Panel of ExpertsAn Anchor Plenary Session

02 October 2019

The Panel• Jonathan Andrus M.S., CQA, CCDM

• Chief Business Officer, Clinical Ink

• Lisbeth Bregnhoj MSc Pharmacy, PhD

• Medicines Inspector, GCP and GVP, Danish Health and Medicines Authority

• Jennifer Duff

• Managing Director and Global R&D Operations Lead, Accenture

• Ni Aye Khin, M.D.

• Director of Division of Clinical Compliance Evaluation, OSI, OoC, CDER at FDA

• Patrick Nadolny M.S.

• Associate VP, Clinical Data Management and Programming, Allergan

• Francois Torche, MBA

• CEO, CluePoints

• Joshua Wilson

• Exec. Director, CDS Strategic Technology Advancement Team, Syneos Health

• Demetris N. Zambas

• VP and Global Head of Data Monitoring and Management, Pfizer

https://scdm.org/publications/white-papers/

EVOLUTION OF CDM

4

Discussion Points

• Perspectives on the rising complexities of trial designs and

how they are impacting the discipline – Patrick and Joshua

• Summary on your perspectives on the evolving regulatory

environments and how they are impacting the discipline - Ni

and Lisbeth

• Summary on your perspectives of the technology

environments and how they are impacting the discipline -

Jonathan and Francois

• Summary on our perspectives on the impacts of the above on

the role of a DM - Jennifer and Demetris

Deep Dive with Audience

• What does the audience feel are the most significant threats

from the ecosystem and our weaknesses across the

roles/environment – panel commentary

• What does the audience feel are our most significant

opportunities and greatest strengths to enable us to not only

adopt but drive the evolution – panel commentary