WELCOME

from the

Department of Biostatistics and

Bioinformatics (B&B)

Duke University School of Medicine

Special Thanks to our Sponsors

2

THANK-YOU

3

Shein Chow Xiaofei Wang

Executive Board

Responsible for Planning

4

• 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)

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)

5

6

Some Context

RTP

Duke U

SOM

B&B

7

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

8

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

9

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

10

Duke Gardens

11

Duke Gardens

12

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

13

Durham Bulls Athletic Park

14

• Situated near old converted tobacco warehouses

• Home of minor league baseball team

• Several bars and restaurants in the area

DPAC Performing Arts Center

• Built in 2008

• Fourth ranked theater in the US

15

Home also to

• American Dance Festival

• Full Frame Documentary Film Festival presented in

the historic Carolina Theater

16

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)

17

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

18

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

19

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

20

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

21

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)

22

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

23