49: Mr. Berry Goes to Washington

In this episode of "In the Interim…", Dr. Scott Berry marks the podcast’s one-year anniversary, sharing listener metrics, watch data, and regional engagement. He then delivers a step-by-step analysis of the FDA meeting process, detailing the progression from initial sponsor meeting requests and question submission to briefing book preparation, feedback cycles, and in-person logistics for a Type C meeting at the White Oak facility. Drawing from more than 25 years of trial design and regulatory experience, Scott offers precise guidance on technical preparation, sponsor responsibilities, and common errors in sponsor-FDA dialog, emphasizing what works and what wastes time inside the one-hour meeting constraint. His practical approach focuses on clarity, respect for process, and actionable advice.

Key Highlights

• Slightly over 30,000 people tuned in during the first year across 45 episodes; about 10,000 via audio, 20,000 via video with a global worldwide reach.

• FDA meeting workflow: request, submit four to eight questions, draft briefing book, receive written feedback, strict one-hour in-person discussion controlled by sponsor.

• Advice on briefing book content, avoiding new materials at the meeting, even what not to bring through the White Oak facility.

• Sponsor pitfalls: disingenuous patient advocacy, asking impossible questions, taking adversarial stance in statistical discussion.