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Tuesday, June 29 • 10:00am - 11:00am
#216 SL: Brave New World: Early Clinical Trials in a Pandemic

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-565-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the impact on early clinical research and development under COVID-19 and measures that were put in place to protect healthy volunteers and staff.

Learning Objectives

Discuss early clinical research and development under COVID-19 pandemic conditions; Identify safety measures and operational set-up for volunteers and staff, consider how next-generation early trials may operate as a result of changes introduced through this disruption.


Anita Nelsen


SARS-CoV-2 Testing, Operational Challenges, and Subject Safety Considerations Under COVID-19 Pandemic Conditions: A New Era
Sandra Stark, PhD, MSc

Early Clinical Trials in a Pandemic: A Big Pharma Story
Jessie Gu, PhD

avatar for Anita Nelsen

Anita Nelsen

Executive Vice President, Translational Medicine, Parexel, United States
Anita is a pharmaceutical industry leader who has applied pharmacogenetic, human and molecular genetics research in drug discovery and development. As Head of Translational Medicine, Anita leads a global team of scientists who are recognized thought leaders and influencers in early... Read More →
avatar for Sandra Stark

Sandra Stark

Head Early Phase Clinical Unit Berlin, Parexel International, Germany
Dr. Stark has worked in Clinical Pharmacology since 2000 and Early Drug Development since 2010 both in industry and Clinical Research Organization. She is a trained Biologist with a Diploma in Germany specializing in Physiology and received a PhD in Immunology from Goettingen University... Read More →

Jessie Gu

Executive Director, Global Head, Ph1 Clinical Pharmacology, Novartis Institutes for BioMedical Research (NIBR), United States
I head up a department to develop and deliver the clinical pharmacology portfolio across all therapeutic areas centrally for Novartis novel therapeutics. Our portfolio responsibility includes First-in-Human (FIH) as well as all the clinical pharmacology profiling and registration... Read More →

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session