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Sunday, June 20 • 12:00pm - 1:00pm
#539 OD: Optimizing Cell and Gene Therapy Clinical Trial Virtualization and Remote Monitoring in the Time of COVID-19

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Component Type: Session
Level: Intermediate

Using virtual-hybrid and remote solutions, we describe an innovative model for monitoring and executing cell and gene therapy clinical trials during COVID-19. These approaches serve as an instructive path forward for the future of these therapies.

Learning Objectives

Describe evolving strategies with innovative solutions for delivering cell and gene therapy trials during COVID-19; Discuss specific areas of trial risk, patient safety, data quality, and how virtual and remote activities are being successfully deployed; Analyze metrics to date and how these support a paradigm shift in the operation of these trials.


Monica Ravindra Shah, DrMed, FACC


Industry Update
Chris Ashby Learn, PhD, PMP

Industry Update
Erin Finot, MBA, MS

Industry Update
Molly Mjolsness, MBA


Monica Shah

Therapeutic Science and Strategy Unit Vice President and Head, CAGT COE, IQVIA, United States
Dr. Shah is Vice President and Head of the Cell and Gene Therapy Center of Excellence (CAGT COE). In this role, Dr. Shah works collaboratively with sponsors, the scientific community, and other stakeholders to develop and implement innovative, patient-centered, data-driven strategic... Read More →

Erin Finot

Vice President, Immuno-Oncology, IQVIA, United States
Erin Finot, MS MSA, the Vice President of Immuno-Oncology at?IQVIA Biotech, is responsible for leading the team’s strategic direction to help sponsors focused on immuno-oncology trial programs meet their goals with high quality and delivery of our innovative services and solutions... Read More →
avatar for Chris Learn

Chris Learn

Senior Director, Clinical Development, Istari Oncology, United States
Chris is a clinical research professional with 20+ years of trial execution and team management experience. He is enthusiastic and passionate about oncology cell and gene therapy clinical development, and served as a team leader in the registrational development, agency submission... Read More →

Molly Mjolsness

Senior Client Delivery Manager, Be The Match Biotherapies, United States
Molly Mjolsness is the Senior Client Delivery Manager for Be The Match BioTherapies®. In her role, Molly’s focus is on envisioning and building a best-in class client delivery capability that supports cell and gene therapy clients from clinical trial through commercial approval... Read More →

Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session