Two-sponsor meeting

An Advisory Committee meeting is always fraught with challenges. When it is a two-sponsor meeting, things get even more challenging.

Two-sponsor meeting to provide advice on development of treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC / BPS)

FDA Committee: Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)

Key Issues

  • Disease definition: Are Interstitial Cystitis and Bladder Pain Syndrome the same or different conditions?
  • What are the implications for trial design and patient selection?
  • What are the appropriate endpoints for these conditions?
  • How should you address outdated diagnostic criteria?

 Challenges for the Sponsors

  • Lack of consensus within the medical community
  • Diversity of disease definitions, terminology and diagnostic criteria
  • Condition largely unfamiliar to the committee
  • Dual sponsor format: Two briefing documents; two presentations; shared Q&A session
  • Evolving direction from the Division over time

How we helped

  • Developed clear, concise and compelling messaging for speakers
  • Coached external experts to maximize impact during core presentation and Q&A
  • Proactive management of message to address late revisions to panel members and agency invited speakers
  • Orientation of advocacy groups and individuals participating in Open Public Hearing through live and remote participation

Unanimous vote ( 15-0 ) that Interstitial Cystitis and Bladder Pain Syndrome (IC and BPS) have overlap and should be evaluated in the same clinical trials.