1st draft of Colon Cancer Workshop Agenda _to begin the discussion_ by shimeiyan


									Agenda for Colon Cancer Workshop November 12, 2003 Topic Introduction 1. Regulatory background -Regulations and endpoints -Past approvals for colorectal cancer drugs Presenter1/ Discussion Leader2 Richard Pazdur (FDA) 1 Grant Williams (FDA) 1 Amna Ibrahim (FDA) 1 Time 8:00 AM

(15 min) (15 min)

2. First-line therapy of advanced colon cancer -TTP discussion Langdon Miller1 -Non-inferiority/surrogates Tom Fleming1 -Questions to speakers -Break

8:40 AM (30 min) (20 min) (15 min)

-Question-based discussion of first-line treatment setting 10:00 AM 2 Survival James Krook TTP and accelerated approval John Marshall2 and Mike O'Connell2 Lunch 3. Second-line and subsequent therapy setting -Question-based discussion of TTP, Jordan Berlin2 survival, and Accelerated Approval 4. Other endpoints in advanced disease Charles Blanke2 12:00 PM 1:00 PM

2:15 PM 2:45 PM (15 min) (60 min)

5. Adjuvant setting: DFS versus survival -DFS versus Survival Dan Sargent1 -Question-centered discussion Mike O'Connell2 & Dan Sargent2 6. Rectal cancer endpoints -Neoadjuvant therapy -Rectal cancer questions Conclude Meg Mooney1 15 min Meg Mooney2 45 min

4:00 PM

5:00 PM

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