Biopharmaceuticals (includes Biologics)

Microbiome: Regulatory Challenges and Opportunities

Session Leader(s)

• 

  Miranda Johnson, PhD

  Regulatory Science Fellow
  Janssen Pharmaceuticals

Speaker(s)

• 

  Rebecca Lipsitz
• 

  Susan Stewart, JD

  SVP Regulatory and Quality
  Kaleido Biosciences
• 

  Jim Weston, MBA

  SVP, Regulatory Affairs
  Sears Therapeutics, Inc

This session will highlight the current regulatory environment for microbiome-based drug products. Speakers will discuss the challenges and regulatory pathways for microbiome-based products. Finally, we will identify key regulatory policy considerations and discuss potential paths moving forward for this novel therapeutic.

Learning Objectives:

• Understand regulatory approval pathways for microbiome-based products.
• Understand the innate qualities of microbiome products that result in unique regulatory considerations.
• Discuss important regulatory policy considerations and prioritize scientific considerations as they relate to regulatory policy.
• Understand potential opportunities for additional policy development.