THE 22nd ANNUAL
      MIDWEST
      BIOPHARMACEUTICAL
      STATISTICS
      WORKSHOP
benny
   PRELIMINARY PROGRAM

      May 24 - 26, 1999

   L. A. Pittenger Student Center
  BALL STATE UNIVERSITY
      MUNCIE, INDIANA
MONDAY, MAY 24
11:30 am - 6:00 pm
REGISTRATION - Terrace Lounge
1:00 p.m. - 2:30 p.m.
TUTORIAL
Presenter:JIM ROCHON, George Washington University
An Introduction to Generalized Linear Models and GEE
2:30 p.m. - 2:45 p.m.
FRANK SHEN, Bristol-Myers Squibb Co.
Ball State University
INTRODUCTION AND WELCOME - Cardinal Hall
FRANK SHEN, Bristol-Myers Squibb Co.
SUSAN M. JOHNSON, Associate Dean
College of Sci. & Hum., Ball State University
2:45 p.m. - 6:15 p.m.
PLENARY SESSION - Cardinal Hall B
"Graphical Methods for Displaying Design of Experiments"
Chair: DAVID STOCK, Bristol-Myers Squibb Co.
Speaker:GEORGE MILLIKEN, Kansas State University
6:45 p.m. - 8:30 p.m.
MIXER - Hotel Roberts Ballroom

TUESDAY, May 25
8:00 - 3:30 pm
REGISTRATION - Terrace Lounge
8:00 - 8:30 pm
CONTINENTAL BREAKFAST - Terrace Lounge
8:30 a.m. - 10:45 a.m.
CONCURRENT SESSIONS
A. Heterogeneity in Clinical Trial Populations - Cardinal Hall B
Organizer/Chair: GORDON PLEDGER, RW Johnson PRI
1. "Adaptively changing subgroup proportions in clinical trials",
DEAN FOLLMANN, National Heart, Lung and Blood Institute.
2. "Clinical trial analysis when response is driven by a subgroup: examples in AIDS",
DAVID HALL, Boehringer-Ingelheim.
3. "Women, Smokers, and Libras: When do We Believe Subgroups?"
JANET WITTES, Statistics Collaborative.

B. Genetics and Bioinformatics - SC301-302

Organizer/Chair: MEG EHM, Glaxo Wellcome Inc.
1. "Novel Gene Identification through Family-Based Classification of EST
Sequences", XIAOJUAN GUAN, Glaxo Wellcome Inc.
2. "Noise Modeling and its Impact on Gene Expression Pattern Recognition",
JOACHIM THEILHABER, STEVEN BUSHNELL, and GUANGZHOU ZOU,
Ariad Pharmaceuticals.
3. "Statistical Genetic Analysis in Pharmaceutical Research",
MEG EHM, Glaxo Wellcome Inc.

C. Secrets of the Lost Data - FORUM

Organizer/Chair: STACY DAVID, Eli Lilly Co.
1. "Handling Missing Data in Clinical Trials: An Overview",
BILL MYERS, Proctor & Gamble Pharmaceuticals.
2. "Analysis of Missing Data Using Mixed-Effects Models",
CRAIG H. MALLINCKRODT, W. SCOTT CLARK, and STACY R. DAVID, Eli Lilly Co.
3. "The Implementation of the Multiple Imputation Approach for Missing Data in the
'SOLAS for Missing Data Analysis' Software Application",
AIDAN MCDONNELL, Statistical Solutions.
Tuesday, May 25
10:50 - 11:50 am
PLENARY SESSION
Organizer/Chair: FRANK SHEN, Bristol-Myers Squibb.
WES COSAND, Bristol-Myers Squibb.
"The Impact of Genomics on Drug Discovery and Development"
12:00 noon - 1:00 p.m.
LUNCH BUFFET - Pittenger Center Ballroom
12:45 p.m. - 1:45 p.m.
POSTER SESSION - Cardinal Hall A/B
Chair: KIM PERRY, Pharmacia-Upjohn.
1:45 - 4:45 pm
CONCURRENT SESSIONS

A. Post Marketing Surveillance - Cardinal Hall B

Organizer/Chair: GREG ENAS, Eli Lilly Co.
TBD
KEN HORNBUCKLE, Eli Lilly & Co.
2. TBD
RALPH LITTLE, FDA
3. TBD
YI TSONG, FDA

B. Analysis and visualization of large data sets - SC 301-302

Organizer/Chair: MICHAEL W. LUTZ, Glaxo Wellcome Inc.
1. Finding the Information in High-Throughput Screening Data.
J. ALAN MENIUS, Glaxo Wellcome Inc.
2. Assimilating High Dimensional Data Through Cluster Correlation.
FRANCES P. STEWART, Smithkline Beecham Pharm.
3. A Perspective on Visual Data Mining.
MARK JOHNSON, Pharmacia & Upjohn, Inc.
Discussant: MICHAEL W. LUTZ, Glaxo Wellcome Inc.

C. Setting of Specification Limits - FORUM

Organizer/Chair: BOB DILLARD, Searle
1. "Regulatory vs. Scientific Aspects of Setting Specifications for Bioassay",
TONY MIRE-SLUIS, NIBSC
2. "Shelf Life, Expiry Specifications, and Release Limits",
JOHN MURPHY, Eli Lilly Co.
3. "In-Vivo, In-Vitro Correlation and Dissolution Specifications",
BO YAN, Searle
4. "Retest, Resample, Remeasure, and Reportable Values for OOS"
LYNN TORBECK, Torbeck Assoc.
6:30 - 7:30
CASH BAR - Hotel Roberts Ballroom
7:30 - 10:00pm
BANQUET- Hotel Roberts Ballroom
TBA
Speaker: JON KETTENRING, Bellcore, Past ASA President

WEDNESDAY, MAY 26
8:00 - 9:00am
REGISTRATION - Terrace Lounge
8:00 - 8:30
CONTINENTAL BREAKFAST - Terrace Lounge
8:30 - 11:30 am
CONCURRENT SESSIONS
A. Design and Analysis Issues in Clinical Trials for Regulatory Use - Cardinal Hall B
Organizer/Chair: TODD SAHLROOT, FDA
1. "Two-stage Designs to Adaptively Modify Sample Size and Clinical Trials",
MICHAEL PROSCHAN, National Heart, Lung and Blood Institute.
2. "Two-stage Designs and Other Sample Size Adjustment Procedure",
QING LIU, RW Johnson PRI.
3. "Enrichment Designs", CHUCK DAVIS, U. of Iowa.

B. High-Throughout Screening - SC 301-302

Organizer/Chair:DAVID STOCK, Bristol-Myers Squibb Co.
1. "The Science of Screening",
SUSAN MANLY, Bristol-Myers Squibb Co.
2. "Boldly Going Where No One Has Gone Before: HTS Validation and Control",
BERT GUNTER, Merck.
3. "Estimating the False Negative Rate of High Throughput Screen",
PHIL IVERSEN, Eli Lilly Co.
4. "Statistical Issues in High Throughput Screening",
JENS PRAESTGAARD, Abbott Laboratories

C. Analysis of Multivariate Data in the Preclinical/Nonclinical Setting - FORUM

Organizer/Chair: JEFF HOFER, Eli Lilly Co.
1. TBD
JOEP TIMMERMANS, Merck and Co.
2. "Application of Partial Least-Squares Regression to the Near-Infrared
Determination of Glucose in Biological Samples," GARY SMALL, Ohio Univ.
3. "Statistics for the Development of Chromatographic Methods",
BRUNO BOULANGER, Eli Lilly Co.
Noon - 1:00pm
LUNCH BUFFET - Pittenger Center Ballroom
Closing Remarks
FRANK SHEN, Bristol-Myers Squibb Co.

We wish to thank the following
for their generous support and contributions:
 
Trilogy Consulting Corp.
Ball State University
Quintiles
WORKSHOP COMMITTEE
 
WORKSHOP CHAIR 

Frank Shen 
Bristol-Myers Squibb 
PO Box 5400 
Princeton, NJ 08543-4000 
e-mail:Frank_Shen@ccmail.bms.com 
 

 CHAIRMAN EMERITUS 

Charles B. Sampson 
CBSCO, Inc. 
11716 Eden Estates Drive 
Carmel, IN 46033-3249 
e-mail: cbsvms@earthlink.net 
 
PAST CHAIR 

Pat O'Meara 
Pat O'Meara Associates, Inc. 
2810 Kucera Drive 
Lincoln, NE 68502 
e-mail: pat@patomeara.com 
 
REGISTRAR 

Shanthi Sethuraman 
Eli Lilly and Company 
Lilly Research Laboratories 
P.O. Box 685, DC TL31 
Lafayette, IN 47902 
e-mail: ssethu@Lilly.com 
 
PROGRAM CO-CHAIRS 

Michael Lutz 
Glaxo Wellcome, Inc. 
e-mail: ML3495@glaxowellcome.com 
 
Gordon Pledger 
R W Johnson Pharm. Res. Inst. 
Box 300, Rt. 202 
Raritan, NJ 08869 
e-mail: gpledger@prius.jnj.com		 LOCAL ARRANGEMENTS CHAIR 

Mir Masoom Ali 
Dept. of Mathematical Sciences 
Ball State University 
Muncie, IN 47306
e-mail: mali@wp.bsu.edu 
Edith Senderak 
Merck & Co., Inc. 
Sunneytown Pike, WP44L-214 
West Point, PA 19486-0004 
e-mail: senderak@merck.com
POSTERS 
Kim Perry 
Pharmacia & Upjohn 
9163-227-400, 7000 Portage Rd. 
Kalamazoo, MI 49001 
e-mail: KTPERRY@am.pnu.com 
 		 PUBLICITY 

Kenneth B. Gerard 
Hoechst Marion Roussel, Inc. 
H4-M2316 
P.O. Box 9627 
Kansas City, MO 64134-0627 
e-mail: kgerald@qkan.quintiles.com 
 
Co-sponsored by the Biopharmaceutical Section
of the American Statistical Association
REGISTRATION
The Workshop will be held in the L. A. Pittenger Student Center of Ball State University. The registration fee is $130.00 by mail ($50.00 for full-time students), $150.00 at the meeting. Maps of the city, campus and the L. A. Pittenger Student Center will be forwarded upon receipt of your registration form. Conference registration will begin at noon on Monday, May 24, 1999, in the Terrace Lounge of the Student Center. A full refund will be made only for cancellations received by Shanthi Sethuraman prior to May 1; there will be no partial refunds. Casual attire is encouraged at all events.
MESSAGES
Messages will be received at the Student Center reception desk and posted on a message board. The telephone number for incoming calls during the Workshop is (765) 285-1399.
MIXER
The "get acquainted" no-host mixer will be held at the Hotel Roberts Ballroom from 6:30 - 8:00p.m. on Monday, May 24 1999.
MEALS
Registration includes tickets for Tuesday and Wednesday luncheons and for the banquet to be held Tuesday evening at the Horizon Convention Center. You will receive your tickets at the time of registration.
PARKING
Parking is available in the Parking Structure near the Student Center for $1.00/day.
ACCOMMODATIONS
The following accommodations are available for your convenience. Please make all reservations directly with the hotel of your choice. 
STUDENT CENTER HOTEL (765)  285-1555 ($43 - $48/room/night)  
HOTEL ROBERTS (800) 333-3333 or (765) 741-7777 ($68 for standard and $78 for suite)
SIGNATURE INN (800) 822-5252 or (765)284-4200 ($73/room/night) 
LEE'S INN (765)  282-7557 ($55/room/night)
A block of rooms is being held at the Hotel Roberts, Student Center Hotel, Lee's Inn and the Signature Inn UNTIL May 1, 1999. Please indicate that you are attending the MBSW at Ball State University when registering. Transportation between the Workshop and the Signature Inn will be available. The accommodations are all within two miles of the Student Center.   
  
  
                TWENTY-SECOND ANNUAL MIDWEST BIOPHARMACEUTICAL STATISTICS WORKSHOP
                
              REGISTRATION FORM
                
  Name as you would like it to appear on your name tag: 
                

   Complete name and address information if, and only if, the address label is incorrect.
                
                
   Name: _______________________________________________
                
                
   Organization:__________________________________________ 
                
                
   Address: ___________________________________________________________
  
                

                    ____________________________________________________________

                                         City                                   State                             Zip
       
        
   Business Phone:_______________________
 
                
                
   Registration Fee:  (Includes mixer, banquet and two luncheons)
    $130.00 Regular    $50.00  Full-Time Student  (should enclose copy of   current student ID card)
 
Check the meals you plan to attend: _____ Tues. lunch _____ Tues. banquet _____Wed. lunch
_____Check here if you want vegetarian meals.
Please check your primary area of reponsibility: ___ Clinical ___Nonclinical ___Discovery ___ Toxicology ___ Manufacturing/ Quality Control
Registration in person at Muncie will cost an additional $20.00. No credit cards accepted. This form must be accompanied by check or money order in US funds payable to Midwest Biopharmaceutical Statistics Workshop for the amount indicated above. Mail Registration Form to: Heather Gordon, Lilly Corporate Center, DC 2233, Indianapolis, IN 46285, Phone: (317)276-6871.  
FOR INFORMATION ON THE WORKSHOP, please contact: KEN GERALD H4-M2512, Hoechst Marion Roussel., PO BOX 9627, Kansas City, MO 64134-0627, (816) 966-7733, e-mail: ken.gerald @qkan.quintiles.com, Frank Shen, Bristol-Myers Squibb Co. PO Box 5400, Princeton, NJ 08543, e-mail: frank_shen@ccmail.bms.com or Mir Ali, Dept. of Mathematical Sciences, Ball State University, Muncie, IN 47306-0490, (765) 285-8670, e-mail: mali@wp.bsu.edu A copy of this will be periodically updated at http://www.cs.bsu.edu/homepages/ali/mbsw21.html.
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