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)
- 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- How should you address outdated diagnostic criteria?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.