ISBS Symposium a Success
Opening plenary session keynote speakers (from left): ShaAvhree Buckman (FDA), Hans-Georg Eichler (EMEA), and Shaohong Jin (SFDA)
T
he First International Symposium
on Biopharmaceutical Statistics—
the first symposium of the
International Society for Biopharmaceutical
Statistics (ISBS)—was held in Shanghai,
Statistics
China, from June 30–July 2, 2008. The
ISBS is a nonprofit organization established
The First International Symposium on Biopharmaceutical Statistics
in February 2007 to provide an international
was cosponsored by 11 institutional sponsors, including the American
platform for statisticians worldwide to share
Statistical Association and 18 corporate sponsors. There were 456
information, experiences, research findings,
registered participants from 26 countries or regions representing
and challenges and improve and promote
academia, regulatory agencies, and the biopharmaceutical industry.
global harmonization of statistical practice
in the biopharmaceutical industry.
The symposium included three plenary
sessions, 52 invited parallel sessions, 11 con-
tributed parallel sessions, and one poster ses-
Another highlight was an invited panel in the Globalization of Drug Development:
sion, with a total of 284 presentations cov-
in which eight statistical executives of biop- The Critical Role of Pharmaceutical
ering statistical theory and applications in
harmaceutical companies shared their visions Statistics,”given by Mark Chang, executive
biopharmaceutical discovery, development,
of current states and future directions for sta- director of AMAG Pharmaceuticals.
and regulations. There also were seven pre-
tistics in global biopharmaceutical research In addition to the plenary and paral-
symposium short courses taught by promi-
and development. Specifically, the panelists lel sessions, there were two open-door
nent experts.
discussed technical statistical issues and the parallel panel sessions titled “Global
The symposium opened with welcome
influence of statistics in shaping drug develop- Statistics Operation and Outsourcing” and
remarks by Yonghao Gui, vice president
ment; core competencies and influence skills; “Preparing the Next Generation of Applied
of Fudan University, the symposium’s
statistics in innovation, nontraditional areas Statisticians: A Global Perspective” and one
local host. Three keynote speeches were
and clinical operations; industry-academia- closed-door parallel panel session titled
featured in the opening plenary session:
government collaboration; new business “Statistical Topics Between Chinese KOLs
ShaAvhree Buckman of the U.S. Food and
models and approaches; and transparency, and Statisticians of Industry/FDA/CROs.”
Drug Administration presented “FDA
public trust, and benefit/risk. The ISBS plans to rotate its annual
Critical Path Initiatives: 2008 Updates”;
At the closing plenary session, Merck symposia among continents. The 2009
Hans-Georg Eichler of the European
Vice President Joseph Heyse presented “The symposium is scheduled to take place in
Medicines Agency presented “Medical
Role of Statistics in the Early Development the United States (see www.isbiostat.org).
Science, Regulation, and Statistics”;
of Biopharmaceutical Products” and ASA As an international organization, the ISBS
and Shaohong Jin of the State Food and
President Peter A. Lachenbruch presented appreciates all sponsorships and welcomes
Drug Administration of China presented
“The JAMA Policy on Statistical Analysis.” statisticians worldwide to join its effort. If
“Current Status of Drug Safety Evaluation
The symposium was wrapped up by a presen- you are interested in being involved, email
in China.”
tation titled “Opportunities and Challenges Info@IsBioStat.org. n
10 AMSTAT NEWS OCTOBER 2008
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