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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.

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

  • 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


Sylva  Collins, PhD


Sylva Collins, PhD

  • Director, Office of Biostatistics, OTS, CDER
  • FDA, United States
John  Scott, PhD, MA


John Scott, PhD, MA

  • Director, Division of Biostatistics, OBE, CBER
  • FDA, United States
Ram  Tiwari, PhD


Ram Tiwari, PhD

  • Director, Division of Clinical Evidence and Analyses 2, Biostatistics, CDRH
  • FDA, United States
Pandurang M Kulkarni, PhD


Pandurang M Kulkarni, PhD

  • Chief Analytics Officer-R&D / Vice President-Biometrics
  • Eli Lilly and Company, United States
Lisa  Lupinacci, PhD, MS


Lisa Lupinacci, PhD, MS

  • Vice President, Late Development Statistics
  • Merck and Co., Inc., United States
Amy  Xia, PhD


Amy Xia, PhD

  • Vice President, Biostatistics, Design & Innovation
  • Amgen Inc., United States

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Additional Information

Biostatistics Industry Resource Kit