Biopharmaceutical
Workshop Rallies Statisticians
for 13th Year
tammy massie, FDA, and Carmen mak, schering-Plough
T
he 13th annual FDA/Industry — Data Monitoring Committee, — Bootstrap Methods and
Statistics workshop is scheduled taught by Tom Fleming and Permutation Tests, taught by
for September 23–25 at the Janet Wittes Tim Hesterberg
Capital Hilton in Washington, DC.
More than 600 statisticians from aca-
— Analysis of Longitudinal Data
Three plenary sessions will focus on
demia, industry, and government will
with Missing Data, taught by
regulatory and statistical issues in global
gather for lively talks about topics of
Diane Fairclough
harmonization, as well as future direc-
interest to all. The workshop will feature
— Cox Regression in Practice, taught
tions in safety analysis. Concurrent ses-
a day of short courses followed by two
by Brenda Gillespie
sions will cover timely topics in adaptive
days of plenary and concurrent presen- designs, noninferiority trials, biomark-
tations, as well as luncheon discussions
— Special Topics in Survival Analysis,
ers, quality of clinical programs, designs
on a variety of topics.
taught by Lee-Jen Wei
of integrated safety and efficacy analysis
Back by popular demand, the follow-
— Bayesian Adaptive Methods, taught
plans, CMC issues, food safety, device
ing eight short courses will offer practi-
by Peter F. Thall
trials, vaccine trials, and veterinary trials.
cal solutions to real-life problems: This year, the luncheon discussions
— Benefits: Risk Assessment, taught will take place over two days and in a
— Adaptive Design, taught by Martin by Scott R. Evans number of rooms, organized by topic.
Posch and Sue-Jane Wang Boxed lunches will be served; workshop
participants will be able to pre-select lunch
when they register. This will allow par-
ticipation to be available on a first-come,
first-served basis (no pre-selection or sign-
up necessary). In addition, roundtables
will be smaller—including six to eight
people each—to foster better discussion.
Physical and Engineering Sciences
A block of rooms at the Capital
Hilton has been reserved for workshop
High-Performance Program
attendees. To receive the workshop
rate, attendees must book their reserva-
tions by August 26. Visit www.amstat.
Planned for FTC 2009
org/meetings/fdaworkshop for additional
information and to register. Conference
Cheryl A. Dingus of Battelle, sPes FtC Program Committee Representative
organizers and others interested in up-
to-date information, including the pre-
liminary workshop programs and lun-
T
he ASA’s Section on Physical and Engineering Sciences and Quality and
cheon discussion topics, may visit http://
Productivity (Q&P) Section are excited to co-host, along with the Statistics
fdaindustry09.blogspot.com.
and CPID divisions of the American Society for Quality, the 2009
The FDA/Industry Statistics
Fall Technical Conference in Indianapolis, Indiana, to take place October 8–9,
Workshop—sponsored by the
2009. The theme for the conference is “Quality and Statistics: Accelerating to
Biopharmaceutical Section of the
Higher Performance.”
American Statistical Association, with
The program includes sessions on topics such as visualization, DOE, reliability,
cooperation from the Food and Drug
and univariate and multivariate statistical process control. Several sessions highlight-
Administration Statistical Association—
ing unique case studies also are included in the program, as well as sessions on both
is a unique forum for statisticians to net-
applied and theoretical topics. Material included in the sessions will range across all
work and discuss topics of mutual inter-
levels of experience.
est. The topics are always relevant and
The conference will be held in the heart of downtown, Indianapolis, close to a
the discussions practical. The organizing
variety of attractions. For additional information about FTC 2009 and to register,
committee looks forward to seeing you
visit
www.indyasq.org/stats. We look forward to seeing you in Indianapolis this fall. n
in September. n
50 AmstAt News AUGUST 2009
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