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Virtual Event

May 27, 2020 10:45 AM - May 29, 2020 3:30 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

DIA/FDA Biostatistics Industry and Regulator Forum

Session 8: Senior Leaders Town Hall Session

Session Chair(s)

Mat  Soukup, PhD

Mat Soukup, PhD

Deputy Director, Division of Biometrics VII, OB, OTS CDER

FDA, United States

Karen Lynn Price, PhD

Karen Lynn Price, PhD

Senior Research Fellow, Statistical Innovation Center/Design Hub

Eli Lilly and Company, United States

If hindsight is 20/20, the year 2020 seems an opportune time to reflect on the past decades of clinical research to gain a clearer understanding of where we’ve been, key lessons we have learned, and apply learnings from the past to tackle tomorrow’s challenges. In this session, senior leaders from the biostatistics community will share examples and provide insights from their own personal experiences on topics from the past that were innovative historically but are commonplace today. These leaders will reflect on the lessons learned and keys to the successful adoption of more innovative approaches to address challenges. Alternatively, innovative ideas that failed to progress may be discussed in an effort to learn for the future.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify opportunities for statistical engagement
  • Apply lessons learned from experienced professionals
  • Recognize the importance of statistical thinking in clinical research

Speaker(s)

Sylva Heghinian  Collins, PhD

Speaker

Sylva Heghinian Collins, PhD

FDA, United States

Director, Office of Biostatistics, FDA, CDER

John  Scott, PhD, MA

Speaker

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Ram  Tiwari, PhD, MS

Speaker

Ram Tiwari, PhD, MS

Bristol Myres Squibb , United States

Head of Statistical Methodology

Pandurang M Kulkarni, PhD

Speaker

Pandurang M Kulkarni, PhD

Eli Lilly and Company, United States

Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics

Lisa  Lupinacci, PhD, MS

Speaker

Lisa Lupinacci, PhD, MS

Merck and Co., Inc., United States

Senior Vice President, Biostatistics and Research Decision Sciences

Amy  Xia, PhD

Speaker

Amy Xia, PhD

Amgen Inc., United States

Vice President, Center for Design and Analysis

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