Clinical Development & Manufacturing Challenges for Microbiome-Based Therapeutics

Microbiome Movement

As cutting-edge organizations such as Seres Therapeutics, Rebiotix, Vedanta Biosciences continue to make the headlines by further advancing clinical development of their microbiome-based therapeutics candidates, we know that there is still a high clinical and regulatory risk due to there not being an approved therapy with no clear benchmark in industry.

Just some of the unresolved challenges include:

  1. With enrolment for two phase III microbiome-based programs underway, how do organizations select patients to expedite clinical results?
  2. Do microbiome companies rely too much on outside experts? What level of in-house experience is required for a scalable and successful therapeutic?
  3. In a new therapeutic area, what are the most relevant departments to contact?
  4. At what point should a company consider its plans to scale-up their product during clinical development?
  5. How are companies and regulatory agencies reacting the need to carefully monitor the stability and shelf life?

Do these challenges resonate with you? Are you looking for a forum to discuss these areas amongst your peers?

If so, join us at the 4th Microbiome Movement – Drug Development Summit – the go-to forum for those new to the field or established players in the microbiome industry to keep up to date with the latest trends and developments and overcome the translational challenges associated with microbiome-based therapeutic and biomarker development.

Part of a three day agenda with over 70+ case studies, and a dedicated track for the Clinical Development, Manufacturing & Commercializing Microbiome-Based Therapeutics check out the agenda highlights below:

  • Finch Therapeutics Group discuss CMC development for full spectrum microbiota products
  • CBER at the FDA share clinical and regulatory considerations for LBPs
  • TargEDys discuss clinical development and scale-up considerations
  • Whole Biome explore clinical trial design challenges
  • University of Minnesota Microbiota Therapeutics discuss how to standardize the process of clinical trial design and capsule development

Access the full event guide here.

If you’re searching a microbiome conference where you can absorb the latest discovery, clinical and commercial advances in microbiome-based therapeutic and biomarker development, whilst accessing a growing community of cutting-edge researchers from industry and academia, join the Microbiome Movement to push your own projects to the next level.

I look forward to you joining the conversation this June!

The Microbiome Movement Team