Agenda – 2017 DMC Optimization Summit

  • Day One
  • Day Two

Day One

 Thursday, October 19, 2017

9:15AM – 10:00AM

MANAGE THE OPERATION AND FORMATION OF YOUR DATA MONITORING COMMITTEE
Joe Massaro, Professor, Biostatistics, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH

10:00AM – 10:45AM

UPDATE ON CURRENT REGULATORY THINKING AROUND DATA MONITORING COMMITTEES
Jonathan Seltzer, M.D., MBA, M.A., FACC, President, ACI CLINICAL / CTTI DMC WORKING GROUP MEMBER

10:45AM – 11:15AM

Networking Break

11:15AM – 12:15PM

PANEL SESSION: ESTABLISH A SUCCESSFUL RELATIONSHIP WITH PERSPECTIVES FROM DMC MEMBERS
Pranab Mitra, Associate Principal Scientist (Biostatistician), MERCK
Joe Massaro, Professor, Biostatistics, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH
Dr. Raj Deo, Cardiologist with Cardiac Electrophysiology Specialty, UNIVERSITY OF PENNSYLVANIA

12:15PM – 1:15PM

Luncheon

 PROVIDING THE RIGHT DATA TO ANSWER THE RIGHT QUESTIONS AT THE RIGHT TIME

1:15PM – 2:00PM

CREATE AN EFFECTIVE DMC CHARTER FOR BETTER OUTCOMES
Frank Rockhold, Professor of Biostatistics, DUKE UNIVERSITY

2:00PM – 2:45PM

STATISTICAL DATA ANALYSIS CENTER AND THE ROLE OF INDEPENDENT STATISTICIAN
Michael Pencina, Director, Biostatistics, DUKE CLINICAL RESEARCH INSTITUTE

2:45PM – 3:15PM

Networking Break

3:15PM – 4:00PM

RISK-BENEFIT CONSIDERATIONS IN DMC FUNCTIONS
Robert Bigelow, Associate Director, DUKE CLINICAL RESEARCH INSTITUTE

 

4:00PM – 4:45PM

ENHANCE DMC INTERACTION AND INTERFACE WITH THE SPONSOR
Keith Usiskin, Executive Director, CELGENE


Day Two

 Friday, October 20, 2017

8:00AM – 9:00AM

Continental Breakfast

9:15AM – 10:00AM

MANAGE THE EVOLVING ROLE OF THE INDEPENDENT DATA MONITORING COMMITTEE IN THE ERA OF ADAPTIVE TRIAL DESIGNS
Marc Buyse, Sc.D., Founder and Chief Scientific Officer, IDDI

10:00AM – 10:45AM

SPONSOR INTERACTIONS WITH STATISTICAL DATA ANALYSIS CENTERS (SDACS)
Joseph Scherer, Sr. Associate Director Biostatistics, BOEHRINGER INGELHEIM PHARMACEUTICALS

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

SPONSOR EXPOSURE TO INTERIM COMPARATIVE DATA AND THE POTENTIAL RISKS
Peter Zhang, Ph.D., Head of Biostatistics Department, OTSUKA

12:00PM – 1:00PM

Luncheon

1:00PM – 1:45PM

DMCS OUTSOURCING OR IN-SOURCE: USE IN EARLY FEASIBILITY STUDIES, TIME FOR A PARADIGM CHANGE?
Murali Reddi, M.D., Manager, Global Safety, Edwards Life Sciences

1:45PM – 2:30PM

THE FUTURE OF DMC AND OVERVIEW OF THE PARADIGM CHANGE
Amit Bhattacharyya, Ph.D., Vice President, Biometrics, ACI CLINICAL