insight into these sessions in addition to the 70+ expert speakers from the pharma, biotech and academic community presenting throughout our comprehensive 3-day agenda.
If you’re looking to absorb the latest discovery, clinical and commercial advances in microbiome-based therapeutic & biomarker development coupled with a unique networking opportunity alongside a growing community of cutting-edge researchers from industry and academia, join the Microbiome Movement and help unlock the therapeutic potential of the microbiome to push your own projects to the next level.
I look forward to meeting many of you in Boston this summer.
