3 Welcome Thank you for attending this organizational meeting We are glad you are here!With your helpthis will be a productive pre-meetingleading to a useful workshop in Sept. 2010
4 Logistics of Today’s Meeting (and rules) Location of Important landmarksPlease turn all pagers/cell phones to vibrateNo private discussions during meetingPlease discretely go to the hall
5 Agenda 9:00 am Continental breakfast available 9:30 am Welcome! 9:35 am Introduction by Attendees9:55 am Workshop Logistics10:10 am Short Courses Discussion10:50 am minute Stretch Break and voting for short courses11:10 am Session Topic Discussion12:00 noon LUNCH & VOTE1:15 pm Report of Top Selection of Topics/Sessions1:30 pm Session Logistics1:40 pm Volunteers for Session Chairs/Session Organizers2:15 pm Minute Stretch Break2:30 pm Roundtable Discussions Logistics2:55 pm Summary of Meeting3:00 pm End of meeting
6 Attendee Introduction Please Introduce yourself very brieflyNameProfessional Affiliation (FDA center)If you have participated in the WorkshopSteering Committee member?
7 Goals Describe the Vision of the 2010 FDA/Industry Statistics Workshop Provide Responsibilities including timelines for contributors to the 2010 workshopSession Chairs/OrganizersSpeakersCourse InstructorsRoundtable DiscussantsSelect for considerationShort CoursesSessions
8 2010 Workshop Format Three Day workshop Sept 20-22, 2010 Grand Hyatt, Washington D.C.Day 1: Short CoursesSix half-day coursesDays 2 to 3: Concurrent/Plenary sessionsRoundtable luncheon on Sept 21st2 to 3 Plenary Sessions27 to 30 Concurrent Sessions2 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 Committeesincluding today’s discussion and votingAt least 1 session for each topicAttractiveness of speakersideally from FDA, industry, and academiaDue to the large number of short course proposals, we will give 2 spots to the short course proposals that are not selectedInvite 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 8Use a template to be suppliedConfirm participation of chairs and speakersSteering committee will review and make final selection (also decide on Plenary sessions) by March 31Instruction with template will be sent out by January 29
12 Correspondence & Communication ALL submitted abstracts MUSTBe received prior to the DeadlineBe in the format provided in the templateBe in a WORD documentBe sent as an attachment to the Yahoo account
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 discussantc) 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 discussants75 minutes for a parallel session. Up to three speakers and an extra discussant (optional)Panel discussion can have up to 5 participantsEach 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 accountOrganizers 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/benefitAdaptive designBiomarkerBiosimilar/follow-on productsMultiplicity
17 Additional Important/Hot Topics For Discussion Today SafetyMulti-regional/global trialsModeling and trial simulationsMeta-analysisMissing data
18 Procedure for Ranking the Concurrent Sessions Each committee member receives 10 stickersSteering committee members get 10 moreVote 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 meetingMarch 31 – Session organizers notified of final decisionFuture tasks’ timeline will be communicated at a later time
20 Our Core Committee (so far) Special Thanks toOur Core Committee (so far)American Statistical Association RepsFay Gallagher (ASA)Kathleen Wert (ASA)Short Course CoordinatorCarmen Mak (Schering Plough) Tammy Massie (FDA-CBER)Roundtable Luncheon CoordinatorJie Chen (Abbott)Yi Tsong (FDA-CBER)And all the volunteers!
21 Special Thanks: Steering Committee FDAIndustry & AcademiaMary Bartholomew (CVM)Bruce Binkowitz (Merck)Joan Buenconsejo (CDER)Jie Chen (Abbott)Gregory Campbell (CDRH)Sonia Davis (Quintiles)James Chen (NCTR)Peter Lam (Boston Scientific)Ghanshyam Gupta (CBER)Kuang-Kuo Gordon Lan (Johnson & J.)Henry Hsu (CBER)Carmen Mak (Merck/Legacy Schering)Amelia (Dale) Horne (CBER)Soo Peter Ouyang (Celgene Corporation)Richard Kotz (CDRH)Brian Wiens (Alcon Labs)Tammie Massie (CBER)Anna Nevius (CVM)Yi Tsong (CDER)Stephen Wilson (CDER)
22 EXCELLENT WORKSHOP September 20-22th! THANK YOU!We look forward to an extremely productive year and with your assistance anEXCELLENT WORKSHOP September 20-22th!