Biopharmaceutical
Sponsored Sessions Numerous in Denver
Kalyan Ghosh, Program Chair, 2008, Biopharmaceutical Section of ASA
T
he 2008 Joint
Statistical Meetings
are coming up in
Denver, Colorado, starting
Sunday, August 3, and ending
FDA/Industry
Thursday, August 7.
Continuing Education classes
Statistics Workshop
start Saturday, August 2.
The Biopharmaceutical
Jeff Maca, Novartis Pharmaceuticals, and Ning Li, FDA
Section, one of the largest sections of the ASA, is sponsoring or
cosponsoring a number of sessions this year. Four invited, 24 top-
The 12th FDA/Industry Statistics Workshop is scheduled
ic-contributed, and 17 contributed sessions will be primarily spon-
for September 15–17 at the Marriott Crystal Gateway in
sored by our section and cover a variety of topics, from the discov-
Arlington, Virginia. It is cosponsored by the Biopharmaceutical
ery to the late phase of drug and device development. The section
Section of the American Statistical Association and the Food
also is sponsoring 16 roundtables with lunchf— ive on Monday,
and Drug Administration Statistical Association. Short courses
six on Tuesday, and five on Wednesday. Additionally, section offi-
are scheduled for the first day, followed by two days of sessions
cers have organized three Continuing Education (CE) courses on
on the science and statistics associated with developing medi-
relevant topics in drug development. Significant efforts have been
cal products (e.g., pharmaceuticals, biologics, and devices).
made to distribute the large number of section activities across the
The workshop has been popular since its inception because it
five days, including Sunday afternoon and Thursday morning.
is designed to bring together statisticians from industry, aca-
demia, and the FDA, and it provides a unique opportunity for
Sponsored CE Courses
open dialogue about issues of mutual interest.
The short courses include Clinical Trial Adaptive Designs, by
Analysis of Clinical Trials: Theory and Applications, by Alex
James Hung and Sue-Jane Wang; Biomarkers in Risk Prediction,
Dmitrienko, Christy Chuang-Stein, and Keaven Anderson
by Margaret Pepe; Statistical Graphics, by Frank Harrell;
Analysis of Censored Health Outcomes Data: Developments
Multiple Testing Problems in Pharmaceutical Statistics, by Alex
for Last 10 Years, by Heejung Bang and Hongwei Zhao
Dmitrienko; Meta-Analysis of Clinical T, by Anne Whitehead;
and Applications of Bayesian Statistics in Clinical Trials, by Tom
Evaluating Probability of Success for Internal Decisionmaking Louis, Andy Mugglin, and Scott Berry.
in Early Drug Development, by Narinder Nangia, Martin King, A series of plenary and parallel sessions will focus on a vari-
and Jane Qian
ety of important, timely issues, including safety risk assessments,
adaptive designs, clinical trial strategies, noninferiority trials, sta-
Sponsored Invited Sessions
tistical challenges/issues in various therapeutic areas and vaccines,
clinical trial simulation and modeling, preclinical statistics, and
New Directions in Safety Planning and Analysis for Clinical
mixed effect modeling.
Development
Based on continued positive feedback from previous attend-
Nested and Crossed Random Effects in Nonlinear Models
ees, luncheon roundtables—with moderated discussion on a vari-
ety of topics—will take place on September 16.
Adaptive Designs: Perspectives from Academia, Industry, and The Marriott Crystal Gateway is a premier meeting site,
Regulatory
located minutes from downtown Washington, DC, and Reagan
National Airport. The hotel offers a full suite of amenities
Imaging Biomarkers in Oncology
and services, including direct access to the Washington Metro
from the lobby. A block of sleeping rooms has been arranged
In addition to the above sessions, the section is cosponsoring for workshop attendees. Visit
www.amstat.org/meetings/
20 other invited sessions. And as is the case every year, the section fdaworkshop for details, including the preliminary program, a
will award the presenters of the 2007 best contributed paper and list of workshop organizers, the registration form, and infor-
2008 best student paper at the Biopharmaceutical Section meeting mation about hotel reservations.
and mixer. Information about section activities will be available at The FDA/Industry Statistics Workshop is a unique forum
the mixer, and members will have a chance to network with others for statisticians to discus topics of mutual interest. The orga-
and give feedback. nizing committee looks forward to seeing you in September.
We look forward to seeing you in Denver this August. n
44 AMSTAT NEWS JULY 2008
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