FDA Industry Statistics Workshop Organizational Meeting January 25, 2010

1. FDA Industry Statistics WorkshopOrganizational MeetingJanuary 25, 2010 Co-Chairs Ivan S.F. Chan (Merck) Qian Graves (FDA)

2. Good Morning and Welcome!

3. Welcome • Thank you for attending this organizational meeting • We are glad you are here! • With your help • this will be a productive pre-meeting • leading to a useful workshop in Sept. 2010

4. Logistics of Today’s Meeting(and rules) • Location of Important landmarks • Please turn all pagers/cell phones to vibrate • No private discussions during meeting • Please discretely go to the hall

5. Agenda 9:00 am Continental breakfast available 9:30 am Welcome! 9:35 am Introduction by Attendees 9:55 am Workshop Logistics 10:10 am Short Courses Discussion 10:50 am 20 minute Stretch Break and voting for short courses 11:10 am Session Topic Discussion 12:00 noon LUNCH & VOTE 1:15 pm Report of Top Selection of Topics/Sessions 1:30 pm Session Logistics 1:40 pm Volunteers for Session Chairs/Session Organizers 2:15 pm 15 Minute Stretch Break 2:30 pm Roundtable Discussions Logistics 2:55 pm Summary of Meeting 3:00 pm End of meeting

6. Attendee Introduction • Please Introduce yourself very briefly • Name • Professional Affiliation (FDA center) • If you have participated in the Workshop • Steering Committee member?

7. Goals • Describe the Vision of the 2010 FDA/Industry Statistics Workshop • Provide Responsibilities including timelines for contributors to the 2010 workshop • Session Chairs/Organizers • Speakers • Course Instructors • Roundtable Discussants • Select for consideration • Short Courses • Sessions

8. 2010 Workshop Format • Three Day workshop Sept 20-22, 2010 • Grand Hyatt, Washington D.C. • Day 1: Short Courses • Six half-day courses • Days 2 to 3: Concurrent/Plenary sessions • Roundtable luncheon on Sept 21st • 2 to 3 Plenary Sessions • 27 to 30 Concurrent Sessions • 2 to 3 CMC sessions

9. Selection Criteria for Concurrent Sessions • Representation from each FDA center (at least 1 session) • Important topics determined by Steering and Organizing Committees • including today’s discussion and voting • At least 1 session for each topic • Attractiveness of speakers • ideally from FDA, industry, and academia • Due to the large number of short course proposals, we will give 2 spots to the short course proposals that are not selected • Invite to further develop and send for review

10. Review Process for Concurrent Sessions • Initial review by Steering Committee (Jan 19) • Second review by Steering and Organizing Committees (today) • Final review by Steering Committee (March) • Proposals that are not picked are encouraged to submit for the roundtable discussions

11. Procedures of Submitting Abstracts for Selected Sessions • Selected proposals will be asked to develop a full abstract by March 8 • Use a template to be supplied • Confirm participation of chairs and speakers • Steering committee will review and make final selection (also decide on Plenary sessions) by March 31 • Instruction with template will be sent out by January 29

12. Correspondence & Communication • ALL submitted abstracts MUST • Be received prior to the Deadline • Be in the format provided in the template • Be in a WORD document • Be sent as an attachment to the Yahoo account fda_industry_WKSP2010@yahoo.com

13. Rules for Participation To ensure each session receives the proper attention and to allow for diverse ideas and active participation by all, we suggest that any individual does not volunteer for more than 2 roles from A-C.  a)  give a presentation   b)  serve as discussant c)  organize up to 2 sessions (preferable one!) *** Any individual is allowed to lead one round table luncheon discussion

14. More Rules About Sessions • 90 minutes for a plenary session. Three speakers and up to 2 additional panel discussants • 75 minutes for a parallel session. Up to three speakers and an extra discussant (optional) • Panel discussion can have up to 5 participants • Each session can have 1-2 chairs and up 4 organizers (incl. chairs). Both FDA and non-FDA participants. • Each session should leave some time (5-10 minutes) for Q&A.

15. Rules for Speakers and Organizers 1) A person cannot be both a speaker and a chair (or an organizer) within one session. 2) The session organizers/chairs need to select a contact person and an alternate to communicate to Ivan/Qian via the Yahoo account • Organizers will be required to be in contact with speakers throughout the spring, summer and fall. • Everyone must register for the workshop.

16. Important/Hot Topics Identified by Steering Committee At least 1 session devoted to each topic: • Risk/benefit • Adaptive design • Biomarker • Biosimilar/follow-on products • Multiplicity

17. Additional Important/Hot Topics For Discussion Today • Safety • Multi-regional/global trials • Modeling and trial simulations • Meta-analysis • Missing data

18. Procedure for Ranking the Concurrent Sessions • Each committee member receives 10 stickers • Steering committee members get 10 more • Vote between 12:00 (noon) to 12:45pm. • Place X # of stickers under your favorite sessions. • Results will be announced after lunch

19. Timeline of Workshop Planning: Upcoming Tasks • March 8 -Full Abstract due for Topics selected from today’s meeting • March 31 – Session organizers notified of final decision • Future tasks’ timeline will be communicated at a later time

20. Special Thanks to Our Core Committee (so far) American Statistical Association Reps Fay Gallagher (ASA) Kathleen Wert (ASA) Short Course Coordinator Carmen Mak (Schering Plough)Tammy Massie (FDA-CBER) Roundtable Luncheon Coordinator Jie Chen (Abbott) Yi Tsong (FDA-CBER) And all the volunteers!

21. Special Thanks: Steering Committee

22. THANK YOU! We look forward to an extremely productive year and with your assistance an EXCELLENT WORKSHOP September 20-22th!