FDA/Industry Statistics Workshop

Wednesday, September 14, 2005 8:00 am – 11:30 pm Short Course #1 - Delaware AB Short Course #2 - Maryland BC Analysis of Micro-arrays Communicating with FDA Statisticians Javier Cabrera Estelle Russek-Cohen (CDRH); Steve Wilson (CDER) 11:30 – 1:30 Lunch (on own) 1:30 – 5:00 pm Short Course #3 - Maryland BC Short Course #4 - Delaware AB Multiple Comparisons for Making Clinical and Genomic Decisions Robust Nonparametric Methods and the General Linear Model Jason Hsu Joe McKean Thursday, September 15, 2005 7:30 – 8:15 am Continental Breakfast Marriott Foyer ** 8:15 – 8:30 am Opening Remarks 8:30 – 10:00 am General Session 1 - Update on Critical Path with Special Attention to Statistical Science Salon I Co-Organizers: Chuck Anello (FDA-CDER) and Naitee Ting (Pfizer) Speakers: Bob O’Neill (FDA-CDER); Walter Offen (Eli Lilly); Richard Simon (NIH-NCI)

10:00 – 10:20am Refreshment Break Marriott Foyer 10:20 am – 11:50pm General Session 2 - Bayesian Trial Design – Case Studies Salon I Co-Organizers: Telba Irony (FDA-CDRH); Suman Bhattacharya (Biogen Idec); Andrew Mugglin (Medtronic) Speakers: Don Berry (MD Anderson); Andrew Mugglin (Medtronic) Panelists: Mike Krams (Pfizer); Stacey Lindborg (Eli Lilly); Suman Bhattacharya (Biogen Idec); Telba Irony (FDA-CDRH)

11:50 – 1:10 pm Luncheon Roundtables R1 – R20 – Cotillion North, R21 – R40 – Cotillion South, R40 – R48 – Wilson BC

1:10 – 2:30 pm General Session 3 - Data Monitoring Committees: Practical Considerations and Useful Strategies Salon I Co-Organizers: Tony Lachenbruch (FDA-CBER); Pat O'Meara (O'Meara Consulting); Barry Schwab (Johnson & Johnson) Speakers: Steve Snapinn (Amgen); Pat D. O'Meara (Pat O'Meara Associates); Janet Wittes (Statistics Collaborative, Inc.) Discussant: Mary Foulkes (FDA-CBER)

2:30 – 2:50 pm Refreshment Break Marriott Foyer 2:50 – 4:10 pm General Session 4 - Pharmacogenomics Salon I Co-Organizers: Estelle Russek-Cohen (FDA-CDRH); Alex Bajamonde (Genentech); Sue-Jane Wang (FDA-CDER) Speakers: Javier Cabrera (Rutgers University ); Sue-Jane Wang (FDA-CDER); ** (Genentech)

4:10 – 4:15 pm Stretch Break (to provide time for speaker change on the podium)

4:15 – 5:35 pm General Session 5 - Multiplicity Issues in Analysis of Clinical Trial Data Salon I Co-Organizers: David Zhang (Genentech); William Wang (Merck) Speakers: Jason Hsu (Ohio State University); Mohammed Huque (FDA-CDER); Alex Dmitrienko (Eli Lilly) Friday, September 16, 2005 7:30 – 8:20 am Continental Breakfast Marriott Foyer 8:20 – 9:40 am Parallel Session1 - Room Parallel Session 2 - Room Parallel Session 3 - Room Parallel Session 4 - Room

Post Market Adverse Development and Use of Bridging Studies – Concept, Statistics in Pre-Clinical Events: FDA Reporting Patient-Centered Issues, and Their Studies Systems and Surveillance Questionnaires in Clinical Applications in Research International Simultaneous Co-Organizers: Drug Development Co-Organizers: Karl Lin (CDER); Gene Pennello (CDRH); Co-Organizers: Ronald Menton (Wyeth Research) Jingyee Kou (CBER) Eileen King (Procter & Gamble); Co-Organizers: Matilde Sanchez (Merck) Junfang Li (Sanofi Aventis); Speakers: Speakers: Zahur Islam (Novartis); Hojin Moon (NCTR); Jane Woo (CBER); Speakers: Yi Tsong (CDER) Ronald Menton (Wyeth); Hesha Duggirala (CDRH); Cindy Rodenberg (Procter & Kimberly Crimin (Pfizer) Jonathan Levine (CDER) Gamble); Speakers: Jeff Sloan (Mayo Clinic); Shein-Chung Chow (formerly at Lisa Kammerman (CDER) Health Research Institutes, Taiwan); Masahiro Takeuchi (Kitasato University, Tokyo, Japan); Junfang Li (Sanofi Aventis) 9:40 – 10:10 am Refreshment Break Marriott Foyer 10:10am – 11:30 pm Parallel Session 5 - Room Parallel Session 6 - Room Parallel Session 7 - Room Parallel Session 8 - Room

Topics in Drug Safety Vaccine Trials CDISC Initiatives: Impact Non-inferiority Studies on Electronic Data Co-Organizers: Co-Organizers: Submission Co-Organizers: Lee Kaiser (Genentech); Jingyee Kou (CBER); Yi Tsong (CDER); Chuck Anello (CDER) Bill Wang (Merck) Co-Organizers: Junfang Li (Sanofi Aventis); Shyam Gupta (CBER); David Breiter (Guidant); Speakers: Panelists: Alex Bajamonde (Genentech); Matilde Sanchez (Merck) Martin Kulldorf (Harvard); Statisticians Cathy Barrows (GlaxoSmithKline) Paul Seligman (CDER); Dale Horne (CBER); Speakers: Pavel Napalkov (Genentech) Joe Heyse (Merck); Speakers: Ralph B. D’Agostino, Sr. (Boston Lawrence Moulton (Hopkins); Dave Christiansen (Christiansen U); Clinicians Consulting); Yi Tsong (CDER); Douglas Pratt (CBER); Michael Nessly (Merck); Junfang Li (Sanofi Aventis) Jill Hackell (Wyeth) Cynthia Liu (CDER) 11:30 – 1:00 pm Lunch (on own) 1:00 – 2:20 pm Parallel Session 9 - Room Parallel Session 10 - Room Parallel Session 11 - Room Parallel Session 12 - Room

Contemporary Challenges Integrated Statistical Flexible Design – Are We Statistical Methods for in Statistical Evaluation of Computing Environments Ready Yet? Nonrandomized Trials and Diagnostic Products for Efficiency and Quality Subverted Randomized Trials Co-Organizers: Co-Organizers: Co-Organizers: Gene Pennello (CDRH); Steve Wilson (CDER); Suman Bhattacharya (Biogen Idec); Co-Organizers and Speakers: Lakshmi Vishnuvajjala (CDRH) Pratap Malik (Waban Software) Shuyen Ho (GlaxoSmithKline); Lilly Yue (CDRH); H.M. James Hung (CDER) Vance Berger (NCI); Speakers: Speakers: Roseann White (Guidant) Marina Kondratovich (CDRH); Alan Hopkins (Theravance, Inc.); Speakers: Stuart Baker (NIH/NCI); Jeff Schumack (Human Genome Martin Posch (U of Vienna); Ping Shi (Abbott Diagnostics) Sciences); Vladimir Dragalin Steve Wilson (CDER) (GlaxoSmithKline); H.M. James Hung (CDER); Mike Krams (Pfizer) 2:20 – 2:30 pm Break Marriott Foyer 2:30– 3:50 pm Parallel Session 13 - Room Parallel Session 14 - Room Parallel Session 15 - Room Parallel Session 16 - Room

Combination Products Re-randomization (Birds of Statistical Issues in Medical QT Intervals a Feather Session) Device Trials (Birds of a Feather Session) Co-Organizers: Co-Organizers: Co-Organizers: Jingyee Kou (CBER); Vance Berger (NCI); Sue Walker (GlaxoSmithKline) Cathy Barrows (GlaxoSmithKline) Jeff Helterbrand (Genentech) Organizer: George Rochester (CDER) Greg Campbell (CDRH) Speakers: Speakers: Sang Ahnn (FDA CBER) and Ivan Venkat Sethuraman (Novartis); Chan (Merck); Juan Zhang (FDA CDER) John Peterson (GlaxoSmithKline); H.M. James Hung (FDA CDER)