masters program in biostatistics - sites@dukemasters and phd in biostatistics impressive group of...
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WELCOME
from the
Department of Biostatistics and
Bioinformatics (B&B)
Duke University School of Medicine
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Special Thanks to our Sponsors
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THANK-YOU
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Shein Chow Xiaofei Wang
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Executive Board
Responsible for Planning
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• Greg Campbell (FDA/CDRH)
• Stephen George (Duke)
• Kerry L. Lee (Duke)
• Olga Marchenko (Quintiles CSDD)
• Claude Petit (Boehringer-Ingelheim)
• Frank Shen (Abbvie)
• Fred Snikeris (Parexel)
• Terry Weber Sosa (Quintiles Biostatistics)
• Maura Stokes (SAS)
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ORGANIZING COMMITTEE
Responsible for Making it Happen
• Joshua Betcher (Quintiles)
• Cliburn Chan (Duke)
• Debbie Medlin (Duke)
• Angel Walker (Duke)
• Marlina Nasution (Parexel)
• Michael Pencina (Duke)
• Claude Petit (Boehringer-Ingelheim)
• Guochen Song (Quintiles)
• Yi Tsong (FDA/CDER)
• Lanju Zhang (Abbvie)
• Sharon Updike (Duke)
• Changbin Guo (SAS)
• Dongshui Li and Nancy Qi (students)
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Some Context
RTP
Duke U
SOM
B&B
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Research Triangle Park
• One of the most prominent high-tech R&D
centers in the US
• Home to over 190 companies employing
50,000 workers
• Has the second largest IBM installation in
the world
• Also, one of GlaxoSmithKline's largest R&D
centers
• Ideal environment for statistical methods
and applications
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Research Triangle Park
Several universities (Two medical schools):
University of North Carolina (Medical School)
North Carolina Central University
NC State University
Duke University (Medical School)
Locally grown companies/entities
Quintiles
RHO
SAS
FHI 360 (previously Family Health International)
RTI (Research Triangle Institute)
Attractive environment for other large companies
engaged in medical research
Parexel
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Duke University
• Home to TWO Nobel Laureates
– 2015 Chemistry – Paul Modrich
– 2012 Chemistry – Robert Lefkowitz
• Home to five NCAA basketball championships
– Two in the last 5 years
– Of lesser importance, but more widely recognized
• Home to a top 10 Medical School
• Home to Rob Califf – next FDA commissioner
• Home to the gorgeous Duke Gardens
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Duke Gardens
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Duke Gardens
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Durham, North Carolina
• The “place to be,” especially for
the sick and the hungry – Used to be known as the “City of
Medicine”
– Several highly acclaimed restaurants
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Durham Bulls Athletic Park
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• Situated near old converted tobacco warehouses
• Home of minor league baseball team
• Several bars and restaurants in the area
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DPAC Performing Arts Center
• Built in 2008
• Fourth ranked theater in the US
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Home also to
• American Dance Festival
• Full Frame Documentary Film Festival presented in
the historic Carolina Theater
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A Bit about B&B
About 50 faculty members
Three academic divisions:
Statistical and Computational Biology
Biostatistics
Translational Biomedical Informatics
Fluid boundaries
Home to a new Center for Statistical Genetics and
Genomics (StatGen)
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Affiliations and Reach
• Duke Clinical Research Institute
• Duke Cancer Institute
• Duke Molecular Physiology Institute
• Duke Global Health Institute
• Most Clinical Research entities and some
basic science
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Educational Programs
Masters and PhD in Biostatistics
Impressive group of students
First PhDs will be awarded probably 2017
CRTP – Clinical Research Training Program
Most students have MD
Graduates make great clinical investigators
MMCI – Master of Management in Clinical
Informatics Targeted toward upper level health professionals
Combines business strategy with analytic strategy
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B&B involvement with Industry
• Duke Clinical Research Institute
– Several ongoing multi-national trials
– Device registries
– New Center for Predictive Modeling
– New Risk Based Monitoring Center
• Duke Cancer Institute – A number of small cancer clinical trials, including Proof of
Concept
– Other trials managed through the Cooperative Groups
• Several faculty members participate in DSMB activities
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B&B involvement with FDA
• Helped develop equivalence methods used for
approval of generic metered dose inhalers
• Participated in International Workshop focused
on establishing harmonization of approaches to
therapeutic interchangeability
• Contributed to several manuscripts with FDA
colleagues on equivalence and generic drugs
• Served on Oncology Drug Advisory Committee
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B&B involvement with FDA
• FDA General and Plastic Surgery Devices
Panel
• Executive Committee and Data Warehouse
Committee of the Cardiac Safety Research
Consortium (CSRC)
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Today’s Symposium
• Great diversity of participants
– Industry
– Academia
– FDA
• Great diversity of topics – difficult choices
– Bioequivalence and Biosimilars, Bayesian Non-Inferiority
Trials, Data Monitoring Committees,
– Randomized Concentration-Controlled Trials, Subgrouping
Analysis, Biosimilars II,
– Advanced Survival Analysis, Enrichment Design for Clinical
Trials, and Dose Finding and Selection in Clinical Phase.
• Great opportunity to network and learn
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